JUVASC® TABLETS 5mg & 10mg Amlodipine
Composition, Actions, Indication, Contraindication, Pregnancy and lactation, Adverse effect, Dosage and administration, Presentation, Storage and Manufacturer of Juvasc Tablet Medicine for Hypertension.
Each tablet contains Amlodipine Besylate equivalent to 5mg amlodipine as the active ingredient. Each tablet contains Amlodipine Besylate equivalent to 10mg amlodipine as the active ingredient.
Amlodipine is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and smooth muscle.
The mechanism of action of amlodipine is due to a direct relaxant effect of vascular smooth muscle. The precise mechanism by which amlodipine relives angina has not been fully determined but amlodipine reduces total ischemic burden by the following two actions. Amlodipine dilates peripheral arterioles and thus, reduces the total peripheral resistance (afterload) against-which the heart works. Since the heart rate remains stable, thus unloading of the heart reduces myocardial energy consumption and oxygen requirements.
Amlodipine is indicated for the first line treatment of hypertension and can be used as a sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition amlodipine which has been used in combination with a thiazide diuretic, alpha-blockers beta adrenoceptor blocking agent, or an angiotensin-converting enzyme inhibitor.
Amlodipine is indicated for the first line treatment of myocardial ischemia, whether due to fixed obstruction (stable angina) or/ vasospasm/ vasoconstriction (Prinzmental’s or variant angina) of coronary vasculature.
Amlodipine may be used where the clinical presentation suggests a possible vasospastic/ vasoconstructive component but where vasospasm/ vasoconstriction has not been confirmed. Amlodipine may be used alone, as monotherapy, or in combination with other anti-angina drugs in patients with angina that is refractory to nitrates and/ or adequate doses of beta- blockers.
Amlodipine is contraindicated in-patients with a known sensitivity to dihydropyridines, amlodipine or any of the inert ingredients.
PREGNANCY AND LACTATION
Safety of amlodipine in human pregnancy or lactation has not been established.
Amlodipine does not demonstrate toxicity in animal reproductive studies other than delay parturition and prolong labor in rat at a dose level fifty times the maximum recommended dose in humans. Accordingly, use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and fetus.
Amlodipine is tolerated in placebo controlled clinical trials involving patients with hypertension or angina, the most commonly observed side effects were headache, edema, fatigue, somnolence, nausea, abdominal pain, flushing palpitation and dizziness. In these clinical trials no pattern of clinically significant laboratory test abnormalities related to amlodipine has been observed.
Less commonly observed side effects in marketing experience include alopecia, altered bowel habits, arthralgia, asthenia, back pain, dyspepsia, dyspnea, gingival hyperglycemia, impotence, increased urinary frequency, leucopenia malaise, mood changes, dry mouth, muscles cramps, myalgia, peripheral neuropathy, pancreoatitis, increased sweating, syncope, thrombocytopenia, vasculitis, and visual disturbances and rarely, erythema multiforme. In many cases, causal association is uncertain.
As with other calcium channel blockers the following adverse events have been rarely reported and cannot be distinguished from the natural history of the underlying disease: myocardial infarction arrhythmia (including ventricular tachycardia and atrial fibrillation) and chest pain.
DOSAGE AND ADMINISTRATION
For hypertension and angina, the initial dose is 5mg amlodipine once daily, which may be increased to a maximum dose of 10mg depending on the individual patient’s response. No dose adjustment of amlodipine is required upon concomitant administration of thiazide diuretic, beta-blockers, and angiotensin-converting enzyme inhibitors.
Juvasc 5mg is supplied as 5mg tablets in blister pack of 100 as well as tamper proof jars of 500 tablets. Juvasc 10mg is supplied as 10mg tablets in blister pack of 100 as well as tamper jars of 500 tablets.
Store in a cool dry place.
Keep this medicine out of the reach of all children.
JUHEL NIGERIA LTD
35, Nkwubor Road,
Enugu State. Nigeria.