Atavir Capsules (Generic Atazanavir Sulfate Capsules)

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Atavir Capsules (Generic Atazanavir Sulfate Capsules)

Atavir Capsules (Generic Atazanavir Sulfate
Capsules) are used in combination with other
HIV medications to help control HIV infection. It
prevents human immunodeficiency virus (HIV)
from multiplying in the body. Atazanavir is for
use in adults and children who are at least 3
months old and weigh at least 11 pounds (5
kilograms).

Active Ingredient
The active ingredient contained in Atavir
Capsules is Atazanavir Sulfate. Each Atavir
capsule contains 300 mg of Atazanavir.

Chemical Structure
The structure of Atazanavir Sulfate is given below:

Atavir Capsules (Generic Atazanavir Sulfate Capsules) are
manufactured by Cipla Limited, India in the strength of
300 mg.
(Website: https://www.cipla.com/ )
URL: https://www.clearskypharmacy.biz/generic-atazanavir-atavir-by-cipla.html

Atazanavir Sulfate Capsules – Brand Names
Atazanavir Sulfate is available under
various drug trade names that include
Reyataz, Atavir, Virataz, Atazor.

Uses of Atavir Capsules
Atavir (Generic Atazanavir Sulfate Capsules) is a protease inhibitor
indicated for use in combination with other antiretroviral agents for the
treatment of HIV-1 infection in adults and in pediatric patients 3 months
and older weighing at least 5 kg.HIV is the virus that causes acquired
immune deficiency syndrome (AIDS).
Atazanavir will not cure or prevent HIV infection or AIDS. It helps keep
HIV from reproducing and appears to slow down the destruction of the
immune system. This may help delay problems that are usually related to
AIDS or HIV disease from occurring. Atazanavir will not keep you from
spreading HIV to other people. People who receive this medicine may
continue to have other problems usually related to AIDS or HIV disease.

Atavir Capsules Dosage
The dosage of Atavir capsules (Generic Atazanavir Sulfate Capsules)
is given below:
The recommended dosage of Atavir Capsules in treatment-experienced
patients is 300 mg with Ritonavir 100 mg once daily with food.
For Pediatric patients (6 years to less than 18 years of age) the dosage
is based on body weight not to exceed the adult dose.
During pregnancy 300 mg with Ritonavir 100 mg once daily with food,
with dosing modifications for some concomitant medications.
Dosing modifications may be required in case of Concomitant therapy,
Renal impairment and Hepatic impairment. Swallow Atavir capsules
whole. Do not open the capsules.

Contraindications
Atavir Capsules are contraindicated in patients with a hypersensitivity (eg,
Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions)
to Atazanavir Sulfate or any other component of this medication.
Coadministration with Alfuzosin, Amiodarone (if Atavir is coadministered
with Ritonavir), Quinidine (if Atavir is coadministered with Ritonavir),
Triazolam, orally administered midazolam, ergot derivatives, Rifampin,
Irinotecan, Lurasidone (if Atavir is coadministered with Ritonavir),
Lovastatin, Simvastatin, Lomitapide, Indinavir, Cisapride, Pimozide, St.
John’s wort, Nevirapine, Elbasvir/Grazoprevir, Glecaprevir/Pibrentasvir,
and Sildenafil.

Storage Instructions
Atavir Capsules (Generic Atazanavir Sulfate
Capsules) have to be stored at controlled
room temperature i.e. from 20°C to 25°C (68°F
to 77°F) with excursions permitted between
15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Cardiac conduction abnormalities: PR interval prolongation could occur in some
patients. Use with caution in patients with preexisting conduction system disease
or when administered with other medications that may prolong the PR interval.
Rash: Discontinue medication if severe rash develops. In controlled clinical trials,
rash (all grades, regardless of causality) occurred in approximately 20% of
subjects with HIV-1 infection treated with atazanavir. The median time to onset of
rash in clinical studies was 7.3 weeks and the median duration of rash was 1.4
weeks.
Chronic Kidney Disease: Chronic kidney disease in patients with HIV-1 infection
treated with Atazanavir, with or without Ritonavir, has been reported during
postmarketing surveillance. Reports included biopsy-proven cases of
granulomatous interstitial nephritis associated with the deposition of atazanavir
drug crystals in the renal parenchyma.

Warnings
Nephrolithiasis and Cholelithiasis: Cases of nephrolithiasis and/or cholelithiasis
have been reported during postmarketing surveillance in patients with HIV-1
infection receiving atazanavir therapy. Some patients required hospitalization for
additional management and some had complications. Consider temporary
interruption or discontinuation.
Hyperbilirubinemia: Most patients experience asymptomatic increases in indirect
bilirubin, which is reversible upon discontinuation. Do not dose reduce. If a
concomitant transaminase increase occurs, evaluate for alternative etiologies.
Hepatotoxicity: Patients with hepatitis B or C are at risk of increased
transaminases or hepatic decompensation. Monitor liver function tests before
therapy and during treatment.

Warnings
Diabetes Mellitus/Hyperglycemia: New-onset diabetes mellitus, exacerbation of
preexisting diabetes mellitus, and hyperglycemia have been reported during
postmarketing surveillance in patients with HIV-1 infection receiving protease
inhibitor therapy.
Fat Redistribution: Redistribution/accumulation of body fat including central
obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial
wasting, breast enlargement, and “cushingoid appearance” have been observed in
patients receiving antiretroviral therapy.
Hemophilia: Spontaneous bleeding could occur and additional factor VIII may be
required.
Resistance/Cross-Resistance: Various degrees of cross-resistance among protease
inhibitors have been observed. Resistance to atazanavir may not preclude the
subsequent use of other protease inhibitors.

Atavir Capsules Side Effects
Most common Atazanavir Sulfate (Atavir Capsules) side
effects with an incidence rate of 2% or greater are nausea,
jaundice/scleral icterus, rash, headache, abdominal pain,
vomiting, insomnia, peripheral neurologic symptoms,
dizziness, myalgia, diarrhea, depression, and fever.

Overdose
Human experience of acute overdose with Atazanavir Sulfate
Capsules is limited. Single doses up to 1200 mg of Atazanavir Sulfate
Capsules (three times the 400 mg maximum recommended dose) have
been taken by healthy volunteers without symptomatic untoward
effects.
A single self-administered overdose of 29.2 g of Atazanavir capsules
in an HIV-infected patient (73 times the 400-mg recommended dose)
was associated with asymptomatic bifascicular block and PR interval
prolongation. These events resolved spontaneously. At Atavir capsules
doses resulting in high Atazanavir exposures, jaundice due to indirect
(unconjugated) hyperbilirubinemia (without associated liver function
test changes) or PR interval prolongation may be observed.

Overdose
Treatment of overdosage with Atazanavir Sulfate (Atavir Capsules)
must consist of general supportive measures, including monitoring of
vital signs and ECG, and observations of the patient's clinical
status. If necessary, elimination of unabsorbed Atazanavir must be
achieved by emesis or gastric lavage.
Administration of activated charcoal may also be used to aid removal
of unabsorbed drug. There is no specific antidote for overdose
with Atazanavir Sulfate capsules. Since Atazanavir is extensively
metabolized by the liver and is highly protein bound, dialysis is
unlikely to be beneficial in significant removal of this medicine.

Atavir Capsules During Pregnancy
Atazanavir Sulfate (Atavir Capsules) is classified by the US FDA as Pregnancy
Category B.
Animal reproduction studies have failed to demonstrate a risk to the fetus and
there are no adequate and well-controlled studies in pregnant women. This
medicine should be used during pregnancy only if clearly needed and the benefit
outweighs the risk.
In animal reproduction studies, there was no evidence of mortality or
teratogenicity in offspring born to animals at systemic drug exposure levels (AUC)
0.7 (in rabbits) to 1.2 (in rats) times those observed at the human clinical dose
(300 mg/day Atazanavir boosted with 100 mg/day Ritonavir).
This medication has been evaluated in a limited number of women during
pregnancy and postpartum. Available data suggest risk of major birth defects
overall (compared to background rate) is not increased by this drug; however,
human studies cannot rule out the possibility of harm.

For more details on
Atavir Capsules click here
Atavir Capsules (Generic Atazanavir Sulfate Capsules) by Cipla
Limited, India.

Atavir Capsules (Generic Atazanavir Sulfate Capsules)

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