Amdocal®is a preparation of Amlodipine. Amlodipine is a dihydropyridine calcium antagonist, with a long duration of action, used for the treatment of hypertension and angina pectoris.
is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Amdocal®is indicated for the treatment of chronic stable angina. It may be used alone or in combination with other antianginal agents.
Amdocal®is indicated for the treatment of confirmed or suspected vasospastic angina. The drug may be used as single therapy or in combination with other antianginal drugs.
Dosage and Administration
The dose should be individualized according to the goal of therapy and patient response.
Usual Adult Dose
The usual initial oral dose for stable or vasospastic angina and hypertension is 5 mg once daily with a maximum dose of 10 mg once daily.
Children with hypertension from 6 years to 17 years of age
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.
Children under 6 years old
The effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
Amlodipine 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.
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Dosage recommendations have not been established in patients with mild to moderate hepatic impairment; therefore dose selection should be cautions and should start at the lower end of the dosing range. The pharmacokinetics of Amlodipine have not been studied in severe hepatic impairment. Amlodipine should be initiated at the lowest dose (2.5 mg once daily) and titrated slowly in patients with severe hepatic impairment.
Peripheral edema may occasionally be severe but is fully reversible. As with other calcium antagonist drugs, peripheral edema and skin erythema occur in a proportion of patients (5-10%) and facial flushing in 2-5% of patients. Complaint of fatigue was also reported more frequently than in placebo-treated patients. There is evidence that these effects are more common in patients treated with doses greater than 10 mg daily