Source: Υπουργείο Υγείας (CY) Revision Year: 2018 Publisher: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Germany Tel: +49 4721 606 0, Fax: +49 4721 606 333, Email: info@tad.de Distributor: Ki.Pa pharrmacal Ltd, 9, Polygyrou Street PO Box 40608 Larnaca, ...
Essential hypertension.
Chronic stable and vasospastic angina pectoris.
For both hypertension and angina, the usual initial dose is 5 mg AmloBe once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient’s response.
In hypertensive patients, AmloBe has been used in combination with a thiazide diuretic, alpha blocker, beta blocker, or an angiotensin converting enzyme inhibitor. For angina, AmloBe may be used as monotherapy or in combination with other antianginal medicinal products in patients with angina that is refractory to nitrates and/or to adequate doses of beta blockers.
No dose adjustment of AmloBe is required upon concomitant administration of thiazide diuretics, beta blockers and angiotensin-converting enzyme inhibitors.
AmloBe used at similar doses in elderly or younger patients is equally well tolerated. Normal dosage regimens are recommended in the elderly, but increase of the dosage should take place with care (see sections 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 pediatric 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 pediatric patients (see sections 5.1 5.2).
Children under 6 years old:
No data are available.
Tablet for oral administration.
The 2.5 mg dose can be obtained with AmloBe 5 mg tablets as these tablets are manufactured to break into two equal halves.
The tablets should be taken with a glass of water independently from meals.
In humans, experience with intentional overdose is limited.
Available data suggest that gross overdosage could result in excessive peripheral vasodilatation 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 beneficial in reversing the effects of calcium channel blockade.
Gastric lavage may be worthwhile in some cases. In healthy volunteers the use charcoal up to 2h after administration of amlodipine 10mg 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 in the original container in order to protect from light.
OPA-Al-PVC/Al blister: 30 tablets.
Not all pack sizes may be marketed.
No special requirements.
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