Olmesartan Medoxomil 5 mg/1
Olmesartan Medoxomil · TABLET, FILM COATED · Alembic Pharmaceuticals Limited
Olmesartan Medoxomil is a tablet, film coated containing olmesartan medoxomil at 5 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Limited.
Key Facts
- Brand Name
- Olmesartan Medoxomil
- Generic Name
- Olmesartan Medoxomil
- NDC Code (Product)
46708-131- Manufacturer
- Alembic Pharmaceuticals Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203012
- Marketing Start
- 04/24/2017
Recall History
Ascend Laboratories LLC
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Teva Pharmaceuticals USA
Failed dissolution specifications
Ascend Laboratories LLC
Presence of Foreign Tablet/Capsule
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).
Daiichi Sankyo Pharma Development
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
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
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 Olmesartan medoxomil and hydrochlorothiazide is indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide is not indicated for the initial therapy of hypertension [see Dosage and Administration (2) ] . Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular 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 olmesartan medoxomil and hydrochlorothiazide. 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 Preven…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide. Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 ) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg ( 2 ) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide ( 2 )
Contraindications
4 CONTRAINDICATIONS Olmesartan medoxomil and hydrochlorothiazide is contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide [see Adverse Reactions ( 6.1 , 6.2 )] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [ s ee Drug Interactions (7.4) ]. Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide in patients with diabetes. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use. 7. 3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Olmesartan medoxom…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Electrolyte and Metabolic Imbalances [see Warnings and Precautions (5.5) ] Acute Myopia and Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6) ] Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Sprue-Like Enteropathy [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and upper respiratory infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 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 observed in practice. Olmesartan medoxomil and…
Frequently Asked Questions
What is Olmesartan Medoxomil used for?
Olmesartan Medoxomil contains Olmesartan Medoxomil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Olmesartan Medoxomil a controlled substance?
Olmesartan Medoxomil is not classified as a controlled substance by the DEA.
What is the generic name for Olmesartan Medoxomil?
The generic name for Olmesartan Medoxomil is Olmesartan Medoxomil. There are 10 other brand versions of Olmesartan Medoxomil.
What is the NDC code for Olmesartan Medoxomil 5 mg/1?
The NDC (National Drug Code) for Olmesartan Medoxomil 5 mg/1 is 46708-131, listed by Alembic Pharmaceuticals Limited.
Other Olmesartan Medoxomil Dosages
Other Olmesartan Brands
See all →- OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE12.5 mg/172603-290
- Benicar40 mg/10713-0862
- Benicar HCT12.5 mg/10713-0864
- olmesartan medoxomil5 mg/116729-320
- Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide10 mg/10093-5003
- Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide5 mg/10093-5006
- Olmesartan medoxomil, amlodipine and hydrochlorothiazide10 mg/131722-896
- OLMESARTAN MEDOXOMIL5 mg/142571-201
- OLMESARTAN MEDOXOMIL40 mg/142571-203
- OLMESARTAN MEDOXOMIL, AMLODIPINE and HYDROCHLOROTHIAZIDE5 mg/142571-245
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)