NORVASC Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

PD-Rx Pharmaceuticals, Inc.

Λέξεις κλειδιά

55289-103

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1. Indications and Usage

1.1 Hypertension NORVASC is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes ...

2. Dosage and Administration

2.1 Adults The usual initial antihypertensive oral dose of NORVASC is 5 mg once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency ...

3. Dosage Forms and Strengths

Tablets: 2.5 mg white, diamond, flat-faced, beveled edged, with NORVASC on one side and 2.5 on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, engraved with both ...

4. Contraindications

NORVASC is contraindicated in patients with known sensitivity to amlodipine.

5. Warnings and Precautions

5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. ...

8.1. Pregnancy

Risk Summary The limited available data based on post-marketing reports with NORVASC use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There ...

8.2. Lactation

Risk Summary Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%. No adverse effects of ...

8.4. Pediatric Use

NORVASC (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies (14.1)]. Effect of NORVASC on blood pressure in patients less than 6 years of ...

8.5. Geriatric Use

Clinical studies of NORVASC did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not ...

10. Overdosage

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of NORVASC is limited. ...

11. Description

NORVASC is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)- 2-[(2-aminoethoxy)methyl]- 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, ...

12.1. Mechanism of Action

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. ...

12.2. Pharmacodynamics

Hemodynamics: Following administration of therapeutic doses to patients with hypertension, NORVASC produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases ...

12.3. Pharmacokinetics

After oral administration of therapeutic doses of NORVASC, absorption produces peak plasma concentrations between 6 and 12 hours. Absolute bioavailability has been estimated to be between 64 and 90%. The ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Rats and mice treated with amlodipine maleate in the diet for up to two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 amlodipine mg/kg/day, showed no evidence ...

14. Clinical Studies

14.1 Effects in Hypertension Adult Patients The antihypertensive efficacy of NORVASC has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on ...

16.1. How Supplied

5 mg Tablets: NORVASC 5 mg Tablets (amlodipine besylate equivalent to 5 mg of amlodipine per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both NORVASC and 5 on ...

16.2. Storage and Handling

Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, light-resistant containers (USP).