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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- andu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Removed Ribavirin-Based Regimens (previous 5.4)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 05/2019
  • Arrayn- Abacavir and lamivudine is 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 and lamivudine or reinitiation of therapy with abacavir and lamivudine, unless patients have a previously documented HLA-B*5701 allele assessment. Discontinue abacavir and lamivudine immediately if a hypersensitivity reaction is suspected, regardless of HLA-B*5701 status and even when other diagnoses are possible n- Arrayn- Following a hypersensitivity reaction to abacavir and lamivudine, NEVER restart abacavir and lamivudine 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 n- Array
  • Arrayn- Arrayn- Array
  • WARNING: HYPERSENSITIVITY REACTIONS AND EXACERBATIONS OF HEPATITIS B
  • See full prescribing information for complete boxed warning.
  • Hypersensitivity Reactions
  • u00a0
  • Exacerbations of Hepatitis B
  • u00a0
  • 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
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  • Before initiating abacavir and lamivudine tablets, screen for the HLA-B*5701 allele because abacavir and lamivudine tablets contains abacavir. ()
  • Adults: One tablet orally once daily. ()
  • Pediatric patients weighing at least 25 kg: One tablet daily. n
  • 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 white to off-white, modified oval shaped, film-coated tablet debossed with u201cYu201d on one side and u201c98u201d 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
  • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.u00a0n
  • 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.u00a0n
  • 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 USPu00a0are for oral administration. Each white to off-white, 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 hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate, 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 is soluble in water.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 ().n n n n Inform patients:
  • Patients with Hepatitis B or C Co-infectionn- [see ].n n- Lactic Acidosis/Hepatomegaly with Steatosisn- [see ].n n- Immune Reconstitution Syndromen- [see ].n n- Pregnancy Registryn n- [see ]n- Arrayn- [see ]n- Arrayn- [see ]n- Availability of Medication Guide
  • Abacavir and Lamivudine Tablets USP
  • (a bak' a vir and la miv' ue deen)
  • What is the most important information I should know about abacavir and lamivudine tablets?
  • Abacavir and lamivudine tablets can cause serious side effects, including:
  • If 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 .
  • What are abacavir and lamivudinn- e 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:
  • 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 lamivudinen- tablets do not cure HIV-1 infection or AIDS.
  • Who should not take abacavir and lamivudinn- e tablets?
  • Do not take abacavir and lamivudinn- e tablets if you:
  • What should I tell my healthcare provider before taking abacavir and lamivudinn- e tablets?
  • Before you take abacavir and lamivudinn- e 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 lamivudinn- e tablets?
  • What are the possible side effects of abacavir and lamivudinn- e tablets?
  • Arrayn- Youu00a0mayu00a0beu00a0moreu00a0likelyu00a0tou00a0getu00a0lacticu00a0acidosisu00a0oru00a0seriousu00a0liveru00a0problemsu00a0ifu00a0youu00a0areu00a0female or very overweightu00a0(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 lamivudine 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.
  • How should I store abacavir and lamivudinn- e tablets?
  • Keep abacavir and lamivudinn- e tablets and all medicines out of the reach of children.
  • General information for safe and effective use of abacavir and lamivudinn- e 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 lamivudine tn- ablets?
  • Active ingredients: abacavir sulfate and lamivudine
  • Inactive ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate, 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 of their respective owners and are not trademarks of 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 Richland, MS 39218n Manufactured by:n Unit-VII (SEZ) Mahaboob Nagar (Dt)-509302 Indian Revised: 07/2019
  • 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 Unit-VII (SEZ), Mahaboob Nagar (Dt)-509302Indian Revised:u00a007/2019
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  • No data

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