Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
ZIDOVUDINE
GLAXOSMITHKLINE PTE LTD
J05AF01
250 mg
CAPSULE
ORAL
Prescription Only
GLAXO WELLCOME OPERATIONS
1993-08-06
1 RETROVIR™ ZIDOVUDINE QUALITATIVE AND QUANTITATIVE COMPOSITION _RETROVIR_ 100mg Capsules Hard gelatin capsules with opaque white cap and body and a central dark-blue band, printed “Wellcome”, “100” and coded Y9C and each containing 100mg Zidovudine. _RETROVIR_ 250mg Capsules Hard gelatin capsules with opaque blue cap, opaque white body and a central dark-blue band, printed “Wellcome”, “250” and coded H2F and each containing 250mg Zidovudine. _RETROVIR_ Oral Solution Oral solution containing 50 mg zidovudine per 5 ml. It is clear, pale yellow, and strawberry- flavoured. Contains sodium benzoate. PHARMACEUTICAL FORM Hard capsules. Oral solution. CLINICAL PARTICULARS INDICATIONS _RETROVIR_ is indicated in combination with other anti-retroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children. DOSAGE AND ADMINISTRATION _RETROVIR_ therapy should be initiated by a physician experienced in the management of HIV infection. DOSAGE IN ADULTS Although a broad range of dosages has been employed, 500 or 600mg/day in three to five divided doses is commonly used worldwide. Alternatively 1000mg/day in two (or four) divided doses is effective. The effectiveness of the lower dosages in the treatment or prevention of HIV- associated neurological dysfunction and malignancies is unknown. DOSAGE IN CHILDREN 2 In children over the age of 3 months, the recommended starting dosage is 180mg/m 2 body surface area every 6 hours (720mg/m 2 /day). The maximum dosage should not exceed 200mg every 6 hours. The optimum dosage regimen remains to be determined and may vary from patient to patient. A range of dosages, generally between 120 and 180mg/m 2 body surface area every 6 hours (between 480 and 720mg/m 2 /day), has been used. The effectiveness of lower dosages in the treatment or prevention of HIV-associated neurological dysfunction and malignancies i Прочитать полный документ