Friday, October 21, 2016

Anaplex DMX Suspension


Generic Name: Brompheniramine/Dextromethorphan/Pseudoephedrine (BROME-fen-IR-a-meen/DEX-troe-meth-OR-fan/SOO-do-e-FED-rin)
Brand Name: Examples include Anaplex DMX and BromTann/DM Tann/PSE Tann


Anaplex DMX Suspension is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.


Anaplex DMX Suspension is a decongestant, antihistamine, and cough suppressant combination. It works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.


Do NOT use Anaplex DMX Suspension if:


  • you are allergic to any ingredient in Anaplex DMX Suspension

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you are unable to urinate or are having an asthma attack

  • you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Anaplex DMX Suspension:


Some medical conditions may interact with Anaplex DMX Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a fast, slow, or irregular heartbeat

  • if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; heart blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; or an overactive thyroid

  • if you have a history of asthma, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

Some MEDICINES MAY INTERACT with Anaplex DMX Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Anaplex DMX Suspension's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Anaplex DMX Suspension

  • Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Anaplex DMX Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Anaplex DMX Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Anaplex DMX Suspension:


Use Anaplex DMX Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Anaplex DMX Suspension by mouth with or without food.

  • Shake well before each use.

  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

  • If you miss a dose of Anaplex DMX Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Anaplex DMX Suspension.



Important safety information:


  • Anaplex DMX Suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Anaplex DMX Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not take diet or appetite control medicines while you take Anaplex DMX Suspension without checking with your doctor.

  • Anaplex DMX Suspension has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do not use Anaplex DMX Suspension for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

  • Anaplex DMX Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Anaplex DMX Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Anaplex DMX Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Anaplex DMX Suspension for a few days before the tests.

  • Tell your doctor or dentist that you take Anaplex DMX Suspension before you receive any medical or dental care, emergency care, or surgery.

  • Use Anaplex DMX Suspension with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Anaplex DMX Suspension in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Anaplex DMX Suspension while you are pregnant. It is not known if Anaplex DMX Suspension is found in breast milk. Do not breast-feed while taking Anaplex DMX Suspension.


Possible side effects of Anaplex DMX Suspension:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Anaplex DMX side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Anaplex DMX Suspension:

Store Anaplex DMX Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Anaplex DMX Suspension out of the reach of children and away from pets.


General information:


  • If you have any questions about Anaplex DMX Suspension, please talk with your doctor, pharmacist, or other health care provider.

  • Anaplex DMX Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Anaplex DMX Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Anaplex DMX resources


  • Anaplex DMX Side Effects (in more detail)
  • Anaplex DMX Use in Pregnancy & Breastfeeding
  • Anaplex DMX Drug Interactions
  • Anaplex DMX Support Group
  • 0 Reviews for Anaplex DMX - Add your own review/rating


Compare Anaplex DMX with other medications


  • Cough and Nasal Congestion

anastrozole



an-AS-troe-zole


Commonly used brand name(s)

In the U.S.


  • Arimidex

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antineoplastic Agent


Pharmacologic Class: Aromatase Inhibitor


Uses For anastrozole


Anastrozole is used to treat certain types of breast cancer in women who have already stopped menstruating (postmenopausal). It is also used for women who have already had other cancer treatments (e.g., tamoxifen).


Many breast cancer tumors grow in response to estrogen. anastrozole interferes with the production of estrogen in the body. As a result, the amount of estrogen that the tumor is exposed to is reduced, limiting the growth of the tumor.


anastrozole is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, anastrozole is used in certain patients with the following medical conditions:


  • Breast cancer, neoadjuvant treatment for hormone receptor-positive, operable or potentially operable, locally advanced disease in postmenopausal women (treatment for advanced breast cancer that may respond to surgery in women who have already stopped menstruating).

Before Using anastrozole


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For anastrozole, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to anastrozole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of anastrozole in children.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of anastrozole in the elderly.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking anastrozole, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using anastrozole with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Tamoxifen

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of anastrozole. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bone problems (osteoporosis) or

  • Hypercholesterolemia (high cholesterol or fat in the blood) or

  • Ischemic heart disease (heart attack, angina), history of, or

  • Liver disease—Use with caution. May make these conditions worse.

  • Premenopausal women (have menstrual cycles)—Should not be used in these patients.

Proper Use of anastrozole


Take anastrozole only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for side effects.


You may take anastrozole with or without food.


Anastrozole sometimes causes nausea, vomiting, or diarrhea. However, it is very important that you continue to use the medicine, even if you begin to feel ill. Ask your doctor for ways to prevent these effects or make them less severe.


anastrozole comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.


Dosing


The dose of anastrozole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of anastrozole. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For breast cancer:
      • Adults—1 milligram (mg) once a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of anastrozole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using anastrozole


It is important that your doctor check your progress at regular visits to make sure that anastrozole is working properly. Blood tests may be needed to check for unwanted effects.


It is unlikely that a postmenopausal woman may become pregnant. But, you should know that using anastrozole while you are pregnant could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


anastrozole may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using anastrozole.


anastrozole may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, talk to your doctor.


anastrozole may increase your cholesterol or fat in the blood. If this happens, your doctor may give you medicine to lower the cholesterol and fat.


Stop taking anastrozole and check with your doctor right away if you start having chest pains or shortness of breath. anastrozole may increase the chance of heart attack or stroke in women who have a history of ischemic heart disease.


anastrozole Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Blurred vision

  • chest pain or discomfort

  • dizziness

  • headache

  • nervousness

  • pounding in the ears

  • shortness of breath

  • slow or fast heartbeat

  • swelling of the feet or lower legs

Less common
  • Arm, back, or jaw pain

  • chest tightness or heaviness

  • cough or hoarseness

  • difficult or painful urination

  • dizziness, severe

  • fever or chills

  • headache, continuing

  • increased blood pressure

  • lower back or side pain

  • nausea

  • pain, tenderness, bluish color, or swelling of the foot or leg

  • sore throat

  • sudden shortness of breath

  • sweating

  • unusual tiredness or weakness

  • vaginal bleeding (unexpected and heavy)

Incidence not known
  • Blistering, peeling, or loosening of the skin

  • hives

  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue

  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

  • red skin lesions, often with a purple center

  • sores, ulcers, or white spots in the mouth or on the lips

  • welts

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Acid or sour stomach

  • back pain

  • belching

  • body aches or pain

  • bone pain

  • congestion

  • constipation

  • decrease in height

  • diarrhea

  • dry mouth

  • dryness or soreness of the throat

  • feeling of warmth

  • fever

  • flushing or redness of the skin, especially on the face and neck

  • heartburn

  • hot flashes

  • increased appetite

  • indigestion

  • lack or loss of strength

  • loss of appetite

  • mood or mental changes

  • pain in the back, ribs, arms, or legs

  • pain, general

  • pelvic pain

  • runny nose

  • skin rash

  • stomach discomfort, upset, or pain

  • tender, swollen glands in the neck

  • trouble in swallowing

  • voice changes

  • vomiting

  • weakness

  • weight loss

Less common
  • Anxiety and confusion

  • breast pain

  • chills

  • cough producing mucus

  • difficulty breathing

  • dryness of the vagina

  • general feeling of discomfort or illness

  • itching of the skin

  • joint pain and stiffness

  • loss of hair

  • muscle pain

  • numbness or tingling of the hands or feet

  • shivering

  • sleepiness or unusual drowsiness

  • trouble sleeping or sleeplessness

  • weight gain

  • wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: anastrozole side effects (in more detail)



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More anastrozole resources


  • Anastrozole Side Effects (in more detail)
  • Anastrozole Dosage
  • Anastrozole Use in Pregnancy & Breastfeeding
  • Drug Images
  • Anastrozole Drug Interactions
  • Anastrozole Support Group
  • 17 Reviews for Anastrozole - Add your own review/rating


  • Anastrozole Prescribing Information (FDA)

  • Anastrozole Professional Patient Advice (Wolters Kluwer)

  • Anastrozole Monograph (AHFS DI)

  • Anastrozole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Arimidex Prescribing Information (FDA)

  • Arimidex Consumer Overview



Compare anastrozole with other medications


  • Breast Cancer
  • Breast Cancer, Metastatic
  • McCune-Albright Syndrome
  • Pubertal Gynecomastia

anastrozole



Generic Name: anastrozole (an AS troe zole)

Brand Names: Arimidex


What is anastrozole?

Anastrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.


Anastrozole is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox).


Anastrozole may also be used for purposes not listed in this medication guide.


What is the most important information I should know about anastrozole?


Do not use anastrozole if you are pregnant. It could harm the unborn baby.

You may need to take a pregnancy test before using anastrozole, to make sure you are not pregnant.


You should not use this medication if you are allergic to anastrozole, if you are breast-feeding a baby, or if you have not yet completed menopause. Anastrozole is not for use in men or children.

Before using anastrozole, tell your doctor if you have heart disease, circulation problems, a history of stroke or blood clot, severe liver disease, high cholesterol, osteoporosis, or low bone mineral density.


Anastrozole may not work as well if you take it together with tamoxifen or an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings). Before you start taking anastrozole, tell your doctor if you also take tamoxifen or estrogen.

You may need to keep taking anastrozole for up to 5 years. Follow your doctor's instructions.


What should I discuss with my healthcare provider before taking anastrozole?


You should not use this medication if you are allergic to anastrozole, if you are breast-feeding a baby, or if you have not yet completed menopause. Anastrozole is not for use in men or children.

To make sure you can safely take anastrozole, tell your doctor if you have any of these other conditions:



  • heart disease;




  • circulation problems;




  • a history of stroke or blood clot;




  • severe liver disease;




  • high cholesterol; or




  • osteoporosis or low bone mineral density.




Anastrozole can decrease bone mineral density, which may increase your risk of developing osteoporosis. Your bone mineral density may need to be tested before and during treatment with anastrozole. FDA pregnancy category D. Do not use anastrozole if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether anastrozole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using anastrozole.

You may need to take a pregnancy test before using anastrozole, to make sure you are not pregnant.


How should I take anastrozole?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.


Anastrozole is usually taken once per day. You may need to keep taking this medication for up to 5 years. Follow your doctor's instructions.


You may take anastrozole with or without food.


Store at room temperature away from moisture and heat.

See also: Anastrozole dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking anastrozole?


This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Anastrozole side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • a bone fracture;




  • swollen glands;




  • feeling short of breath;




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);




  • swelling in your hands or feet; or




  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.



Less serious side effects may include:



  • numbness, tingling, cold feeling, or weakness in your hand or wrist;




  • problems with your fingers while gripping;




  • hot flashes;




  • joint pain or stiffness;




  • depression, mood changes, sleep problems (insomnia);




  • cough, sore throat;




  • thinning hair;




  • mild nausea, vomiting; or




  • back pain, bone pain.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Anastrozole Dosing Information


Usual Adult Dose for Breast Cancer:

For the first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer: 1 mg tablet once a day.

Treatment should continue until tumor progression is evident.


What other drugs will affect anastrozole?


Anastrozole may not work as well if you take it together with tamoxifen or an estrogen medication (such as hormone replacement therapy, estrogen creams, or birth control pills, injections, implants, skin patches, and vaginal rings). Before you start taking anastrozole, tell your doctor if you also take tamoxifen or estrogen.

There may be other drugs that can interact with anastrozole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More anastrozole resources


  • Anastrozole Side Effects (in more detail)
  • Anastrozole Dosage
  • Anastrozole Use in Pregnancy & Breastfeeding
  • Drug Images
  • Anastrozole Drug Interactions
  • Anastrozole Support Group
  • 17 Reviews for Anastrozole - Add your own review/rating


  • anastrozole Advanced Consumer (Micromedex) - Includes Dosage Information

  • Anastrozole Prescribing Information (FDA)

  • Anastrozole Professional Patient Advice (Wolters Kluwer)

  • Anastrozole Monograph (AHFS DI)

  • Anastrozole MedFacts Consumer Leaflet (Wolters Kluwer)

  • Arimidex Prescribing Information (FDA)

  • Arimidex Consumer Overview



Compare anastrozole with other medications


  • Breast Cancer
  • Breast Cancer, Metastatic
  • McCune-Albright Syndrome
  • Pubertal Gynecomastia


Where can I get more information?


  • Your pharmacist can provide more information about anastrozole.

See also: anastrozole side effects (in more detail)


analgesic combination, acetaminophen/salicylate


Class Name: analgesic combination, acetaminophen/salicylate (Oral route)


Commonly used brand name(s)

In the U.S.


  • Backprin

  • Be-Flex Plus

  • By-Ache

  • Cafgesic Forte

  • Combiflex

  • Combiflex ES

  • Durabac

  • Durabac Forte

  • Genaced

  • Goody's Fast Pain Relief

  • Levacet

  • Pain-Off

Available Dosage Forms:


  • Tablet

  • Capsule, Liquid Filled

  • Packet

  • Capsule

Uses For This Medicine


Acetaminophen and salicylate combination medicines relieve pain and reduce fever. They may be used to relieve occasional pain caused by mild inflammation or arthritis (rheumatism). The acetaminophen, aspirin, and caffeine combination also may be used to relieve pain associated with migraine headaches.


Neither acetaminophen nor salicylamide is as effective as aspirin for treating chronic or severe pain, or other symptoms, caused by inflammation or arthritis. Some of these combination medicines do not contain any aspirin. Even those that do contain aspirin may not contain enough to be effective in treating these conditions.


A few reports have suggested that acetaminophen and salicylates used together may cause kidney damage or cancer of the kidney or urinary bladder. This may occur if large amounts of both medicines are taken together for a very long time. However, taking usual amounts of these combination medicines for a short time has not been shown to cause these unwanted effects. Also, these effects are not likely to occur with either acetaminophen or a salicylate used alone, even if large amounts have been taken for a long time. Therefore, for long-term use, it may be best to use either acetaminophen or a salicylate, but not both, unless you are under a doctor's care.


Before giving any of these combination medicines to a child, check the package label very carefully. Some of these medicines are too strong for use in children. If you are not certain whether a specific product can be given to a child, or if you have any questions about the amount to give, check with your health care professional.


These medicines are available without a prescription. However, your doctor may have special instructions on the proper dose of these medicines for your medical condition.


Before Using This Medicine


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


  • For acetaminophen: Acetaminophen has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

  • For aspirin and for salicylamide: Do not give a medicine containing aspirin or salicylamide to a child with symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

  • For caffeine: There is no specific information comparing use of caffeine in children younger than 12 years of age with use in other age groups. However, caffeine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric


Elderly people may be more likely than younger adults to develop serious kidney problems if they take large amounts of these combination medicines for a long time. Therefore, it is best that elderly people not take this medicine for more than 5 days in a row unless they are under a doctor's care.


  • For acetaminophen: Acetaminophen has been tested and, in effective doses, has not been shown to cause different side effects or problems in older people than it does in younger adults.

  • For aspirin: People 60 years of age and older are especially sensitive to the effects of aspirin. This may increase the chance of side effects during treatment.

  • For caffeine: Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Pregnancy


  • For acetaminophen: Studies on birth defects have not been done in humans. However, acetaminophen has not been reported to cause birth defects or other problems.

  • For aspirin: Studies in humans have not shown that aspirin causes birth defects. However, aspirin has been shown to cause birth defects in animals. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor. Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn infant. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these unwanted effects. However, there is a chance that regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or newborn infant. Use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery, or in the newborn infant. Also, too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery.

  • For salicylamide: Studies on birth defects have not been done in humans.

  • For caffeine: Studies in humans have not shown that caffeine causes birth defects. However, use of large amounts of caffeine by the mother during pregnancy may cause problems with the heart rhythm of the fetus and may affect the growth of the fetus. Studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to the amount of caffeine in 12 to 24 cups of coffee a day).

Breast Feeding


  • For acetaminophen and for aspirin: Acetaminophen and aspirin pass into breast milk; however, they have not been reported to cause problems in nursing babies.

  • For caffeine: Caffeine (contained in some of these combination medicines) passes into breast milk in small amounts. Taking caffeine in the amounts present in these medicines has not been reported to cause problems in nursing babies. However, studies have shown that babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages. Therefore, breast-feeding mothers who use these medicines probably should limit the amount of caffeine they take in from other medicines or from beverages

Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Influenza Virus Vaccine, Live

  • Ketorolac

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abciximab

  • Acenocoumarol

  • Alteplase, Recombinant

  • Anisindione

  • Argatroban

  • Beta Glucan

  • Bivalirudin

  • Cilostazol

  • Citalopram

  • Clovoxamine

  • Dabigatran Etexilate

  • Desirudin

  • Desvenlafaxine

  • Dicumarol

  • Dipyridamole

  • Duloxetine

  • Eptifibatide

  • Escitalopram

  • Femoxetine

  • Flesinoxan

  • Fluoxetine

  • Fluvoxamine

  • Fondaparinux

  • Ginkgo

  • Heparin

  • Ketoprofen

  • Lepirudin

  • Methotrexate

  • Milnacipran

  • Mycophenolate Mofetil

  • Mycophenolic Acid

  • Naproxen

  • Nefazodone

  • Paroxetine

  • Phenindione

  • Phenprocoumon

  • Protein C

  • Quinine

  • Reteplase, Recombinant

  • Rilpivirine

  • Rivaroxaban

  • Sertraline

  • Sibutramine

  • Ticlopidine

  • Tirofiban

  • Varicella Virus Vaccine

  • Venlafaxine

  • Vilazodone

  • Warfarin

  • Zimeldine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Alcohol abuse or

  • Asthma, allergies, and nasal polyps (history of) or

  • Hepatitis or other liver disease or

  • Kidney disease—The chance of serious side effects may be increased.

  • Anemia or

  • Stomach ulcer or other stomach problems—Aspirin (present in some of these combination medicines) may make these conditions worse.

  • Gout—Aspirin (present in some of these combination medicines) can make this condition worse and can also lessen the effects of some medicines used to treat gout.

  • Heart disease—Caffeine (present in some of these combination medicines) can make your condition worse.

  • Hemophilia or other bleeding problems—Aspirin (present in some of these combination medicines) increases the chance of serious bleeding.

Proper Use of This Medicine


Take this medicine with food or a full glass (8 ounces) of water to lessen the chance of stomach upset.


Unless otherwise directed by your doctor:


  • Do not take more of this medicine than directed on the package label. Taking too much acetaminophen may cause liver damage or lead to other medical problems because of an overdose. Also, taking too much aspirin can cause stomach problems or lead to other medical problems because of an overdose.

  • Children up to 12 years of age should not take this medicine more often than five times a day

  • Check with your doctor before taking one of these combination medicines to treat severe or chronic inflammation or arthritis (rheumatism). These combination medicines may not relieve the severe pain, redness, swelling, or stiffness caused by these conditions unless very large amounts are taken for a long time. It is best not to take acetaminophen and salicylate combination medicines in large amounts for a long time unless you are under a doctor's care.

  • If a combination medicine containing aspirin has a strong vinegar-like odor, do not use it. This odor means the medicine is breaking down. If you have any questions about this, check with your pharmacist.

Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral (capsules or tablets [including caplets]) dosage forms:
    • For pain, fever, or mild arthritis symptoms:
      • Adults and teenagers—The usual dose is 1 or 2 capsules or tablets every three, four, or six hours, depending on the strength of the product. Do not take any of these combination medicines for more than ten days, unless otherwise directed by your doctor

      • Children—Use and dose must be determined by your doctor.


    • For migraine headaches:
      • Adults and teenagers—The usual dose is 2 tablets (250 mg acetaminophen, and 250 mg of aspirin, and 65 mg of caffeine in combination) every six hours as necessary for relief from migraine headaches. Do not take for relief of migraine headache for more than two days, unless otherwise directed by your doctor

      • Children—Use and dose must be determined by your doctor.



  • For oral (powder) dosage form:
    • For pain, fever, or mild arthritis symptom:
      • Adults and teenagers—This medicine is very strong. Each packet of powder contains 260 mg of acetaminophen and 520 mg of aspirin (a total of 780 mg of both medicines). The usual dose is one packet of powder every four to six hours. Do not take this medicine for more than ten days, unless otherwise directed by your doctor.

      • Children—The oral powder dosage form is too strong to use in children 12 years of age or younger.



Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using This Medicine


If you will be taking this medicine for a long time, or in high doses, your doctor should check your progress at regular visits. This is especially important for elderly people, who may be more likely than younger adults to develop serious kidney problems if they take large amounts of this medicine for a long time.


Check with your doctor:


  • If you are taking this medicine to relieve pain and the pain lasts for more than 10 days (5 days for children), if the pain gets worse, if new symptoms occur, or if the painful area is red or swollen. These could be signs of a serious condition that needs treatment.

  • If you are taking this medicine to bring down a fever, and the fever lasts for more than 3 days or returns, if your fever gets worse, if new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition that needs treatment.

  • If you are taking this medicine for a sore throat, and the sore throat is very painful, lasts for more than 2 days, or occurs together with or is followed by fever, headache, skin rash, nausea, or vomiting.

Do not take any of the combination medicines containing aspirin for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems.


Check the label of all over-the-counter (OTC), nonprescription, and prescription medicines you now take. If any of them contain acetaminophen, aspirin, other salicylates such as bismuth subsalicylate (e.g., Pepto Bismol) or magnesium salicylate (e.g., Nuprin Backache Caplets), or salicylic acid (present in some shampoos and skin products), check with your health care professional. Using any of them together with this medicine may cause an overdose.


Stomach problems may be more likely to occur if you drink three or more alcoholic beverages while you are taking aspirin. Also, liver damage may be more likely to occur if you drink three or more alcoholic beverages while you are taking acetaminophen.


Taking certain other medicines together with acetaminophen and salicylates may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your medical doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take any of the following medicines together with any of these combination medicines for more than a few days unless your doctor has directed you to do so and is following your progress:


  • Diclofenac (e.g., Voltaren)

  • Diflunisal (e.g., Dolobid)

  • Etodolac (e.g., Lodine)

  • Fenoprofen (e.g., Nalfon)

  • Floctafenine (e.g., Idarac)

  • Flurbiprofen, oral (e.g., Ansaid)

  • Ibuprofen (e.g., Motrin)

  • Indomethacin (e.g., Indocin)

  • Ketoprofen (e.g., Orudis)

  • Ketorolac (e.g., Toradol)

  • Meclofenamate (e.g., Meclomen)

  • Mefenamic acid (e.g., Ponstel)

  • Nabumetone (e.g., Relafen)

  • Naproxen (e.g., Naprosyn)

  • Oxaprozin (e.g., Daypro)

  • Phenylbutazone (e.g., Butazolidin)

  • Piroxicam (e.g., Feldene)

  • Sulindac (e.g., Clinoril)

  • Tenoxicam (e.g., Mobiflex)

  • Tiaprofenic acid (e.g., Surgam)

  • Tolmetin (e.g., Tolectin)

The antacid present in buffered forms of these combination medicines can keep other medicines from working properly. If you need to take a buffered form of this medicine, and you are also taking one of the following medicines, be sure to take the buffered acetaminophen and salicylate combination medicine:


  • At least 6 hours before or 2 hours after taking ciprofloxacin (e.g., Cipro) or lomefloxacin (e.g., Maxaquin).

  • At least 8 hours before or 2 hours after taking enoxacin (e.g., Penetrex).

  • At least 2 hours after taking itraconazole (e.g., Sporanox).

  • At least 3 hours before or after taking ketoconazole (e.g., Nizoral).

  • At least 2 hours before or after taking norfloxacin (e.g., Noroxin) or ofloxacin (e.g., Floxin).

  • At least 3 or 4 hours before or after taking a tetracycline antibiotic by mouth.

  • At least 1 or 2 hours before or after taking any other medicine by mouth.

If you are taking a laxative containing cellulose, do not take it within 2 hours of taking this medicine. Taking the laxative and this medicine close together may make this medicine less effective by preventing the salicylate in it from being absorbed by your body.


Acetaminophen and salicylate combinations may interfere with the results of some medical tests. Before you have any medical tests, tell the person in charge if you have taken any of these combination medicines within the past 3 or 4 days. If possible, it is best to call the laboratory where the test will be done about 4 days ahead of time to find out whether the medicine may be taken during the 3 or 4 days before the test.


For patients with diabetes:


  • Acetaminophen and salicylate combinations may cause false results with some blood and urine glucose (sugar) tests. If you notice any change in your test results, or if you have any questions about this possible problem, check with your health care professional. This is especially important if your diabetes is not well-controlled.

For patients taking one of the products that contain caffeine:


  • Caffeine may interfere with the results of a test that uses adenosine (e.g., Adenocard) or dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. Therefore, you should not have any caffeine for 8 to 12 hours before the test.

If you think that you or anyone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of a salicylate may cause unconsciousness or death. The first symptom of an aspirin overdose may be ringing or buzzing in the ears. Other signs include convulsions (seizures), hearing loss, confusion, severe drowsiness or tiredness, severe excitement or nervousness, and unusually fast or deep breathing. Signs of severe acetaminophen overdose may not appear until 2 to 4 days after the overdose is taken, but treatment to prevent liver damage or death must be started within 24 hours or less after the overdose is taken.


Side Effects of This Medicine


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common or rare
  • Coughing

  • difficulty in swallowing

  • dizziness, lightheadedness, or feeling faint (severe)

  • flushing, redness, or other change in skin color

  • shortness of breath, troubled breathing, tightness in chest, or wheezing

  • sudden decrease in amount of urine

  • swelling of eyelids, face, or lips

Get emergency help immediately if any of the following symptoms of overdose occur:


Signs and symptoms of overdose
  • Agitation, anxiety, excitement, irritability, nervousness, or restlessness

  • any loss of hearing

  • bloody urine

  • confusion or delirium

  • convulsions (seizures)

  • diarrhea (severe or continuing)

  • dizziness or lightheadedness

  • drowsiness (severe)

  • fast or deep breathing

  • fast or irregular heartbeat (for medicines containing caffeine

  • frequent urination (for medicines containing caffeine)

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increased sensitivity to touch or pain (for medicines containing caffeine)

  • increased sweating

  • loss of appetite

  • muscle trembling or twitching (for medicines containing caffeine)

  • nausea or vomiting (continuing, sometimes with blood)

  • ringing or buzzing in ears (continuing)

  • seeing flashes of lights (for medicines containing caffeine)

  • stomach cramps or pain (severe or continuing)

  • swelling, pain, or tenderness in the upper abdomen or stomach area

  • trouble in sleeping (for medicines containing caffeine)

  • uncontrollable flapping movements of the hands, especially in elderly patients

  • unexplained fever

  • unexplained fever

Signs of overdose in children
  • Changes in behavior

  • drowsiness or tiredness

  • fast or deep breathing

Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Bloody or black, tarry stools

  • bloody or cloudy urine

  • fever with or without chills (not present before treatment and not caused by the condition being treated)

  • pain in lower back and/or side (severe and/or sharp)

  • pinpoint red spots on skin

  • skin rash, hives, or itching

  • sores, ulcers, or white spots on lips or in mouth

  • sore throat (not present before treatment and not caused by the condition being treated)

  • stuffy nose

  • swelling of face, fingers, feet, or lower legs

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting of blood or material that looks like coffee grounds

  • weight gain

  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Heartburn or indigestion (for medicines containing aspirin)

  • nausea, vomiting, or stomach pain (for medicines containing aspirin)

Less common
  • Drowsiness (for medicines containing salicylamide)

  • trouble in sleeping, nervousness, or jitters (for medicines containing caffeine)

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:


Rare
  • Bloody or cloudy urine

  • decreased urination

  • swelling of face, fingers, feet, or lower legs

  • weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

Anbesol Maximum Strength


Generic Name: benzocaine topical (BENZ oh kane TOP ik al)

Brand Names: Americaine, Americaine Hemorrhoidal, Anacaine, Anbesol Gel, Anbesol Liquid, Babee Teething Lotion, Benzo-O-Stetic, Boil Ease Pain Relieving, Cepacol Extra Strength, Cepacol Fizzlers, Dent-O-Kain, Dermoplast, Detane, Hurricaine, Lanacane, Maintain, Medicone Maximum Strength, Num-Zit, Numzident, Orabase, Orabase Gel-B, Orajel, Orajel Denture, Oral Pain Relief, OraMagic Plus, Outgro Pain Relief, Retre-Gel, Rid-A-Pain, Skeeter Stik, Solarcaine Aerosol, Sting-Kill, Topex, Trocaine, Vagisil Feminine Cream, zilactin-B


What is Anbesol Maximum Strength (benzocaine topical)?

Benzocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.


Benzocaine topical is used to reduce pain or discomfort caused by minor skin irritations, sore throat, sunburn, teething pain, vaginal or rectal irritation, ingrown toenails, hemorrhoids, and many other sources of minor pain on a surface of the body. Benzocaine is also used to numb the skin or surfaces inside the mouth, nose, throat, vagina, or rectum to lessen the pain of inserting a medical instrument such as a tube or speculum.


There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.


Benzocaine topical may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Anbesol Maximum Strength (benzocaine topical)?


There are many brands and forms of benzocaine topical available and not all brands are listed on this leaflet.


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms of methemoglobinemia may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE ANY OF THESE SYMPTOMS: headache, tired feeling, confusion, fast heart rate, and feeling light-headed or short of breath, with a pale, blue, or gray appearance of your skin, lips, or fingernails.


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. Do not use this medicine on a child younger than 2 years old without medical advice. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Use the smallest amount of this medication needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Before using benzocaine topical, tell your doctor if you have any type of inherited enzyme deficiency, heart disease, a breathing disorder such as asthma, bronchitis, or emphysema, or if you smoke.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


What should I discuss with my health care provider before using Anbesol Maximum Strength (benzocaine topical)?


Do not use benzocaine topical if you have ever had methemoglobinemia in the past. An overdose of numbing medications can cause fatal side effects if too much of the medicine is absorbed through your skin and into your blood. This is more likely to occur when using a numbing medicine without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). Overdose symptoms may include uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:



  • asthma, bronchitis, emphysema, or other breathing disorder;




  • heart disease;




  • a personal or family history of methemoglobinemia, or any genetic (inherited) enzyme deficiency; or




  • if you smoke.




FDA pregnancy category C. It is not known whether benzocaine topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. It is not known whether benzocaine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medicine on a child younger than 2 years old without medical advice.

How should I use Anbesol Maximum Strength (benzocaine topical)?


Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.


Your body may absorb more of this medication if you use too much, if you apply it over large skin areas, or if you apply heat, bandages, or plastic wrap to treated skin areas. Skin that is cut or irritated may also absorb more topical medication than healthy skin.

Use the smallest amount of medicine needed to numb the skin or relieve pain. Do not use large amounts of benzocaine topical, or cover treated skin areas with a bandage or plastic wrap without medical advice. Be aware that many cosmetic procedures are performed without a medical doctor present.


This medication comes with instructions for safe and effective application. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


To treat minor skin conditions, apply a thin layer of benzocaine topical to the affected area up to 4 times per day. If using the spray, hold the container 6 to 12 inches away from the skin. Do not spray this medication onto your face. Spray it instead on your hands and then rub it onto the face, avoiding contact with your eyes.


To treat hemorrhoids, clean the area with soap and water before applying benzocaine topical. Apply the medication up to 6 times per day. If you are using the rectal suppository, try to empty your bowel and bladder before inserting the suppository. Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.


Do not use benzocaine topical to treat large skin areas or deep puncture wounds. Avoid using the medicine on skin that is raw or blistered, such as a severe burn or abrasion.

Call your doctor if your symptoms do not improve or if they get worse within the first 7 days of using benzocaine topical. Also call your doctor if your symptoms had cleared up but then came back.


If you are treating a sore throat, call your doctor if the pain is severe or lasts longer than 2 days, especially if you also develop a fever, headache, skin rash, swelling, nausea, vomiting, cough, or breathing problems.


Store at room temperature away from moisture and heat. Do not freeze.

What happens if I miss a dose?


Since benzocaine topical is used as needed, you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).

What should I avoid while taking Anbesol Maximum Strength (benzocaine topical)?


Avoid eating within 1 hour after using benzocaine topical on your gums or inside your mouth.


Benzocaine topical is for use only on the surface of your body, or just inside the mouth, vagina, or rectum. Avoid getting this medication in your eyes. Avoid swallowing the gel, liquid, or ointment while applying it to your gums or the inside of your mouth. The throat spray or oral lozenge may be swallowed gradually during use.

Do not apply other medications to the same affected areas you treat with benzocaine topical, unless your doctor has told you otherwise.


Anbesol Maximum Strength (benzocaine topical) side effects


Benzocaine topical used in the mouth or throat may cause a life-threatening condition in which the amount of oxygen in your blood stream becomes dangerously low. This condition is called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a) and it may occur after only one use of benzocaine or after several uses.

Signs and symptoms may occur within minutes or up to 2 hours after using benzocaine topical in the mouth or throat. GET EMERGENCY MEDICAL HELP IF YOU HAVE:



  • headache, tired feeling, confusion;




  • fast heart rate;




  • feeling light-headed or short of breath; and




  • pale, blue, or gray appearance of your skin, lips, or fingernails.




Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using benzocaine topical and call your doctor at once if you have any of these other serious side effects:

  • headache, weakness, dizziness, breathing problems, fast heart rate, and gray or bluish colored skin (rare but serious side effects of benzocaine);




  • severe burning, stinging, or sensitivity where the medicine is applied;




  • swelling, warmth, or redness; or




  • oozing, blistering, or any signs of infection.



Less serious side effects may include:



  • mild stinging, burning, or itching where the medicine is applied;




  • skin tenderness or redness; or




  • dry white flakes where the medicine was applied.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Anbesol Maximum Strength (benzocaine topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied benzocaine topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.



More Anbesol Maximum Strength resources


  • Anbesol Maximum Strength Side Effects (in more detail)
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  • Anbesol Maximum Strength Support Group
  • 0 Reviews for Anbesol Maximum Strength - Add your own review/rating


  • Americaine Ointment MedFacts Consumer Leaflet (Wolters Kluwer)

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  • Anbesol Extra Strength Advanced Consumer (Micromedex) - Includes Dosage Information

  • Benz-O-Sthetic Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lanacane Aerosol Spray MedFacts Consumer Leaflet (Wolters Kluwer)

  • OraMagic Plus Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

  • Rid-A-Pain Topical Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Anbesol Maximum Strength with other medications


  • Aphthous Ulcer
  • Oral and Dental Conditions


Where can I get more information?


  • Your pharmacist can provide more information about benzocaine topical.

See also: Anbesol Maximum Strength side effects (in more detail)


anakinra Subcutaneous


an-a-KIN-ra


Commonly used brand name(s)

In the U.S.


  • Kineret

Available Dosage Forms:


  • Solution

Therapeutic Class: Immunological Agent


Pharmacologic Class: Interleukin-1 Inhibitor


Uses For anakinra


Anakinra is used to treat moderate to severe symptoms of rheumatoid arthritis. It may relieve redness, pain, tenderness, and warmth in hands, feet, wrists, shoulders, elbows, and ankles. anakinra is used in patients 18 years of age or older. Anakinra will not cure the disease, but will help with the symptoms as long as you continue to take it.


anakinra is available only with your doctor's prescription.


Before Using anakinra


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For anakinra, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to anakinra or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on anakinra have been done only in adult patients, and there is no specific information comparing use of anakinra in children with use in other age groups.


Geriatric


anakinra has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking anakinra, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using anakinra with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Abatacept

  • Adalimumab

  • Certolizumab Pegol

  • Etanercept

  • Golimumab

  • Infliximab

  • Rilonacept

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of anakinra. Make sure you tell your doctor if you have any other medical problems, especially:


  • Active infections—May be worsened by anakinra

  • Asthma—Patients with asthma may be at higher risk of getting a serious infection when taking anakinra.

  • Immunosuppression—Anakinra has not been studied in patients who have immune system problems. The effects of the medicine in these patients is not known

  • Kidney disease—Higher blood levels of anakinra may occur

Proper Use of anakinra


Your health care professional will teach you or your caregiver how to give the injection. You must demonstrate the procedure so that your health care professional knows you understand. Before taking the injection, check the medicine to make sure it is clear and doesn't have any particles in it. If it looks cloudy or discolored, or has any particles floating in it, you should throw it away. Do not shake the syringe. Give the entire dose and then throw away the syringe. Your health care professional will tell you how to dispose of your syringes. Do not reuse syringes. Do not keep part of a dose for later use. Take the medicine at the same time each day. If you have questions or problems with the procedure, call your health care professional.


Dosing


The dose of anakinra will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of anakinra. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For injection dosage form
    • For rheumatoid arthritis:
      • Adults—100 milligrams (mg) a day injected under the skin.

      • Children—Use and dose must be determined by your doctor. Anakinra is not usually recommended for use in children.



Missed Dose


If you miss a dose of anakinra, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store in the refrigerator. Do not freeze.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using anakinra


It is important that your doctor check your progress at regular visits to make sure that anakinra is working properly and to check for unwanted effects.


Your body's ability to fight infection may be reduced while you are being treated with anakinra, it is very important that you call your doctor at the first signs of any infection (for example, if you get a fever or chills).


While you are being treated with anakinra, do not have any immunizations (vaccinations) without your doctor's approval.


anakinra Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Chest pain

  • cough

  • diarrhea

  • fever or chills

  • general feeling of discomfort or illness

  • headache

  • itching, pain, redness, swelling, tenderness or warmth on skin

  • joint pain

  • loss of appetite

  • muscle aches and pains

  • nausea

  • pain or tenderness around eyes and cheekbones

  • redness, bruising pain at the injection site

  • runny nose

  • shivering

  • shortness of breath

  • sneezing

  • sore throat

  • sweating

  • tightness in chest

  • trouble sleeping

  • unusual tiredness or weakness

  • vomiting

  • wheezing

Less common or rare
  • Black, sticky stools

  • difficulty in swallowing

  • itching

  • lower back pain or side pain

  • painful or difficult urination

  • pale skin

  • rash; hives; swelling of face or lips

  • ulcers, sores or white spots in mouth

  • unusual bruising or bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: anakinra Subcutaneous side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More anakinra Subcutaneous resources


  • Anakinra Subcutaneous Side Effects (in more detail)
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  • Anakinra Subcutaneous Drug Interactions
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  • 4 Reviews for Anakinra Subcutaneous - Add your own review/rating


Compare anakinra Subcutaneous with other medications


  • Rheumatoid Arthritis
  • Schnitzler Syndrome
  • Still's Disease

Anakinra


Class: Disease-modifying Antirheumatic Agents
Chemical Name: N2-l-methionyl-interleukin 1 receptor antagonist (human isoform × reduced)
Molecular Formula: C759H1186N208O232S10
CAS Number: 143090-92-0
Brands: Kineret

Introduction

Recombinant human interleukin-1 (IL-1) receptor antagonist; biologic response modifier and disease-modifying antirheumatic drug (DMARD).1 11


Uses for Anakinra


Rheumatoid Arthritis in Adults


Used alone or in combination with DMARDs other than tumor necrosis factor (TNF) blocking agents (e.g., adalimumab, etanercept, infliximab) for the management of signs and symptoms of rheumatoid arthritis and to inhibit progression of structural damage associated with the disease in adults with moderately to severely active disease who have had an inadequate response to therapy with one or more DMARDs.1 3 4 5 12 13 (See Interactions.)


Anakinra Dosage and Administration


General



  • Monitor neutrophil counts prior to and during anakinra therapy.1 12 (See Neutropenia under Cautions.)



Administration


Sub-Q Administration


Administer sub-Q at approximately the same time each day.1


Administer sub-Q injections into the thighs, abdomen, upper arms, or buttocks.17 Rotate injection sites.17 Do not make injections into areas where the skin is tender, bruised, red, or hard; into scars or stretch marks; or close to a vein.17


Allow anakinra prefilled syringe to reach room temperature (about 60–90 minutes) prior to administration.17 Do not remove the needle cover until the prefilled syringe has reached room temperature.17


Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to prepare and safely administer the drug.1


Dosage


Adults


Rheumatoid Arthritis

Sub-Q

100 mg (entire contents [0.67 mL] of one prefilled syringe) daily.1


Prescribing Limits


Adults


Rheumatoid Arthritis

Sub-Q

Dosages >100 mg daily do not appear to provide additional benefit.1


Special Populations


Renal Impairment


Rheumatoid Arthritis

Sub-Q

Consider decreasing dosage to 100 mg every other day in patients with severe renal insufficiency or end-stage renal disease (Clcr <30 mL/minute, as estimated from Scr).1 15 (See the Special Populations sections under Pharmacokinetics and under Cautions.)


Cautions for Anakinra


Contraindications



  • Known hypersensitivity to Escherichia coli-derived proteins, anakinra, or any ingredient in the formulation.1



Warnings/Precautions


Warnings


Infectious Complications

Increased incidence of serious infections reported.1 9 12 (See Infection under Cautions.) Do not initiate anakinra therapy in patients with active infections.1 Discontinue the drug in patients who develop a serious infection.1 Safety and efficacy have not been evaluated in immunosuppressed patients or patients with chronic infections.1


Interactions

Concomitant use of TNF blocking agents (e.g., adalimumab, etanercept, infliximab) not recommended.1 Increased incidence of serious infections and lack of additional clinical benefit with combined anakinra and etanercept therapy.1


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylaxis and anaphylactoid reactions reported rarely.1 11


If a severe hypersensitivity reaction occurs, discontinue anakinra immediately and institute appropriate interventions as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen, IV fluids, antihistamines, maintenance of BP).1


Latex Sensitivity

The needle cover of the prefilled syringe contains dry natural rubber (latex); individuals sensitive to latex should not handle the needle cover.1


Major Toxicities


Infection

The incidence of infection, including serious infections, is increased in patients receiving anakinra.1 Infections of bacterial origin (e.g., cellulitis, pneumonia, bone and joint) most common.1 Opportunistic infections (fungal, mycobacterial, bacterial, viral) reported rarely.1 Patients with asthma may be at a higher risk for developing serious infections.1


Risk of serious infection and neutropenia increased in patients receiving concomitant anakinra and etanercept compared with etanercept alone.1 5


Hematologic Effects

Small reductions reported in WBC, ANC, and platelet counts; small increases in eosinophil counts reported.1 13


General Precautions


Immunologic Effects

Effect of anakinra in patients with active and/or chronic infections or on the subsequent development of malignancy not fully elucidated.1


Anti-anakinra antibodies reported after therapy; not associated with increased adverse events.1 Effect of neutralizing antibodies on clinical response not fully elucidated.1 3 11 13


Do not administer live-virus vaccines to patients receiving anakinra.1 (See Vaccines under Interactions.)


Neutropenia

Neutropenia (ANC < 1000/mm2) and/or reduced neutrophil counts reported.1 Monitor ANC before therapy is initiated, monthly for 3 months, and then every 3 months for a period up to 1 year during anakinra therapy.1 12


Malignancies and Lymphoproliferative Disorders

Increased incidence of lymphoma compared with general population reported in patients with rheumatoid arthritis receiving anakinra.1 However, patients with rheumatoid arthritis, especially those with highly active disease, may be at increased risk of lymphoma.1 Role of human interleukin-1 receptor antagonist (IL-1Ra)-induced immunosuppression in the development of malignancies is unknown.1


Increased incidence of malignancies involving the breast and respiratory and digestive systems has been reported.1 Increased incidence of melanoma also reported; clinical importance unknown.1


Specific Populations


Pregnancy

Category B.1


Lactation

Not known whether anakinra is distributed into milk.1 Caution if used in nursing women.1


Pediatric Use

Evaluated in a limited number of children 2–17 years of age with polyarticular course juvenile rheumatoid arthritis; efficacy not established (insufficient numbers of children have been enrolled in trials).1 Adverse effects observed in children similar to those in adults.1 Use of anakinra in pediatric patients is not recommended.1 The currently available prefilled syringes are not designed to deliver pediatric doses accurately.1


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1


Geriatric patients may be at increased risk of serious infection; use with caution.1


Geriatric patients may be at increased risk of toxic reactions due to impaired renal function; use with caution.1 (See Renal Impairment under Cautions.)


Hepatic Impairment

Not studied in patients with severe hepatic impairment.1


Renal Impairment

Risk of toxic reactions increased; consider dosage reduction.1 (See Renal Impairment under Dosage and Administration.)


Elimination reduced in patients with renal insufficiency.1 (See Special Populations under Pharmacokinetics.)


Common Adverse Effects


Injection-site reaction,1 3 5 9 10 12 13 infections (principally bacterial origin),1 3 11 13 headache,1 13 nausea,1 neutropenia,1 diarrhea,1 influenza-like symptoms,1 11 abdominal pain.1 13


Interactions for Anakinra


Used concomitantly with methotrexate, sulfasalazine, hydroxychloroquine, gold, penicillamine, leflunomide, and/or azathioprine in clinical studies;1 3 13 specific drug interactions not evaluated in humans.1 11


Vaccines


Live virus vaccines should not be administered to patients receiving anakinra.1 Information is not available regarding whether anakinra would affect the rate of secondary transmission of vaccine virus following administration of a live virus vaccine or regarding any other effect of vaccination on patients receiving the drug.1


Information not available regarding effects of vaccination with inactivated vaccine.1


Specific Drugs


















Drug



Interaction



Comments



Abatacept



Concomitant use not recommended; clinical experience insufficient to establish safety and efficacy16



Methotrexate



Pharmacokinetic interaction unlikely;1 no alterations in clearance or toxicologic profile of anakinra or methotrexate with concomitant administration in rats1



Tetanus toxoid



Immunologic response preserved in 1 study1



TNF blocking agents (e.g., adalimumab, etanercept, infliximab)



Increased incidence of adverse effects (serious infections, neutropenia) and no added clinical benefit reported with combined anakinra and etanercept therapy compared with etanercept alone1 14



Concomitant use not recommended1 14


Anakinra Pharmacokinetics


Absorption


Bioavailability


Absolute bioavailability is 95% after sub-Q administration; peak plasma concentrations attained within 3–7 hours.1


Distribution


Extent


Not known whether anakinra crosses the placenta or is distributed into milk.1


Elimination


Metabolism


Metabolic fate of anakinra not fully elucidated; no unexpected accumulation after daily sub-Q dosing for up to 24 weeks.1 15


Elimination Route


Excreted principally in urine.1 15


Half-life


Terminal half-life averages 4–6 hours.1


Special Populations


In patients with renal impairment, plasma clearance was reduced by 16–75% depending on Clcr.1 15 Less than 2.5% of dose removed by hemodialysis or CAPD.1 (See Renal Impairment under Dosage and Administration.)


Gender and age (adjusted for Clcr and body weight) do not have substantial effect on mean plasma clearance.1


Pharmacokinetics not studied in patients with hepatic impairment.1


Stability


Storage


Parenteral


Injection

2–8°C; do not freeze or shake.1 Protect from light.1


ActionsActions



  • A biosynthetic (recombinant DNA origin) form of human interleukin-1 (IL-1) receptor antagonist (IL-1Ra).




  • A biologic response modifier that blocks the biologic activity of endogenous IL-1.1 3 4 5 9 10 12 11




  • Competitively inhibits binding of IL-1 to the interleukin-1 type I receptor (IL-1RI) expressed in many tissues and organs.1 10 Decreases inflammation and cartilage degradation associated with rheumatoid arthritis.1 2 5 10 12



Advice to Patients



  • Importance of providing patient a copy of manufacturer’s patient information.1




  • Importance of patient informing clinician about existing or recurrent infections prior to initiating therapy.1 17




  • Importance of instructing patient and/or caregiver regarding proper dosage and administration of anakinra, including the use of aseptic technique and safe disposal of needles and syringes, in patients whose clinician has determined that the drug can safely and effectively be self-administered in the patient’s home by the patient, family member, or other responsible individual.1




  • Importance of advising patient and/or caregiver about recognition and reporting of adverse effects of anakinra (e.g., sensitivity reactions, infection).1




  • Importance of informing clinician if allergy to latex exists.11




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1




  • Importance of informing patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.













Anakinra (Recombinant DNA Origin)

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Injection, for subcutaneous use



100 mg/0.67 mL



Kineret (preservative-free; available in prefilled disposable syringes)



Amgen


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Kineret 100MG/0.67ML Solution (BIOVITRUM AB): 4/$406.6 or 18/$1599.06



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References



1. Amgen Inc. Kineret (anakinra) injection prescribing information. Thousand Oaks, CA; 2006 Dec 15.



2. Schiff MH. Role of interleukin 1 and interleukin 1 receptor antagonist in the mediation of rheumatoid arthritis. Ann Rheum Dis. 2000; 59(Suppl 1):i103-8. [IDIS 455654] [PubMed 11053099]



3. Bresnihan B, Alvaro-Gracia JM, Cobby M, et al., Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum1998; 41:2196-204.



4. Jiang Y, Genant HK, Watt I, et al.A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores. Arthritis Rheum 2000; 43:1001-9. [PubMed 10817552]



5. Anon. Anakinra (kineret) for rheumatoid arthritis. Med Lett Drugs Ther. 2002; 44:18-9.



6. Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatology Association 1987: revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988; 31:315-24. [PubMed 3358796]



7. Hochberg MC, Chang RW, Dwosh I et al. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum. 1992; 35:498-502. [PubMed 1575785]



8. Felson DT, Anderson JJ, Boers M et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995; 38:727-35. [PubMed 7779114]



9. Bresnihan B.The safety and efficacy of interleukin-1 receptor antagonist in the treatment of rheumatoid arthritis. Semin Arthritis Rheum. 2001; 30(Suppl 2):17-20. [PubMed 11357167]



10. Bresnihan B. The prospect of treating rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. BioDrugs. 2001; 15:87-97. [PubMed 11437678]



11. Amgen Inc,Thousand Oaks, CA: Personal communication.



12. Calabrese LH. Anakinra treatment of patients with rheumatoid arthritis. Ann Pharmacother. 2002; 36:1204-9. [IDIS 485217] [PubMed 12086555]



13. Cohen S, Hurd E, Cush J, Schiff M et al. Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2002; 46:614-24. [PubMed 11920396]



14. Spencer-Green G. Dear healthcare professional letter: Important Drug Warning. Abbott Park, IL: Abbott Laboratories; 2004 Nov.



15. Yang BB, Baughman S, Sullivan JT. Pharmacokinetics of anakinra in subjects with different levels of renal function. Clin Pharmacol Ther. 2003; 74:85-94. [PubMed 12844139]



16. Bristol-Myers Squibb. Orencia (abatacept) prescribing information. Princeton, NJ; 2005 Dec.



17. Amgen Inc. Kineret (anakinra) patient information. Thousand Oaks, CA; 2006 Dec 15.



More Anakinra resources


  • Anakinra Side Effects (in more detail)
  • Anakinra Use in Pregnancy & Breastfeeding
  • Anakinra Drug Interactions
  • Anakinra Support Group
  • 4 Reviews for Anakinra - Add your own review/rating


  • Anakinra MedFacts Consumer Leaflet (Wolters Kluwer)

  • Anakinra Professional Patient Advice (Wolters Kluwer)

  • anakinra Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Kineret Prescribing Information (FDA)

  • Kineret Consumer Overview



Compare Anakinra with other medications


  • Rheumatoid Arthritis
  • Schnitzler Syndrome
  • Still's Disease