Azor 10 mg/1

amlodipine besylate and olmesartan medoxomil · TABLET, FILM COATED · Cosette Pharmaceuticals, Inc.

1 Recall on RecordCurrently in Shortage

Plain English

Azor is a tablet, film coated containing amlodipine besylate and olmesartan medoxomil at 10 mg/1, taken oral. Manufactured by Cosette Pharmaceuticals, Inc..

Key Facts

Brand Name: Azor
Generic Name: amlodipine besylate and olmesartan medoxomil
NDC Code (Product): 0713-0871
Manufacturer: Cosette Pharmaceuticals, Inc.
Strength: 10 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA022100
Marketing Start: 09/01/2022

Recall History

1 Recall on Record

Class II07/12/2014

Daiichi Sankyo Pharma Development

Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

sprue-like enteropathy327 reports

gastrooesophageal reflux disease210 reports

diarrhoea182 reports

dizziness178 reports

acute kidney injury169 reports

weight decreased165 reports

drug ineffective146 reports

nausea138 reports

haemorrhoids133 reports

chronic kidney disease126 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Azor is indicated for the treatment of hypertension, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) 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 the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Azor. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechan…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The usual starting dose of Azor is 5/20 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of one 10/40 mg tablet once daily as needed to control blood pressure [ s ee Clinical Studies ( 14.1 )] . Recommended starting dose: 5/20 mg once daily ( 2 ). Titrate as needed in two-week intervals up to a maximum of 10/40 mg once daily ( 2 ).

Contraindications

4 CONTRAINDICATIONS Do not co-administer aliskiren with Azor in patients with diabetes [ see Drug Interactions ( 7.2 )] . Do not co-administer aliskiren with Azor in patients with diabetes ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS Amlodipine ( 7.1 ): If simvastatin is co-administered with amlodipine, do not exceed 20 mg daily of simvastatin. Increased exposure of cyclosporine and tacrolimus. Increased exposure of amlodipine when coadministered with CYP3A inhibitors. Olmesartan medoxomil ( 7.2 ): Nonsteroidal anti-inflammatory drugs (NSAIDS) may lead to increased risk of renal impairment and loss of antihypertensive effect. Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Lithium: Increases in serum lithium concentrations and lithium toxicity. 7.1 Drug Interactions with Amlodipine 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 of trough blood levels of cyclosporine and tacrolimus is recommended and adjus…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Azor The data described below reflect exposure to Azor in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Azor was studied in one placebo-controlled factorial trial [s ee Clinical Trials ( 14.1 ) ] . The population had a mean age of 54 years and included approximately 55% males. Seventy-one percent were Caucasian and 25% were Black. Patients received doses ranging from 5/20 mg to 10/40 mg orally once daily. The overall incidence of adverse reactions on therapy with Azor was similar to that seen with corresponding doses of the individual components of Azor, and to placebo. The reported adverse react…

Frequently Asked Questions

What is Azor used for?

Azor contains amlodipine besylate and olmesartan medoxomil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Azor a controlled substance?

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

What is the generic name for Azor?

The generic name for Azor is amlodipine besylate and olmesartan medoxomil. There are 8 other brand versions of amlodipine besylate and olmesartan medoxomil.

What is the NDC code for Azor 10 mg/1?

The NDC (National Drug Code) for Azor 10 mg/1 is 0713-0871, listed by Cosette Pharmaceuticals, Inc..

Product NDC

0713-0871

Package NDC

0713-0871-30

Other Azor Dosages

Other Amlodipine Brands

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

Data from openFDA · Public domain (CC0 1.0)