Amlodipine and olmesartan medoxomil is the generic equivalent of the brand-name drug AMLODIPINE AND OLMESARTAN MEDOXOMIL. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Amlodipine and olmesartan medoxomil through Premier Pharma with same-day fulfillment on in-stock SKUs.
Clinical Identifiers
- RxCUI
- 730861730866730869730872
- Therapeutic Equivalence (TE) Code
ABTherapeutically equivalent — meets FDA bioequivalence requirements
- Pharmacologic Class
- ["Angiotensin 2 Receptor Antagonists [MoA]","Angiotensin 2 Receptor Blocker [EPC]","Calcium Channel Antagonists [MoA]","Calcium Channel Blocker [EPC]","Cytochrome P450 3A Inhibitors [MoA]","Dihydropyridine Calcium Channel Blocker [EPC]","Dihydropyridines [CS]"]
FDA Drug Information
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 m…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥3%) is edema ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-332-1088 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 obse…
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 impairm…
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 ).
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Pregnancy: Advise female patients of childbearing age about the consequences of exposure to amlodipine and olmesartan medoxomil tablets during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Lactation: Advise nursing women not to breastfeed during treatment with amlodipine and olmesartan medoxomil tablets [see Use in Specific Populations (8.2) ]. Potassium Supplements: Advise patie…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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