Enap HL (enalapril maleate) tablets 10 mg/12.5 mg. №60

Description

Enap HL №60 Storage
active substances: 1 tablet contains enalapril maleate 10 mg and hydrochlorothiazide 12.5 mg or enalapril maleate 10 mg and hydrochlorothiazide 25 mg;

Enap HL №60 Excipients: sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, talc, magnesium stearate, quinoline yellow dye (E 104) – only in Enap®-H.

Enap HL №60 Dosage form
Tablets.

Basic physical and chemical properties:

Enap®-HL: round flat white tablets with a notch on one side, with beveled edges.

Enap®-H: round flat yellow tablets with a notch on one side, with beveled edges.

Pharmacotherapeutic group
Combined drugs of angiotensin-converting enzyme (ACE) inhibitors. ATX code C09B A02.

Pharmacological properties

Pharmacodynamics.

The drug is a combination of an ACE inhibitor (enalapril maleate) and a diuretic (hydrochlorothiazide).

ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the pressor substance angiotensin II. After absorption, enalapril is hydrolyzed to enalaprilat, which inhibits ACE inhibitors. Inhibition of ACE leads to a decrease in plasma levels of angiotensin II, which leads to increased plasma renin activity (due to inhibition of negative feedback during renin release) and decreased aldosterone secretion.

ACE is identical to kininase II. Therefore, enalapril can also block the breakdown of bradykinin, which is a potent vasodepressant peptide. However, the role of this fact in the realization of the therapeutic effects of enalapril remains unclear.

Mechanism of action

Although the mechanism by which enalapril lowers blood pressure is primarily associated with inhibition of the activity of the renin-angiotensin-aldosterone system (RAAS), which plays a major role in regulating blood pressure, enalapril may have an antihypertensive effect even in patients with hypertension.

Indication
Hypertension in patients treated with combination therapy.

Contraindication
Hypersensitivity to enalapril and to other ACE inhibitors, hydrochlorothiazide and to other sulphonamide derivatives or to other components of Enap®-H or Enap®-HL.
History of angioneurotic edema associated with prior ACE inhibitor therapy.
Hereditary or idiopathic angioneurotic edema.
Severe renal impairment [creatinine clearance less than 30 ml / min or serum creatinine level exceeds 265 μmol / l (3 mg / 100 ml)].
Renal artery stenosis.
During hemodialysis.
Clinical condition after kidney transplantation.
Severe liver dysfunction.
Anuria, primary hyperaldosteronism.
Hypokalemia or hyperkalemia resistant to treatment.
Refractory hyponatremia.
Symptomatic hyperuricemia (gout).
Pregnancy or pregnancy planning (see “Use during pregnancy or breastfeeding”).
Enalapril should not be used with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml / min / 1.73 m2) (see sections “Pharmacodynamics” and “Specifics”).
Concomitant use with sacubitril / valsartan therapy is due to an increased risk of angioneurotic edema. The drug should not be used within 36 hours after the last dose of sacubitril / valsartan – a drug containing a neprilysin inhibitor – or after switching from it to another drug (see sections “Interaction with other medicinal products and other forms of interaction” and “Special precautions for use”). »).