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norvasc

Norvasc
Amlodipine Besylate

 

1. NAME OF MEDICINAL PRODUCT
NORVASC


2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Ingredient: amlodipine
The tablets contain amlodipine besylate equivalent to 5 and 10mg amlodipine.


3. PHARMACEUTICAL FORM

Tablets


4. CLINICAL PARTICULARS

4.1 Therapeutic Indications
Amlodipine is indicated for the first line treatment of hypertension and can be used as the 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 of 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) and/or vasospasm/vasoconstriction (Prinzmetal's or variant angina) of coronary vasculature. Amlodipine may be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Amlodipine may be used alone, as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or adequate doses of beta blockers.


4.2 Posology and Method of Administration
For both hypertension and angina the usual 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 diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors.


Use in the Elderly
Normal dosage regimens are recommended. Amlodipine, used at similar doses in elderly or younger patients, is equally well tolerated.


Use in Children
Safety and effectiveness of amlodipine in children have not been established.


Use in Patients with Impaired Hepatic Function
See section 4.4 Special Warnings and Special Precautions for Use.


Use in Renal Failure
Amlodipine may be used in such patients at normal doses. Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment. Amlodipine is not dialyzable.


4.3 Contraindications
Amlodipine is contraindicated in patients with a known sensitivity to dihydropyridines, amlodipine, or any of the inert ingredients.


4.4 Special Warnings and Special Precautions for Use

Use in Patients with Heart Failure
In a long-term, placebo controlled study (PRAISE-2) of amlodipine in patients with NYHA III and IV heart failure of nonischemic etiology, amlodipine was associated with increased reports of pulmonary edema despite no significant difference in the incidence of worsening heart failure as compared to placebo (see section 5.1 Pharmacodynamic Properties).


Use in Patients with Impaired Hepatic Function
As with all calcium antagonists, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations have not been established. The drug should therefore be administered with caution in these patients.


4.5 Interaction with Other Medicaments and Other Forms of Interaction
Amlodipine has been safely administered with thiazide diuretics, alpha blockers, beta blockers, angiotensinconverting enzyme inhibitors, long-acting nitrates, sublingual nitroglycerine, anti-inflammatory drugs, antibiotics, and oral hypoglycemic drugs.


In vitro data from studies with human plasma indicate that amlodipine has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).


In the following studies listed below, there were no significant changes in the pharmacokinetics of either amlodipine or another drug within the study. when co-administered.


Special Studies: Effect of other agents on amlodipine.

CIMETIDINE: Co-administration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine.


GRAPEFRUIT JUICE: Co-administration of 240 mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine.


ALUMINUM/MAGNESIUM (antacid): Co-administration of an aluminum/magnesium antacid with a single dose of amlodipine had no significant effect on the pharmacokinetics of amlodipine.


SILDENAFIL: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of amlodipine. When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.


Special Studies: Effect of amlodipine on other agents.

ATORVASTATIN: Co-administration of multiple 10 mg doses of amlodipine with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin.


DIGOXIN: Co-administration of amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers.


ETHANOL (alcohol): Single and multiple 10 mg doses of amlodipine had no significant effect on the pharmacokinetics of ethanol.


WARFARIN: Co-administration of amlodipine with warfarin did not change the warfarin prothrombin response time.


CYCLOSPORIN: Pharmacokinetic studies with cyclosporin have demonstrated that amlodipine does not significantly after the pharmacokinetics of cyclosporin.


Drug/Laboratory Test Interactions: None known.

 

4.6 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 to delay parturition and prolong labor in rats 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.


4.7 Effects on Ability to Drive and Use Machines
Clinical experience with amlodipine indicates that it is unlikely to impair a patient's ability to drive or use machinery.
 

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