USASARTIM PLUS 150

COMPOSITION: Each film-coated tablet contains:

Irbesartan.................................................................... 150 mg

Hydrochlorothiazide.................................................. 12.5 mg

Excipients: Lactose, Microcrystalline cellulose, Copovidone, Croscarmellose sodium, Magnesium stearate, Colloidal anhydrous silica, Opadry II white, Red iron oxide, Yellow iron oxide q.s. one tablet.

INDICATIONS

USASARTIM PLUS is indicated for the treatment of hypertension.

USASARTIM PLUS may be used in patients whose blood pressure is not adequately controlled on monotherapy.

USASARTIM PLUS may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of USASARTIM PLUS as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

DOSAGE AND ADMINISTRATION

Add-On Therapy

In patients not controlled on monotherapy with irbesartan or hydrochlorothiazide, the recommended doses of USASARTIM PLUS are 150/12.5 mg and 300/12.5 mg. The largest incremental effect will likely be in the transition from monotherapy to irbesartan/ hydroclorothiazid 150/12.5 mg.

Initial Therapy

The usual starting dose is USASARTIM PLUS 150/12.5 mg once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 300/25 mg once daily as needed to control blood pressure. USASARTIM PLUS is not recommended as initial therapy in patients with intravascular volume depletion.

USASARTIM PLUS may be administered ONCE daily, with or without food. Maximum antihypertensive effects are attained within 2 to 4 weeks after a change in dose. The daily dose of hydrochlorothiazide should preferentially be administered in the morning.

Renal impairment

The usual regimens of therapy with USASARTIM PLUS may be followed as long as the patient's creatinine clearance is > 30 mL/min.

In patients with more severe renal impairment, USASARTIM PLUS is not recommended.

Hepatic impairment

No dosage adjustment is necessary in patients with hepatic impairment.

CONTRAINDICATIONS

USASARTIM PLUS is contraindicated in patients who are hypersensitive to any component of this product.

Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs (sulfadiazine, sulfamethoxazole, etc.).

Do not co-administer Aliskiren with USASARTIM PLUS in patients with diabetes.

WARNING AND PRECAUTIONS

Pregnancy

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. Thiazides cross the placenta, and use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.

When pregnancy is detected, discontinue USASARTIM PLUS as soon as possible.

Nursing Mothers

It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats.

Thiazides appear in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric

Safety and effectiveness in pediatric patients have not been established.

Hepatic impairment

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Other precautions

Lithium generally should not be given with thiazides.

Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.

Hydrochlorothiazide can cause an idiosyncratic reaction, resulting in transient myopia and acute angle-closure glaucoma.

PRESENTATION: Blister of 10 film-coated tablets, box of 3blisters.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A PHARMACEUTICAL JOINT-STOCK COMPANY

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203