Abacavir (Abacavir)

Trade Name : Abacavir

Camber Pharmaceuticals, Inc.

TABLET

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 Camber Pharmaceuticals, Inc.. 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.

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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  • Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2018 Warnings and Precautions, Lactic Acidosis and Severeu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a005/2018 Hepatomegaly with Steatosis () Warnings and Precautions, Fat Redistribution (previous )u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Removedu00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2018u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Warnings and Precautions, Myocardial Infarction ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2018
  • WARNING: HYPERSENSITIVITY REACTIONSn n
  • u2022u00a0Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir tablets. () u2022u00a0Hypersensitivity to abacavir is a multi-organ clinical syndrome. () u2022u00a0Patients who carry the HLA-B*5701 allele are at a higher risk ofu00a0u00a0 experiencing a hypersensitivity reaction to abacavir. () u2022u00a0Abacavir tablets are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. () u2022u00a0Discontinue 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. () u2022u00a0Following a hypersensitivity reaction to abacavir, NEVER restart abacavir tablet 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 tablet, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ()
  • u2022u00a0Before initiating abacavir, screen for the HLA-B*5701 allele. () u2022u00a0Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. () u2022u00a0Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) and should not exceed 600 mg daily. () u2022u00a0Patients with Hepatic Impairment: Mild hepatic impairment u2013 200 mg twice daily. ()
  • Abacavir tablets, USP containing abacavir sulfate, USP equivalent to 300 mg abacavir, are yellow colored, biconvex, capsule shaped, film coated tablets debossed with 'H' on one side and '139' on other side separating 13 & 9 with score line.
  • u2022u00a0Tablets: 300 mg scored ()
  • Abacavir tablet is contraindicated in patients: u2022u00a0who have the HLA-B*5701 allele n u2022u00a0with prior hypersensitivity reaction to abacavirn u2022u00a0with moderate or severe hepatic impairmentn
  • u2022u00a0Presence of HLA-B*5701 allele. () u2022u00a0Prior hypersensitivity reaction to abacavir. () u2022u00a0Moderate or severe hepatic impairment. ()
  • u2022u00a0Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. () u2022u00a0Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ()
  • The following adverse reactions are discussed in other sections of the labeling: u2022u00a0Serious and sometimes fatal hypersensitivity reactionsn u2022u00a0Lactic acidosis and severe hepatomegaly with steatosis n u2022u00a0Immune reconstitution syndromen u2022u00a0Myocardial infarctionn
  • u2022u00a0 The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 10%) in adult HIV-1 clinical trials were nausea, headache, malaise and fatigue, nausea and vomiting, and dreams/sleep disorders. () u2022u00a0 The most commonly reported adverse reactions of at least moderate intensity (incidence greater than or equal to 5%) in pediatric HIV-1 clinical trials were fever and/or chills, nausea and vomiting, skin rashes, and ear/nose/throat infections. ()n n n n
  • In a trial of 11 HIV-1-infected subjects receiving methadone-maintenance therapy withu00a0 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.
  • u2022u00a0Methadone: An increased methadone dose may be required in a small number of patients. ()
  • u2022u00a0Lactation: Women infected with HIV should be instructed not to breastfeed due to potential for HIV transmission. ()
  • 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, USP is a synthetic carbocyclic nucleoside analogue with inhibitory activity against HIV-1. The chemical name of abacavir sulfate, USP is (1S,4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol sulfate (salt) (2:1). Abacavir sulfate, USP is the enantiomer with 1S, 4R absolute configuration on the cyclopentene ring. It has a molecular formula of (C14H18N6O)2u2022H2SO4 and a molecular weight of 670.74 daltons. It has the following structural formula:
  • Abacavir sulfate, USP is a white to off-white powder. Soluble in water, slightly soluble in methanol. It has an octanol per water (pH 3.3) partition coefficient (log ) of approximately 1 by UV-spectrometry at 25u00b0C. 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: microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The tablets are coated with opadry yellow which contains hypromellose, titanium dioxide, triacetin, iron oxide yellow, polysorbate 80.n abacavir sulfate, USP dissociates to its free base, abacavir. All dosages for abacavir sulfate, USP are expressed in terms of abacavir.
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  • Abacavir tablets, USP containing abacavir sulfate, USP equivalent to 300 mg abacavir are yellow colored, biconvex, capsule shaped, film coated tablets debossed with 'H' on one side and '139' on other side separating 13 & 9 with score line. They are packaged as follows: Bottles of 60 tablets (NDC 31722-557-60)n n
  • Advice the patient to read the FDA-approved patient labeling (Medication Guide) n n Inform patients: u2022u00a0that a Medication Guide and Warning Card summarizing the symptoms of the abacavir hypersensitivity reaction and other product information will be dispensed by the pharmacist with each new prescription and refill of abacavir tablets, and instruct the patient to read the Medication Guide and Warning Card every time to obtain any new information that may be present about abacavir tablets. The complete text of the Medication Guide is reprinted at the end of this document. u2022u00a0to carry the Warning Card with them. u2022u00a0how to identify a hypersensitivity reaction n u2022u00a0that if they develop symptoms consistent with a hypersensitivity reaction they shouldu00a0 call their healthcare provider right away to determine if they should stop taking abacavir tablets. u2022u00a0that a hypersensitivity reaction can worsen and lead to hospitalization or death if abacavir tablet is not immediately discontinued. u2022u00a0to not restart abacavir tablet or any other abacavir-containing product following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death. u2022u00a0that if they have a hypersensitivity reaction, they should dispose of any unused abacavir tablets to avoid restarting abacavir. u2022u00a0that a hypersensitivity reaction is usually reversible if it is detected promptly and abacavir tablet is stopped right away. u2022u00a0that if they have interrupted abacavir tablets for reasons other than symptoms of hypersensitivity (for example, those who have an interruption in drug supply), a serious or fatal hypersensitivity reaction may occur with reintroduction of abacavir. u2022u00a0to not restart abacavir tablet or any other abacavir-containing product without medical consultation and only ifu00a0 medical care can be readily accessed by the patient or others. n n Advise patients that lactic acidosis and severe hepatomegaly with steatosis have been reported with use of nucleoside analogues and other antiretrovirals. Advise patients to stop taking abacavir tablets if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicityn n n 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 tablets is started n n n Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancyn n n Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milkn n n n n Instruct patients that if they miss a dose of abacavir tablet, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dosen n n 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.n The other brands listed are trademarks of their respective owners and are not trademarks of the Hetero Labs Limited. The makers of these brands are not affiliated with and do not endorse the Hetero Labs Limited or its products.
  • Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854
  • Byn Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India
  • Revised: 08/2019
  • Abacavir Tablets, USP (ah-BAH-kah-veer)n- What is the most important information I should know about abacavir tablets?n- Serious allergic reaction (hypersensitivity reaction)n- 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 u2022u00a0If you have an allergic reaction, dispose of any unused abacavir tablets. Ask your pharmacist how to properly dispose of medicines. u2022u00a0If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction, you may get that may include n u2022u00a0If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before.n n Abacavir tablet is a prescription HIV-1 (Human Immunodeficiency Virus type 1) medicine used with other antiretroviral medicines to treat HIV-1 infection. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). The safety and effectiveness of abacavir has not been established in children under 3 months of age.n n u2022u00a0reduce the amount of HIV-1 in your blood. This is called ''viral load''. u2022u00a0increase the number of CD4+ (T) cells in your blood, that help fight off other infections. 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 You must keep taking HIV-1 medicines to control HIV-1 infection and decrease HIV-related illnesses.
  • Who should not take abacavir tablets? Do not take abacavir tablets if you:n- What should I tell my healthcare provider before taking abacavir tablets? Before you take abacavir tablets, tell your healthcare provider if you:n- Pregnancy Registryn- Tell your healthcare provider about all the medicines you take,n- Keep a list of your medicines to show your healthcare provider and pharmacistn- Do not start taking a new medicine without telling your healthcare provider. n- Tell your healthcare provider if you take:n- How should I take abacavir tablet? u2022u00a0Take abacavir tablet exactly as your healthcare provider tells you.n- ''What is the most important information I should know about abacavir tablets?'' u2022u00a0Build-up of acid in your blood (lactic acidosis). n- Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:n- Serious liver problemsn- Call your healthcare provider right away if you have any of the following signs of liver problems:n- You may be more likely to get lactic acidosis or serious liver problems if you are female, very overweight (obese).n- Changes in your immune system (Immune Reconstitution Syndrome)n- u00a0Heart attack (myocardial infarction).n- The most common side effects of abacavir tablets in adults include:n- The most common side effects of abacavir tablets in children include:n- How should I store abacavir tablets?n- Keep abacavir tablets and all medicines out of the reach of children. General information for safe and effective use of abacavir tabletsn- What are the ingredients in abacavir tablets? Tablets
  • Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854
  • By:n Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India
  • Revised: 08/2019n All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited. This Medication Guide has been approved by the U.S. Food and Drug Administration. Medication Guide available at http://camberpharma.com/medication-guides
  • Container label for Abacavir Tablets, 300 mg, 60s countu00a0
  • Container carton for Abacavir Tablets, 300 mg, 60s countu00a0

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