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Combivir 150-300 Mg Tabs 120 Unit Dose By Viiv Healthcare

Image 0 of Combivir 150-300 Mg Tabs 120 Unit Dose By Viiv Healthcare

Combivir 150-300 Mg Tabs 120 Unit Dose By Viiv Healthcare

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Combivir 150-300 Mg Tabs 120 Unit Dose By Viiv Healthcare. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4376877/RXB10092405
Size : 120
Selling UoM : EA
NDC: 49702-0202-29
UPC Barcode : 349702202290
Supplier:
Supplier Material : 020229
Generic Code : 034186 LAMIVUDINE/ZIDOVUDINE ORAL TABLET 150-30
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

GX FC3, GX FC3
tablet , film-coated , white , scored , oblong oblong
Debossed

WARNING: HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS, EXACERBATIONS OF HEPATITIS B

Zidovudine, one of the 2 active ingredients in COMBIVIR, has been associated with hematologic toxicity including neutropenia and anemia, particularly in patients with advanced HIV-1 disease [see WARNINGS AND PRECAUTIONS].

Prolonged use of zidovudine has been associated with symptomatic myopathy [see WARNINGS AND PRECAUTIONS].

Lactic acidosis and hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including lamivudine, zidovudine, and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur [see WARNINGS AND PRECAUTIONS].

Acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV-1 and have discontinued lamivudine, which is one component of COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co-infected with HIV-1 and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see WARNINGS AND PRECAUTIONS].
DRUG DESCRIPTION

COMBIVIR: COMBIVIR Tablets are combination tablets containing lamivudine and zidovudine. Lamivudine (EPIVIR) and zidovudine (RETROVIR, azidothymidine, AZT, or ZDV) are synthetic nucleoside analogues with activity against HIV-1.

COMBIVIR Tablets are for oral administration. Each film-coated tablet contains 150 mg of lamivudine, 300 mg of zidovudine, and the inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, and titanium dioxide.

Lamivudine is a white to off-white crystalline solid with a solubility of approximately 70 mg/mL in water at 20?C.

Zidovudine is a white to beige, odorless, crystalline solid with a solubility of 20.1 mg/mL in water at 25?C.

INDICATIONS

COMBIVIR, a combination of two nucleoside analogues, is indicated in combination with other antiretrovirals for the treatment of HIV-1 infection.
DOSAGE AND ADMINISTRATION
Adults and Adolescents Weighing > 30 kg

The recommended oral dose of COMBIVIR in HIV-1-infected adults and adolescents weighing greater than or equal to 30 kg is 1 tablet (containing 150 mg of lamivudine and 300 mg of zidovudine) twice daily.
Pediatric Patients

The recommended oral dosage of scored COMBIVIR Tablets for pediatric patients who weigh greater than or equal to 30 kg and for whom a solid oral dosage form is appropriate is 1 tablet administered twice daily.

Before prescribing COMBIVIR Tablets, children should be assessed for the ability to swallow tablets. If a child is unable to reliably swallow a COMBIVIR tablet, the liquid oral formulations should be prescribed: EPIVIR? (lamivudine) Oral Solution and RETROVIR? (zidovudine) Syrup.
Patients Requiring Dosage Adjustment

Because COMBIVIR is a fixed-dose combination tablet, it should not be prescribed for pediatric patients weighing less than 30 kg or patients requiring dosage adjustment, such as those with reduced renal function (creatinine clearance less than 50 mL/min), patients with hepatic impairment, or patients experiencing dose-limiting adverse reactions. Liquid and solid oral formulations of the individual components of COMBIVIR are available for these populations.