Lotense Capsules (Hard Gelatin)

Amlodipine
5mg
Tabuk Pharmaceutical Manufacturing Co.
Pack size 30's (10's Blister x 3)
Dispensing mode POM
Source SAUDI ARABIA
AgentALPHAMED SHARJAH EST.
Retail Price 43.50 AED

Available as:

10mg - Capsules (Hard Gelatin)

Indications

Lotense Capsules (Hard Gelatin) 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.

Adverse 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.

Mechanism 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

Lotense 5mg Capsules (Hard Gelatin) manufactured by Tabuk Pharmaceutical Manufacturing Co.. Its generic name is Amlodipine. Lotense is availble in United Arab Emirates. Farmaco UAE drug index information on Lotense Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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