ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

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Overview

What is ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Abacavir, lamivudine and zidovudine tablets contain the following 3 synthetic nucleoside analogues: abacavir (ZIAGEN), lamivudine (also known as EPIVIR or 3TC), and zidovudine (also known as RETROVIR, azidothymidine, or ZDV) with inhibitory activity against HIV-1.

Abacavir, lamivudine and zidovudine tablets are for oral administration. Each film-coated tablet contains the active ingredients 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine, and the inactive ingredients crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and yellow ferric oxide. The tablets are coated with a film opadry green that is made of FD&C blue no. 2, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and yellow ferric oxide.

Abacavir Sulfate

The chemical name of abacavir sulfate is (1)-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)·HSO and a molecular weight of 670.74 g per mol. It has the following structural formula:

Abacavir sulfate is a white to off-white powder and soluble in water. Dosages are expressed in terms of abacavir.

Lamivudine

The chemical name of lamivudine is (-)-1-(2-Cis)-4-amino-1-[(2-hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1H)-pyrimidin-2-one, 0.2 hydrate. Lamivudine is the (-) enantiomer of a dideoxy analogue of cytidine. Lamivudine has also been referred to as (-)2',3'-dideoxy, 3'-thiacytidine. It has a molecular formula of CHNOS·0.2HO and a molecular weight of 232.86 g per mol. It has the following structural formula:

Lamivudine is a white to off-white solid and is soluble in water.

Zidovudine

The chemical name of zidovudine is 3'-azido-3'-deoxythymidine. It has a molecular formula of CHNO and a molecular weight of 267.24 g per mol. It has the following structural formula:

Zidovudine is a white to yellowish powder with a solubility of 20.1 mg/mL in water at 25°C.

What does ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE look like?

What are the available doses of ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Abacavir, lamivudine and zidovudine tablets contain 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side.

What should I talk to my health care provider before I take ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

How should I use ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Abacavir, lamivudine and zidovudine tablet, a combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.()

Before initiating abacavir, lamivudine and zidovudine tablets, screen for the HLA-B*5701 allele because abacavir, lamivudine and zidovudine tablets contains abacavir. ()

Adults and pediatric patients weighing at least 40 kg: 1 tablet twice daily. ()

Because abacavir, lamivudine and zidovudine tablet is a fixed-dose tablet and cannot be dose adjusted, abacavir, lamivudine and zidovudine tablets are not recommended in patients requiring dosage adjustment or patients with hepatic impairment. (, )

What interacts with ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Sorry No Records found

What are the warnings of ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Sorry No Records found

What are the precautions of ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Sorry No Records found

What are the side effects of ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Sorry No records found

What should I look out for while using ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Presence of HLA-B*5701 allele. ()

Prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine ()

Moderate or severe hepatic impairment. (, )

What might happen if I take too much ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

There is no known specific treatment for overdose with abacavir, lamivudine and zidovudine tablets. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.

Abacavir

It is not known whether abacavir can be removed by peritoneal dialysis or hemodialysis.

Lamivudine

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.

Zidovudine

Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of hematological disturbances. Patients recovered without permanent sequelae. Hemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine, while elimination of its primary metabolite, 3′- azido-3′-deoxy-5′--β--glucopyranuronosylthymidine (GZDV), is enhanced.

How should I store and handle ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE?

Unopened vials of Gemcitabine for Injection are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] . Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows:Bottles of 60 Tablets NDC 68180-286-07Bottles of 100 Tablets NDC 68180-286-01Bottles of 500 Tablets NDC 68180-286-02Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows:Bottles of 60 Tablets NDC 68180-286-07Bottles of 100 Tablets NDC 68180-286-01Bottles of 500 Tablets NDC 68180-286-02Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows:Bottles of 60 Tablets NDC 68180-286-07Bottles of 100 Tablets NDC 68180-286-01Bottles of 500 Tablets NDC 68180-286-02Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows:Bottles of 60 Tablets NDC 68180-286-07Bottles of 100 Tablets NDC 68180-286-01Bottles of 500 Tablets NDC 68180-286-02Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows:Bottles of 60 Tablets NDC 68180-286-07Bottles of 100 Tablets NDC 68180-286-01Bottles of 500 Tablets NDC 68180-286-02Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Abacavir, lamivudine and zidovudine tablet is an antiretroviral agent .

Non-Clinical Toxicology

Presence of HLA-B*5701 allele. ()

Prior hypersensitivity reaction to abacavir, lamivudine, or zidovudine ()

Moderate or severe hepatic impairment. (, )

Serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of abacavir, lamivudine and zidovudine tablets. These hypersensitivity reactions have included multi-organ failure and anaphylaxis and typically occurred within the first 6 weeks of treatment with abacavir (median time to onset was 9 days); although abacavir hypersensitivity reactions have occurred any time during treatment . Patients who carry the HLA-B*5701 allele are at a higher risk of abacavir hypersensitivity reactions; although, patients who do not carry the HLA-B*5701 allele have developed hypersensitivity reactions. Hypersensitivity to abacavir was reported in approximately 206 (8%) of 2,670 patients in 9 clinical trials with abacavir-containing products where HLA-B*5701 screening was not performed. The incidence of suspected abacavir hypersensitivity reactions in clinical trials was 1% when subjects carrying the HLA-B*5701 allele were excluded. In any patient treated with abacavir, the clinical diagnosis of hypersensitivity reaction must remain the basis of clinical decision making.

Due to the potential for severe, serious, and possibly fatal hypersensitivity reactions with abacavir:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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