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Atazotec

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Composition:

Each Film-Coated Tablet Contains:
Atazanavir Sulphate
equivalent to Atazanavir 300 mg
Ritonavir USP 100 mg
 

List of Excipients:

Stearic acid, Hydroxy Propyl cellulose, Sodium Starch Glycolate, Crospovidone, Microcrystalline cellulose, Magnesium Stearate,
Poloxamer (188), Colloidal Anhydrous Silica, film coat ( HPMC 5cps, FCM orange).
 

Therapeutic Indications

Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets is indicated for the treatment of HIV-1 infected adults in combination with other antiretroviral medicinal products.
The choice of fixed dose combination Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets for use in treatment- experienced patients should be based on treatment history of patients and, if available, also on individual viral resistance testing.
 
Consideration should be given to official treatment guidelines for HIV-1 infection.
 

Posology and method of administration

Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets should be prescribed by physicians who are experienced in the treatment of HIV infection.
Adults: The recommended dose of Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg tablets is one tablet taken once daily with food. Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg tablets should be swallowed whole and not chewed, broken or crushed.
Patients weighing < 39 kg:
For these patients separate formulations containing lower amounts of atazanavir or ritonavir are available.
Hepatic impairment: Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets should be used with caution in patients with mild hepatic impairment. Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets is contraindicated in patients with moderate to severe hepatic impairment.
Renal impairment: No dosage adjustment is needed. Atazanavir (as sulfate)/Ritonavir 300 mg/100 mg Tablets is not recommended in patients undergoing haemodialysis.
 

Contraindications

Hypersensitivity to the active substances or to any of the excipients.

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