Drugplain

amlodipine besylate and olmesartan medoxomil 10 mg/1

amlodipine besylate and olmesartan medoxomil · TABLET, FILM COATED · Golden State Medical Supply, Inc.

No Recall HistoryCurrently in Shortage
Plain English

This combination medication contains a calcium channel blocker and an angiotensin II receptor blocker, used together to treat high blood pressure. It works by relaxing blood vessels and reducing the heart's workload to help lower blood pressure.

Key Facts

Brand Name
amlodipine besylate and olmesartan medoxomil
Generic Name
amlodipine besylate and olmesartan medoxomil
NDC Code (Product)
51407-858
Manufacturer
Golden State Medical Supply, Inc.
Strength
10 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
NDA022100
Drug Class
Angiotensin 2 Receptor Antagonists [MoA]; Angiotensin 2 Receptor Blocker [EPC]
Marketing Start
09/26/2007

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective31 reports
oedema peripheral29 reports
hypotension17 reports
blood pressure increased14 reports
headache11 reports
drug administration error10 reports
renal failure acute10 reports
dizziness9 reports
infarction9 reports
fall8 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Amlodipine besylate and olmesartan medoxomil 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 amlodipine besylate and olmesartan medoxomil. 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 antihyper…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The usual starting dose of amlodipine besylate and olmesartan medoxomil 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 amlodipine besylate and olmesartan medoxomil in patients with diabetes [ see Drug Interactions ( 7.2 )] . Do not co-administer aliskiren with amlodipine besylate and olmesartan medoxomil 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. Amlodipine besylate and olmesartan medoxomil The data described below reflect exposure to amlodipine besylate and olmesartan medoxomil in more than 1600 patients including more than 1000 exposed for at least 6 months and more than 700 exposed for 1 year. Amlodipine besylate and olmesartan medoxomil 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 amlodipine besy…

Frequently Asked Questions

What is amlodipine besylate and olmesartan medoxomil used for?

This combination medication contains a calcium channel blocker and an angiotensin II receptor blocker, used together to treat high blood pressure. It works by relaxing blood vessels and reducing the heart's workload to help lower blood pressure.

Is amlodipine besylate and olmesartan medoxomil a controlled substance?

amlodipine besylate and olmesartan medoxomil is not classified as a controlled substance by the DEA.

What is the generic name for amlodipine besylate and olmesartan medoxomil?

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

What is the NDC code for amlodipine besylate and olmesartan medoxomil 10 mg/1?

The NDC (National Drug Code) for amlodipine besylate and olmesartan medoxomil 10 mg/1 is 51407-858, listed by Golden State Medical Supply, Inc..

Product NDC

51407-858

Package NDC

51407-858-30

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

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