Source: Υπουργείο Υγείας (CY) Revision Year: 2017 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
For both hypertension and angina the usual initial dose is 5 mg Amlorine once daily which may be increased to a maximum dose of 10 mg depending on the individual patient’s response.
In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, alpha blocker, beta blockers or an angiotensin converting enzyme inhibitor. For angina, Amlorine may be used as monotherapy or in combination with other antianginal medical products in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.
No dose adjustment of Amlorine is required upon concomitant administration of thiazide diuretics, beta blockers, and angiotensin-converting enzyme inhibitors.
Amlorine used at similar doses in elderly or younger patients, is equally well tolerated. Normal dosage regimens are recommended but increase of the dosage should take place with care (see section 4.4 and 5.2).
Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautious and should start at the lower end of the dosing range (see sections 4.4 and 5.2). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose and titrated slowly in patients with severe hepatic impairment.
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Children and adolescents with hypertension from 6 years to 17 years of age:
The recommended antihypertensive oral dose in paediatric patients ages 6-17 years is 2.5 mg once daily as a starting dose, up-titrated to 5 mg once daily if blood pressure goal is not achieved after 4 weeks. Doses in excess of 5 mg daily have not been studied in paediatric patients (see sections 5.1 and 5.2).
Doses of amlodipine 2.5 mg are not possible with this medicinal product.
Children under 6 years old:
No data are available.
Oral administration.
In humans experience with intentional overdose is limited.
Available data suggest that gross overdosage could result in excessive peripheral vasodilation and possibly reflex tachycardia. Marked and probably prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular support including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous calcium gluconate may be benefitial in reversing the effects of calcium channel blockade.
Gastric lavage may be worthwhile in some cases. In healthy volunteers the use of charcoal up to 2 hours after administration of amlodipine 10 mg has been shown to reduce the absorption rate of amlodipine.
Since amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
5 years.
Store below 25°C.
Protect from light and moisture.
PVC-PE-PVDC/Aluminium blisters.
Pack-sizes of 10, 20, 30, 50, and 100 tablets.
No special requirements.
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