ASOMEX Tablet

・Essential hypertension

・Angina pectoris

Dosage and Administration

The normal recommended dose is 2.5mg once a day. Based on the clinical response of the patient, the dose may be enhanced up to 5mg once a day.

Duration of Therapy: S(-) Amlodipine is prescribed as part of therapy for chronic conditions like hypertension and angina. Duration of therapy will be for as long as required and will be decided by treating doctor based on individual response to therapy and tolerability.

Hypersensitivity to any of the components of the formulation.

On the basis of the clinical data available, following non-serious adverse events with incidence <2% have been reported with the use of S(-) Amlodipine:

pedal edema, headache, dizziness, asthenia, somnolence, blushing, chest pain, vomiting, abdominal pain, myalgia, rash, frequent urination, palpitation, fever, presyncopy, difficulty in breathing, tachycardia, cough, cheerlessness, facial puffiness, heavy headedness, worsening of hyperlipidemia, impaired glycemic control, and diarrhea.

Clinical studies have shown that Amlodipine has been safely administered with thiazide diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, NSAIDs, antibiotics, and oral hypoglycemic drugs. Hence no such interactions are expected with S(-) Amlodipine.

The pharmacokinetic studies with fixed dose combinations (FDC) of S(-)Amlodipine with Atorvastatin, Hydrochlorothiazide, Ramipril, Atenolol and S(-) Metoprolol reported no any adverse interaction profile. So the above mentioned drugs can be administered with S(-) Amlodipine as co-prescription or in FDC.

See the package insert about the details below:

Atorvastatin

beta Blockers

AngiotensinⅡReceptor Antagonist

Digoxin

Ethanol (alcohol)

Warfarin

Nicotine

There is no data available on the use of S(-) Amlodipine in pregnant and lactating women, hence the drug should be administered only when the potential benefits outweighs the risk to the patient.

No controlled clinical study of S(-) Amlodipine 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 S(-) Amlodipine. However, caution should be taken while administering S(-) Amlodipine to patients with hepatic and renal impairment.

S(-)Amlodipine, 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. S(-) Amlodipine is 1000 times more potent than the R(+) isomer in binding to the dihydropyridine receptor. In humans, the dominant effects of Amlodipine are consequent to vasodilation. S(-) Amlodipine lowers peripheral vascular resistance without causing a reflex tachycardia. It is effective as a once daily dosage in the control of hypertension.