Stavudine


Concise Prescribing Info
Indications/Uses
HIV infection.
Dosage/Direction for Use
Adult : PO <60 kg: 30 mg 12 hrly; ≥60 kg: 40 mg 12 hrly.
Dosage Details
Oral
HIV infection
Adult: <60 kg: 30 mg 12 hrly; ≥60 kg: 40 mg 12 hrly.
Child: Birth to 13 days 0.5 mg/kg 12 hrly; ≥14 days <30 kg: 1 mg/kg 12 hrly; ≥30 kg: Same as adult dose.
Renal Impairment
 CrCl (mL/min)  Dosage
 <26  <60 kg: 15 mg 24 hrly; ≥60 kg: 20 mg 24 hrly. 
 26-50  <60 kg: 15 mg 12 hrly; ≥60 kg: 20 mg 12 hrly.
Administration
May be taken with or without food.
Reconstitution
Oral soln: Reconstitute w/ purified water to provide a soln containing 1 mg/mL.
Contraindications
Hypersensitivity to stavudine. Lactation.
Special Precautions
Patient w/ hepatomegaly, hepatitis or other risk factors for liver disease (esp obese women); pre-existing bone marrow suppression; history of peripheral neuropathy; history of or risk factors for pancreatitis. Renal or hepatic impairment. Pregnancy.
Adverse Reactions
Peripheral neuropathy, abdominal pain, nausea, drowsiness, diarrhoea, dyspepsia, fatigue, dizziness, headache, abnormal dreams, depression, insomnia, pruritus, rash, immune reconstitution syndrome, lipodystrophy (including central obesity, facial and peripheral wasting, breast enlargement, cushingoid appearance, dorsocervical fat enlargement), metabolic abnormalities (e.g. hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperglycaemia, hyperlactataemia), mitochondrial dysfunction (manifesting as abnormal behaviour, convulsions, anaemia, hyperlipasaemia, hypertonia, neutropenia), myalgia, myositis, elevated creatine phosphokinase, osteonecrosis. Rarely, rhabdomyolysis.
Potentially Fatal: Lactic acidosis associated w/ severe hepatomegaly and steatosis. Rarely, hepatitis, hepatic failure, pancreatitis.
Patient Counseling Information
This drug may cause dizziness and/or somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor LFTs, renal function tests, viral load, CD4 count.
Overdosage
Symptoms: Peripheral neuropathy and hepatic toxicity. Management: Supportive and symptomatic treatment.
Drug Interactions
Increased risk of pancreatitis, peripheral neuropathy and hepatotoxicity in combination w/ didanosine and hydroxycarbamide. Risk of hepatic decompensation w/ interferon and ribavirin. Risk of peripheral neuropathy w/ isoniazid. Zidovudine may decrease the phosphorylation of stavudine to its active triphosphate form. Doxorubicin and ribavirin may inhibit stavudine activation.
Food Interaction
Food delays but does not reduce absorption.
Action
Description: Stavudine, a thymidine analogue, is converted intracellularly to the active metabolite stavudine triphosphate which inhibits HIV reverse transcriptase by competing w/ the natural substrate, thymidine triphosphate. It also inhibits viral DNA synthesis by causing DNA chain termination.
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Bioavailability: Approx 86%. Time to peak plasma concentration: W/in 1 hr.
Distribution: Distributed into CSF. Crosses the blood-brain barrier and enters breast milk. Volume of distribution: 46 L.
Metabolism: Undergoes intracellular phosphorylation by thymidine kinase to the active metabolite, stavudine triphosphate.
Excretion: Via urine (95%, 74% as unchanged drug) and faeces (3%, 62% as unchanged drug). Elimination half-life: Approx 1-1.5 hr.
Chemical Structure

Chemical Structure Image
Stavudine

Source: National Center for Biotechnology Information. PubChem Database. Stavudine, CID=18283, https://pubchem.ncbi.nlm.nih.gov/compound/Stavudine (accessed on Jan. 23, 2020)

Storage
Store at 25°C. Reconstituted soln: Store between 2-8°C.
MIMS Class
ATC Classification
J05AF04 - stavudine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
References
Anon. Stavudine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 10/02/2016.

Buckingham R (ed). Stavudine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2016.

Joint Formulary Committee. Stavudine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/02/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Stavudine. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 10/02/2016.

Stavudine Capsule (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 10/02/2016.

Disclaimer: This information is independently developed by MIMS based on Stavudine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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