Norvasc 2.5 mg/1

amlodipine besylate · TABLET · PFIZER LABORATORIES DIV PFIZER INC

No Recall HistoryCurrently in Shortage

Plain English

Norvasc is a prescription tablet containing amlodipine besylate that is taken by mouth to treat high blood pressure and certain types of chest pain. It works by relaxing blood vessels to help improve blood flow and reduce the workload on your heart.

Key Facts

Brand Name: Norvasc
Generic Name: amlodipine besylate
NDC Code (Product): 0069-1520
Manufacturer: PFIZER LABORATORIES DIV PFIZER INC
Strength: 2.5 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA019787
Marketing Start: 07/31/1992

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue9,546 reports

nausea8,218 reports

diarrhoea7,744 reports

dyspnoea7,645 reports

drug ineffective6,930 reports

pain6,699 reports

dizziness6,422 reports

headache6,292 reports

asthenia5,666 reports

fall5,318 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE NORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o 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 and myocardial infarctions. • Coronary Artery Disease ( 1.2 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 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 and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including NORVASC. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smo…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) o Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) • Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation : Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 ) 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 may be started on 2.5 mg once daily and this dose may be used when adding NORVASC to other antihypertensive therapy. Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina : The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect. Coronary artery disease: The reco…

Contraindications

4 CONTRAINDICATIONS NORVASC is contraindicated in patients with known sensitivity to amlodipine. • Known sensitivity to amlodipine ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 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. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3) ] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology (12.2) ] . 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3) ] . Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring …

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 drug and may not reflect the rates observed in practice. NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with NORVASC was well‑tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with NORVASC were of mild or moderate severity. In controlled clinical trials directly comparing NORVASC (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of NORVASC because of adverse reactions was required in only about 1.5% of patients and was not significant…

Frequently Asked Questions

What is Norvasc used for?

Is Norvasc a controlled substance?

Norvasc is not classified as a controlled substance by the DEA.

What is the generic name for Norvasc?

The generic name for Norvasc is amlodipine besylate. There are 11 other brand versions of amlodipine besylate.

What is the NDC code for Norvasc 2.5 mg/1?

The NDC (National Drug Code) for Norvasc 2.5 mg/1 is 0069-1520, listed by PFIZER LABORATORIES DIV PFIZER INC.

Product NDC

0069-1520

Package NDC

0069-1520-68

Other Amlodipine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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