Lakhasly

Absorption: Enalapril is rapidly absorbed with peak serum concentrations of enalapril occurring within one hour.The 10 mg tablet contains iron oxide red 30 and the 20 mg tablet contains iron oxide brown 70.DOSAGE FORMS, COMPOSITION AND PACKAGING ENALAPRIL ENALAPRIL 2.5 mg Tablets are white, oval shaped bi-convex tablets, debossed with "2.5" scoreline "G" on one side and scoreline on the other side. Available in blisters of 10's (cartons of 30) and in HDPE bottles of 100 and 500 tablets. ENALAPRIL 5 mg Tablets are white, arc triangle shaped bi-convex tablets, debossed with "5" over "G" on one side and scoreline on the other side.Composition Each tablet of ENALAPRIL is made with 2.5, 5, 10 or 20 mg enalapril maleate that appears as 2, 4, 8 or 16 mg enalapril sodium, respectively in the tablets, and the following non-medicinal ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium bicarbonate.ENALAPRIL 10 mg Tablets are rusty red, arc triangle shaped bi-convex tablets, debossed with "10" over "G" on one side and scoreline on the other side. Available in blisters of 10's (cartons of 30) and in HDPE bottles of 100 and 500 tablets. ENALAPRIL 20 mg Tablets are peach coloured, arc triangle shaped bi-convex tablets, debossed with "20" over "G" on one side and scoreline on the other side.Metabolism: Following absorption, enalapril is rapidly and extensively hydrolyzed to enalaprilat, a potent angiotensin converting enzyme inhibitor (which itself is poorly absorbed).Special Populations and Conditions Pediatrics: In pediatric patients the antihypertensive effect of enalapril has been studied in hypertensive children aged 6 -16 years (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).With renal function <=30 mL/min (<=0.50 mL/s), peak and trough enalaprilat levels increase, time to peak concentration increases and time to steady state may be delayed.Excretion: Excretion of enalapril is primarily renal.Keep container tightly closed.

Absorption: Enalapril is rapidly absorbed with peak serum concentrations of enalapril occurring within one hour. Based on urinary recovery the extent of absorption of enalapril from enalapril is approximately 60%. The absorption of enalapril is not influenced by the presence of food in the gastrointestinal tract.
Metabolism: Following absorption, enalapril is rapidly and extensively hydrolyzed to enalaprilat, a potent angiotensin converting enzyme inhibitor (which itself is poorly absorbed). Peak serum concentrations of enalaprilat occur 3 to 4 hours after an oral dose of enalapril. Except for conversion to enalaprilat, there is no evidence of significant metabolism of enalapril.
Excretion: Excretion of enalapril is primarily renal. Approximately 94% of the dose is recovered in the urine and feces as enalaprilat or enalapril. The principal components in urine are enalaprilat, accounting for about 40% of the dose, and intact enalapril.
The serum concentration profile of enalaprilat exhibits a prolonged terminal phase, apparently associated with binding to ACE. The effective half-life for accumulation of enalaprilat following multiple doses of enalapril is 11 hours.
In hypertensive children aged 2 months to 15 years the kinetics of enalapril were approximately similar to adults (see DOSAGE AND ADMINISTRATION).
Special Populations and Conditions
Pediatrics: In pediatric patients the antihypertensive effect of enalapril has been studied in hypertensive children aged 6 -16 years (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics).
Race: The antihypertensive effect of angiotensin converting enzyme inhibitors is generally lower in black than in non-black patients.
Renal Insufficiency: The disposition of enalapril and enalaprilat in patients with renal insufficiency is similar to that in patients with normal renal function until the glomerular filtration rate is 30 mL/min (0.50 mL/s) or less. With renal function ≤30 mL/min (≤0.50 mL/s), peak and trough enalaprilat levels increase, time to peak concentration increases and time to steady state may be delayed. The effective half-life of enalaprilat following multiple doses of enalapril is prolonged at this level of renal insufficiency (see DOSAGE AND ADMINISTRATION). Enalaprilat is dialyzable at the rate of 62 mL/min (1.03 mL/s).
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STORAGE AND STABILITY
ENALAPRIL
Store at controlled room temperature (15°C – 30°C). Keep container tightly closed. Protect from moisture.
NOTE: 100 and 500 tablet bottle: discard remaining tablets six months after opening bottle.
DOSAGE FORMS, COMPOSITION AND PACKAGING
ENALAPRIL
ENALAPRIL 2.5 mg Tablets are white, oval shaped bi-convex tablets, debossed with “2.5” scoreline “G” on one side and scoreline on the other side. Available in blisters of 10’s (cartons of 30) and in HDPE bottles of 100 and 500 tablets.
ENALAPRIL 5 mg Tablets are white, arc triangle shaped bi-convex tablets, debossed with “5” over “G” on one side and scoreline on the other side. Available in blisters of 10’s (cartons of 30) and in HDPE bottles of 100 and 500 tablets.
ENALAPRIL 10 mg Tablets are rusty red, arc triangle shaped bi-convex tablets, debossed with “10” over “G” on one side and scoreline on the other side. Available in blisters of 10’s (cartons of 30) and in HDPE bottles of 100 and 500 tablets.
ENALAPRIL 20 mg Tablets are peach coloured, arc triangle shaped bi-convex tablets, debossed with “20” over “G” on one side and scoreline on the other side. Available in blisters of 10’s (cartons of 30) and HDPE bottles of 100 and 500.
The splitting of ENALAPRIL Tablets is not advised.
Composition
Each tablet of ENALAPRIL is made with 2.5, 5, 10 or 20 mg enalapril maleate that appears as 2, 4, 8 or 16 mg enalapril sodium, respectively in the tablets, and the following non-medicinal ingredients: corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium bicarbonate. The 10 mg tablet contains iron oxide red 30 and the 20 mg tablet contains iron oxide brown 70.
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PART II: SCIENTIFIC INFORMATION