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Drug Catalog - Product Detail

OLMESARTAN MEDOXOMIL TAB 20MG 30CT

NDC Mfr Size Str Form
68462-0437-30 GLENMARK PHARMACEUTICALS 30 20MG TABLET
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Generic Name
OLMESARTAN MEDOXOMIL
Substance Name
OLMESARTAN MEDOXOMIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA203281
Description
11 DESCRIPTION Olmesartan medoxomil, USP a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT 1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil, USP is described chemically as 4-(1-Hydroxy-1-methylethyl)-2-propyl-1-2-(1H-5-tetrazolyl) biphenyl-4-ylmethyl] imidazole-5-carboxylic acid 5-methyl-2-oxo-1,3-dioxol-4-ylmethyl ester. Its molecular formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.58 g/mol. It is sparingly soluble in methanol; practically insoluble in water. Olmesartan Medoxomil Tablets, USP are available for oral use as film‑coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil, USP and the following inactive ingredients: hydrogenated castor oil, hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. FDA approved dissolution test specifications differ from USP. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Olmesartan Medoxomil Tablets, USP 5 mg are light yellow to yellow, round, film-coated tablets debossed with ‘C’ on one side and plain on the other side. They are supplied as follows: Bottles of 30 with child-resistant closure NDC 68462-436-30 Olmesartan Medoxomil Tablets, USP 20 mg are white to off-white, round, film-coated tablets debossed with ‘437’ on one side and plain on the other side. They are supplied as follows: Bottles of 30 with child-resistant closure NDC 68462-437-30 Olmesartan Medoxomil Tablets, USP 40 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘438’ on one side and plain on the other side. They are supplied as follows: Bottles of 30 with child-resistant closure NDC 68462-438-30 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Bottles: Keep tablets in tightly closed containers with desiccants.
Indications & Usage
1 INDICATIONS AND USAGE Olmesartan medoxomil tablets are 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 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 antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents. Olmesartan medoxomil tablets are an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension in adult and pediatric patients six years of age and older, alone or with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Adult Hypertension ( 2.1 ) 20 mg once daily 20 to 40 mg once daily Pediatric Hypertension (6 years of age and older) ( 2.2 ) 20 to < 35 kg 10 mg once daily > 35 kg 20 mg once daily 20 to < 35 kg 10 to 20 mg once daily > 35 kg 20 to 40 mg once daily 2.1 Adult Hypertension Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil tablets 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 olmesartan medoxomil tablets 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 olmesartan medoxomil tablets 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 recommended starting dose of olmesartan medoxomil tablets are 10 mg once daily for patients who weigh 20 to <35 kg (44 to 77 lb), or 20 mg once daily for patients who weigh ≥35 kg. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of olmesartan medoxomil tablets may be increased to a maximum of 20 mg once daily for patients who weigh <35 kg or 40 mg once daily for patients who weigh ≥35 kg. Use of olmesartan medoxomil tablets in children <1 year of age is not recommended [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.4 )] . For children who cannot swallow tablets, the same dose can be given using an extemporaneous suspension as described below [see Clinical Pharmacology ( 12.3 )]. Follow the suspension preparation instructions below to administer olmesartan medoxomil as a suspension. Preparation of Suspension (for 200 mL of a 2 mg/mL suspension) Add 50 mL of Purified Water to an amber polyethylene terephthalate (PET) bottle containing twenty olmesartan medoxomil 20 mg tablets and allow to stand for a minimum of 5 minutes. Shake the container for at least 1 minute and allow the suspension to stand for at least 1 minute. Repeat 1-minute shaking and 1-minute standing for four additional times. Add 100 mL of ORA-Sweet ® * and 50 mL of ORA-Plus ® * to the suspension and shake well for at least 1 minute. The suspension should be refrigerated at 2°C to 8°C (36°F to 46°F) and can be stored for up to 4 weeks. Shake the suspension well before each use and return promptly to the refrigerator. * ORA-Sweet ® and ORA-Plus ® are registered trademarks of Paddock Laboratories, Inc.