Each tablet contains: Levamlodipine (as besilate) 2.5 mg.
Each tablet contains: Levamlodipine (as besilate) 5 mg.
Levamlodipine is pharmacologically active isomer of Amlodipine. Levamlodipine is chemically designated as S(-) 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulphonate. Its empirical formula is: C20H25ClN2O5·C6H6O3S.
Pharmacology: Pharmacodynamics: Levamlodipine, the chirally pure form of Amlodipine is a calcium channel antagonist belonging to the dihydropyridine class. The S (-) isomer of Amlodipine is found to possess greater pharmacological effects than R (+) Amlodipine.
Levamlodipine is 1000 times more potent than the R (+) isomer binding to the dihydropyridine receptor. In humans, the dominant effects of Amlodipine are consequent to vasodilation. Levamlodipine lowers peripheral vascular resistance without causing reflex tachycardia. It is effective as a once daily dosage in the control of hypertension.
Pharmacokinetics and Metabolism: Administration of Levamlodipine 5 mg as a single dose in the fasting state produced maximum plasma concentration (Cmax) of 8.30±1.071 ng/mL in 2.73±0.88 hrs. (Tmax). Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine. Ex-vivo studies have shown that approximately 93% of the circulating drug is bound to plasma proteins in hypertensive patients. The mean AUC0-t value (t=48 hrs.) of tablet S (-) Amlodipine (5 mg) is 95.33±14.45 ng.hr/mL. The AUC0-∞ value is recorded to be 140.91. Plasma elimination half life of S (-) Amlodipine has been found to be 31.09±12.65 hrs.
For the management of Essential Hypertension and Angina Pectoris.
The normal recommended dose of Levamlodipine 2.5 mg is 1 tablet once a day for the treatment of hypertension. Based on the clinical response of the patients, the dose may be enhanced, up to 5 mg once a day. Or as prescribed by the physician.
There are no reported cases of overdosage with the use of Levamlodipine.
Overdosage with racemic Amlodipine may cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Hence caution should be taken in case of overdosage with Levamlodipine. If massive overdosage occurs, active cardiac and respiratory monitoring should be instituted.
Frequent blood pressure measurements should be performed. If hypotension occurs, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as norepinephrine bitartrate and noradrenaline bitartrate) should be considered with attention to the circulating drug. If massive overdose occurs, gastric lavage should be employed. As this drug is highly protein bound in the plasma, hemodialysis is not likely to be of benefit.
It should not be taken with Isoprinoline and Dopamine for it may induce further vasodilation.
Hypersensitivity to any of the components of the formulation.
No controlled clinical study of Levamlodipine has been performed in patients with hepatic impairment and renal impairment. Clinical studies in patients with normal liver function have shown that there is no elevation in the hepatic enzymes with the use of Levamlodipine. However, caution should be taken while administering Levamlodipine to patients with hepatic and renal impairment.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation section for further information.
Use in Children: Safety and effectiveness of this product in children has not been established.
There is no data available on the use of Levamlodipine in pregnant and lactating women, hence the drug should be administered only when potential benefits outweighs the risk to the patients.
On the basis of the clinical data available, the following adverse events have been reported in less than 2% of the patients.
Vertigo (0.05%), tachycardia (0.5%), cough (0.5%), headache (0.43%), difficulty in breathing (0.1%), edema (0.75-1.92%), cheerlessness (0.05%) and facial puffiness (0.05%). These effects were mild in nature.
Clinical studies have shown that Levamlodipine when combined with aspirin, nitrates, beta-blockers, statins, ACE inhibitors, H2 blockers and Proton Pump Inhibitors produced no drug interactions.
Store at temperatures not exceeding 30°C.
C08CA17 - levamlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
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