Information about Amtas 5mg Tablet
- Product Composition:
- Amlodipine
- Precautions:
- Impaired liver or renal function, CHF, sick-sinus syndrome, severe ventricular dysfunction, hypertrophic cardiomyopathy, severe aortic stenosis. Caution when used in patients with idiopathic hypertrophic subaortic stenosis. Elderly, children. Pregnancy, lactation. Use in renal failure: Although Amlodipine is excreted primarily via kidney, mild renal impairment does not appear to have an effect on the plasma concentrations. Severe renal impairment may however require a dosage reduction. Amlodipine is not dialyzable. Use in patients with impaired hepatic function: Amlodipine half-life is prolonged in patient with impaired hepatic function. Amlodipine should therefore be administered at lower (5mg) initial dose in these patients. Use in heart failure: An increased number of pulmonary oedema has been reported. Lactation: Unknown whether drug is excreted in milk; use not recommended
- Indications:
- Mild to moderate hypertension, Chronic stable and vasospastic angina, Raynaud's disease, Coronary Artery Disease, HTN, Stroke prevention
- Contraindications:
- Hypersensitivity to Amlodipine or other calcium channel antagonist, Severe hypertension.
- Dosage:
- Adult: PO Stable angina; HTN; Prinzmetal's angina Initial: 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. Child: >12 yr Initially, 2.5 mg once daily, increased to 5 mg once daily if necessary. Elderly: Initially, 2.5 mg once daily. Hepatic impairment: Initially, 2.5 mg once daily.
- Common Side Effects:
- >10% Edema (1.8-10.8%),Pulmonary edema (7-15%) 1-10% Headache (7.3%),Fatigue (4.5%),Palpitations (0.7-4.5%),Dizziness (1.1-3.4%),Nausea (2.9%),Flushing (0.7-2.6%),Abdominal pain (1.6%),Somnolence (1.4%),Male sexual disorder (1-2%),Drowsiness (1%),Pruritus (1-2%),Skin rash (1-2%),Muscle cramps (1-2%),Muscle weakness (1-2%) Potentially Fatal: Hypotension, bradycardia, conductive system delay and CCF.
- Mode Of Action:
- Amlodipine relaxes peripheral and coronary vascular smooth muscle. It produces coronary vasodilation by inhibiting the entry of Ca ions into the slow channels or select voltage-sensitive channels of the vascular smooth muscle and myocardium during depolarisation. It also increases myocardial oxygen delivery in patients w/ vasospastic angina.
- Interaction:
- Plasma concentrations may be elevated w/ CYP3A4 inhibitors (e.g. azole antifungals, ritonavir). Concomitant therapy w/ simvastatin may increase risk of myopathy including rhabdomyolysis. May increase ciclosporin plasma levels and conivaptan.
- Pregnancy Interaction:
- Pregnancy Category - C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
- Therapeutic Class:
- Calcium-channel blockers,Calcium-channel blockers,Calcium channel blockers,Calcium-channel blockers,Calcium-channel blockers