Widely known as amlodipine, a Norvasc dosage is commonly used for hypertension – chronic high blood pressure. Further tests and real-life application show that norvasc can also be highly effective for migraines, angina and for anxiety.
Working as a calcium channel blocker, norvasc relaxes the smooth muscle in the arterial wall, softening accumulated hardness and relieving high blood pressure. It also increases blood flow to the heart and by doing so; the heart doesn’t need to work as hard.
With norvasc blood pressure reduction means that it’s also effective at relieving anxiety and migraine, with few side effects, but as with all medicines, it’s always necessary to consult your doctor before beginning any course of treatment.
In keeping hypertension in check and relaxing anxiety, Norvasc is an easy choice.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 5 mg tablet contains: Active ingredient: Amlodipine besylate 6.944 mg (equivalent to amlodipine base 5 mg). Excipients: Microcrystalline cellulose - Dibasic calcium phosphate anhydrous, Sodium starch glycollate, Magnesium stearate.
PHARMACEUTICAL FORM AND CONTENT
Blister pack containing 28 scored 5 mg tablets.
Antihypertensives (calcium antagonists).
Norvasc (amlodipine) is indicated in the treatment of hypertension and, in most cases, can be used as monotherapy. Patients insufficiently controlled with a single antihypertensive may benefit from the addition of NORVASC (amlodipine). The drug has been used in combination with thiazide diuretics, beta-blockers or converting enzyme inhibitors. NORVASC (amlodipine) is indicated in the first treatment of angina pectoris, both in cases of chronic stenosis (stable angina), and/or in cases following vasoconstriction or coronary vasospasm (Prinzmetal's angina or variant). NORVASC (amlodipine) can therefore be used in cases where the clinical picture suggests a possible vasospastic component even if there is no confirmation of this clinical situation. NORVASC (amlodipine) can be used in monotherapy or in combination with other anti-angina drugs), in patients suffering from angina who do not respond to nitrates or beta-blockers.
NORVASC (amlodipine) is contraindicated in patients with hypersensitivity to the components or other chemically closely related substances. There is no experimental data on the safety of the product during pregnancy, lactation and in children. Under these conditions, the drug is contraindicated.
SPECIAL PRECAUTIONS FOR USE
Use in patients with impaired hepatic function: As with all calcium antagonists, the plasma half-life of amlodipine is prolonged in patients with impaired liver function. For these patients specific dosage recommendations have not been established. The drug should therefore be used with caution in this type of patient.
Use in cases of impaired renal function: NORVASC (amlodipine) is widely metabolised in inactive form and 10% is excreted unchanged in the urine. The degree of renal compromise is not linked to variations in the plasma concentrations of NORVASC (amlodipine) which can be used in this condition at normal doses. NORVASC (amlodipine) is not dialyzable.
Use in pregnancy and lactation: Animal reproduction studies have shown that amlodipine has no toxic effects with the exception of retarded and prolonged parts in rats at doses 50 times greater than the maximum dose recommended in humans. Since the tolerability of amlodipine has not be been established in pregnant women or during lactation, the use of the product is contraindicated in these circumstances (See "Contraindications").
Use in the elderly: The time needed for amlodipine to reach the peak plasma concentration in the elderly and in younger subjects is identical. In elderly patients, the clearance of amlodipine tends to diminish, causing increases in the AUC and of the elimination half-life of the drug. At similar doses, NORVASC (amlodipine) is equally well tolerated in the elderly and young patient. Nevertheless, the recommended doses should not be exceeded, also in the elderly.
DRUG AND OTHER INTERACTIONS
NORVASC (amlodipine) has been administered without any undesirable interactions in combination with thiazide diuretics, beta-blockers, converting enzyme inhibitors, long half-life nitrates, sublingual nitroglycerine, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycaemic drugs. Specific studies in healthy volunteers have shown that the administration of NORVASC (amlodipine) does not alter the plasma levels of digoxin or its renal clearance. The concomitant administration of cimetidine does not affect the pharmacokinetics of NORVASC (amlodipine). In vitro studies on human plasma show that NORVASC (amlodipine) does not interfere with the protein binding of digoxin, phenytoin, warfarin and indomethacin. In healthy male volunteers, the co-administration of amlodipine does not alter the effects of warfarin on prothrombin response time. A pharmacokinetic study carried out with cyclosporin has shown that amlodipine does not significantly alter the pharmacokinetics of cyclosporin.
No effect of NORVASC (amlodipine) has been reported on the ability to drive and operate machinery.
Keep the medicine out of the reach of children.
DOSAGE AND METHOD OF ADMINISTRATION
For both hypertension and angina, the initial recommended dose is 5 mg of NORVASC (amlodipine) once daily; this dose may be increased to a maximum dose of 10 mg depending on the individual patient's response in case of concomitant administration of thiazide diuretics, beta-blockers or converting enzyme inhibitors.
In humans, experience with intentional overdose of NORVASC (amlodipine) is limited. Gastric lavage may be worthwhile in some cases. Following overdose with NORVASC (amlodipine), available data suggests that excessive peripheral vasodilation with subsequent marked and probably prolonged systemic hypotension could occur. Clinically significant hypotension due to overdose of NORVASC (amlodipine) calls for active monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output. A vasoconstrictor maybe helpful in restoring vascular tone and blood pressure provided there is no contraindication to its use. Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade. Since NORVASC (amlodipine) is highly protein bound, dialysis is not likely to be of benefit.
NORVASC (amlodipine) is well tolerated. In placebo-controlled clinical studies in patients with hypertension or angina, the most commonly observed side effects were: headache, oedema, fatigue, drowsiness, nausea, abdominal pain, flushing, palpitations and dizziness. In the post-marketing phase of the product, rare cases have been reported of pruritus, rash, dyspnoea, asthenia, muscle cramps, dyspepsia, gingival hyperplasia and rarely, erythema multiform. As with other calcium-antagonists, adverse events have rarely been reported for which a link cannot be ruled out with the natural history of the underlying disease: myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation) and chest pain. Blood chemistry tests performed in patients treated with NORVASC (amlodipine) have shown clinically significant changes compared to standard values. The patient is invited to tell his doctor or pharmacist of any undesirable effects not described in this leaflet.
It is important not to use the medicine after the expiry date printed on the pack.
This date refers to the product in an unopened and correctly stored pack.
PRODUCT STORAGE PRECAUTIONS
There are no special storage precautions.
The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician.