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Zidovudine (Zidovudine)

Trade Name : Zidovudine

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 300 mg/1

ZIDOVUDINE Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase 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 Zidovudine (Zidovudine) which is also known as Zidovudine and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 300 mg/1 per ml. Read more

Zidovudine (Zidovudine) 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

Packaging and Delivery

Validated Cold Chain Shipment

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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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
  • Hematologic Toxicity: Zidovudine tablets have been associated with hematologic toxicity including neutropenia and severe anemia, particularly in patients with advanced HIV-1 disease n
  • Myopathy: Prolonged use of zidovudine has been associated with symptomatic myopathy n
  • Lactic Acidosis and Severe Hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including zidovudine and other antiretrovirals. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur n
  • WARNING: RISK OF HEMATOLOGICAL TOXICITY, MYOPATHY, LACTIC ACIDOSIS
  • See full prescribing information for complete boxed warning.
  • Hematologic toxicity including neutropenia and severe anemia have been associated with the use of zidovudine. ()
  • Symptomatic myopathy associated with prolonged use of zidovudine. ()
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including zidovudine. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. ()
  • Zidovudine tablets, USP are a nucleoside analogue reverse transcriptase inhibitor indicated for:
  • No data
  • Tablets: 300 mg ()
  • Zidovudine tablets are contraindicated in patients who have had a potentially life-threatening hypersensitivity reaction (e.g., anaphylaxis, Stevens-Johnson syndrome) to any of the components of the formulations.
  • Hypersensitivity to zidovudine or any of the components (e.g., anaphylaxis, Stevens-Johnson syndrome). ()
  • No data
  • 5.1n- 5.3n- 5.4
  • 5.7n- 5.8
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch.
  • No data
  • No data
  • Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine while elimination of its primary metabolite, 3u02b9u2011azido-3u02b9-deoxy-5u02b9--u03b2--glucopyranuronosylthymidine (GZDV), is enhanced. If overdose occurs, the patient should be monitored for evidence of toxicity and given standard supportive treatment as required.
  • Zidovudine (formerly called azidothymidine [AZT]), is a pyrimidine nucleoside analogue active against HIV-1. The chemical name of zidovudine is 3u02b9-Azido-3u02b9-deoxythymidine; it has the following structural formula:
  • Zidovudine, USP is a white to yellowish powder with a molecular weight of 267.24 and a solubility of 20.1 mg per mL in water at 25u00b0C. The molecular formula is CHNO.
  • Zidovudine tablets, USP are for oral administration. Each film-coated tablet contains 300 mg of zidovudine, USP and the inactive ingredients hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide.
  • No data
  • No data
  • Therapy with zidovudine has been shown to prolong survival and decrease the incidence of opportunistic infections in patients with advanced HIV-1 disease and to delay disease progression in asymptomatic HIV-1-infected patients.
  • Zidovudine Tablets, USPare available containing 300 mg of zidovudine, USP.
  • The 300 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-6106-91bottles of 60 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Arrayn- Hypersensitivity Reactions:
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  • Advise HIV-1-infected pregnant women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected .
  • Arrayn- Information About HIV-1 Infection:
  • Patients should be informed to take all HIV medications exactly as prescribed.
  • Patients should be advised to avoid doing things that can spread HIV-1 infection to others.
  • Instruct patients that if they miss a dose, they should just take their next dose at the usual time. Patients should not double their next dose.
  • The brands mentioned are trademarks of their respective owners.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured in India by:n n Hyderabad u2014 500 034, IndiaCode No.: MH/DRUGS/25/NKD/89
  • 75057864
  • REVISED OCTOBER 2015MX:ZIDO:R7
  • NDC 0378-6106-91
  • Zidovudinen- Tablets, USPn- 300 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a060 Tablets
  • Each film-coated tablet contains:Zidovudine, USP u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0300 mg
  • Usual Dosage:
  • Keep this and all medication outn- of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).[See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Mylan.com
  • RMX6106D4
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Code No.: MH/DRUGS/25/NKD/89

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