Captopril
Generic Name: captopril
Brand Names:
Captopril
DESCRIPTION Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl] -L-proline [MW 217.28] and has the following structure: Captopril USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx.
Overview
DESCRIPTION Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. Captopril is designated chemically as 1-[(2S)-3-mercapto-2-methylpropionyl] -L-proline [MW 217.28] and has the following structure: Captopril USP is a white to off-white crystalline powder that may have a slight sulfurous odor; it is soluble in water (approx.
Uses
INDICATIONS AND USAGE Hypertension: Captopril tablets, USP, are indicated for the treatment of hypertension. In using captopril tablets, USP, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets, USP may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets, USP are effective alone and in combination with other antihypertensive agents, especially thiazidetype diuretics.
Dosage
DOSAGE AND ADMINISTRATION Captopril tablets, USP should be taken one hour before meals. Dosage must be individualized. Hypertension: Initiation of therapy requires consideration of recent antihypertensive drug treatment, the extent of blood pressure elevation, salt restriction, and other clinical circumstances. If possible, discontinue the patient’s previous antihypertensive drug regimen for one week before starting captopril. The initial dose of captopril tablets, USP is 25 mg twice daily or three times a day. If satisfactory reduction of blood pressure has not been achieved after one week or two weeks, the dose may be increased to 50 mg twice daily or three times a day. Concomitant sodium restriction may be beneficial when captopril is used alone.
Side Effects
ADVERSE REACTIONS Reported incidences are based on clinical trials involving approximately 7,000 patients. Renal : About one of 100 patients developed proteinuria (see WARNINGS ). Each of the following has been reported in approximately 1 to 2 of 1,000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency. Hematologic : Neutropenia/agranulocytosis has occurred (see WARNINGS ). Cases of anemia, thrombocytopenia, and pancytopenia have been reported. Dermatologic : Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy.
Warnings
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue captopril tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including captopril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1,000 solution of epinephrine should be promptly instituted. CONTRAINDICATIONS Captopril is contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril in patients with diabetes (see PRECAUTIONS , Drug Interactions ).
Storage
HOW SUPPLIED Captopril tablets, USP are available containing 12.5 mg, 25 mg, 50 mg or 100 mg of captopril, USP. The 12.5 mg tablets are white to off-white, oval shaped, flat beveled edged uncoated tablets having break line on both sides and one side debossed with “C” on one side of the break line and “1” on other side of the break line (bisect).
Frequently Asked Questions
What is Captopril used for?▼
INDICATIONS AND USAGE Hypertension: Captopril tablets, USP, are indicated for the treatment of hypertension. In using captopril tablets, USP, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets, USP may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low. In patients with impaired renal function, particularly those with collagen vascular disease, captopril should be reserved for hypertensives who have either developed unacceptable side effects on other drugs, or have failed to respond satisfactorily to drug combinations. Captopril tablets, USP are effective alone and in combination with other antihypertensive agents, especially thiazidetype diuretics.
What are the side effects of Captopril?▼
ADVERSE REACTIONS Reported incidences are based on clinical trials involving approximately 7,000 patients. Renal : About one of 100 patients developed proteinuria (see WARNINGS ). Each of the following has been reported in approximately 1 to 2 of 1,000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency. Hematologic : Neutropenia/agranulocytosis has occurred (see WARNINGS ). Cases of anemia, thrombocytopenia, and pancytopenia have been reported. Dermatologic : Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy.
What are the important warnings for Captopril?▼
WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue captopril tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS: Fetal Toxicity WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including captopril) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema: Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been seen in patients treated with ACE inhibitors, including captopril. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Emergency therapy, including but not necessarily limited to, subcutaneous administration of a 1:1,000 solution of epinephrine should be promptly instituted. CONTRAINDICATIONS Captopril is contraindicated in patients who are hypersensitive to this product or any other angiotensin-converting enzyme inhibitor (e.g., a patient who has experienced angioedema during therapy with any other ACE inhibitor). Do not co-administer aliskiren with captopril in patients with diabetes (see PRECAUTIONS , Drug Interactions ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.