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About Truvada® Tablets
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| 1. |
Brand Name: |
Truvada® Tablets |
| 2. |
Generic Name: |
emtricitabine · tenofovir disoproxyl fumarate |
| 3. |
Indication: |
HIV-1 infection |
| 4. |
Dosage and Administration: |
In adults, Truvada® should usually be administered orally with one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate), once daily. Truvada® should be used in combination with other anti-HIV drugs. |
| 5. |
Warning: |
Sufficient caution should be exercised to patient with complication of chronic hepatitis B in case administration of Truvada® is discontinued since exacerbation of chronic hepatitis B might be observed after discontinuation of Truvada® administration. Especially, particular caution should be exercised to patient with complication of decompensated hepatitis B since decompensated hepatitis B might be aggravated. |
| 6. |
Contraindications: |
Patients with a previously demonstrated hypersensitivity to any of the components of the product. |
| 7. |
Adverse Drug Reactions: |
In two clinical studies of Emtriva® in antiretroviral treatment experienced and naïve patients in foreign countries, 303 (52.2%) of the 580 cases that received Emtriva® presented adverse drug reactions. The common adverse drug reactions were diarrhea, dizziness, nausea, abdominal pain, headache, insomnia, and asthenia etc.
In three double-blind clinical studies of Viread® in antiretroviral treatment experienced and naïve patients in foreign countries, 379 (41.6%) of 912 cases that received Viread® presented adverse drug reactions through week 48. The common adverse drug reactions were nausea, diarrhea, asthenia, headache, abdominal pain, vomiting, and dizziness etc. The majority of the adverse drug reactions were in relation to gastrointestinal system. The common laboratory abnormalities were CK increased, triglycerides increased, serum amylase increased, etc.
Clinically significant adverse drug reactions, including kidney failure and severe renal impairment , pancreatitis and lactic acidosis , might occur. |
| 8. |
Packaging: |
Truvada® Tablets, 30 tablets per bottle |
| 9. |
NHI Price: |
¥3,862.80 per tablet |
| 10. |
Date of NHI Price Listing: |
April 6, 2005 |
| 11. |
Marketing Authorization Holder: |
Japan Tobacco Inc. |
| 12. |
Distributed by: |
Torii Pharmaceutical Co., Ltd. |
| 13. |
Licensed by: |
Gilead Sciences, Inc. |
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