Olmesartan medoxomil Amlodipine and Hydrochlorothiazide 5 mg/1
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide · TABLET, FILM COATED · Macleods Pharmaceuticals Limited
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide is a tablet, film coated containing olmesartan medoxomil amlodipine and hydrochlorothiazide at 5 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.
Key Facts
- Brand Name
- Olmesartan medoxomil Amlodipine and Hydrochlorothiazide
- Generic Name
- Olmesartan medoxomil Amlodipine and Hydrochlorothiazide
- NDC Code (Product)
33342-245- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 5 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207088
- Drug Class
- Thiazide Diuretic [EPC]
- Marketing Start
- 07/18/2025
Recall History
No Recall HistorySide 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, amlodipine and hydrochlorothiazide tablet 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 olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet. 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 Bl…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Dose once daily. Dosage may be increased in 2-week intervals, as needed. The maximum recommended dose of olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is 40/10/25 mg. Dose selection should be individualized based on previous therapy. • Dose once daily. Dosage may be increased after 2 weeks to a maximum dose of 40 /10 /25 mg once daily ( 2 ). • Dose selection should be individualized based on previous therapy ( 2 ).
Contraindications
4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet is contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not co-administer aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet in patients with diabetes [ See Drug Interactions (7.2)]. • Anuria: Hypersensitivity to sulfonamide-derived drugs ( 4 ). • Do not co-administer aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablet in patients with diabetes ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Olmesartan medoxomil ( 7.1 ): • 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. Amlodipine ( 7.2 ): • Limit simvastatin to 20 mg daily when coadministered. • Increased exposure to cyclosporin and tacrolimus. • Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): • Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. • Cholestyramine and colestipol: Reduced absorption of thiazides. • NSAIDs: Can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. 7.1 Drug Interactions with Olmesartan Medoxomil 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 wi…
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥2%) are dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 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. Olmesartan medoxomil, amlodipine and hydrochlorothiazide In the controlled trial of olmesartan medoxomil, amlodipine and hydrochlorothiazide, patients were randomized to olmesartan medoxomil, amlodipine and hydrochlorothiazide 40/10/25 mg, olmesartan medoxomil/amlodipine 40/10 mg, olmesartan medoxomil/hydrochlorothiazide 40/25 mg, or amlodipine/hydrochlorothiazide 10/25 mg. Subjects who received triple combination therapy were treated between two and four weeks with one of the three dual combination thera…
Frequently Asked Questions
What is Olmesartan medoxomil Amlodipine and Hydrochlorothiazide used for?
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide contains Olmesartan medoxomil Amlodipine and Hydrochlorothiazide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Olmesartan medoxomil Amlodipine and Hydrochlorothiazide a controlled substance?
Olmesartan medoxomil Amlodipine and Hydrochlorothiazide is not classified as a controlled substance by the DEA.
What is the generic name for Olmesartan medoxomil Amlodipine and Hydrochlorothiazide?
The generic name for Olmesartan medoxomil Amlodipine and Hydrochlorothiazide is Olmesartan medoxomil Amlodipine and Hydrochlorothiazide. There are no other listed brand versions of Olmesartan medoxomil Amlodipine and Hydrochlorothiazide.
What is the NDC code for Olmesartan medoxomil Amlodipine and Hydrochlorothiazide 5 mg/1?
The NDC (National Drug Code) for Olmesartan medoxomil Amlodipine and Hydrochlorothiazide 5 mg/1 is 33342-245, listed by Macleods Pharmaceuticals Limited.
Other Olmesartan medoxomil Amlodipine and Hydrochlorothiazide Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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