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Enalapril H, tablets

Drug formTablets

ATC categoryCardiology, angiology

ATC subcategoryCombined antihypertensive drugs

Brand nameEnalapril H

Generic nameEnalapril / Hydrochlorothiazide

Qualitative and quantitative composition

Each tablet contains:

active ingredients: enalapril maleate – 10 mg, hydrochlorothiazide – 25 mg;

excipients: microcrystalline cellulose, lactose monohydrate, povidone, maize starch, sodium starch glycolate, magnesium stearate, calcium hydrogen phosphate.

Pharmacological group and ATC code

Combined antihypertensive drugs; C09BA02.

Posology and method of administration

The drug is intended for oral treatment.

The dosage of the drug is based primarily on the experience with its active substance Enalapril maleate. The usual dose is one tablet once daily. If required, the dose may be increase to two tablets once daily.

For most patients, 20 mg (exceptionally 40 mg) enalapril maleate or 50 mg hydrochlorothiazide a day is sufficient; therefore, not more than two Enalapril-H 10 mg/25 mg tablets a day are recommended. If no satisfactory response is achieved, addition of a second drug or changed therapy is recommended (see sections 4.3, 4.4, 4.5 and 5.1).

Prior diuretic therapy

Symptomatic hypotension may occur following the initial dose of the drug; this is more likely in patients who are volume and/or salt depleted as a result of prior diuretic therapy. The diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with Enalapril-H 10 mg/25 mg.

Dosage in renal insufficiency

Thiazide diuretics may not be appropriate for patients with renal impairment. They are ineffective in patients with creatinine clearance values of 0.5 ml/s or less (i.e. moderate and severe renal insufficiency).

In patients with creatinine clearance between 0.5 ml/s and 1.3 ml/s, treatment should be started with a suitable dose of individual active substances.

Dosage in elderly patients

In clinical studies, the efficacy and tolerability of enalapril maleate and hydrochlorothiazide, administered concomitantly, were similar in both elderly and younger hypertensive patients.

Dosage in children

Safety and efficacy in children have not been established.

There is no time limit to the duration of treatment.

 

For more detailed information about the drug, click:http://pharm.cals.am/pharm/data/drug_134595/1734095524530.pdf