Atazanavir Sulfate 150 mg/1
Atazanavir Sulfate · CAPSULE · Teva Pharmaceuticals USA, Inc.
Atazanavir Sulfate is a capsule containing atazanavir sulfate at 150 mg/1, taken oral. Manufactured by Teva Pharmaceuticals USA, Inc..
Key Facts
- Brand Name
- Atazanavir Sulfate
- Generic Name
- Atazanavir Sulfate
- NDC Code (Product)
0093-5526- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA091673
- Marketing Start
- 12/27/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: Atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations ( 8.4 )] . Use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology ( 12.4 )] . Atazanavir capsules are 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 6 years and older weighing at least 15 kg. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Pretreatment testing: Renal laboratory testing should be performed in all patients prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. Hepatic testing should be performed in patients with underlying liver disease prior to initiation of atazanavir capsules and continued during treatment with atazanavir capsules. ( 2.2 ) Treatment-naive adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food or atazanavir capsules 400 mg once daily with food. ( 2.3 ) Treatment-experienced adults: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food. ( 2.3 ) Pediatric patients: Atazanavir capsule dosage is based on body weight not to exceed the adult dose and must be taken with food. ( 2.4 ) Pregnancy: Atazanavir capsules 300 mg with ritonavir 100 mg once daily with food, with dosing modifications for some concomitant medications. ( 2.6 ) Dosing modifications: may be required for concomitant therapy ( 2.3 , 2.4 , 2.6 ), renal impairment ( 2.7 ), and hepatic impairment. ( 2.8 ) 2.1 Overview Atazanavir capsules must be taken with food. Do not open the capsules. The recommended oral dosage o…
Contraindications
4 CONTRAINDICATIONS Atazanavir is contraindicated: in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions ( 5.2 )] . when coadministered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see Table 6). when coadministered with drugs that are strong inducers of CYP3A due to the potential for loss of therapeutic effect and development of resistance. Coadministration is contraindicated with, but not limited to, the following drugs listed in Table 6: Table 6: Drugs Contraindicated with Atazanavir (Information in the table applies to Atazanavir with or without ritonavir, unless otherwise indicated) Drug Class Drugs within class that are contraindicated with Atazanavir Alpha 1-adrenoreceptor antagonist Alfuzosin Antiarrhythmics Amiodarone (with ritonavir), quinidine (with ritonavir) Anticonvulsants Carbamazepine, phenobarbital, phenytoin Antimycobacterials Rifamp…
Drug Interactions
7 DRUG INTERACTIONS Coadministration of atazanavir can alter the concentration of other drugs and other drugs may alter the concentration of atazanavir. The potential drug-drug interactions must be considered prior to and during therapy. ( 4 , 7 , 12.3 ) 7.1 Potential for Atazanavir to Affect Other Drugs Atazanavir is an inhibitor of CYP3A and UGT1A1. Coadministration of atazanavir and drugs primarily metabolized by CYP3A or UGT1A1 may result in increased plasma concentrations of the other drug that could increase or prolong its therapeutic and adverse effects. Atazanavir is a weak inhibitor of CYP2C8. Use of atazanavir without ritonavir is not recommended when coadministered with drugs highly dependent on CYP2C8 with narrow therapeutic indices (eg, paclitaxel, repaglinide). When atazanavir with ritonavir is coadministered with substrates of CYP2C8, clinically significant interactions are not expected [see Clinical Pharmacology, Table 22 ( 12.3 )]. The magnitude of CYP3A-mediated drug interactions on coadministered drug may change when atazanavir is coadministered with ritonavir. See the complete prescribing information for ritonavir for information on drug interactions with ritona…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: cardiac conduction abnormalities [see Warnings and Precautions ( 5.1 )] rash [see Warnings and Precautions ( 5.2 )] hyperbilirubinemia [see Warnings and Precautions ( 5.8 )] chronic kidney disease [see Warnings and Precautions (5.5)] nephrolithiasis and cholelithiasis [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Treatment-Naive Adult Participants The safety profile of atazanavir in treatment-naive adults is based on 1625 partici…
Frequently Asked Questions
What is Atazanavir Sulfate used for?
Atazanavir Sulfate contains Atazanavir Sulfate. It is a capsule taken oral. Consult your doctor for specific uses.
Is Atazanavir Sulfate a controlled substance?
Atazanavir Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Atazanavir Sulfate?
The generic name for Atazanavir Sulfate is Atazanavir Sulfate. There are no other listed brand versions of Atazanavir Sulfate.
What is the NDC code for Atazanavir Sulfate 150 mg/1?
The NDC (National Drug Code) for Atazanavir Sulfate 150 mg/1 is 0093-5526, listed by Teva Pharmaceuticals USA, Inc..
Other Atazanavir Sulfate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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