Plot 3c, blk A, Aswani Market Road, Isolo,Oshodi, Lagos, Nigeria
Tel: 234-1-8105555,234-1-4523570, 4523721, 4527160, 4529288.
Fax: 234-01-4525288, 2693531
Baroque Pharmaceuticals Pvt. Ltd, Sokhada-388620, Ta-Khambhat, Dist: Anand, Gujarat(India).
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablets (NRN: A4-4603): Amlodipine besylate equivalent to 5 mg amlodipine, amlodipine besylate equivalent to 10 mg amlodipine.
Pack sizes: 3 x 10's Alu/Alu Blister strip packed in a carton.
Amlodipine is a dihydropyridine calcium channel blocker. It inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle without affecting serum calcium concentrations. Direct relaxation of vascular smooth muscle forms the basis of the antihypertensive action.
In angina pectoris, Amlodipine acts as a peripheral arteriolar vasodilator resulting in a reduction in total peripheral resistance (afterload). Myocardial energy and oxygen requirements are reduced. Amlodipine exerts its activity by binding to the dihydropyridine binding sites. It exerts minimal action on cardiac conduction, contraction and heart rate.
Treatment of Angina pectoris
Treatment of mild to moderate hypertension, alone or in combination with other antihypertensives.
Hypersensitivity to any of the ingredients or any of the dihydropyridines.
Use in the Elderly:
Amlodipine clearance is decreased (40-60%) in the elderly, which results in increases of amlodipine concentration in the area under the concentration-time curve (AUC) and elimination half-life. Therefore, elderly patients should start Amlodipine besylate therapy at a lower dose.
Use in Renal Failure:
Although Amlodipine besylate is excreted primarily via the 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 dialysable.
Use in impaired hepatic Function:
The half-life of Amlodipine Besylate is significantly prolonged in patients with impaired hepatic function. Amlodipine Besylate should therefore be administered at lower doses in these patients.
Use in Children:
Safety and efficacy has not been established.
Use in Heart Failure:
An increased incidence of pulmonary oedema has been reported. Amlodipine Besylate may have a negative inotropic effect. AUC of Amlodipine Besylate may increase in patients with heart failure.
Safety has not been established.
Pregnancy and lactation:
Safety in pregnancy and lactation has not been established
Concurrent administration of sublingual nitroglycerin, long acting nitrates, beta-blockers or other antianginal agents with amlodipine may produce additive antihypertensive and antianginal effects. Sublingual nitroglycerin may be used as needed to abort acute angina attacks during amlodipine therapy.
Nitrate medication may be used during amlodipine therapy for angina prophylaxis. Amlodipine will not protect against the consequences of abrupt beta-blocker withdrawal; gradual beta blocker dose reduction is recommended.
Although no "rebound effect" has been reported upon discontinuation of amlodipine, a gradual decrease of dosage with medical practitioner supervision is recommended.
Cardiac: Frequent: Palpitations.
Less Frequent: Myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation), chest pain.
Vascular: Frequent: Peripheral oedema.
Less Frequent: Hypotension (including orthostatic hypotension); syncope; vasculitis.
Neurological: Frequent: Dizziness; headache; somnolence.
Less Frequent: Hypertonia; hypoesthesia/paresthesia; peripheral neuropathy; tremor; insomnia; mood changes; dry mouth; increase sweating.
Gastro-intestinal: Frequent: Nausea; abdominal pain.
Less Frequent: Altered bowel habits, vomiting, dyspepsia, gingival hyperplasia.
Musculoskeletal: Less Frequent: Arthralgia, asthenia, back pain, muscle cramps, myalgia, pain.
Hepato-billiary: Less Frequent: Hepatitis, jaundice, raised liver enzymes (mostly consistent with cholestasis).
Blood: Less Frequent: Purpura, thrombocytopenia, leucopoenia.
Renal and urinary: Less Frequent: Increased urinary frequency.
Reproductive system and breast: Less Frequent: Impotence; gynaecomastia.
Endocrine: Less frequent: Hyperglycemia; pancreatitis.
Skin: Less frequent: Alopecia.
Respiratory: Less frequent: Coughing, dyspnoea.
Eye: Less Frequent: Visual disturbances.
Ear: Less Frequent: Tinnitus.
Metabolism and nutritional: Less Frequent: Weight increase/decrease.
Immune system: Less Frequent: Allergic reactions with pruritus, rash, angioedema and erythema multiforme.
General: Frequent: Fatigue; flushing.
Less Frequent: Taste perversion.
Dosage & Administration
Hypertension and Angina Pectoris:
An initial dose of 5 mg Amlodipine once daily is recommended which may be increased to 10 mg once a day after 10-14 days of therapy if there is no improvement.
No dose reduction is required when adding Amlodipine Besylate to thiazide diuretics, beta-blockers, or angiotensin-converting enzyme inhibitors.
Known Symptoms of Overdosage and Particulars of its Treatment:
There is no documented experience with Amlodipine Besylate over dosage. Gastric lavage may be of benefit. Gross overdosage could result in excessive peripheral vasodilatation, resulting in marked and probably prolonged systemic hypotension.
Clinically significant hypotension due to Amlodipine besylate overdosage requires active cardiovascular support. Intravenous calcium gluconate may be of benefit in reversing the effects of calcium channel blockade. Since Amlodipine is highly protein-bound, dialysis is not likely to be of benefit.
Treatment is symptomatic and supportive.
Store below 25oC. Protect from light.
Do not remove blisters from outer carton until required for use.
Keep out of reach of children.