Abacavir (Abacavir)

Trade Name : Abacavir

Major Pharmaceuticals

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

Abacavir (Abacavir) 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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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
  • Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2018
  • Warnings and Precautions, Lactic Acidosis and Severeu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2018
  • Hepatomegaly with Steatosis n
  • Warnings and Precautions, Fat Redistribution (previousu00a0u00a0u00a0u00a0u00a0 Removed
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a005/2018
  • Warnings and Precautions, Myocardial Infarctionu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2018
  • WARNING: HYPERSENSITIVITY REACTIONS
  • See full prescribing information for complete boxed warning.
  • u00a0
  • Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir. ()
  • Hypersensitivity to abacavir is a multi-organ clinical syndrome. ()
  • Patients who carry the HLA-B5701 allele are at a higher risk of experiencing a hypersensitivity reaction to abacavir. ()
  • Abacavir is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. ()
  • Discontinue abacavir as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B5701 status, permanently discontinue abacavir if hypersensitivity cannot be ruled out, even when other diagnoses are possible. ()
  • Following a hypersensitivity reaction to abacavir, NEVER restart abacaviru00a0 or any other abacavir-containing product. ()
  • Abacavir tablets, in combination with other antiretroviral agents,u00a0are 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, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, coated tablet, debossed with u2018Du2019 and u201888u2019 on either side of the score line on one side and plain with a score line on other side.
  • Tablets: 300 mg scored n
  • Abacavir tablets areu00a0contraindicated in patients:
  • No data
  • The following adverse reactions are discussed in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 oru00a0 www.fda.gov/medwatch.
  • In au00a0trial of 11 HIV-1-infectedu00a0subjects 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
  • No data
  • u2022
  • 8.2
  • 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 14-[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 USPu00a0is a white to off-white solid and is soluble in water.u00a0n Abacavir tablets USP are for oral administration. Each tablet contains abacavir sulfate USP equivalent to 300 mg of abacavir as active ingredient and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are coated with a film that is made of hypromellose,u00a0iron oxide yellow, polysorbate 80, titanium dioxide, and triacetin.n n abacavir sulfate dissociates to its free base, abacavir. Dosages are expressed in terms of abacavir.
  • No data
  • No data
  • No data
  • Abacavir tablets USP, containing abacavir sulfate equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, coated tablet, debossed with u2018Du2019 and u201888u2019 on either side of the score line on one side and plain with a score line on other side. They are packaged as follows:n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Cartons of 30 tablets (10 tablets per blister card x 3), NDC 0904-6874-04u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Hypersensitivity Reactions
  • Inform patients:
  • Lactic Acidosis/Hepatomegaly with Steatosis
  • [see ]n- Immune Reconstitution Syndrome
  • Advise patients to inform their healthcare provider immediately of any signs and symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when abacavir is started n
  • Pregnancy Registry
  • Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy .
  • Lactation
  • Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk .
  • Missed Dose
  • Instruct patients that if they miss a dose of abacavir, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose .
  • Availability of Medication Guide
  • Instruct patients to read the Medication Guide before starting abacavir and to re-read it each time the prescription is renewed. Instruct patients to inform their physician or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.
  • Distributed by:n n 279 Princeton-Hightstown Road East Windsor, NJ 08520n Manufactured by:n n Hyderabad-500 038, India
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • Abacavir Tablets USPn- (a bak' a vir)n- What is the most important information I should know about abacavir tablets?n- Abacavir tablets can cause serious side effects, including:
  • If you get a symptom from 2 or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets.
  • A list of these symptoms is on the Warning Card your pharmacist gives you. n n n n
  • If your healthcare provider tells you that you can take abacavir tablets again, start taking them when you are around medical help or people who can call a healthcare provider if you need one.n- What are abacavir tablets?n- When used with other antiretroviral medicines to treat HIV-1 infection, abacavir tablets 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).n n You must keep taking HIV-1 medicines to control HIV- 1 infection and decrease HIV-related illnesses.n n n n n n
  • What should I tell my healthcare provider before taking abacavir tablets?n- Before you take abacavir tablets, tell your healthcare provider if you:
  • Pregnancy Registry.
  • 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.
  • Tell your healthcare provider if you take:
  • How should I take abacavir tablets?
  • What are the possible side effects of abacavir tablets?
  • The most common side effects of abacavir tablets in adults include:
  • The most common side effects of abacavir tablets in children include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.n These are not all the possible side effects of abacavir tablets. 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.n n n
  • Keep abacavir tablets and all medicines out of the reach of children.n- General information for safe and effective use of abacavir tabletsn- What are the ingredients in abacavir tablets?n- Aurobindo Pharma USA, Inc.n- Aurobindo Pharma Limited
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152n Revised: 06/2018
  • (Front of Card)n n n n n n n u00a0
  • Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.n (Back of Card)n n n n n n If you must stop treatment with abacavir tablets because you have had an allergic reaction to abacavir, take abacavir tablets or another abacavir-containing medicine (EPZICOM, TRIUMEQ,u00a0or TRIZIVIR) again.u00a0If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines.u00a0If you take abacavir tablets or another abacavir-containing medicine again after you have had an allergic reaction, you may get that may include or .n Please read the Medication Guide for additional information on abacavir tablets.n EPZICOM, TRIUMEQ, and TRIZIVIR are registered trademarks of the ViiV Healthcare group of companies.n Distributed by:n n 279 Princeton-Hightstown Road East Windsor, NJ 08520n Manufactured by:n n Hyderabad-500 038, India
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152n Revised: 06/2018
  • Abacavir Tablets USP
  • 300 mg
  • 30 Tablets

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