abacavir sulfate


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abacavir sulfate

Ziagen

Pharmacologic class: Carbocyclic nucleoside reverse transcriptase

Therapeutic class: Antiretroviral

Pregnancy risk category C

FDA Box Warning

• Drug may cause serious and potentially fatal hypersensitivity reactions, including multi-organ syndrome marked by fever, rash, GI distress, malaise, fatigue, achiness, dyspnea, cough, and pharyngitis. Discontinue immediately if you suspect such a reaction. If hypersensitivity can't be ruled out, discontinue permanently, even if other diagnoses are possible.

• After hypersensitivity reaction, never restart drug or other agents containing it, because more severe symptoms (including severe hypotension and death) may arise within hours.

Action

Converts via intracellular enzymes to active metabolite carbovir triphosphate, which inhibits activity of human immunodeficiency virus-1 (HIV-1) reverse transcriptase. Inhibits viral reproduction by interfering with DNA and RNA synthesis.

Availability

Oral solution: 20 mg/ml

Tablets: 300 mg

Indications and dosages

HIV-1 infection

Adults: 300 mg P.O. b.i.d. or 600 mg P.O. daily

Children ages 3 months to 16 years: 8 mg/kg P.O. b.i.d., to a maximum dosage of 300 mg b.i.d.

Contraindications
• Hypersensitivity to drug
• Hepatic disease, lactic acidosis
• Breastfeeding
• Children younger than age 3 months

Precautions

Use cautiously in:
• impaired renal function, bone marrow suppression
• risk factors for hepatic disease
• elderly patients
• pregnant patients.

Administration
• Always give in combination with other antiretrovirals.

Be aware that drug may cause fatal hypersensitivity reactions.
• Give with food if GI upset occurs.

Adverse reactions

CNS: headache, weakness, insomnia

GI: nausea, vomiting, diarrhea, poor appetite, pancreatitis

Hematologic: neutropenia, severe anemia

Hepatic: hepatic failure

Metabolic: mild hyperglycemia, lactic acidosis

Skin: rash, erythema multiforme, toxic epidermal necrolysis

Other: body fat redistribution, Stevens-Johnson syndrome, fatal hypersensitivity reaction, immune reconstitution syndrome

Interactions

Drug-drug.Methadone: Increased oral methadone clearance

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase, creatine phosphokinase, gamma-glutamyltransferase, glucose, triglycerides: increased levels

Drug-herbs.St. John's wort: decreased drug blood level and reduced drug effect

Drug-behaviors.Alcohol use: increased drug half-life and concentration

Patient monitoring

Assess for severe lactic acidosis, especially in women and obese patients.

Evaluate closely for signs and symptoms of hypersensitivity reaction, which can be fatal. These include fever, rash, fatigue, nausea, vomiting, diarrhea, abdominal pain, dyspnea, cough, and pharyngitis.

Be aware that immune reconstitution syndrome may occur in patients receiving combination antiretroviral therapy. During initial phase of therapy, patient whose immune system responds may develop inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium complex, cytomegalovirus, Pneumocystis jiroveci pneumonia, and tuberculosis), which may necessitate further evaluation and treatment.

Never restart therapy if patient has experienced a previous hypersensitivity reaction to this drug.
• Check for liver enlargement.
• Monitor CBC, serum electrolytes, and liver and kidney function test results.

Patient teaching

• Advise patient to take drug with food to minimize GI upset.
• Instruct patient to refrigerate drug but not to freeze it.

Teach patient how to recognize hypersensitivity reaction. Instruct him to stop taking drug and contact pre-scriber immediately if signs or symptoms of such a reaction occur.

Tell patient to contact prescriber if he develops a rash (possible sign of Stevens-Johnson syndrome).

Instruct patient to immediately report signs and symptoms of immune reconstitution syndrome (such as new signs and symptoms of a previously subclinical infection, worsening or progression of a known infection despite treatment, a new infection or illness, or failure of antiretroviral therapy).
• Inform patient that drug doesn't cure HIV but lowers viral count.
• Instruct patient to obtain medication guide and warning card with each refill.
• Tell patient he'll undergo frequent blood and urine testing during therapy.
• Advise patient to consult prescriber before drinking alcohol or using herbs.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

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References in periodicals archive ?
Hyderabad-based pharmaceutical firm Aurobindo Pharma (NSE: AUROPHARMA) announced on Thursday that it had been granted approval from the US Food and Drug Administration (FDA) to manufacture abacavir sulfate and lamivudine tablets, which are used in the treatment of HIV.
Aurobindo said in a BSE filing: "The company has received final approval from the US Food and Drug Administrationto manufacture abacavir sulfate and lamivudine tablets, 600 mg/ 300 mg.
Pharmaceutical company Mylan Inc (Nasdaq:MYL) reported on Thursday the receipt of tentative approval from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) for Abacavir Sulfate and Lamivudine Tablets, 60 mg/30 mg.
Drug supply PNSP 2014-1-083: Abacavir sulfate and lamivudine.
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M2 PHARMA-February 18, 2011-FDA grants tentative approval of Cipla's abacavir sulfate in HIV-1 infection(C)2011 M2 COMMUNICATIONS
Pharmaceutical company Lupin Ltd has received final approval for Abacavir Sulfate, Lamivudine, and Zidovudine Tablets, 300 mg (base) / 150 mg / 300 mg from the United States Food and Drugs Administration (FDA) for selling generic version of ViiV Healthcare s (ViiV)Trizivir Tablets, 300 mg (base) / 150 mg / 300mg.