Active Ingredient: Enalapril
For this indication, competent medicine agencies globally authorize below treatments:
Oral, between 5 milligrams enalapril and 20 milligrams enalapril, once daily. Afterwards, oral, between 20 milligrams enalapril and 40 milligrams enalapril, once daily.
The initial dose is 5 to maximally 20 mg, depending on the degree of hypertension and the condition of the patient. Enalapril is given once daily. In mild hypertension, the recommended initial dose is 5 to 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (e.g. renovascular hypertension, salt and/or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 5 mg or lower is recommended in such patients and the initiation of treatment should take place under medical supervision.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with enalapril. A starting dose of 5 mg or lower is recommended in such patients. If possible, diuretic therapy should be discontinued for 2-3 days prior to initiation of therapy with enalapril. Renal function and serum potassium should be monitored.
The usual maintenance dose is 20 mg daily. The maximum maintenance dose is 40 mg daily.
Regimen A: In case that patient weight is ≥ 20 kg and patient weight is ≤ 50 kg, oral, 2.5 milligrams enalapril,. Afterwards, in case that patient weight is ≥ 20 kg and patient weight is ≤ 50 kg, oral, between 2.5 milligrams enalapril and 20 milligrams enalapril,.
Regimen B: In case that patient weight is ≥ 50 kg, oral, 5 milligrams enalapril,. Afterwards, in case that patient weight is ≥ 50 kg, oral, between 5 milligrams enalapril and 40 milligrams enalapril,.
For patients who can swallow tablets, the dose should be individualised according to patient profile and blood pressure response. The recommended initial dose is 2.5 mg in patients 20 to <50 kg and 5 mg in patients ≥50 kg. Enalapril is given once daily. The dosage should be adjusted according to the needs of the patient to a maximum of 20 mg daily in patients 20 to <50 kg and 40 mg in patients ≥50 kg.
Enalapril is not recommended in neonates and in paediatric patients with glomerular filtration rate <30 ml/min/1.73 m², as no data are available.
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