Atazanavir Sulfate (Atazanavir Sulfate)

Trade Name : Atazanavir Sulfate

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 150 mg/1

Storage and handling for Atazanavir Sulfate

ATAZANAVIR SULFATE HIV Protease Inhibitors [MoA],Protease Inhibitor [EPC],UGT1A1 Inhibitors [MoA],UDP Glucuronosyltransferases Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atazanavir Sulfate (Atazanavir Sulfate) which is also known as Atazanavir Sulfate and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 150 mg/1 per ml. Read more

Atazanavir Sulfate (Atazanavir Sulfate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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Atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg.n
Limitations of Use:
Atazanavir sulfate capsules are a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 6 years and older weighing at least 15 kg. ()

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Pretreatment testing:
Treatment-naive adults:
Treatment-experienced adults:
Pediatric patients:
Pregnancy:
Dosing modifications:

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Capsules: 150 mg, 200 mg, 300 mg. (, )

Atazanavir sulfate capsules are contraindicated:
Table 6 displays drugs that are contraindicated with atazanavir sulfate.n

Atazanavir sulfate capsules are contraindicated in patients with previously demonstrated hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product. ()
Coadministration with alfuzosin, triazolam, orally administered midazolam, ergot derivatives, rifampin, irinotecan, lurasidone (if atazanavir sulfate capsules are coadministered with ritonavir), lovastatin, simvastatin, indinavir, cisapride, pimozide, St. Johnu2019s wort, nevirapine, elbasvir/grazoprevir, glecaprevir/pibrentasvir, and sildenafil u00a0when dosed as REVATIO. ()

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Cardiac conduction abnormalities:
Severe Skin Reactions:
Hyperbilirubinemia:
Hepatotoxicity:
Chronic kidney disease
Nephrolithiasis and cholelithiasis
The concomitant use of atazanavir sulfate/ritonavir and certain other medications may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions. (, )
Patients receiving atazanavir sulfate may develop new onset or exacerbations of diabetes mellitus/hyperglycemia (), immune reconstitution syndrome (), and redistribution/accumulation of body fat ().
Hemophilia:

The following adverse reactions are discussed in greater detail in other sections of the labeling:
Most common adverse reactions (u2265 2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. ()
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Coadministration of atazanavir sulfate 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. (, , )

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Pregnancy:
Lactation:
Hepatitis B or C co-infection:
Renal impairment:
Hepatic impairment:

Human experience of acute overdose with atazanavir sulfate is limited. Single doses up to 1200 mg (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 sulfate 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 atazanavir sulfate 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 n
Treatment of overdosage with atazanavir sulfate should consist of general supportive measures, including monitoring of vital signs and ECG, and observations of the patientu2019s clinical status. If indicated, elimination of unabsorbed atazanavir should 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. 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.

The active ingredient in atazanavir sulfate capsules is atazanavir sulfate, which is an HIV-1 protease inhibitor.
The chemical name for atazanavir sulfate is (3,8,9,12)-3,12-bis(1,1-dimethylethyl)-8-hydroxy-4,11-dioxo-9-(phenylmethyl)-6-[[4-(2-pyridinyl)phenyl]methyl]-2,5,6,10,13-pentaazatetradecanedioic acid dimethyl ester, sulfate (1:1). Atazanavir sulfate has the following structural formula:
CHNOu2022HSO M.W. 704.9 (free base) 802.9 (sulfuric acid salt)
Atazanavir sulfate is a white to pale yellow crystalline powder. It is slightly soluble in water (4 to 5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 u00b1 3u00b0 C.
Atazanavir sulfate capsules are available for oral administration in strengths containing the equivalent of 150 mg, 200 mg or 300 mg of atazanavir as atazanavir sulfate and the following inactive ingredients: crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, gelatin, iron oxide black, lactose monohydrate, magnesium stearate, propylene glycol, shellac, sodium lauryl sulfate, sorbitan monolaurate, and titanium dioxide. Additionally, the 300 mg capsules also contain FD&C red #40.

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Carcinogenesis
Long-term carcinogenicity studies in mice and rats were carried out with atazanavir for two years. In the mouse study, drug-related increases in hepatocellular adenomas were found in females at 360 mg/kg/day. The systemic drug exposure (AUC) at the NOAEL (no observable adverse effect level) in females, (120 mg/kg/day) was 2.8 times and in males (80 mg/kg/day) was 2.9 times higher than those in humans at the clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir, non-pregnant patients). In the rat study, no drug-related increases in tumor incidence were observed at doses up to 1200 mg/kg/day, for which AUCs were 1.1 (males) or 3.9 (females) times those measured in humans at the clinical dose.
Mutagenesis
Atazanavir tested positive in an clastogenicity test using primary human lymphocytes, in the absence and presence of metabolic activation. Atazanavir tested negative in the Ames reverse-mutation assay, micronucleus and DNA repair tests in rats, and DNA damage test in rat duodenum (comet assay).
Impairment of Fertility
At the systemic drug exposure levels (AUC) 0.9 (in male rats) or 2.3 (in female rats) times that of the human clinical dose, (300 mg/day atazanavir boosted with 100 mg/day ritonavir) significant effects on mating, fertility, or early embryonic development were not observed.

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Atazanavir sulfate capsules are available as:
150 mg u2013 capsules with light-turquoise-blue-opaque cap and aqua-blue-opaque body, imprinted u201c5526u201d on the body and u201cTEVAu201d on the cap, in bottles of 60 (NDC 0093-5526-06).
200 mg u2013 capsules with light-turquoise body and light-turquoise cap, imprinted u201c93u201d over u201c5527u201d on both the cap and the body, in bottles of 60 (NDC 0093-5527-06).
300 mg u2013 capsules with light-blue-opaque body and red-opaque cap, imprinted u201c93u201d over u201c5528u201d on both the cap and the body, in bottles of 30 (NDC 0093-5528-56).
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling ). n
Atazanavir sulfate capsules are not a cure for HIV infection. Advise patients to remain under the care of a healthcare provider while using atazanavir sulfate capsules. n
Cardiac Conduction Abnormalities Inform patients that atazanavir may produce changes in the electrocardiogram (e.g., PR prolongation). Tell patients to consult their healthcare provider if they are experiencing symptoms such as dizziness or lightheadedness n
Severe Skin Reaction Inform patients that there have been reports of severe skin reactions (e.g., Stevens-Johnson syndrome, erythema multiforme, and toxic skin eruptions) with atazanavir sulfate capsules use. Advise patients that if signs or symptoms of severe skin reactions or hypersensitivity reactions develop, they must discontinue atazanavir sulfate capsules and seek medical evaluation immediately .
Hyperbilirubinemia
Inform patients that asymptomatic elevations in indirect bilirubin have occurred in patients receiving atazanavir sulfate capsules. This may be accompanied by yellowing of the skin or whites of the eyes and alternative antiretroviral therapy may be considered if the patient has cosmetic concerns .
Chronic Kidney Disease
Inform patients that treatment with atazanavir sulfate capsules may lead to the development of chronic kidney disease, and to maintain adequate hydration while taking atazanavir sulfate capsules n
Nephrolithiasis and CholelithiasisInform patients that kidney stones and/or gallstones have been reported with atazanavir sulfate use. Some patients with kidney stones and/or gallstones required hospitalization for additional management and some had complications. Discontinuation of atazanavir sulfate capsules may be necessary as part of the medical management of these adverse events n
Drug Interactions Atazanavir sulfate capsules may lead to significant interaction with some drugs; therefore, advise patients to report the use of any other prescription, nonprescription medication, or herbal products, particularly St. Johnu2019s wort, to their healthcare provider prior to use n
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any symptoms of infection, as in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started n .
Fat Redistribution
Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy including protease inhibitors and that the cause and long-term health effects of these conditions are not known at this time n
Dosing Instructions
Advise patients to take atazanavir sulfate capsules with food every day and take other concomitant antiretroviral therapy as prescribed. Atazanavir sulfate capsules must always be used in combination with other antiretroviral drugs. Advise patients that they should not alter the dose or discontinue therapy without consulting with their healthcare provider. Tell patients if a dose of atazanavir sulfate capsules is missed, they should take the dose as soon as possible and then return to their normal schedule; however, if a dose is skipped the patient should not double the next dose.
PregnancyInform pregnant patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atazanavir sulfate capsules during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry .
Lactation Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk. Atazanavir can also be passed to the baby in breast milk and it is not known whether it could harm the baby .
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454n
Rev. D 5/2018

ATAZANAVIR (a ta ZAN a vir) SULFATE CAPSULES
Important: Ask your healthcare provider or pharmacist about medicines that should not be taken with atazanavir sulfate capsules. For more information, see u201cWho should not take atazanavir sulfate capsules?u201d and u201cWhat should I tell my healthcare provider before taking atazanavir sulfate capsules?u201dn
What are atazanavir sulfate capsules?
Atazanavir sulfate capsules are a prescription HIV-1 (Human Immunodeficiency Virus-type 1) medicine that is used with other antiretroviral medicines to treat HIV-1 infection in adults and children at least 6 years of age and older and who weigh at least 15 kg. HIV-1 is the virus that causes AIDS (Acquired Immunodeficiency Syndrome).
Atazanavir sulfate capsules should not be used in children younger than 3 months of age.n
When used with other antiretroviral medicines to treat HIV-1 infection, atazanavir sulfate capsules may help:
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help improve your immune system. This may reduce your risk of death or getting infections that can happen when your immune system is weak (opportunistic infections).
Atazanavir sulfate capsules do not cure HIV-1 infection or AIDS.
Who should not take atazanavir sulfate capsules?
Do not take atazanavir sulfate capsules if you:
Serious problems can happen if you or your child takes any of the medicines listed above with atazanavir sulfate capsules.n
What should I tell my healthcare provider before taking atazanavir sulfate capsules?
Before taking atazanavir sulfate capsules, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take,n- Keep a list of your medicines to show your healthcare provider and pharmacist.n- Do not start taking a new medicine without telling your healthcare provider.
How should I take atazanavir sulfate capsules?
When your supply of atazanavir sulfate capsules starts to run low,
What are the possible side effects of atazanavir sulfate capsules?
Atazanavir sulfate capsules can cause serious side effects, including:
The most common side effects of atazanavir sulfate capsules include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of atazanavir sulfate capsules. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store atazanavir sulfate capsules?
Keep atazanavir sulfate capsules and all medicines out of the reach of children.
General information about the safe and effective use of atazanavir sulfate capsules
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use atazanavir sulfate capsules for a condition for which they were not prescribed. Do not give atazanavir sulfate capsules to other people, even if they have the same symptoms that you have. They may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about atazanavir sulfate capsules that is written for health professionals.
What are the ingredients in atazanavir sulfate capsules?
Active ingredient:
Inactive ingredients:
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454n
Orap is a registered trademark of Teva Pharmaceuticals USA, Inc.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
This Patient Information has been approved by the U.S. Food and Drug Administration.
Rev. D 5/2018

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