Amlodipine and Olmesartan Medoxomil 5 mg/1
Amlodipine and Olmesartan Medoxomil · TABLET, FILM COATED · AvKARE
Amlodipine and Olmesartan Medoxomil is a tablet, film coated containing amlodipine and olmesartan medoxomil at 5 mg/1, taken oral. Manufactured by AvKARE.
Key Facts
- Brand Name
- Amlodipine and Olmesartan Medoxomil
- Generic Name
- Amlodipine and Olmesartan Medoxomil
- NDC Code (Product)
42291-002- Manufacturer
- AvKARE
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209010
- Marketing Start
- 06/18/2024
Recall History
Aurobindo Pharma USA Inc.
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Ascend Laboratories, LLC
Failed Dissolution Specifications: low dissolution results
Macleods Pharma Usa Inc
cGMP deviations
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Daiichi Sankyo Pharma Development
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing 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 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 tablets 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 [ See 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 adjust …
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reaction (incidence ≥ 3%) is edema (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals Inc. at 1-855-724-3436 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 1,000 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 olmes…
Frequently Asked Questions
What is Amlodipine and Olmesartan Medoxomil used for?
Amlodipine and Olmesartan Medoxomil contains Amlodipine and Olmesartan Medoxomil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Amlodipine and Olmesartan Medoxomil a controlled substance?
Amlodipine and Olmesartan Medoxomil is not classified as a controlled substance by the DEA.
What is the generic name for Amlodipine and Olmesartan Medoxomil?
The generic name for Amlodipine and Olmesartan Medoxomil is Amlodipine and Olmesartan Medoxomil. There are 3 other brand versions of Amlodipine and Olmesartan Medoxomil.
What is the NDC code for Amlodipine and Olmesartan Medoxomil 5 mg/1?
The NDC (National Drug Code) for Amlodipine and Olmesartan Medoxomil 5 mg/1 is 42291-002, listed by AvKARE.
Other Amlodipine and Olmesartan Medoxomil Dosages
- Amlodipine and Olmesartan Medoxomil5 mg/165862-855
- Amlodipine and Olmesartan Medoxomil5 mg/150090-7863
- Amlodipine and Olmesartan Medoxomil5 mg/168462-566
- Amlodipine and Olmesartan Medoxomil5 mg/168462-568
- Amlodipine and Olmesartan Medoxomil10 mg/131722-447
- Amlodipine and Olmesartan Medoxomil10 mg/150228-367
- Amlodipine and Olmesartan Medoxomil10 mg/165862-857
- Amlodipine and Olmesartan Medoxomil10 mg/168462-567
Other Amlodipine Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)