Captotab Tablets

Hypertension Captopril tablets are indicated for the treatment of hypertension. In using captopril tablets, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril tablets 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 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 tablets
• The initial dose of captopril tablets is 25 mg b.i.d. or t.i.d
• If satisfactory reduction of blood pressure has not been achieved after one or two weeks, the dose may be increased to 50 mg b.i.d. or t.i.d
• Concomitant sodium restriction may be beneficial when captopril tablets are used alone
• The dose of captopril tablets in hypertension usually does not exceed 50 mg t.i.d
• Therefore, if the blood pressure has not been satisfactorily controlled after one to two weeks at this dose, (and the patient is not already receiving a diuretic), a modest dose of a thiazide-type diuretic (e.g., hydrochlorothiazide, 25 mg daily), should be added
• The diuretic dose may be increased at one- to two-week intervals until its highest usual antihypertensive dose is reached
• If captopril tablets are being started in a patient already receiving a diuretic, captopril tablets therapy should be initiated under close medical supervision (see WARNINGS and PRECAUTIONS: Drug Interactions regarding hypotension), with dosage and titration of captopril tablets as noted above
• If further blood pressure reduction is required, the dose of captopril tablets may be increased to 100 mg b.i.d. or t.i.d. …

• Neonates with a History of In Utero Exposure to Captopril Tablets If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion
• Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function
• While captopril may be removed from the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the circulation of neonates or children. …

• Patients should be advised to immediately report to their physician any signs or symptoms suggesting angioedema (e.g., swelling of face, eyes, lips, tongue, larynx and extremities; difficulty in swallowing or breathing; hoarseness) and to discontinue therapy (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema )
• Patients should be told to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of neutropenia, or of progressive edema which might be related to proteinuria and nephrotic syndrome. …

• Captopril tablets are 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 tablets in patients with diabetes (see PRECAUTIONS : Drug Interactions )
• Captopril tablets are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). …

Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on captopril tablets and other agents that block the RAS. Do not coadminister aliskiren with captopril tablets in patients with diabetes. …

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 tablets) 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. …

Reported incidences are based on clinical trials involving approximately 7000 patients. Renal About one of 100 patients developed proteinuria (see WARNINGS ). Each of the following has been reported in approximately 1 to 2 of 1000 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. …

Pregnancy Female patients of childbearing age should be told about the consequences of exposure to captopril tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Correction of hypotension would be of primary concern. Volume expansion with an intravenous infusion of normal saline is the treatment of choice for restoration of blood pressure. While captopril may be removed from the adult circulation by hemodialysis, there is inadequate data concerning the effectiveness of hemodialysis for removing it from the circulation of neonates or children. Peritoneal dialysis is not effective for removing captopril; there is no information concerning exchange transfusion for removing captopril from the general circulation.

STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. …

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