Indications
Amlotab Tablet is used for:
Mild to moderate hypertension, Chronic stable and vasospastic angina, Raynaud's disease, Coronary Artery Disease, HTN, Stroke prevention
Adult Dose
Oral
Prinzmetal's angina; Stable angina
Adult: Initially, 5 mg once daily increased to 10 mg once daily if necessary.
Elderly: Initially, 2.5 mg once daily. maintenance: 10 mg/day
Hepatic impairment: Initially, 2.5 mg once daily.
Hypertension
Adult: Initially, 5 mg once daily increased to 10 mg once daily if necessary.
Elderly: Initially, 2.5 mg once daily. may be increased by 2.5 mg/day every 7-14 days; not to exceed 10 mg/day PO; maintenance: 5-10 mg/day PO
Hepatic impairment: Initially, 2.5 mg once daily.
Child Dose
Hypertension
<6 years: Safety and efficacy not established
>6 years: 2.5-5 mg/day PO
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity to Amlodipine or other calcium channel antagonist, Severe hypertension.
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
Pregnancy-Lactation
Pregnancy
Limited available data based on postmarketing reports are insufficient to inform a drug-associated risk for major birth defects and miscarriage during pregnancy
Clinical considerations
Hypertension in pregnancy increases maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section, postpartum hemorrhage)
Hypertension increases fetal risk for intrauterine growth restriction and intrauterine death
Carefully monitor pregnant women with hypertension and manage accordingly
Lactation
Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose
No adverse effects of amlodipine on breastfed infant reported
There is no available information on effects of amlodipine on milk production
Interactions
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.
Side Effects
Side effects of Amlodipine :
>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.
Note
Amlotab 5mg Tablet generic name is Amlodipine. Amlotab 5mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Amlotab is availble in all over Bangladesh.
Mes BD drug index information on Amlotab Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.