Preparation
CCB 5 Tablet : Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg.
CCB 10 Tablet : Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 10 mg.
Indication
Patients with mild to moderate hypertension (alone or in combination with other antihypertensives). chronic stable and vasospastic angina, Reynaud\'s disease.
Contraindication
Hypersensitivity to CCB (Amlodipine) or other calcium channel antagonist, severe hypertension
Dosage & Administration
For treatment of both hypertension and angina pectoris, the usual initial dose is 5 mg once daily. If the desired therapeutic effect cannot be achieved within 2-4 weeks, the dose may be increased to a maximum dose of 10 mg once daily. CCB (Amlodipine) 10 mg once daily provide symptomatic improvement in patients with Reynaud\'s disease.
Side Effect
CCB (Amlodipine) is generally well tolerated. The most commonly observed side effects are headache, peripheral oedema, palpitations, flushing, dizziness, nausea, abdominal pain.
Precaution
Use in renal failure
Although CCB (Amlodipine) is excreted primarily via the kidney; mild renal impairment does not appear to have an effect on the plasma concentrations. Severe renal impairment may however require a dosage reduction. CCB (Amlodipine) is not dialyzable.
Use in patients with impaired hepatic function
CCB (Amlodipine) half-life is prolonged in patient with impaired hepatic function. CCB (Amlodipine) should therefore be administered at lower (5mg) initial dose in these patients.
Use in heart failure
An increase number of pulmonary oedema has been reported.
Use in pregnancy & lactation
Pregnancy: Safety in pregnancy has not been established.
Lactation: It is not known whether CCB (Amlodipine) is excreted in breast milk. It is advised to stop breastfeeding during treatment with CCB (Amlodipine).
Use in children: Use of CCB (Amlodipine) in children (under 12 years of age) is not recommended.
Drug Interaction
Digoxin : Absence of any interaction between amlodipine and digoxin in healthy volunteers has been documented in a controlled clinical study.
Warfarin : An unpublished study in healthy volunteers indicates that amlodipine does not significantly alter the effect of warfarin on prothrombin time.
Cimetidine : An unpublished clinical study indicated no interaction between amlodipine& cimetidine in healthy volunteers.
Presentation
CCB 5 Tablet : Each box contains 5 blister strips of 10 tablets.
CCB 10 Tablet : Each box contains 5 blister strips of 10 tablets.
