STADOVAS 5 Tablet

- Amlodipine is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.

- For the management of Prinzmetal variant angina and chronic stable angina pectoris. The drug has been used alone or in combination with other antianginal agents.

Dosage and administration

Administration

Orally and may be given without regard to meals.

Dosage

Hypertension:

- Adults: The usual initial dosage is 2.5-5mg once daily. In geriatric and small frail individuals, an initial dosage of 2.5mg once daily is recommended. Subsequent dosage of amlodipine should be adjusted according to the patient’s blood pressure response and tolerance and usually should not exceed 10mg once daily. The usual maintenance dosage for the management of hypertension in adults is 5-10mg once daily.

- Children 6 years of age and older: The usual effective dosage is 2.5-5mg once daily.

Angina:

For the management of Prinzmetal variant angina or chronic stable angina, the usual adult dosage is 5-10mg once daily. In geriatric patients, the lower dosage of 5mg once daily is recommended.

Maintenance dosage is 10mg daily.

Patients who are hypersensitive to amlodipine, to any other calcium antagonist, or any ingredient in the formulation.

Common: Ankle oedema, flushing, headache, skin rash, and fatigue.

Uncommon:

- Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis.

- Central and peripheral nervous system: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.

- Gastrointestinal: anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.

- General: allergic reaction, asthenia, back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.

- Musculoskeletal system: arthralgia, muscle cramps, myalgia.

- Psychiatric: sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.

- Respiratory system: dyspnea, epistaxis.

- Skin and appendages: angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular.

- Special senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.

- Urinary system: micturition frequency, micturition disorder, nocturia.

- Autonomic nervous system: dry mouth, sweating increased.

- Metabolic and nutritional: hyperglycemia, thirst.

- Hemopoietic: leukopenia, purpura, thrombocytopenia.

Amlodipine has been safely administered with thiazide diuretics, alpha blockers, beta-blockers, angiotensin-converting enzyme inhibitors, long-acting nitrates, sublingual glyceryl trinitrate, NSAIDs, antibiotics, and oral hypoglycaemic drugs.

See the package insert about the details below:

Effect of other agents on amlodipine

- Cimetidine, grapefruit juice, antacid

- Sildenafil

Effect of amlodipine on other agents

- Atorvastatin, ethanol (alcohol)

- Digoxin

- Cyclosporine

No clinical experience with the preparation in pregnancy or lactation.

Accordingly, amlodipine should not be administered during pregnancy, or lactation, or to women of childbearing potential unless effective contraception is used.

- Amlodipine should be used with caution in patients with hypotension, cardiac reserve is poor, heart failure.

- The drug should not be used in cardiogenic shock, in patients who have suffered a myocardial infarction in the previous 2-4 weeks, or in acute unstable angina, in treatment an anginal attack in chronic stable angina.

- In patients with severe aortic stenosis amlodipine may increase the risk of developing heart failure. Sudden withdrawal of amlodipine might be associated with an exacerbation of angina.

- The dose may need to be reduced in patients with hepatic impairment.

Amlodipine 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. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.

Amlodipine inhibits calcium ion flux across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. 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.