Amlodipine Teva Pharma, Teva Pharmaceuticals Polska
the product in the database has an inactive status
indications:
Hypertension. Stable angina. The nephrotic form of angina (Prinzmetal angina). Amlodipine can be used in monotherapy or in combination therapy with other antihypertensive and / or anti-anginal drugs.
Composition:
1 tabl contains 10 mg of amlodipine in the form of besilate.
Action:
Amlodipine is a dihydropyridine derivative, it inhibits the inflow of Calcium ions into the cell, it belongs to the III genotype blockers of free calcium channels (calcium antagonists), characterized by a long-lasting, not shorter than 24 h operation. It inhibits the transepithelial influx of calcium ions into the cells of the myocardium and the smooth muscle cells of the blood vessels. The antihypertensive effect is the result of direct expansion of the blood vessels, mainly peripheral. Amlodipine reduces the degree of hypoxia by: extending peripheral arterioles (thus reducing total peripheral resistance and associated left ventricular burden) and extending large vessels and coronary arterioles both in the area of ischemia and in areas with proper blood supply (vasodilatation causes better blood supply and oxygenation of the myocardium in patients with ischemic disease, resulting from the contraction of coronary vessels in the course of Principal angina). After oral administration, amlodipine is well absorbed from the gastrointestinal tract, reaching a maximum blood concentration after 6-12 h. The bioavailability is 64-80%. Food does not affect the absorption of amlodipine. Approximately 97% of the drug is bound to plasma proteins. Plasma concentrations at steady-state are achieved after 7-8 days. Amlodipine is extensively metabolised in the liver to inactive metabolites. About 60% of amlodipine is excreted in the urine (10% in unchanged form). T0,5 is 35-50 h. In patients with impaired liver function and in elderly patients, the half-life is prolonged.
Contraindications:
Hypersensitivity to Amlodipine, other dihydropyridines or other components of the preparation. Cardiogenic shock. Haemodynamically significant aortic stenosis. Unstable angina with the exception of the vasospastic form (Prinzmetal angina).
Precautions:
The safety and efficacy of amlodipine in children has not been established. Caution should be exercised in patients with impaired hepatic function (due to prolongation of half-life) and in elderly patients (amlodipine excretion and an increase in area under the concentration curve - AUC). The efficacy and safety of amlodipine at hypertensive crisis has not been established. The safety of use has not been established in patients with myocardial infarction within one month of its occurrence. Amlodipine, like other calcium channel blockers, may cause hypotension, but the risk of hypotension is lower than for drugs belonging to the first and second generation of this pharmacotherapeutic group, due to the slow build-up of antihypertensive effect.
Pregnancy and lactation:
There are no adequate data from the use of amlodipine in pregnant women. Amlodipine should not be given to pregnant women. Before starting treatment with amlodipine, confirm that the woman is not pregnant and propose effective contraception. If pregnancy is confirmed, amlodipine should be discontinued and the treatment should be changed. It is not known whether amlodipine is excreted in human milk; women treated with amlodipine should not breast-feed.
Side effects:
The most common dose-related adverse reaction is a slight to moderate swelling of the ankle area. Common: peripheral edema, especially around the ankles, feet, and shins; pain and dizziness; feeling of excessive fatigue, drowsiness; nausea, abdominal pain, indigestion; feeling of palpitations, feeling of breathlessness, muscle cramps.Uncommon: hypotension, tachycardia, chest pain, vasculitis, fainting; back pain, joints, muscles, more frequent urination; mood disorders, dry mouth, peripheral nerve neuropathy (paresthesia, muscle spasms, muscle paresis), blurred vision; insomnia, depression, excessive excitability, mood disorders, decreased libido; pancreatitis, rash, pruritus, skin redness, alopecia, gynaecomastia, edema and / or gingival hyperplasia; hepatitis, thrombocytopenia. Rare: angioedema, arrhythmia (premature spasms), urticaria, increased liver enzymes, hepatitis, jaundice (usually cholestatic), hyperglycemia, confusion. There have also been reports of individual hypersensitivity reactions (including erythema multiforme). In isolated cases, patients with coronary artery stenosis may experience worsening of symptoms associated with myocardial ischemia (arrhythmias, myocardial infarction), but no causal relationship has been established between the occurrence of this type of disorder and the use of amlodipine.
Dosage:
Orally. Adults: the starting dose is 5 mg / day; if the expected effect of the drug (lowering blood pressure, reducing the incidence and severity of anginal pain, increasing tolerance to exercise) will not be achieved within 2-4 weeks, the dose may be increased up to a maximum of 10 mg / day (in a single dose). In patients with impaired liver function, caution should be exercised because no dosage has been established in this group of patients. The tablets should be taken regardless of meals once a day, preferably in the morning.
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