Posology : מינונים

2. DOSAGE AND ADMINISTRATION
2.1. overview
•    Atazanavir Teva Capsules must be taken with food.
•    Do not open the capsules.
•    The recommended oral dosage of Atazanavir Teva depends on the treatment history of the patient and the use of other coadministered drugs. When coadministered with H2-receptor antagonists or proton-pump inhibitors, dose separation may be required [see Dosage and Administration (2.3,2.4,2.5 and 2.6) and drug interactions (7)].
•    When coadministered with didanosine buffered or enteric-coated formulations, Atazanavir Teva should be given (with food) 2 hours before or 1 hour after didanosine.
•    Atazanavir Teva without ritonavir is not recommended for treatment-experienced adult or pediatric patients with prior virologic failure [see Clinical Studies (13)].
•    Efficacy and safety of Atazanavir Tevawith ritonavir when ritonavir is administered in doses 
greater than 100 mg once daily have not been established. The use of higher ritonavir doses may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and, therefore, is not recommended. Prescribers should consult the complete prescribing information for ritonavir when using ritonavir.
2.2. Testing Prior to Initiation and During Treatment with Atazanavir Teva
Renal laboratory testing should be performed in all patients prior to initiation of Atazanavir Teva and continued during treatment with Atazanavir Teva. Renal laboratory testing should include serum creatinine, estimated creatinine clearance, and urinalysis with microscopic examination [see Warnings and Precautions (5.5, 5.6)].
Hepatic laboratory testing should be performed in patients with underlying liver disease prior to initiation of Atazanavir Teva and continued during treatment with Atazanavir Teva [see Warnings and Precautions (5.4)].


2.3. Dosage of Atazanavir Teva in Adult patients
Table 1 summarizes the recommended Atazanavir Teva dosing regimen in adults. All Atazanavir Teva dosing regimens are to be administered as a single dose with food.


Table 1: Atazanavir Teva Dosing Regimens
Treatment-Naive Patients                             Atazanavir Teva 300 mg with ritonavir 100 mg once daily 

If unable to tolerate ritonavir                    Atazanavir Teva 400 mg once daily When combined with any of the following:           Atazanavir Teva 300 mg with ritonavir 100 mg once daily Tenofovir
H2-receptor antagonist
Proton-pump inhibitor


• The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 40 mg twice daily.
Administer Atazanavir Teva and ritonavir simultaneously with, and/or at least 10 hours after the H2- receptor antagonist
• If unable to tolerate ritonavir, administer Atazanavir Teva 400 mg once daily at least 2 hours before and at least 10 hours after the H2-receptor antagonist. No single dose of the H2-receptor antagonist should exceed a dose comparable to famotidine 20 mg and the total daily dose should not exceed a dose comparable to famotidine 40 mg.
• The proton-pump inhibitor dose should not exceed a dose comparable to omeprazole 20 mg daily and must be taken approximately 12 hours prior to Atazanavir Teva and ritonavir.



When combined with efavirenz                         Atazanavir Teva 400 mg with ritonavir 100 mg once daily 

• Efavirenz should be administered on an empty stomach, preferably at bedtime.
Treatment-Experienced Patients                   Atazanavir Teva 300 mg with ritonavir 100 mg once daily 

Do not coadminister with proton-pump inhibitors or efavirenz in treatment-experienced patients.
When given with an H2-receptor antagonist            Atazanavir Teva 300 mg with ritonavir 100 mg once daily 

• The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily.
Administer Atazanavir Teva and ritonavir simultaneously with, and/or at least 10 hours after the H2- receptor antagonist.

When given with both tenofovir and an H2-            Atazanavir Teva 400 mg with ritonavir 100 mg once daily receptor antagonist

The H2-receptor antagonist dose should not exceed a dose comparable to famotidine 20 mg twice daily.
Administer Atazanavir Tevaand ritonavir simultaneously with, and/or at least 10 hours after the H2-receptor antagonist.


[For these drugs and other antiretroviral agents for which dosing modification may be appropriate, see Drug Interactions (7).]


2.4. Dosage of Atazanavir Teva in pediatric patients
The recommended daily dosage of Atazanavir Teva for pediatric patients (6 to less than 18 years of age) is based on body weight and should not exceed the recommended adult dosage. Atazanavir Teva Capsules must be taken with food. The data are insufficient to recommend dosing of Atazanavir Teva for any of the following: (1) patients less than 6 years of age, (2) without ritonavir in any pediatric patient less than 13 years of age, and (3) patients less than 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors.
The recommended dosage of Atazanavir Teva with ritonavir in pediatric patients at least 6 years of age is shown in Table 2.
Table 2: Dosage for Pediatric Patients (6 to less than 18 years of age) for Atazanavir Teva Capsules with ritonavira

Body Weight                             Atazanavir Teva dose                        ritonavir dose 15 kg to less than 20 kg                150 mg                                      100 mg 

20 kg to less than 40 kg                200 mg                                    100 mg at least 40 kg                          300 mg                                    100 mg a
The Atazanavir Teva and ritonavir dose should be taken together once daily with food.
For treatment-naive patients at least 13 years of age and at least 40 kg, who are unable to tolerate ritonavir, the recommended dose is Atazanavir Teva 400 mg (without ritonavir) once daily with food.
For patients at least 13 years of age and at least 40 kg receiving concomitant tenofovir, H2-receptor antagonists, or proton-pump inhibitors, Atazanavir Teva should not be administered without ritonavir.


Pregnancy Dosing During and the Postpartum Period:
•   Atazanavir Teva should not be administered without ritonavir.
•   Atazanavir Teva should only be administered to pregnant women with HIV-1 strains susceptible to atazanavir.
•   For pregnant patients, no dose adjustment is required for Atazanavir Teva with the following exceptions: o   For treatment-experienced pregnant women during the second or third trimester, when Atazanavir Teva is coadministered with either an H2-receptor antagonist or tenofovir, Atazanavir Teva 400 mg with ritonavir 100 mg once daily is recommended. There are insufficient data to recommend a Atazanavir Teva dose for use with both an H2-receptor antagonist and tenofovir in treatment-experienced pregnant women.
•   No dose adjustment is required for postpartum patients. However, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery. [See Use in Specific Populations (8.1) and Clinical Pharmacology (11.3)] 

2.5. Renal Impairment
For patients with renal impairment, including those with severe renal impairment who are not managed with hemodialysis, no dose adjustment is required for Atazanavir Teva. Treatment-naive patients with end stage renal disease managed with hemodialysis should receive Atazanavir Teva 300 mg with ritonavir 100 mg. Atazanavir Teva should not be administered to HIV-treatment- experienced patients with end stage renal disease managed with hemodialysis. [See Use in Specific Populations (8.7).] 

2.6. Hepatic Impairment
Atazanavir Teva should be used with caution in patients with mild-to-moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not experienced prior virologic 

failure, a dose reduction to 300 mg once daily should be considered. Atazanavir Teva should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
Atazanavir Teva/ritonavir has not been studied in subjects with hepatic impairment and is not recommended. [See Warnings and Precautions (5.5) and Use in Specific Populations (8.8).] 

3. DOSAGE FORMS AND STRENGTHS
Atazanavir Teva Capsules:
•   150 mg capsule –non transparent capsule, with dark blue cap and black mark 150 on light blue body.
•   200 mg capsule- non transparent capsule, with blue cap and black mark 200 on blue body.
•   300 mg capsule- non transparent capsule, with red cap and black mark 300 on blue body.