Benicar 40 mg/1
olmesartan medoxomil · TABLET, FILM COATED · Cosette Pharmaceuticals, Inc.
Benicar is a tablet, film coated containing olmesartan medoxomil at 40 mg/1, taken oral. Manufactured by Cosette Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Benicar
- Generic Name
- olmesartan medoxomil
- NDC Code (Product)
0713-0862- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Strength
- 40 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA021286
- Marketing Start
- 09/01/2022
Recall History
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
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
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 Benicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. 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 Benicar. 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 antihypertensive drugs, from a variety of pharmacologic classes and with different …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Adult Hypertension ( 2.1 ) 20 mg once daily 20 - 40 mg once daily Pediatric Hypertension (6 years of age and older) ( 2.2 ) 20 to <35 kg 20 to <35 kg 10 mg once daily 10 - 20 mg once daily ≥ 35 kg ≥ 35 kg 20 mg once daily 20 - 40 mg once daily 2.1 Adult Hypertension Dosage must be individualized. The usual recommended starting dose of Benicar is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate Benicar under close medical supervision and give consideration to use of a lower starting dose [see Warnings and Precautions (5.3) ] . 2.2 Pediatric Hypertension (6 Years of Age and Older) Dosage must be individualized. For children who can swallow tablets, the usual recom…
Contraindications
4 CONTRAINDICATIONS Do not co-administer aliskiren with Benicar in patients with diabetes [see Drug Interactions (7.3) ]. Do not co-administer aliskiren with Benicar in patients with diabetes ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ). Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7.4 ). Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ). 7.1 Agents Increasing Serum Potassium Concomitant use of olmesartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium. If co-medication is considered necessary, monitoring of serum potassium is advisable. 7.2 Non-Steroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with comp…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction in adults was dizziness (3%) ( 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. Adult Hypertension Benicar has been evaluated for safety in more than 3825 patients/subjects, including more than 3275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and more than 525 for at least 1 year. Events generally were mild, transient and had no relationship to the dose of Benicar. Analysis of gender, age and race groups demonstrated no differences between Benicar and placebo-treated patients. The rate of withdrawals due to adverse reactions in all trials of hypertensive patients was 2.4% (i.e., 79/3278) of patients treated with Benicar and 2.7% (i.e., 32/1179) of cont…
Frequently Asked Questions
What is Benicar used for?
Benicar contains olmesartan medoxomil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Benicar a controlled substance?
Benicar is not classified as a controlled substance by the DEA.
What is the generic name for Benicar?
The generic name for Benicar is olmesartan medoxomil. There are 11 other brand versions of olmesartan medoxomil.
What is the NDC code for Benicar 40 mg/1?
The NDC (National Drug Code) for Benicar 40 mg/1 is 0713-0862, listed by Cosette Pharmaceuticals, Inc..
Other Olmesartan Brands
See all →- Olmesartan Medoxomil5 mg/172241-078
- OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE12.5 mg/172603-290
- 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.
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