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Abacavir Sulfate (Abacavir Sulfate)

Trade Name : Abacavir Sulfate

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 300 mg/1

ABACAVIR SULFATE 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 Abacavir Sulfate (Abacavir Sulfate) which is also known as Abacavir Sulfate and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 300 mg/1 per ml. Read more

Abacavir Sulfate (Abacavir 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

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.

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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
  • Warnings and Precautions, Lactic Acidosis and Severe u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2018Hepatomegaly with Steatosis ()
  • Warnings and Precautions, Fat Redistribution (previous 5.4)u00a0u00a0u00a0u00a0u00a0u00a0u00a0Removedu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2018
  • Warnings and Precautions, Myocardial Infarction ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2018
  • u00a0
  • Arrayn- Serious and sometimes fatal hypersensitivity reactions, with multiple organ involvement, have occurred with abacavir.
  • Arrayn- Patients who carry the HLA-B*5701 allele are at a higher risk of a hypersensitivity reaction to abacavir; although, hypersensitivity reactions have occurred in patients who do not carry the HLA-B*5701 allele .
  • Arrayn- Abacavir tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients . All patients should be screened for the HLA-B*5701 allele prior to initiating therapy with abacavir or reinitiation of therapy with abacavir, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir tablets immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible .
  • Arrayn- Following a hypersensitivity reaction to abacavir, NEVER restart abacavir tablets or any other abacavir-containing product because more severe symptoms, including death can occur within hours. Similar severe reactions have also occurred rarely following the reintroduction of abacavir-containing products in patients who have no history of abacavir hypersensitivity .
  • WARNING: HYPERSENSITIVITY REACTIONS
  • See full prescribing information for complete boxed warning.
  • Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. ()
  • Hypersensitivity to abacavir is a multi-organ clinical syndrome. ()
  • Patients who carry the HLA-B*5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. ()
  • Abacavir tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. ()
  • Discontinue abacavir tablets as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue abacavir tablets if hypersensitivity cannot be ruled out, even when other diagnoses are possible. ()
  • Following a hypersensitivity reaction to abacavir, NEVER restart abacavir tablets or any other abacavir-containing product. ()
  • Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection.
  • Abacavir tablets, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ()
  • No data
  • Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir.
  • u2022
  • 3
  • Abacavir tablets are contraindicated in patients:
  • No data
  • The following adverse reactions are discussed in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or n
  • In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy with 600 mg of abacavir twice daily (twice the currently recommended dose), oral methadone clearance increased This alteration will not result in a methadone dose modification in the majority of patients; however, an increased methadone dose may be required in a small number of patients.
  • u2022
  • 7.1
  • Lactation: Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. ()u00a0n
  • There is no known specific treatment for overdose with abacavir. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required. It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.
  • Abacavir sulfate is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate is (1,4)-4-[2-Amino-6-(cyclopropylamino)-9-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate is the enantiomer with absolute configuration on the cyclopentene ring. It has a molecular formula of (CHNO)u2022HSO and a molecular weight of 670.76 g per mol. It has the following structural formula:
  • Abacavir sulfate, USP is a white to off-white powder and is soluble in water.
  • Abacavir tablets, USP are for oral administration. Each tablet contains abacavir sulfate equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide.
  • In vivo
  • No data
  • No data
  • No data
  • Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir.
  • The 300 mg tablets are peach, film-coated, capsule shaped, functionally scored tablets debossed with on one side of the score and on the other side of the score on one side of the tablet and blank on the other side. They are available as follows:
  • NDC 0378-4105-91carton of one bottle containing 60 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Hypersensitivity Reactions:
  • Lactic Acidosis/Hepatomegaly with Steatosis:n- [see ]
  • Immune Reconstitution Syndrome: n- [see n- Arrayn- ]
  • Pregnancy Registry:n- [see ]
  • Lactation:n- [see ]
  • Missed Dose:n- [see ]
  • Availability of Medication Guide:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Manufactured by:n n Hyderabad u2014 500 096, India
  • 75064798
  • Revised: 9/2018MX:ABCV:R7
  • NDC 0378-4105-91
  • Abacavirn- Tablets, USPn- 300 mg
  • Notice to Authorized Dispenser:n- Each time abacavir tablets are dispensed,n- give the patient a Medication Guide andn- Warning Card from the carton.
  • Rx only 60 Tablets
  • Each film-coated tablet containsabacavir sulfate, USP equivalent to300 mg of abacavir.
  • Usual Dosage:
  • Keep this and all medication out of then- reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [Seen- USP Controlled Room Temperature.]
  • Dispense in original container withattached prescribing information thatcontains the Medication Guide.
  • Keep container tightly closed.
  • Manufactured for:n n Morgantown, WV 26505 U.S.A.
  • Made in India
  • Code No.: MH/DRUGS/25/NKD/89
  • Mylan.com
  • MX:4105:1C:R3

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