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Abacavir And Lamivudine (Abacavir And Lamivudine)

Trade Name : Abacavir and Lamivudine

Burel Pharma

TABLET, FILM COATED

Strength 600300 mg/1mg/1

ABACAVIR SULFATE; LAMIVUDINE Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],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 And Lamivudine (Abacavir And Lamivudine) which is also known as Abacavir and Lamivudine and Manufactured by Burel Pharma. It is available in strength of 600; 300 mg/1; mg/1 per ml. Read more

Abacavir And Lamivudine (Abacavir And Lamivudine) 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
  • Warnings and Precautions, Use with Interferon- andu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Removed Ribavirin-Based Regimens (previous 5.4)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2019
  • WARNING: HYPERSENSITIVITY REACTIONSu00a0ANDu00a0EXACERBATIONS OF HEPATITIS B
  • See full prescribing information for complete boxed warning.n
  • Hypersensitivity Reactionsn n
  • u2022 Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, a component of abacavir and lamivudine. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment. (n
  • Abacavir and lamivudine tablets, in combination with other antiretroviral agents, are indicatedu00a0for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
  • Abacavir and lamivudine tablets, a combination of abacavir and lamivudine, both nucleoside analogue HIV-1 reverse transcriptase inhibitors, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. n
  • u2022 Before initiating abacavir and lamivudine tablets, screen for the HLA-B*5701 allele because abacavir and lamivudine tablets contains abacavir. () u2022 Adults: One tablet orally once daily. () u2022 Pediatric patients weighing at least 25 kg: One tablet daily. n u2022 Because abacavir and lamivudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir and lamivudine tablets are not recommended in patients requiring dosage adjustment or patients with hepatic impairment. , )
  • Abacavir and lamivudine tablets USP 600 mg/300 mg contain 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange colored, modified capsule shaped, film-coated tablets debossed with u2018Hu2019 on one side and u201827u2019 on other side.
  • Tablets: 600 mg of abacavir and 300 mg of lamivudine. n
  • Abacavir and lamivudine tablets are contraindicated in patients:
  • u2022 who have the HLA-B*5701 allele n u2022 with prior hypersensitivity reactionu00a0to abacavir or lamivudine. u2022 with moderate or severe hepatic impairment n
  • Presence of HLA-B*5701 allele. ()
  • Prior hypersensitivity reaction to abacavir or lamivudine. ()
  • Moderate or severe hepatic impairment. (, )
  • No data
  • u00a0Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. ()
  • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. ()u00a0
  • The following adverse reactions are discussed in other sections of the labeling:
  • The most commonly reported adverse reactions of at least moderate intensity (incidence greater than 5%) in an adult HIV-1 clinical trial were drug hypersensitivity, insomnia, depression/depressed mood, headache/migraine, fatigue/malaise, dizziness/vertigo, nausea, and diarrhea. n n n
  • No data
  • Methadone: An increased methadone dose may be required in a small number of patients. ()
  • Sorbitol: Coadministration of lamivudine and sorbitol may decrease lamivudine concentrations; when possible, avoid chronic coadministration. ()n
  • No data
  • Lactation: 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 and lamivudine. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required.n n It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.n n Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.
  • Abacavir and lamivudine
  • Abacavir and lamivudine tablets USP are for oral administration. Each orange, film-coated tablet contains the active ingredients 600 mg of abacavir as abacavir sulfate USP and 300 mg of lamivudine USP, and the inactive ingredients magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The tablets are coated with a film (opadry orange YS-1-13065-A) that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.n n The chemical name of abacavir sulfate is 1-4-[2-amino-6-(cyclopropylamino)-9-purin-9u00ad-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:
  • u00a0n n n Abacavir sulfate USP is a white to off-white powder and soluble in water, slightly soluble in methanol and practically insoluble in ethyl acetate and in absolute alcohol.n , abacavir sulfate dissociates to its free base, abacavir.u00a0Dosages are expressed in terms of abacavir.n n n n The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2u00b4,3u00b4-dideoxy, 3u00b4-thiacytidine. It has a molecular formula of CHNOS and a molecular weight of 229.3 g per mol. It has the following structural formula:n n n n Lamivudine USP is a white to off-white solid and is soluble in water.
  • No data
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  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Hypersensitivity Reactions
  • Inform patients:
  • Patients with Hepatitis B or C Co-infection
  • Advise patients co-infected with HIV-1 and HBV that worsening of liver disease has occurred in some cases when treatment with lamivudine was discontinued. Advise patients to discuss any changes in regimen with their physician n
  • Lactic Acidosis/Hepatomegaly with Steatosisn n- [see ].n n- Arrayn- [see ].n n- Arrayn- [see ]n- Lactationn n n- [see ]n- Missed Dosen n n- [see ]n- Availability of Medication Guiden
  • Abacavir and Lamivudine Tablets USPn- Array
  • Arrayn- Array
  • Abacavir and lamivudine tabletsn- can cause serious side effects, including:
  • Ifn- you get a symptom from 2 or more of the following groups while taking abacavir and lamivudine tablets, call your healthcare provider right away to find out if you should stop taking abacavir and lamivudine tablets.
  • A list of these symptoms is on the Warning Card your pharmacist gives you. n
  • If you stop abacavir and lamivudine tablets because of an allergic reaction, never take abacavir and lamivudine tablets or any other abacavir-containing medicine (TRIUMEQ, TRIZIVIR, n- or ZIAGEN) again.
  • If your healthcare provider tells you that you can take abacavir and lamivudine tablets again, start takingu00a0them when you are around medical help or people who can call a healthcare provider if you need one.
  • What are abacavir and lamivudine tablets?
  • Abacavir and lamivudine tablets are 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). Abacavir and lamivudine tablets contain 2 prescription medicines, abacavir (ZIAGEN) and lamivudine (EPIVIR).
  • Abacavir and lamivudine tablets should not be used in children weighing less than 55 pounds (25 kg).
  • When used with other antiretroviral medicines to treat HIV-1 infection, abacavir and lamivudine tablets may help:
  • 1. reduce the amount of HIV-1 in your blood. This is called u201cviral loadu201d.
  • 2. increase 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).
  • Abacavir and lamivudine tablets do not cure HIV-1 infection or AIDS.
  • Who should not take abacavir and lamivudine tablets?
  • Do not take abacavir and lamivudine tablets if you:
  • What should I tell my healthcare provider before taking abacavir and lamivudine tablets?
  • Before you take abacavir and lamivudine tablets tell your healthcare provider if you:
  • Pregnancy Registry.
  • Tell your healthcare provider about all the medicines you take,
  • Some medicines interact with abacavir and lamivudine tablets. You can ask your healthcare provider or pharmacist for a list of medicines that interact with abacavir and lamivudine tablets. Your healthcare provider can tell you if it is safe to take abacavir and lamivudine tablets with other medicines.
  • Tell your healthcare provider if you take:
  • How should I take abacavir and lamivudine tablets?
  • What are the possible side effects of abacavir and lamivudine tablets?
  • You may be more likely to get lactic acidosis or serious liver problems if you are female or very overweight (obese).
  • The most common side effects of abacavir and lamivudine tablets include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of abacavir and lamivudineu00a0tablets. 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.
  • How should I store abacavir and lamivudinen- tablets?
  • Keep abacavir and lamivudinen- tablets and all medicines out of the reach of children.
  • General information for safe and effective use of abacavir and lamivudinen- tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use abacavir and lamivudine tablets for a condition for which it was not prescribed. Do not give abacavir and lamivudine tablets to other people, even if they have the same symptoms that you have. They may harm them.
  • If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for the information about abacavir and lamivudine tablets that is written for health professionals.
  • For more information, call Aurobindo Pharma USA, Inc at 1-866-850-2876.
  • What are the ingredients in abacavir and lamivudinen- tablets?
  • Active ingredients: abacavir sulfate and lamivudine
  • Inactive ingredients: magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
  • Tablet film coating contains: Opadry Orange YS-1-13065-A that is made of FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol 400, polysorbate 80, and titanium dioxide.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • EPIVIR, TRIUMEQ, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies.
  • The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to the Aurobindo Pharma Limited. The makers of these brands are not affiliated with and do not endorse the Aurobindo Pharma Limited or its products.
  • Manufactured for: n n Richland, MS 39218n Manufactured by:n Hyderabad-500 090, Indian Issued: October 2019
  • Abacavir and Lamivudine Tablets USP
  • Arrayn- u00a0
  • Always carry this Warning Card with you to help recognize symptoms of this allergic reaction.
  • If you must stop treatment with abacavir and lamivudine tablets because you have had an allergic reaction to abacavir, take abacavir and lamivudine tablets or another abacavir-containing medicine (ZIAGEN, TRIUMEQ, or TRIZIVIR) again.u00a0If you have an allergic reaction, dispose of any unused abacavir and lamivudine tablets. Ask your pharmacist how to properly dispose of medicines. If you take abacavir and lamivudine tablets or another abacavir-containing medicine again after you have had an allergic reaction, you may get that may include or n
  • u00a0
  • Please read the Medication Guide for additional information on abacavir and lamivudine tablets.
  • ZIAGEN, TRIUMEQ, and TRIZIVIR are registered trademarks of ViiV Healthcare group of companies.
  • Manufactured for: n n Richland, MS 39218n Manufactured by:n Hyderabad-500 090, Indian Issued: October 2019
  • No data
  • NDC 35573-430-30n n- burelpharmaAbacavir andu00a0Lamivudineu00a0 Tablets USP600 mg / 300 mgn- Notice to Authorized Dispenser:n n- 30 Tabletsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Rx only

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