Zerit


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stavudine (d4T)

Zerit

Pharmacologic class: Nucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral

Pregnancy risk category C

FDA Box Warning

• Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have occurred with use of drug alone or in combination with other nucleoside analogs. Fatal lactic acidosis has been reported in pregnant women who received stavudine-didanosine combination with other antiretrovirals. Use this combination cautiously in pregnant women and only if potential benefit clearly outweighs potential risk.

• Pancreatitis (fatal and nonfatal cases) has occurred when stavudine was used as part of combination regimen that included didanosine, in both treatment-naive and treatment-experienced patients.

Action

Inhibits replication of human immunodeficiency virus (HIV) by interfering with the enzyme reverse transcriptase, thereby terminating DNA chain

Availability

Capsules: 15 mg, 20 mg, 30 mg, 40 mg

Powder for oral solution: 1 mg/ml

Indications and dosages

HIV-1 infection

Adults weighing 60 kg (132 lb) or more: 40 mg P.O. q 12 hours

Adults and children weighing less than 60 kg (132 lb): 30 mg P.O. q 12 hours

Children weighing 30 kg (66 lb) or more: 30 mg P.O. q 12 hours

Children 14 days and older who weigh less than 30 kg (66 lb): 1 mg/kg P.O. q 12 hours

Newborns to infants 13 days old: 0.5 mg/kg P.O. q 12 hours

Dosage adjustment

• Renal impairment

• Elderly patients

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:

• advanced HIV infection, bone marrow depression, renal failure, peripheral neuropathy, hepatic dysfunction, hyperlactatemia, lactic acidosis

• concurrent use of hydroxyurea or didanosine (avoid use)

• elderly patients (with renal impairment)

• pregnant or breastfeeding patients.

Administration

• Give with or without food.

• Know that drug is usually given with other antiretrovirals.

Adverse reactions

CNS: headache, insomnia, peripheral neuropathy

GI: nausea, vomiting, diarrhea, abdominal pain, anorexia, pancreatitis

Hematologic: anemia, leukopenia, thrombocytopenia

Hepatic: hepatic steatosis, hepatitis, hepatic failure

Metabolic: increased glucose tolerance, lactic acidosis

Musculoskeletal: myalgia

Skin: rash

Other: body fat redistribution or accumulation, chills, fever, allergic reaction, immune reconstitution syndrome

Interactions

Drug-drug. Chloramphenicol, dapsone, didanosine, ethambutol, hydralazine, hydroxyurea, lithium, phenytoin, vincristine, zalcitabine: increased risk of peripheral neuropathy

Doxorubicin, ribavarin, zidovudine: inhibition of stavudine's absorption and metabolism

Myelosuppressants: increased bone marrow depression

Drug-diagnostic tests. Alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, gamma-glutamyl transferase, lipase: increased levels

Neutrophils, platelets: decreased counts

Patient monitoring

Monitor closely for signs and symptoms of lactic acidosis, hyperlactatemia, or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Consult prescriber about suspending drug if these occur. Consider permanent discontinuation of drug for patients with confirmed lactic acidosis.

• Monitor patient for signs and symptoms of immune reconstitution syndrome.

• Watch for and report onset and worsening of peripheral neuropathy.

Monitor CBC. Report evidence of bone marrow depression.

• Monitor liver function tests and blood chemistry results.

Patient teaching

• Tell patient he may take with or without food.

Teach patient to recognize and promptly report signs and symptoms of lactic acidosis (such as fatigue, GI distress, and difficult or rapid breathing), hepatotoxicity, immune reconstitution syndrome, and pancreatitis.

• Instruct patient to report numbness or tingling in arms, legs, hands, or feet.

• Caution female patient not to breastfeed, because she may transmit drug effects and HIV to infant.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Zerit

(zâr′ĭt)
A trademark for the drug stavudine.

Zerit®

D4T, stavudine AIDS An oral stavudine for treating HIV-infected infants. See AIDS, Stavudine.
References in periodicals archive ?
This analysis also assessed the impact of five individual nucleoside antiretrovirals on development of cardiomyopathy--Retrovir (zidovudine), Videx (didanosine), Zerit (stavudine), Ziagen (abacavir), and Hivid (zalcitabine) (Hivid is no longer used).
Questions and answers on the review of Zerit (stavudine): Outcome of a renewal procedure.
Stavudine for Oral Aurobindo Pharma USA Zerit for Oral
If a trial had been launched in '97, he notes, "we would just be getting final results, and we would have a lot of information on d4T, Crixivan and Viracept regimens [stavudine (Zerit), indinavir, and nelfinavir].
The triple cocktail of ARVs combines the generic versions of three proprietary brands: Zerit (Bristol-Myers Squibb; United States); Epivir (Glaxo-Smith-Kline; Great Britain) and Viramune (Boehringer Ingelheim; Germany).
Drug Abbreviation Trade name Zidovudine ZDV Retrovir Stavudine d4T Zerit Lamivudine 3TC Epivir Emtricitabine FTC Emtriva Didanosine ddI Videx/Videx EC Abacavir ABC Ziagen Tenofovir TDF Viread ZDV/3TC Combivir ABC/3TC Kivexa TDF/FTC Truvada ZDV/3TC/ABC TZV Trizivir FTC/TDF/efavirenz Atripla
Table 1 Common Antiretroviral Drugs (14-16) Classification Generic Name Trade Name Nucleoside reverse Abacavir sulfate Ziagen transcriptase inhibitors Abacavir sulfate + Trizivir (NRTI) lamivudine + zidovudine Didanosine (ddl) Videx, Videx EC Lamivudine (3TC) Epivir Lamiudine + zidovudine Combivir Stavudine (d4T) Zerit Tenofovir disoproxil Viread fumarate Zalcitabine (ddC) Hivid Zidovudine (AZT, ZDV) Retrovir Non-nucleoside reverse Delavirdine mesylate Rescriptor transcriptase inhibitors Efavirenz Sustiva (NNRTI) Nevirapine Viramune Protease inhibitors (PI) Amprenavir Agenerase Indinavir sulfate Crixivan Lopinavir + ritonavir Kaletra Nelfinavir Viracept Ritonavir Norvir Saquinavir Fortovase Saquinavir mesylate Invirase Fusion inhibitors (FI) Enfuvirtide Fuzeon
This product is the first generic version of the already approved Zerit for oral solution manufactured by Bristol-Myers Squibb.
The investigators studied changes in limb fat as measured by dual energy x-ray absorptiometry (DXA) and visceral fat as measured by computed tomography in 105 HIV-infected adults in whom zidovudine (AZT, Retrovir) or stavudine (d4T, Zerit) therapy was replaced with either the nucleoside analogue abacavir (Ziagen) or the NRTI tenofovir (Viread).
Patients who take stavudine (Zerit) should switch to tenofovir (Viread), he advised.
NRTIs--Ziagen, Trizivir, Videx, Epivir, 3TC, Combivir, Zerit, d4T, Viread, Hivid, Retrovir, AZT