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Tyzeka 600 Mg Tabs 30 By Novartis Pharma

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Tyzeka 600 Mg Tabs 30 By Novartis Pharma

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Tyzeka 600 Mg Tabs 30 By Novartis Pharma. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4056354/RXB10052561/RXA312747
Size : 30
Selling UoM : EA
NDC: 00078-0538-15
UPC Barcode : 300780538152
Supplier: 0050001965 NOVARTIS PHARM CORP
Supplier Material : 053815
Generic Code : 061680 TELBIVUDINE ORAL TABLET 600 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

LDT
tablet , film-coated , white , oval oblong
Ovaloid-shapedWhite to slightly yellowish

Tyzeka is the trade name for telbivudine, a synthetic thymidine nucleoside analogue with activity against hepatitis B virus (HBV). The chemical name for telbivudine is 1-((2S,4R,5S)-4-hydroxy-5-hydroxymethyltetrahydrofuran-2-y1)-5-methyl-1H-pyrimidine-2,4-dione, or 1-(2-deoxy-β-L-ribofuranosyl)-5 methyluracil. Telbivudine is the unmodified β-L enantiomer of the naturally occurring nucleoside, thymidine.

Telbivudine is a white to slightly yellowish powder. Telbivudine is sparingly soluble in water ( > 20 mg/mL), and very slightly soluble in absolute ethanol (0.7 mg/mL) and n-octanol (0.1 mg/mL).

Tyzeka film-coated tablets are available for oral administration in 600 mg strength. Tyzeka 600 mg film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. The tablet coating contains titanium dioxide, polyethylene glycol, talc and hypromellose.

Tyzeka oral solution is available for oral administration in 100 mg/5 mL strength. Tyzeka oral solution contains the following inactive ingredients: citric acid anhydrous, benzoic acid, passion fruit flavor, sodium saccharin, sodium hydroxide, and purified water. A 600 mg dose (30 mL) of Tyzeka oral solution contains approximately 47 mg of sodium.

INDICATIONS
Chronic Hepatitis B

Tyzeka is indicated for the treatment of chronic hepatitis B in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

The following points should be considered when initiating therapy with Tyzeka:

* This indication is based on virologic, serologic, biochemical and histologic responses in nucleoside-treatment-na?ve adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [see Clinical Studies].
* Tyzeka has not been evaluated in patients co-infected with HIV, HCV or HDV.
* Tyzeka has not been evaluated in liver transplant recipients or in patients with decompensated liver disease.
* Tyzeka has not been studied in well-controlled trials for the treatment of patients with established nucleoside analog reverse transcriptase inhibitor-resistant hepatitis B virus infection, but is expected to be cross-resistant to lamivudine

SIDE EFFECTS

The following adverse reactions are discussed in other sections of the labeling:

* Lactic acidosis and severe hepatomegaly with steatosis [See Boxed Warning, WARNINGS AND PRECAUTIONS]
* Severe acute exacerbations of hepatitis after discontinuation of treatment [See Boxed Warning, WARNINGS AND PRECAUTIONS]
* Myopathy [See WARNINGS AND PRECAUTIONS]
* Peripheral Neuropathy [See WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Assessment of adverse reactions is primarily based on two studies (007 GLOBE and NV-02B-015) in which 1,699 subjects with chronic hepatitis B received double-blind treatment with Tyzeka 600 mg/day (n=847 subjects) or lamivudine (n=852 subjects) for 104 weeks. The median duration of therapy was 104 weeks for both treatment groups.

In the 104 week clinical studies, most adverse experiences reported with Tyzeka were classified as mild or moderate in severity and were not attributed to Tyzeka. Selected adverse events of any severity which were reported in ≥ 3% of Tyzeka and lamivudine recipients are shown in Table 2. With the exception of increased creatine kinase (CK), which was reported more frequently among Tyzeka recipients, the adverse event profile was similar for the two drugs.