Salamol may be available in the countries listed below.
Salbutamol is reported as an ingredient of Salamol in the following countries:
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Salamol in the following countries:
International Drug Name Search
Gluzit may be available in the countries listed below.
Gliclazide is reported as an ingredient of Gluzit in the following countries:
International Drug Name Search
DESCRIPTION: Sodium sulfacetamide is a sulfacetamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
Each pad of SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads is coated with a cleanser-based formulation contains 100mg of Sodium Sulfacetamide and 40mg of Sulfur. The cleanser base consists of: aloe, butylated hydroxytoluene, cetyl alcohol, disodium oleamido MEA sulfosuccinate, edetate disodium, fragrance, glycerin, glyceryl steartate/PEG-100 stearate, green tea, methylparaben, propylparaben, purified water, sodium cocoyl isethionate, sodium lauryl sulfoacetate, sodium thiosulfate, stearyl alcohol.
CLINICAL PHARMACOLOGY: The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours. The exact mode of action of sulfur in the treatment of acne is unknown, but it has been reported that it inhibits the growth of Propionibacterium acnes and the formation of free fatty acids.
INDICATIONS:SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
CONTRAINDICATIONS: SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%)Cleansing Pads are contraindicated for the use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads are not used by patients with kidney disease.
WARNINGS: Although rare, sensitivity to sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hermorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. Particular caution should be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
PRECAUTIONS: General - If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Information for Patients - Avoid contact with eyes, eyelids, lips and mucous membranes. If accidental contact occurs, rinse with water. If excessive irritation develops, discontinue use and consult your physician.
Carcinogenesis, Mutagenesis and Impairment of Fertility - Long-term studies in animals have not been performed to evaluate carcinogenic potential.
PREGNANCY: Category C - Animal reproduction studies have not been conducted with SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads. It is also not know whether SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads should be given to a pregnant woman only if clearly needed.
If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.
NURSING MOTHERS: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads. However, small amounts of orally adminstered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when SulfatolTM 10-4 (sodium sulfacetamide 10% and sulfur 4%) Cleansing Pads are administered to a nursing woman.
PEDIATRIC USE: Safety and effectiveness in children under the age of 12 have not been established.
ADVERSE REACTIONS: Although rare, sodium sulfacetamide may cause local irritation.
DOSAGE AND ADMINISTRATION: Wash affected area(s) with cleansing pad once or twice daily, or as directed by your physician. Wet area(s) with water. Wet pad with a little water and work into a full lather. Cleanse area(s) with pad for 10-20 seconds, avoiding eyes. Rinse thoroughly and pat dry. Discard pad. Do not flush.
| SULFATOL 10-4 CLEANSING PADS sodium sulfacetamide, sulfur cloth | ||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 01/13/2010 | ||
| Labeler - Breckenridge Pharmaceutical inc. (150554335) |
| Registrant - Groupe Parima inc. (252437850) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Groupe Parima inc. | 252437850 | manufacture | |
Preventing or treating symptoms of hay fever and other upper respiratory allergies such as stuffy nose, runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes. It is also used for preventing or treating chronic hives. It may also be used for other conditions as determined by your doctor.
Cetirizine Syrup is an antihistamine. It works by blocking the action of histamine, which reduces the symptoms of an allergic reaction.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Cetirizine Syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Cetirizine Syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
Theophylline because it may increase the risk of Cetirizine Syrup's side effects
Use Cetirizine Syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Cetirizine Syrup.
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:
Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of eyes or skin.
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: Cetirizine side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include irritability; restlessness; severe drowsiness.
Store Cetirizine Syrup at 77 degrees F ( 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Cetirizine Syrup may be refrigerated at 36 to 46 degrees F (2 to 8 degrees C). Do not store in the bathroom. Keep Cetirizine Syrup out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Cetirizine Syrup. 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.
Generic Name: succimer (SUCK sih mer)
Brand Names: Chemet
Succimer is a chelating (binding) agent. Succimer binds to lead in the blood and allows it to be passed out in the urine.
Succimer is used in the treatment of lead poisoning.
Succimer may also be used for purposes other than those listed here.
Succimer can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection such as fever, sore throat, or coughing.
Before taking succimer, talk to your doctor if you have
had a previous reaction to treatment with succimer;
blood problems;
You may not be able to take succimer, or you may require a dosage adjustment or special monitoring during treatment.
Take succimer exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
If swallowing the capsules is difficult, the capsules can be opened and the contents sprinkled onto a small amount of soft food. The mixture should be consumed entirely and immediately, not saved for later use. Alternatively, the contents of the capsule may be placed on a spoon, administered, and followed with a drink of fruit juice or other liquid.
It is important to take succimer regularly to get the most benefit.
Your doctor may want you to have blood tests or other medical evaluations during treatment with succimer to monitor progress and side effects.
See also: Chemet dosage (in more detail)
Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose unless otherwise directed by your doctor.
Symptoms of a succimer overdose may include poor coordination, weakness, seizures, difficulty breathing, and death.
Succimer can lower the activity of the immune system making you more susceptible to infection. Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection such as fever, sore throat, or coughing.
an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
skin rash or sores in the mouth; or
signs of infection such as fever, sore throat, or coughing.
Other, less serious side effects may be more likely to occur. Continue to take succimer and talk to your doctor if you experience
nausea, vomiting, or decreased appetite;
diarrhea;
metallic taste in the mouth;
drowsiness;
dizziness;
watering eyes; or
headache.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
No other medications are known to interact with succimer. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
See also: Chemet side effects (in more detail)
Generic Name: chlorpheniramine (KLOR fen IR a meen)
Brand Names: AHist, Aller-Chlor, Allergy Relief, C.P.M., Chlo-Amine, Chlor-Mal, Chlor-Trimeton, Chlor-Trimeton Allergy SR, Chlorphen, ChlorTan, Ed Chlor-Tan, Ed ChlorPed, PediaTan, TanaHist-PD, Triaminic Allergy, Wal-finate
Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Chlorpheniramine is used to treat sneezing, itching, watery eyes, and runny nose caused by allergies or the common cold.
Chlorpheniramine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before taking chlorpheniramine if you have glaucoma, a stomach ulcer, severe constipation, kidney disease, urination problems, an enlarged prostate, or a thyroid disorder.
Ask a doctor or pharmacist before using any other cold, cough, or allergy medicine. Chlorpheniramine is contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
glaucoma;
a stomach ulcer;
severe constipation;
kidney disease;
urination problems or an enlarged prostate; or
a thyroid disorder.
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. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cold or allergy medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease perspiration and you may be more prone to heat stroke.
urinating less than usual or not at all;
confusion, extreme drowsiness;
severe dizziness, anxiety, restless feeling, nervousness; or
weak or shallow breathing.
Less serious side effects may include:
mild dizziness, drowsiness;
blurred vision;
dry mouth;
nausea, stomach pain, constipation;
problems with memory or concentration; or
feeling restless or excited (especially in children).
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.
Tell your doctor about all other medicines you use, especially:
glycopyrrolate (Robinul);
mepenzolate (Cantil);
probenecid (Benemid, Probalan);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
zidovudine (Retrovir, AZT);
a diuretic (water pill);
atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro-Banthine); or
salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others;
This list is not complete and other drugs may interact with chlorpheniramine. 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.
See also: Chlor-Trimeton Allergy SR side effects (in more detail)
Treating high blood pressure and certain types of angina (chest pain) in adults. It may be used in combination with other high blood pressure and angina medicines. It may also be used to treat other conditions as determined by your doctor.
Cardene is a calcium channel blocker. It works by relaxing blood vessels, which helps to lower blood pressure and reduce angina (chest pain).
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Cardene. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Cardene. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Cardene 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.
Use Cardene as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Cardene.
If you suddenly stop taking Cardene, you may experience WITHDRAWAL symptoms including increased chest pain (angina) and more frequent chest pain.
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:
Dizziness; headache; nausea; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain, swelling, or redness; confusion; fainting; fast or irregular heartbeat; fever; increased chest pain; pounding in the chest; shortness of breath or wheezing; swelling of the feet, ankles, or hands; unusual bruising or bleeding.
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: Cardene side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; drowsiness; flushing; fast or slowed heart rate; slurred speech; weakness.
Store Cardene at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cardene out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Cardene. 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.
Litocit may be available in the countries listed below.
Potassium Citrate is reported as an ingredient of Litocit in the following countries:
International Drug Name Search
Generic Name: telaprevir (tel A pre vir)
Brand Names: Incivek
Telaprevir is an antiviral medication that prevents certain virus cells from multiplying in your body. Telaprevir is used in combination with peginterferon alfa (Pegasys, PegIntron) and ribavirin (Copegus, Rebetol, Ribasphere, RibaTab) to treat hepatitis C in adults.
Telaprevir is usually given to people who have never been treated for hepatitis C, or after interferon and ribavirin have been tried without successful treatment of symptoms.
Telaprevir may also be used for purposes not listed in this medication guide.
Telaprevir may cause a severe skin reaction. Call your doctor right away if you have a 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.
There are many other drugs that can interact with telaprevir. Tell your doctor about all medications you use.
To make sure you can safely take telaprevir, tell your doctor if you have any of these other conditions:
hepatitis B or liver problems other than hepatitis C;
kidney disease (or if you are on dialysis);
anemia (lack of red blood cells);
if you have had an organ transplant;
HIV or AIDS;
a history of gout; or
if you have ever used medicine to treat hepatitis in the past and it did not work.
alfuzosin (Uroxatral);
atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), or simvastatin (Zocor, Simcor, Vytorin);
cisapride (Propulsid);
pimozide (Orap);
midazolam (Versed) or triazolam (Halcion);
sildenafil (Revatio) or tadalafil (Adcirca) when used to treat pulmonary arterial hypertension;
St. John's wort;
rifampin (Rifadin, Rifater, Rifamate); or
ergonovine, ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).
Use at least 2 non-hormonal forms of birth control while either sexual partner is using telaprevir with interferon alfa and ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
If you are a woman, do not use telaprevir with interferon alfa and ribavirin if you are pregnant.
If you are a man, do not use telaprevir with interferon alfa and ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. Ask your doctor about using a non-hormone method of birth control (such as a condom, intrauterine device (IUD), diaphragm with spermicide) to prevent pregnancy while taking telaprevir.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is using telaprevir with interferon alfa and ribavirin.
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.
This combination treatment is usually given for 12 to 48 weeks. The usual dose of telaprevir is 2 tablets taken 3 times per day, every 7 to 9 hours. Follow your doctor's instructions.
Your total daily dose of 6 tablets is contained in a single blister strip of telaprevir. A package of telaprevir contains 4 cartons of 7 blister strips for a 4-week supply.
See also: Incivek dosage (in more detail)
If you are less than 4 hours late in taking your medicine, 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.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; 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:
tired feeling;
nausea, vomiting, diarrhea, altered sense of taste;
rectal itching, burning, or discomfort; or
altered sense of taste; or
mild skin rash.
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.
Tell your doctor about all other medicines you use, especially:
an antibiotic or an antifungal medication;
an antidepressant;
anti-malaria drugs;
anti-psychotic medication;
asthma or allergy medication (including inhaled steroids);
birth control or hormone replacement therapy that contains estrogen or progesterone;
a blood thinner or medicine to prevent blood clots;
cancer medicine;
cholesterol-lowering drugs;
cold or allergy medicine that contains an antihistamine;
erectile dysfunction medicines (Viagra, Levitra, Cialis);
gout medication;
heart or blood pressure medication, heart rhythm medication;
HIV/AIDS medications;
medicines used to prevent organ transplant rejection;
heart rhythm medication;
narcotic medication;
oral diabetes medication;
a sedative (Valium, Xanax, BuSpar, and others) or sleep medicine (Ambien);
seizure medication; or
steroids (dexamethasone, prednisone, and others).
This list is not complete and there are many other drugs that can interact with telaprevir. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.
See also: Incivek side effects (in more detail)
Rabec may be available in the countries listed below.
Rabeprazole sodium salt (a derivative of Rabeprazole) is reported as an ingredient of Rabec in the following countries:
International Drug Name Search
Atenolol / Chlortalidone Mylan may be available in the countries listed below.
Atenolol is reported as an ingredient of Atenolol / Chlortalidone Mylan in the following countries:
Chlortalidone is reported as an ingredient of Atenolol / Chlortalidone Mylan in the following countries:
International Drug Name Search
Retarbolin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Nandrolone 17ß-cyclohexylpropionate (a derivative of Nandrolone) is reported as an ingredient of Retarbolin in the following countries:
International Drug Name Search
Treating itching, redness, and swelling caused by certain skin conditions.
Momexin Cream is a kit that contains a topical corticosteroid and a humectant. The corticosteroid reduces skin inflammation (redness, swelling, itching, and irritation). The humectant moisturizes and softens the skin.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Momexin Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Momexin Cream. Because little, if any, of Momexin Cream is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Momexin Cream 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.
Use Momexin Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Momexin Cream.
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:
Mild burning, itching, peeling, redness, or stinging.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, itching, numbness, peeling, redness, stinging, or tingling not present before you began using Momexin Cream; inflamed hair follicles; inflammation around the mouth; muscle weakness; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; unusual drowsiness; flushing; rapid breathing); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.
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: Momexin side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store the cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Momexin Cream out of the reach of children and away from pets.
Store the mousse at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not store at temperatures above 120 degrees F (49 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Momexin Cream out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Momexin Cream. 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.
Generic Name: lidocaine and tetracaine (Topical application route)
LYE-doe-kane, TE-tra-kane
In the U.S.
Available Dosage Forms:
Therapeutic Class: Anesthetic Combination
Chemical Class: Amino Amide
Lidocaine and tetracaine combination is used on the skin to cause numbness or loss of feeling for patients having certain medical or skin procedures.
Lidocaine and tetracaine combination belongs to a group of medicines known as topical local anesthetics. It deadens the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.
This medicine is available only with your doctor's prescription.
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in children. However, safety and efficacy have not been established in children below 3 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lidocaine and tetracaine combination in the elderly.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health care professional will apply this medicine before your medical procedure.
The patch is applied to your skin about 20 to 30 minutes before your procedure. Tell your doctor if you still have feeling in the skin after 30 minutes have passed.
Be careful not to get any of this medicine in your eyes, because it can cause severe eye irritation. If any of the medicine does get in your eyes, wash the eyes with water and check with your doctor right away.
It is very important that your doctor check you closely for any problems or unwanted effects that may be caused by this medicine.
This medicine 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 with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
Check with your doctor right away if you have a skin rash, burning, stinging, swelling, or irritation of your skin.
Lidocaine and tetracaine combination cause numbness or loss of feeling in the skin. Be careful not to injure the treated skin by rubbing, scratching, or exposing the skin to extreme cold or heat.
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 or nurse immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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: Synera side effects (in more detail)
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Class: Platelet-Aggregation Inhibitors
ATC Class: B01AC04
Brands: Plavix
Clopidogrel is a prodrug; requires activation by CYP enzyme system (principally by CYP2C19) to produce its pharmacologically active metabolite.1 2 6 8 11 121
Genetic variations of CYP2C19 can result in impaired metabolism and reduced effectiveness of clopidogrel.1 121 (See Reduced Efficacy Associated with Impaired CYP2C19 Function under Cautions.) Higher rates of major adverse cardiovascular events (e.g., death, MI, stroke) have been reported in poor metabolizers of CYP2C19 receiving clopidogrel at recommended dosages following acute coronary syndrome or PCI compared with those who have normal CYP2C19 function.1 121
Genetic tests are available to determine a patient's CYP2C19 genotype; results of such tests may be used to guide treatment decisions.1 20 121 122
Consider use of other antiplatelet agents or alternative dosing strategies for clopidogrel in patients with variant CYP2C19 genotypes.1 121
REMS:
FDA approved a REMS for clopidogrel to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().
Platelet-aggregation inhibitor; thienopyridine derivative.1
Reduction of the risk of cardiovascular or cerebrovascular events (new MI, new ischemic stroke, and vascular death) in patients with a history of recent MI, recent ischemic stroke, or established peripheral arterial disease.1 2 6 8 15 23 25 27 Recommended as an alternative to aspirin in those with aspirin allergy.10 14 17 21 25 26 28 30
Clopidogrel monotherapy or aspirin in combination with dipyridamole may be preferable to aspirin monotherapy for secondary prevention of stroke based on a somewhat greater absolute risk reduction for stroke; weigh benefit against additional costs of therapy.25 63
In patients with peripheral arterial disease, clopidogrel recommended over ticlopidine or no antiplatelet therapy for prevention of death and disability from stroke or MI.29
In children who have recurrent arterial ischemic strokes or TIAs despite aspirin therapy, ACCP suggests changing from aspirin therapy to clopidogrel or an anticoagulant, such as a low molecular weight heparin or warfarin.63
Use of aspirin rather than clopidogrel for most patients requiring long-term antiplatelet therapy is suggested by many clinicians because of lower cost and modest additional benefit of clopidogrel over aspirin.5 8 10 20 23 29 66 71
Used in combination with aspirin for reduction of the risk of cardiovascular or cerebrovascular events in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (NSTE ACS), including unstable angina and non-ST-segment-elevation MI (NSTEMI).1 5 10 14 17 18 21 26 28 30 34 35 39 64 65 66 Used in patients who are managed medically or with coronary intervention (e.g., PCI with or without coronary artery stenting, CABG).1 5 10 18 21 26 28 30 34 35 39 40
Long-term use recommended by ACCP as an alternative to aspirin in patients with unstable angina or NSTEMI, including those undergoing CABG, who are allergic to aspirin†.10 14 17 26 28 30
Recommended by ACC/AHA and other clinicians as an adjunct to acute therapy with heparin and aspirin in patients with NSTE ACS who are managed medically and in those undergoing PCI who are not at high risk for bleeding.18 21 34 39
Dual-drug antiplatelet therapy (aspirin plus clopidogrel or prasugrel) recommended by ACC/AHA for patients with definite or likely NSTEMI in whom an invasive approach is selected.134 Begin treatment as early as possible before or at the time of PCI and continue for ≥1 month, ideally ≤1 year in patients who are not at high risk for bleeding.134
Balance potential benefit of pretreatment with clopidogrel in patients undergoing PCI against increased risk of bleeding should emergency CABG be needed.28 34 35 Temporarily discontinue therapy 5–10 days prior to CABG and reinitiate therapy in conjunction with aspirin after the procedure.26 30 35 40 66 69
In patients undergoing PCI with an absolute contraindication to aspirin†, ACCP states that pretreatment with clopidogrel and/or a GP IIb/IIIa-receptor inhibitor is reasonable.64 (See General under Dosage and Administration.)
Following implantation of a bare-metal coronary artery stent in patients at low risk for bleeding, ACC/AHA currently recommend use in combination with aspirin for ≥1 month, ideally for ≤12 months.134
In patients at low atherosclerotic risk, ACCP recommends combination therapy with aspirin for ≥2 weeks after implantation of a bare-metal stent.28
Following bare-metal stent placement in patients at high risk for bleeding, ACC/AHA recommend short-term (a minimum of 2 weeks) therapy with clopidogrel and aspirin.134
Prolonged dual-drug therapy (≥12 months) with clopidogrel and aspirin recommended in patients with drug-eluting stents (DES) who are not at high risk of bleeding.43 44 45 46 50 51 52 54 134 (See Compliance with Therapy in Patients with Drug-eluting Stents under Cautions.)
Used in combination with aspirin for reduction of the rate of ischemic cardiovascular and cerebrovascular events in patients with ST-segment elevation MI (STEMI).1 10 27 31 36 67 134 Net benefits of a particular thienopyridine (clopidogrel or prasugrel) in patients with STEMI undergoing PCI not fully elucidated; ACC/AHA state that choice of clopidogrel or prasugrel in individual patients should take into account antithrombotic efficacy, bleeding risk, and clinician experience with a given drug.134
Recommended by ACCP, ACC, AHA, and other clinicians for 14–28 days in addition to aspirin, with or without reperfusion therapy (i.e., thrombolytic therapy, primary PCI), in patients with suspected acute STEMI.67 68 ACCP suggests continuance of clopidogrel and aspirin beyond 28 days and up to 1 year in patients with STEMI who have not undergone stent implantation.67
In patients in whom CABG is planned, withhold clopidogrel for at least 5 days and preferably for 7–10 days prior to surgery unless urgency of revascularization outweighs risks of excess bleeding.69 134
Suggested as adjunct to thrombolytic therapy in patients with acute STEMI who are allergic to aspirin or in whom aspirin is otherwise contraindicated.10 23 27
In patients with STEMI in whom PCI is planned, ACC/AHA and ACCP recommend pretreatment with a loading dose of a thienopyridine derivative (e.g., clopidogrel, prasugrel) before or at the time of PCI in conjunction with aspirin therapy.67 134
Recommended by ACC/AHA in combination with aspirin as short-term prophylaxis (≥ 1 month) in patients with STEMI who have undergone PCI with bare-metal coronary artery stent implantation.39 134
Ideally, use long term (≥12 months) in conjunction with aspirin therapy in patients with STEMI who have undergone PCI with bare-metal stent implantation and are at low risk of bleeding.134
Recommended as short-term (minimum of 2 weeks) therapy with aspirin in patients with STEMI who have undergone PCI with bare-metal stent implantation and are at high risk of bleeding.134
Prolonged (≥12 months) prophylaxis in combination with aspirin strongly recommended in patients who have undergone PCI with DES implantation and are not at high risk of bleeding.43 44 45 46 50 51 52 54 134 (See Compliance with Therapy in Patients with Drug-eluting Stents under Cautions.) Consider continuation of thienopyridine therapy beyond 15 months in patients with drug-eluting stents; may use abbreviated period of thienopyridine therapy (less than 12 months) in patients with STEMI and a drug-eluting stent in whom the risk of morbidity due to bleeding outweighs the anticipated benefit of such therapy.134
Triple antithrombotic therapy with clopidogrel, low-dose aspirin, and warfarin anticoagulation† (target INR 2–2.5) recommended, based on case studies or expert opinion, in patients who have indications for anticoagulation (e.g., atrial fibrillation, left ventricular dysfunction, cerebral emboli, extensive wall-motion abnormality, mechanical heart valves) and who require clopidogrel and aspirin after PCI.23 42 65 In patients who have undergone stent placement and have indications for anticoagulation, warfarin (INR 2–3) and aspirin suggested in addition to clopidogrel;23 42 66 continue clopidogrel therapy for 4 weeks or 1 year following bare-metal or drug-eluting stent implantation, respectively, in addition to warfarin and aspirin.66 Such triple antithrombotic regimens are associated with an increased risk of bleeding; monitor closely.65 70
Suggested by American Diabetes Association (ADA) as alternative to aspirin for primary prevention of MI† in aspirin-allergic patients with type 1 or type 2 diabetes mellitus who are at high risk for cardiovascular events (i.e., family history of CHD, smoking, hypertension, obesity, albuminuria, and elevated blood cholesterol or triglyceride concentrations).95 Recommended by ACCP for primary prevention of cardiovascular events as an alternative to aspirin for aspirin-allergic patients who are at moderate to high risk for cardiovascular events.66
Use in combination with aspirin suggested by ACCP for reduction of the risk of AMI in high-risk patients with symptomatic chronic stable angina†.26
Used as an alternative to aspirin in patients with symptomatic chronic stable angina who cannot tolerate aspirin†.96
Aspirin generally recommended for all clinical conditions in which antiplatelet prophylaxis has a favorable benefit-to-risk profile.5 8 10 11 However, use recommended by ACCP as alternative and/or adjunctive antithrombotic therapy in selected patients with a number of atherosclerotic and ischemic conditions,13 14 15 16 17 including rheumatic mitral valve disease† 13 24 and saphenous vein CABG†.14 26 30 40
Use in combination with aspirin in patients undergoing brachytherapy for restenosis following PCI and coronary artery stent implantation† suggested by ACC/AHA.34
Considered a reasonable choice for antiplatelet therapy in high-risk patients with prosthetic heart valves in whom aspirin cannot be used† or in patients with prosthetic heart valves receiving aspirin who have breakthrough embolic events†.41
In patients with ACS in whom PCI is planned, ACC/AHA recommend administration of a loading dose of clopidogrel as early as possible before or at the time of the procedure.134
Temporarily discontinue therapy 5–10 days prior to CABG and reinitiate clopidogrel in conjunction with aspirin after the procedure.26 30 35 40 69 134
Administer orally without regard to meals.1 6 8
Available as clopidogrel bisulfate; dosage expressed in terms of clopidogrel.1
Pharmacogenomic factors can influence response to clopidogrel; although a higher dosage or administration of additional loading doses may increase the antiplatelet response in patients who are poor metabolizers, manufacturer states that an appropriate dosage of the drug in such patients has not been determined.1 121 123 130 (See Reduced Efficacy Associated with Impaired CYP2C19 Function under Cautions.)
75 mg once daily.1 2 3 5 6 8 23 25 26
300-mg initial loading dose promptly at diagnosis, then 75 mg daily given with aspirin daily for ≥1 month, ideally for ≤1 year in patients at low risk of bleeding.1 17 18 20 21 22 26 34 39 64 66
Most patients generally have received concomitant heparin acutely.1 18
Patients allergic to or intolerant of aspirin†: 300-mg loading dose, then 75 mg daily continued indefinitely.10 14 17 21 26 28 30 64
Planned PCI: 300–600 mg as loading dose as early as possible prior to or at time of the procedure with aspirin, then 75 mg once daily for ≤1 year in patients at low risk of bleeding.64 66 134 Larger loading doses (e.g., ≥900 mg) used to achieve higher level of antiplatelet activity more rapidly, but efficacy and safety not established.64 134
Planned PCI in patients unable to tolerate aspirin†: 600-mg loading dose ≥24 hours prior to procedure, followed by 75 mg once daily.64
Patients undergoing CABG: 75 mg once daily with aspirin, beginning postoperatively and continuing for 9–12 months.66
Patients undergoing CABG who are allergic to aspirin: ACCP recommends initiation of a 300-mg loading dose of clopidogrel 6 hours after the procedure, followed by 75 mg once daily, continued indefinitely.66
Following bare-metal stent implantation: 75 mg once daily with aspirin for ≥1 month.134 Ideally, continue for ≤12 months in conjunction with daily aspirin therapy in patients at low risk for bleeding.134 In patients in whom a high risk of bleeding is deemed to outweigh anticipated benefit, administer clopidogrel with aspirin for a minimum of 2 weeks.134
Following drug-eluting stent (DES) implantation: 75 mg once daily with aspirin for ≥12 months in patients not at high risk for bleeding.43 44 45 46 50 51 52 54 66 134 (See Compliance with Therapy in Patients with Drug-eluting Stents under Cautions.)
Usual recommended dosage: 75 mg once daily with or without a loading dose in combination with aspirin.1 39 67 134 ACCP recommends a clopidogrel loading dose of 300 mg in patients ≤75 years of age;67 loading dose for patients >75 years of age not established.134
ACC/AHA state that clopidogrel should be continued as the thienopyridine of choice in patients with STEMI who will undergo PCI and have already received clopidogrel and thrombolytic therapy.134
Patients with STEMI who have received any thrombolytic agent (fibrin-specific or not) and in whom PCI is planned within 24 hours: ACC/AHA recommend a clopidogrel loading dose of 300 mg.134
Patients with STEMI receiving a non-fibrin-specific thrombolytic agent who will undergo PCI within 24–48 hours: ACC/AHA recommend a clopidogrel 300-mg loading dose.134
Patients with STEMI who have received a fibrin-specific thrombolytic agent and will undergo PCI >24 hours later: ACC/AHA recommend a clopidogrel loading dose of 300–600 mg.134
Patients with STEMI who have received a non-fibrin-specific thrombolytic agent and will be undergoing PCI >48 hours later: ACC/AHA recommend a clopidogrel loading dose of 300–600 mg.134
Patients with STEMI who have not received thrombolytic or thienopyridine therapy and who will undergo nonprimary PCI: ACC/AHA recommend a clopidogrel loading dose of 300–600 mg.134
Patients allergic to or intolerant of aspirin†: 75 mg of clopidogrel once daily indefinitely as an adjunct to thrombolytic therapy.66
Planned PCI: ACC/AHA recommend a loading dose of 300–600 mg as early as possible before or at the time of PCI in conjunction with aspirin therapy.134 Larger loading doses (e.g., ≥900 mg) have been used to achieve higher level of antiplatelet activity more rapidly, but efficacy and safety not established.67 134
Following bare-metal stent implantation: 75 mg once daily with aspirin for ≥1 month.66 134 Ideally, continue for ≤12 months in conjunction with daily aspirin therapy in patients at low risk for bleeding.66 134 In patients at high risk for bleeding, administer clopidogrel and aspirin for a minimum of 2 weeks.134
Following DES implantation: 75 mg once daily with aspirin for ≤1 month.66 134 Continue for ≥12 months with aspirin in patients not at high risk for bleeding.28 43 44 45 46 50 51 52 54 66 134
No dosage adjustment necessary.1
No dosage adjustment necessary.1
Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage).1 6
Known hypersensitivity to clopidogrel or any ingredient in the formulation.1
Stent thrombosis with potentially fatal sequelae, particularly with DES, associated with premature discontinuance of therapy with a thienopyridine derivative and aspirin.43 44 45 46 47 48 49 54 (See Acute Coronary Syndromes: Unstable Angina or Non-ST-Segment Elevation MI under Uses.)
Before implantation of a DES, carefully assess patients for likelihood of compliance with prolonged dual-drug antiplatelet therapy.45 59 Consider avoiding use of a DES in patients who are not expected to comply.45 59 (See Advice to Patients.) In patients who are likely to require invasive or surgical procedures ≤12 months after DES implantation, consider implantation of a bare-metal stent or use of balloon angioplasty with provisional stent implantation instead.45
Clinicians performing invasive procedures must understand the consequences of premature discontinuance of thienopyridine derivative therapy in patients with DES.45 If issues about a patient’s antiplatelet therapy are unclear (e.g., concern about periprocedural bleeding), such professionals should contact the patient’s cardiologist.45 Defer elective procedures with substantial bleeding risk until completion of dual-drug antiplatelet therapy.45 For non-elective procedures that mandate discontinuance of thienopyridine-derivative therapy, continue aspirin therapy if at all possible.45 Restart thienopyridine therapy as soon as possible after the procedure.45
Possible reduced efficacy of clopidogrel (i.e., increased risk of cardiovascular events) due to genetic polymorphism of CYP2C19 or concurrent use of drugs (e.g., omeprazole) that inhibit CYP2C19.1 72 76 78 79 80 81 82 83 84 85 86 100 101 121 Consider use of other antiplatelet agents or alternative dosing strategies for clopidogrel in patients with variant CYP2C19 genotypes.1 121 123 (See Boxed Warning.)
Specific variant alleles of CYP2C19 (e.g., CYP2C19*2, CYP2C19*3) associated with reduced metabolism of and diminished antiplatelet response to clopidogrel; data on clinical outcomes are conflicting, but higher rates of major adverse cardiovascular events (e.g., death, MI, stroke, stent thrombosis) reported in patients receiving recommended dosages of clopidogrel who possess such alleles.1 76 78 79 80 82 83 88 89 90 92 104 117 118 121 (See Actions.) Genetic tests (e.g., Plavitest) are available to identify patients with variant CYP2C19 genotypes.1 20 121 122 While such tests are appropriate for any patient currently receiving or considering treatment with clopidogrel, the need for pharmacogenetic testing should be determined individually.121 122 123 Genetic variants of other CYP isoenzymes (e.g., CYP2C19*17, CYP2B6) also may affect response to clopidogrel.1 78 123 131 Role of either pharmacogenomic testing or platelet function testing in managing therapy with thienopyridines and proton-pump inhibitors not established.136
Concurrent use of clopidogrel and omeprazole, a potent inhibitor of CYP2C19, also shown to reduce antiplatelet effects of clopidogrel.1 72 79 84 88 89 98 100 101 102 103 109 (See Proton-Pump Inhibitors under Interactions.) Clinical importance not fully elucidated, but reduced effectiveness in preventing cardiovascular events possible.1 73 74 81 89 91 92 98 100 101 102 103 115 Concomitant use of other drugs that inhibit CYP2C19 also may decrease response to clopidogrel.1 100 101 (See Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.) Avoid concomitant therapy with known inhibitors of CYP2C19 activity.1 20 101
Rarely reported, sometimes after short exposure (<2 weeks) to the drug.1 11 12 Potentially fatal; requires urgent treatment, including plasmapheresis.1
Increased risk of bleeding.1 136 138
Discontinue clopidogrel 5–10 days prior to elective surgery if antiplatelet effect is undesirable.1 23 43 68 69
May restore hemostasis with exogenous administration of platelets; however, platelet transfusions within 4 hours of a loading dose or within 2 hours of a maintenance dose may have reduced effectiveness.1
Bleeding is unlikely to be resolved or prevented by withholding a dose of clopidogrel because of the drug's prolonged inhibitory effects on platelet function.1
American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) recommends prophylactic proton-pump inhibitor therapy to reduce risk of ulcer complications and GI bleeding in patients with additional GI risk factors receiving clopidogrel and aspirin.81 87 89 136 However, consider possibility of reduced antiplatelet effects when clopidogrel is used concomitantly with a proton-pump inhibitor (e.g., omeprazole).1 76 100 101 (See Interactions: Proton-Pump Inhibitors.)
In general, treatment with a thienopyridine derivative should not be discontinued prematurely because of the increased risk of cardiovascular events.1 (See Compliance with Therapy in Patients with Drug-eluting Stents under Cautions.)
Advise patient to never stop clopidogrel therapy without first consulting prescribing clinician.1 45
If temporary discontinuance is necessary (e.g., prior to surgery), reinitate therapy as soon as possible.1 (See Advice to Patients.)
Category B.1
Distributed into milk in rats; not known whether distributed into human milk.1 Discontinue nursing or the drug.1
Manufacturer states that safety and efficacy not established in patients <21 years of age.1 20
In neonates and infants† up to 24 months of age with systemic to pulmonary artery shunts or other cardiac conditions predisposing to thrombosis, clopidogrel 0.2 mg/kg daily for 1–4 weeks achieved similar inhibition of platelet aggregation as a 75-mg daily dosage in adults; no serious hemorrhagic events reported.97
In patients ≥75 years of age, no difference in platelet aggregation observed compared with younger healthy individuals.1 In a clinical trial, geriatric patients were at greater risk for thrombotic events and major bleeding than younger patients.1
Inhibition of ADP-induced platelet aggregation in patients with severe hepatic impairment appears to be similar to that observed in healthy individuals.1
Experience limited in patients with moderate or severe renal impairment.1
Inhibition of ADP-induced platelet aggregation is decreased in patients with moderate (Clcr 30–60 mL/minute) or severe (Clcr 5–15 mL/minute) renal impairment.1
Chest pain,1 6 accidental injury,1 6 influenza-like symptoms,1 6 pain,1 6 headache,1 6 dizziness,1 6 abdominal pain,1 6 8 dyspepsia,1 2 3 6 8 diarrhea,1 2 3 6 8 10 11 nausea,1 2 3 6 arthralgia,1 6 back pain,1 6 purpura,1 6 upper respiratory tract infection,1 6 rash,1 2 3 6 8 10 11 pruritus.1 6
Appears to inhibit CYP2C9 isoenzyme in vitro at high concentrations.1 8 20
Converted to active metabolite by CYP2C19.1 72 78 80 81 82 83 (See Metabolism under Pharmacokinetics.) Potential pharmacokinetic (decreased concentrations of active metabolite) and pharmacodynamic (reduced antiplatelet effects) interaction with inhibitors of CYP2C19.1 72 76 81 88 89 Avoid concomitant use of drugs (e.g., omeprazole) known to be potent inhibitors of CYP2C19.1 20 101
Potential for reduced systemic exposure to clopidogrel's active metabolite and reduced antiplatelet effects with certain proton-pump inhibitors (via inhibition of CYP2C19 by proton-pump inhibitor).1 20 72 73 74 84 86 88 89 91 100 101 102 103 106 107 109 (See Reduced Efficacy Associated with Impaired CYP2C19 Function under Cautions and see Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes under Interactions.) Interaction demonstrated with omeprazole, but not consistently observed with other proton-pump inhibitors.1 20 72 79 84 88 102 103 106 109 Conflicting data on clinical outcomes reported, but increased risk of adverse cardiovascular events possible.1 72 73 74 81 91 98 102 103 104 105 107 108 110 111 112 113 115 119
Based on currently available information, FDA and manufacturer of clopidogrel state that concomitant use (including separation of administration times) of clopidogrel and omeprazole should be avoided.1 100 101 113 FDA also states that esomeprazole should be avoided in patients receiving clopidogrel because of its potent CYP2C19-inhibitory activity.101 Extent to which other proton-pump inhibitors, which differ in CYP2C19-inhibitory potency, also may interfere with clopidogrel’s effects is unknown.100 106 114 If concomitant proton-pump inhibitor therapy is considered necessary, pantoprazole (which appears to be the weakest inhibitor of CYP2C19 among proton-pump inhibitors) has been suggested by some clinicians.81 89 92 102 103 109 111 112 114 However, weigh risks and benefits of concomitant use of any proton-pump inhibitor in individual patients.102 103 112 119 American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that use of a proton-pump inhibitor concomitantly with dual antiplatelet therapy may provide the optimal balance of risk and benefit in patients with acute coronary syndrome (ACS) who have a history of upper GI bleeding.136 Risk/benefit tradeoff may favor concomitant use of dual antiplatelet therapy and a proton-pump inhibitor in stable patients with a history of GI bleeding who undergo coronary revascularization and receive a coronary stent.136 ACCF/ACG/AHA states that the risk reduction with proton-pump inhibitors is substantial in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or nonsteroidal anti-inflammatory drugs (NSAIDs); H. pylori infection) and may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug–drug interaction.136 In patients without such risk factors for GI bleeding, risk/benefit balance may favor use of antiplatelet therapy without a concomitant proton-pump inhibitor.136 Alternatively, consider concomitant therapy with antacids or H2-receptor antagonists (i.e., ranitidine, famotidine, nizatidine), except for cimetidine (also a potent CYP2C19 inhibitor).1 81 89 92 100 103 112
Drug | Interaction | Comments |
|---|---|---|
Antacids | Currently no evidence that antacids interfere with antiplatelet effects of clopidogrel101 | |
Cilostazol | Potential additive antiplatelet effects93 94 Pharmacokinetic interaction unlikely19 93 | Caution advised; monitor bleeding times during concurrent administration93 |
Dexlansoprazole | Reduced efficacy observed with concomitant clopidogrel and omeprazole; extent to which other proton-pump inhibitors also may interfere with clopidogrel’s effects is unknown1 100 101 106 114 | FDA states that insufficient information available to make specific recommendations about concomitant use with clopidogrel100 |
Esomeprazole | Possible decreased plasma concentrations of clopidogrel's active metabolite and diminished antiplatelet effect101 | FDA recommends that concomitant use be avoided10 |
