Naprilate

Naprilate

enalapril

Manufacturer:

Taiwan Biotech

Distributor:

New Smart Formulae
Full Prescribing Info
Contents
Enalapril maleate.
Description
Each tablet contains Enalapril Maleate 20 mg.
Action
Enalapril Maleate (Naprilate) is a derivative of two amino acids, L-proline. Following oral administration, Enalapril maleate is rapidly absorbed and then hydrolyzed to enalaprilat, which is an angiotensin converting enzyme (ACE) inhibitor.
Indications/Uses
For the treatment of hypertension and congestive heart failure.
Dosage/Direction for Use
Since absorption is not affected by food, the tablets may be administered before, during or after meals.
Essential Hypertension: the initial dose is 10 to 20 mg 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 20 mg and the dosage should be adjusted according to the needs of the patient.
Renovascular Hypertension: The therapy should be initiated with a lower starting dose (e.g 5 mg or less). The dosage should then be adjusted according to the needs of the patients. For patients with hypertension who have been treated recently with diuretics, symptomatic hypotension may occur following the initial dose of Enalapril maleate (Naprilate). 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 Enalapril maleate (Naprilate). If this is not possible, the initial dose should be low (5 mg or less) to determine the initial effect on the blood pressure. Dosage should be then adjusted to the needs of the patients.
Renal Insufficiency: See table.

Click on icon to see table/diagram/image

Heart Failure:
Initial dose should be given lower than 5 mg and 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 Enalapril maleate (Naprilate) in heart failure, the dose should be increased gradually to the usual maintenance dose of 20 mg given in a single or two divided doses.
Contraindications
Hypersensitivity to enalaprilat, enalapril, other ACE inhibitors, or any component of this product or in the formulation.
Special Precautions
Renal function impairment: Patients with renal insufficiency may require reduced and/or less frequent doses of Enalapril maleate (Naprilate).
Additive effect may occur when Enalapril maleate (Naprilate) is used together with other antihypertensive therapy.
In patients treated with other antihypertensive therapy.
In patients treated with Enalapril maleate (Naprilate) plus thiazide diuretic, the potassium-losing effect of the diuretic was attenuated usually by the effect of Enalapril.
Enalapil maleate (Naprilate) is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with ACE inhibitor.
Use in Pregnancy: The use of Enalapril maleate (Naprilate) during pregnancy is not recommended. When pregnancy is detected, Enalapril maleate (Naprilate) should be discontinued as soon as possible, unless it is considered life saving for the mother. Enalapril maleate (Naprilate) can cause fetal and neonatal morbidity and mortality when administered to pregnant women during the second and third trimesters. Use of ACE inhibitors during this period has been associated with the fetal and neonatal injury including hypotension, renal failure, hyperkalemia and/or skull hypoplasia in the newborn.
Use in Lactation: Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if Enalapril maleate (Naprilate) is given to a nursing mother.
Use In Pregnancy & Lactation
Use in Pregnancy: The use of Enalapril maleate (Naprilate) during pregnancy is not recommended. When pregnancy is detected, Enalapril maleate (Naprilate) should be discontinued as soon as possible, unless it is considered life saving for the mother. Enalapril maleate (Naprilate) can cause fetal and neonatal morbidity and mortality when administered to pregnant women during the second and third trimesters. Use of ACE inhibitors during this period has been associated with the fetal and neonatal injury including hypotension, renal failure, hyperkalemia and/or skull hypoplasia in the newborn.
Use in Lactation: Enalapril and enalaprilat are secreted in human milk in trace amounts. Caution should be exercised if Enalapril maleate (Naprilate) is given to a nursing mother.
Adverse Reactions
Dizziness and headache were the more commonly reported adverse or undesirable effects. Fatigue and asthenia were reported in 2-3% of patients. Other adverse effects occurred in less than 2% of patients including hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, rash and cough.
Drug Interactions
Additive effect may occur when Naprilate is used together with other antihypertensive therapy. In patients treated with Naprilate plus a thiazide diuretic, the potassium-losing effect of the diuretic was attenuated usually by the effect of enalapril.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
C09AA02 - enalapril ; Belongs to the class of ACE inhibitors. Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 5 mg x 100's. 20 mg x 100's.
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