Levamolin 2.5 Tablet: Each tablet contains Levamlodipine Maleate INN equivalent to
Levamlodipine 2.5 mg.
Levamolin 5 Tablet: Each tablet contains Levamlodipine Maleate INN equivalent to
Levamlodipine 5 mg.
Levamlodipine is a pharmacologically active isomer of amlodipine. It is a dihydropyridine
calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the
transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle
to cause a reduction in peripheral vascular resistance and reduction in blood pressure.
Levamlodipine is a calcium channel blocker and may be used alone or in combination with
other antihypertensive agents for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily strokes and myocardial infarctions.
Dosage & Administrations:
Adults: The usual initial antihypertensive oral dose of levamlodipine is 2.5 mg once daily,
and the maximum dose is 5 mg once daily.
Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on
1.25 mg once daily and this dose may be used when adding levamlodipine to other
antihypertensive therapy. Adjust dosage according to blood pressure goals.
Children: The effective antihypertensive oral dose in pediatric patients ages 6-17 years is
1.25 mg to 2.5 mg once daily. Doses in excess of 2.5 mg daily have not been studied in
Warning & Precautions:
Hypotension: Symptomatic hypotension is possible, particularly in patients with severe aortic
stenosis. Because of the gradual onset of action, acute hypotension is unlikely.
Increased Angina or Myocardial Infarction: Worsening angina and acute myocardial
infarction can develop after starting or increasing the dose of amlodipine, particularly in
patients with severe obstructive coronary artery disease.
Patients with Hepatic Failure: Because amlodipine is extensively metabolized by the liver and
the plasma elimination half-life (t ) is 56 hours in patients with impaired hepatic function,
titrate slowly when administering amlodipine to patients with severe hepatic impairment.
Most common adverse reactions to amlodipine is edema which occurred in a dose related
manner. Other adverse experiences not dose related but reported with an incidence >1.0%
are fatigue, nausea, abdominal pain and somnolence.
Impact of Other Drugs on Amlodipine:
CYP3A Inhibitors: Co-administration with CYP3A inhibitors (moderate and strong) results in
increased systemic exposure to amlodipine and may require dose reduction.
Sildenafil: Monitor for hypotension when sildenafil is co-administered with amlodipine.
Impact of Amlodipine on Other Drugs:
Simvastatin: Co-administration of simvastatin with amlodipine increases the systemic
exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg
Immunosuppressants: Amlodipine may increase the systemic exposure of cyclosporine or
tacrolimus when co-administered.
Use in Special Groups:
Pregnancy and Lactation:
Pregnancy: The limited available data based on post-marketing reports with amlodipine use
in pregnant women are not sufficient to inform a drug-associated risk for major birth defects
and miscarriage. There are risks to the mother and fetus associated with poorly controlled
hypertension in pregnancy.
Lactation: No adverse effects of amlodipine on the breastfed infant have been observed.
Paediatric Use: Effect of levamlodipine on blood pressure in patients less than 6 years of
age is not known.
Geriatric Use: In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or others drug therapy.
Levamlodipine is contraindicated in patients with known sensitivity to amlodipine.
Store at below 30°C temperature, protected from light and moisture. Keep out of reach of
Levamolin 2.5 Tablet: Each Box contains 2 x 14 Tablet in Alu-Alu blister.
Levamolin 5 Tablet: Each Box contains 2 x 14 Tablet in Alu-Alu blister.