AMLODIPINE BESYLATE 10 mg 10 mg/1

AMLODIPINE BESYLATE · TABLET · PD-Rx Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

AMLODIPINE BESYLATE 10 mg is a tablet containing amlodipine besylate at 10 mg/1, taken oral. Manufactured by PD-Rx Pharmaceuticals, Inc..

Key Facts

Brand Name: AMLODIPINE BESYLATE 10 mg
Generic Name: AMLODIPINE BESYLATE
NDC Code (Product): 72789-262
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Strength: 10 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA078414
Marketing Start: 10/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

fatigue5,254 reports

diarrhoea3,997 reports

dyspnoea3,746 reports

nausea3,731 reports

pain3,537 reports

drug ineffective3,462 reports

off label use3,139 reports

headache3,132 reports

pneumonia2,855 reports

dizziness2,850 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Amlodipine besylate tablets are 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 ) Amlodipine besylate tablets are 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 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are 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 amlodipine besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as approp…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily. ( 2.1 ) 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 ) I mportant 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 amlodipine besylate tablets 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 amlodipine besylate tablets 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 to 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 …

Contraindications

4 CONTRAINDICATIONS Known sensitivity to amlodipine ( 4 ) Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

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 monitorin…

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% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oxford, at 1-844-508-1455, 8:00 am -4:30 pm ET, Monday – Friday 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. Amlodipine besylate tablets have been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate tablets was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine besylate tablets were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate tablets (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlod…

Frequently Asked Questions

What is AMLODIPINE BESYLATE 10 mg used for?

AMLODIPINE BESYLATE 10 mg contains AMLODIPINE BESYLATE. It is a tablet taken oral. Consult your doctor for specific uses.

Is AMLODIPINE BESYLATE 10 mg a controlled substance?

AMLODIPINE BESYLATE 10 mg is not classified as a controlled substance by the DEA.

What is the generic name for AMLODIPINE BESYLATE 10 mg?

The generic name for AMLODIPINE BESYLATE 10 mg is AMLODIPINE BESYLATE. There are 11 other brand versions of AMLODIPINE BESYLATE.

What is the NDC code for AMLODIPINE BESYLATE 10 mg 10 mg/1?

The NDC (National Drug Code) for AMLODIPINE BESYLATE 10 mg 10 mg/1 is 72789-262, listed by PD-Rx Pharmaceuticals, Inc..

Product NDC

72789-262

Package NDC

72789-262-30

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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