GENERIC NAME: captopril

BRAND NAME: Capoten

DRUG CLASS AND MECHANISM: Captopril is an oral drug and a member of a class of drugs called angiotensin converting enzyme (ACE) inhibitors.ACE inhibitors are used for treating high blood pressure, heart failure, and for preventing kidney failure due to high blood pressure and diabetes. Other ACE inhibitors include enalapril (Vasotec), quinapril (Accupril), ramipril(Altace), fosinopril (Monopril), benazepril (Lotensin), lisi nopril (Zestril, Prinivil), moexipril (Univasc) and trandolapril (Mavik). Angiotensin II is a very potent chemical that causes the muscles surrounding blood vessels to contract, thereby narrowing the vessels. The narrowing of the vessels increases the pressure within the vessels causing high blood pressure (hypertension). Angiotensin II is formed from angiotensin I in the blood by the enzyme angiotensin converting enzyme or ACE. ACE inhibitors are medications that slow (inhibit) the activity of the enzyme ACE and decrease the production of angiotensin II. As a result, blood vessels enlarge or dilate, and blood pressure is reduced. The lower blood pressure makes it easier for the heart to pump blood and can improve the function of a failing heart. In addition, progression of the blood vessel disease within the kidney caused by high blood pressure or diabetes is slowed. The FDA approved captopril in April 1981. PRESCRIPTION: Yes GENERIC AVAILABLE: Yes PREPARATIONS: Tablets: 12.5, 25, 50, 100 mg STORAGE: Captopril should be stored at room temperature, 15 to 30 C (59 to 86 F) and away from moisture. PRESCRIBED FOR: Captopril is used alone or in combination with other drugs for the treatment of high blood pressure and heart failure. Captopril also is used for improving survival and preventing heart failure and hospitalizations for heart failure after a heart attack. Like other ACE inhibitors, captopril may slow the progression of kidney failure in patients with diabetes or high blood pressure. DOSING: The recommended dose of captopril is 25-150 mg two or three times daily. The maximum dose is 450 mg daily. It should be taken on an empty stomach one hour before or two hours after meals since absorption of captopril is reduced when it is taken with food. DRUG INTERACTIONS: The use of ACE inhibitors with potassium supplements, salt substitutes or diuretics , for example, spironolactone(Aldactone), that increase potassium in the blood may lead to excessive potassium levels (hyperkalemia). Potassium levels should be monitored whenever ACE inhibitors are used in combination with these drugs. There have been reports of increased lithium (Eskalith, Lithobid) levels when lithium is used in combination with ACE inhibitors. The reason for this interaction is not known, but the increased levels may lead to toxicity from lithium. There have been reports that aspirin and other nonsteroidal antiinflammatory drugs (NSAIDs) such as ibuprofen (Advil, Children's Advil/Motrin, Medipren, Motrin, Nuprin, PediaCare Fever, etc.), indomethacin(Indocin, Indocin-SR), and naproxen (Anaprox, Naprelan, Naprosyn, Aleve) may reduce the effects of ACE inhibitors.

PREGNANCY: ACE inhibitors, including captopril, can be harmful to the fetus and should not be taken by pregnant women. NURSING MOTHERS: Captopril is secreted in breast milk. Therefore it should be avoided by nursing mothers.

SIDE EFFECTS: Captopril generally is well tolerated, and side effects are usually mild and transient. A dry, persistent cough has been reported commonly with the use of captopril and other ACE inhibitors. Coughing resolves after discontinuing the drug. Other side effects include abdominal pain, constipation, diarrhea, rash, dizziness, fatigue, headache, loss of taste, loss of appetite, nausea, vomiting, fainting and numbness or tingling in the hands or feet. Captopril and other ACE inhibitors also may cause kidney failure and increased levels of potassium in the blood. Serious but, fortunately, very rare side effects are liver failure and angioedema (swelling of lips and throat that can obstruct breathing). Reference: FDA Prescribing Information

Representative sample of the labeling (see the HOW SUPPLIED section for completed listing): PRINCIPAL DISPLAY PANEL - 12.5 mg BOTTLE LABEL APOTEX CORP. NDC 60505-0003-6 CAPTOPRIL TABLETS USP 12.5 mg Rx only 100 Tablets

WARNING: This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately. USES: Captopril is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat heart failure, protect the kidneys from harm due to diabetes, and to improve survival after a heart attack.Captopril is an ACE inhibitor and works by relaxing blood vessels so that blood can flow more easily.

HOW TO USE: Take this medication by mouth on an empty stomach (at least 1 hour before meals) as directed by your doctor, usually two to three times a day.The dosage is based on your medical condition and response to treatment.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.For the treatment of high blood pressure, it may take up to 2 weeks before you get the full benefit of this medication. For the treatment of heart failure, it may take weeks to months before you get the full benefit of this medication. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase). SIDE EFFECTS: Dizziness, lightheadedness, or loss of taste may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, fast heartbeat, muscle weakness, signs of infection (such as fever, chills, persistent sore throat), change in the amount of urine, cloudy urine.This drug may rarely cause serious (possibly fatal) liverproblems. Tell your doctor

right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash,itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking captopril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction that included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDL apheresis, dialysis), collagen vascular disease(such as lupus, scleroderma), high level of potassium in the blood.This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lightheadedness. Report prolonged diarrhea or vomiting to your doctor. Be sure to drink enough fluids to prevent dehydration unless your doctor directs you otherwise.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.Older adults may be more sensitive to the effects of this product, especially dizziness.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Drug interactions. See also Precautions section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aliskiren, lithium, drugs that may increase your potassium level (including birth control products that contain drospirenone).Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen your heart failure. Ask your pharmacist for more details.A very serious reaction may occur if you are getting injections for bee/wasp sting allergy (desensitization) and are also taking captopril. Make sure all your doctors know which medicines you are using.This product may interfere with certain laboratory tests (including acetone urine test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, fast heartbeat.

NOTES: Do not share this medication with others.Lifestyle changes such asstress reduction programs, exercise and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.Laboratory and/or medical tests (such as kidney function, potassium levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.Check your blood pressure regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. It is normal for the drug to have a slight sulfur-like odor. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.