Atazanavir (Reyataz)

Trade Name : REYATAZ

E.R. Squibb & Sons, L.L.C.

CAPSULE, GELATIN COATED

Strength 300 mg/1

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]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atazanavir (Reyataz) which is also known as REYATAZ and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 300 mg/1 per ml. Read more

Atazanavir (Reyataz) 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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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.

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About GNH

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.

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.

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  • No data
  • Dosage and Administration,u00a0u00a0u00a0u00a0u00a0u00a0Testing Prior to Initiation and During Treatment with REYATAZ u00a0u00a0u00a0u00a0u00a0u00a010/2017u00a0u00a0u00a0u00a0u00a0u00a0Dosage of REYATAZ Capsules in Pediatric Patients u00a0u00a0u00a0u00a0u00a0u00a05/2017u00a0u00a0u00a0u00a0u00a0u00a0Dosage and Administration of REYATAZ Oral Powder in Pediatric Patients u00a0u00a0u00a0u00a0u00a0u00a05/2017Contraindications u00a0u00a0u00a0u00a0u00a0u00a03/2018Warnings and Precautionsu00a0u00a0u00a0u00a0u00a0u00a0Chronic Kidney Disease u00a0u00a0u00a0u00a0u00a0u00a010/2017
  • REYATAZ (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg.
  • Limitations of Use:
  • REYATAZ is a protease inhibitor indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection for patients 3 months and older weighing at least 5 kg. n
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Pretreatment testing:
  • Treatment-naive adults:
  • Treatment-experienced adults:
  • Pediatric patients:
  • REYATAZ oral powder:
  • Pregnancy:
  • Dosing modifications:
  • REYATAZ Capsules:
  • REYATAZ Oral Powder:
  • (3n- 16)
  • (3n- 16)
  • REYATAZ is contraindicated:
  • Table 6 displays drugs that are contraindicated with REYATAZ.
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  • Cardiac conduction abnormalities:
  • Severe Skin Reactions:
  • Hyperbilirubinemia:
  • Phenylketonuria:
  • Hepatotoxicity:
  • Chronic kidney disease
  • Nephrolithiasis and cholelithiasis
  • (5.7n- 7.3)
  • (5.9)n- (5.10)n- (5.11)
  • Hemophilia:
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Most common adverse reactions (u22652%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. n
  • To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or n
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  • Coadministration of REYATAZ 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. , , n
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  • Pregnancy:
  • Lactation:
  • Hepatitis B or C co-infection:
  • Renal impairment:
  • Hepatic impairment:
  • Human experience of acute overdose with REYATAZ 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 REYATAZ 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 REYATAZ 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 n .
  • Treatment of overdosage with REYATAZ 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 REYATAZ. 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 REYATAZ capsules and oral powder 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). Its molecular formula is CHNOu2022HSO, which corresponds to a molecular weight of 802.9 (sulfuric acid salt). The free base molecular weight is 704.9. Atazanavir sulfate has the following structural formula:
  • Atazanavir sulfate is a white to pale-yellow crystalline powder. It is slightly soluble in water (4-5 mg/mL, free base equivalent) with the pH of a saturated solution in water being about 1.9 at 24 u00b1 3u00b0C.
  • REYATAZ Capsules are available for oral administration in strengths of 150 mg, 200 mg, or 300 mg of atazanavir, which are equivalent to 170.8 mg, 227.8 mg, or 341.69 mg of atazanavir sulfate, respectively. The capsules also contain the following inactive ingredients: crospovidone, lactose monohydrate, and magnesium stearate. The capsule shells contain the following inactive ingredients: gelatin, FD&C Blue No. 2, titanium dioxide, black iron oxide, red iron oxide, and yellow iron oxide. The capsules are printed with ink containing shellac, titanium dioxide, FD&C Blue No. 2, isopropyl alcohol, ammonium hydroxide, propylene glycol, n-butyl alcohol, simethicone, and dehydrated alcohol.
  • REYATAZ oral powder comes in a packet containing 50 mg of atazanavir equivalent to 56.9 mg of atazanavir sulfate in 1.5 g of powder. The powder is off-white to pale yellow and contains the following inactive ingredients: aspartame, sucrose, and orange-vanilla flavor.
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  • Advise the patient to read the FDA-approved patient labeling ().
  • REYATAZ is not a cure for HIV infection. Advise patients to remain under the care of a healthcare provider while using REYATAZ.
  • No data
  • Instructions for Usen- REYATAZ (RAY-ah-taz)n- (atazanavir)n- oral powder
  • Read this Instructions for Use before you prepare your childu2019s first dose of REYATAZ oral powder, each time you get a refill, and as needed. There may be new information. This information does not take the place of talking to your childu2019s healthcare provider about their medical condition or treatment. Ask your childu2019s healthcare provider or pharmacist if you have questions about how to mix or give a dose of REYATAZ oral powder.
  • Important information:
  • Instructions for mixing REYATAZ oral powder:
  • REYATAZ oral powder should be mixed with food such as applesauce or yogurt, instead of a liquid (milk, infant formula, or water) in young children and infants who can take food.
  • When preparing REYATAZ oral powder with either food or liquid, choose a clean, flat work surface. Place a clean paper towel on the work surface. Place the supplies you will need on the paper towel.
  • Wash and dry your hands before and after preparing REYATAZ oral powder.
  • Preparing a dose of REYATAZ oral powder mixed with food:
  • Before you prepare a dose of REYATAZ oral powder mixed with food, gather the following supplies:
  • How should I store REYATAZ oral powder?
  • See section for a complete list of available packages of REYATAZ.
  • NDC 0003-3624-12Bristol-Myers Squibb60 Capsulesn n (atazanavir) capsules150 mgRx only
  • Note to pharmacist: Do not cover ALERT box with pharmacy label.n- ALERT: Find out about medicines that should NOT be taken with REYATAZn
  • NDC 0003-3631-12Bristol-Myers Squibb60 Capsulesn n (atazanavir) capsules200 mgRx onlyn n n n
  • NDC 0003-3622-12Bristol-Myers Squibb30 Capsulesn n (atazanavir) capsules300 mgRx onlyn n n n
  • NDC 0003-3638-10Bristol-Myers SquibbOne Packetn n (atazanavir) oral powder50 mgRx onlyn n n n n n n n Each packet contains 50 mg of atazanavir as atazanavir sulfate in 1.5 g of powder.n Contains phenylalanine 35 mg per 1.5 g of powder (per packet).n n

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