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Amlodipine besylate and Olmesartran medoxomil 5 mg/1

Amlodipine besylate and Olmesartran medoxomil · TABLET, FILM COATED · Alembic Pharmaceuticals Limited

No Recall HistoryCurrently in Shortage
Plain English

Amlodipine besylate and Olmesartran medoxomil is a tablet, film coated containing amlodipine besylate and olmesartran medoxomil at 5 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.

Key Facts

Brand Name
Amlodipine besylate and Olmesartran medoxomil
Generic Name
Amlodipine besylate and Olmesartran medoxomil
NDC Code (Product)
46708-212
Manufacturer
Alembic Pharmaceuticals Limited
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
ANDA207073
Marketing Start
07/18/2017

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Amlodipine and olmesartan medoxomil tablets are 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 amlodipine and olmesartan medoxomil tablets. 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 antihypert…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The usual starting dose of amlodipine and olmesartan medoxomil tablet 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 [see 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 amlodipine and olmesartan medoxomil tablets in patients with diabetes [ s ee Drug Interactions ( 7.2 ) ] . Do not co-administer aliskiren with amlodipine and olmesartan medoxomil tablets 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 a…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 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. Amlodipine and Olmesartan Medoxomil Tablets The data described below reflect exposure to amlodipine and olmesartan medoxomil tablets in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Amlodipine and olmesartan medoxomil tablets were studied in one placebo-controlled factorial trial [see 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 amlodipine and olme…

Frequently Asked Questions

What is Amlodipine besylate and Olmesartran medoxomil used for?

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

Is Amlodipine besylate and Olmesartran medoxomil a controlled substance?

Amlodipine besylate and Olmesartran medoxomil is not classified as a controlled substance by the DEA.

What is the generic name for Amlodipine besylate and Olmesartran medoxomil?

The generic name for Amlodipine besylate and Olmesartran medoxomil is Amlodipine besylate and Olmesartran medoxomil. There are no other listed brand versions of Amlodipine besylate and Olmesartran medoxomil.

What is the NDC code for Amlodipine besylate and Olmesartran medoxomil 5 mg/1?

The NDC (National Drug Code) for Amlodipine besylate and Olmesartran medoxomil 5 mg/1 is 46708-212, listed by Alembic Pharmaceuticals Limited.

Product NDC

46708-212

Package NDC

46708-212-30

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

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