Berlin Pharm


Full Prescribing Info
Enalapril maleate.
Anapril is the maleate salt of enalapril, a derivative of 2 amino acids, L-alanine and L-proline. Following oral administration, enalapril is rapidy absorbed and then hydrolysed to enalaprilat, which is a highly specific, long acting, non-sulfhydryl angiotensin-converting enzyme inhibitor.
Anapril is indicated in all grade of essential hypertension, renovascular hypertension and in the treatment of all degrees of heart failure. In patients with symptomatic heart failure. Anapril is also indicated to improve survival, retard the progression of heart failure, reduce hospitalization for heart failure, reduce myocardial infarction, reduce hospitalization for unstable vagina pectoris.
Dosage/Direction for Use
Essential Hypertension: The initial dose is 10-20 mg, depending on the degree of hypertension, and is given once daily. In mild hypertension, the recommended initial dose is 10 mg daily. For other degrees of hypertension the initial dose is 20 mg daily. The usual maintenance dose is one 20 mg tab taken once daily. The dosage should be adjusted according to the patient to a maximum of 40 mg daily.
Renovascular Hypertension: Since blood pressure and renal function in such patients may be particularly sensitive to ACE inhibitor, therapy should be initiated with a lower starting dose (eg. 5 mg or less). The dosage should then be adjusted according to the needs of the patient. Most patients may be expected to respond to one 20 mg tab taken once daily. For patients with hypertension who have been treated recently with diuretics, caution is recommended.
Concomitant Diuretic Therapy in Hypertension: Symptomatic hypotension may occur following the initial dose of Anapril, this is more likely in patients who are being treated currently with diuretics. Caution is recommended, therefore, since these patients may be volume or salt depleted. The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Anapril. If this is not possible, the initial dose of Anapril should be low (5 mg or less) to determine the initial effect on the blood pressure. Dosage should then be adjusted according to the needs of the patient.
Dosage in Renal Insufficiency: Generally, the intervals between the administration of enalapril should be prolonged and/or the dosage reduced.
Heart Failure: The initial dose of Anapril in patients with heart failure is 2.5 mg and it should be administered under close medical supervision to determine the initial effect on the blood pressure. In the absence of, or after effective management of symptomatic hypotension following initiation of therapy with Anapril in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg, given in a single dose or 2 divided doses, as tolerated by the patient. This dose titration may be performed over 2-4 week period or more rapidly if indicated by the presence of residual signs and symptoms of heart failure. This dosage regimen was effective in reducing mortality. Blood pressure and renal function should be monitored closely both before and after starting treatment with Anaprill because hypotension and (more rarely) consequent renal failure have been reported. If possible, the dose of diuretic should be reduced before beginning treatment. The appearance of hypotension after the initial dose of Anapril dose not imply that hypotension will recur during chronic therapy with Anapril and dose not preclude continued use of the drug. Serum potassium also should be monitored.
Administration: Since absorption of Anapril tablet is not affected by food, tablets may be administered before, during or after meals.
Anapril is contraindicated in patients who are hypersensitive to any component of Anapril and in patients with a history of angioneurotic edema relating to previous treatment with an angiotensin-converting enzyme inhibitor.
Use in Pregnancy: The use of Anapril during pregnancy is not recommended.
Use in Lactation: Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if Anapril is given to a nursing mother.
Use in Children: Anapril has not been studied in children.
Use In Pregnancy & Lactation
Use in Pregnancy: The use of Anapril during pregnancy is not recommended.
Use in Lactation: Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if Anapril is given to a nursing mother.
Side Effects
Anapril has been demonstrated to be generally well-tolerated. For the most part, side effects have been mild and transient in nature and have not required discontinuation of therapy. Dizziness, Headache, Fatigue and Asthenia were reported. Other side effects occured in <2% of patients and included hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, rash and cough.
Drug Interactions
Antihypertensive Therapy: Additive effect may occur when Anapril is used together with other antihypertensive therapy.
Serum Potassium: In clinical trial, serum potassium usually remained within normal limits. In hypertensive patients treated with Anapril alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with Anapril plus a thiazide diuretic, the potassium losing effects of the diuretic was attenuated usually by the effect of enalapril.
If Anapril is given with a potassium-losing diuretic, diuretic-induced hypokalemia may be ameliorated.
Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene or amiloride), potassium supplements or potassium-containing salt substitutes. The use of potassium supplements, potassium-sparing diuretics or potassium-containing salt substitutes particularly in patients with impaired renal function may lead to a significant in serum potassium.
If concomitant use of previously-mentioned agents is deemed appropriate, they should be used with caution and with frequent monitoring of serum potassium.
Serum Lithium: As with other drugs which eliminate sodium, lithium clearance may be reduced. Therefore, the serum lithium levels should be monitored carefully if lithium salts are to be administered.
ATC Classification
C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Tab 5 mg x 10 x 10's. 20 mg x 10 x 10's.
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