Olmesartan Medoxomil

OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated
OLMESARTAN MEDOXOMIL- olmesartan medoxomil tablet, film coated
Apotex Corp.

Olmesartan Tablets — Package Label — 20 mg 30 ct Bottle LabelOlmesartan Tablets — Package Label — 40 mg 30 ct Bottle Label

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue olmesartan medoxomil as soon as possible (5.1).
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1).

1 INDICATIONS AND USAGE

Olmesartan medoxomil tablets are indicated for the treatment of hypertension, 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.

2 DOSAGE AND ADMINISTRATION

2.1 Adult Hypertension

Dosage must be individualized. The usual recommended starting dose of olmesartan medoxomil 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.

No initial dosage adjustment is recommended for elderly patients, for patients with moderate to marked renal impairment (creatinine clearance <40 mL/min) or with moderate to marked hepatic dysfunction [see Warnings and Precautions (5.4), Use in Specific Populations (8.5, 8.6, 8.7) and Clinical Pharmacology (12.3)]. 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)].

Olmesartan medoxomil tablets may be administered with or without food.

If blood pressure is not controlled by olmesartan medoxomil alone, a diuretic may be added. Olmesartan medoxomil may be administered with other antihypertensive agents.

2.2 Pediatric Hypertension (6 to 16 years of age)

Dosage must be individualized. For children who can swallow tablets, the usual recommended starting dose of olmesartan medoxomil is 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 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.

Children <1 year of age must not receive olmesartan medoxomil tablets for hypertension.

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 — 8°C (36 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.

3 DOSAGE FORMS AND STRENGTHS

  • 5 mg light yellow to yellow, round, film-coated tablets debossed with ‘C’ on one side and plain on theother side
  • 20 mg white to off white, round, film-coated tablets debossed with ‘437’ on one side and plain on theother side
  • 40 mg white to off white, oval-shaped, film-coated tablets debossed with ‘438’ on one side and plainon the other side

4 CONTRAINDICATIONS

Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions (7)].

5 WARNINGS AND PRECAUTIONS

5.1 Fetal Toxicity

Pregnancy Category D
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue olmesartan medoxomil as soon as possible [ see Use in specific Populations (8.1)].

5.2 Morbidity in Infants

Children <1 year of age must not receive olmesartan medoxomil for hypertension. Drugs that act directly on the renin-angiotensin aldosterone system (RAAS) can have effects on the development of immature kidneys [see Use in Specific Populations (8.4)].

5.3 Hypotension in Volume- or Salt-Depleted Patients

In patients with an activated renin-angiotensin aldosterone system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may be anticipated after initiation of treatment with olmesartan medoxomil. Initiate treatment under close medical supervision. If hypotension does occur, place the patient in the supine position and, if necessary, give an intravenous infusion of normal saline [see Dosage and Administration (2.1)]. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.

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