Dosing and uses of Zerit, d4T (stavudine)
Adult dosage forms and strengths
capsule
- 15mg
- 20mg
- 30mg
- 40mg
oral solution
- 1mg/mL (200mL)
HIV Infection
>60 kg: 40 mg PO BId
<60 kg: 30 mg PO BId
Renal Impairment
>60 kg
- CrCl >50 mL/min: 40 mg PO q12hr
- CrCl 26-50 mL/min: 20 mg PO q12hr
- CrCl 10-25 mL/min: 20 mg PO qD
<60 kg
- CrCl >50 mL/min: 30 mg PO q12hr
- CrCl 26-50 mL/min: 15 mg PO q12hr
- CrCl 10-25 mL/min: 15 mg PO qD
Pediatric dosage forms and strengths
capsule
- 15mg
- 20mg
- 30mg
- 40mg
oral solution
- 1mg/mL (200mL)
HIV Infection
Birth-13 days: 0.5 mg/kg PO q12hr
<30 kg, >14 days: 1 mg/kg PO q12hr
30-<60 kg: As adults; 30 mg PO BId
>60 kg: As adults; 40 mg PO BId
Zerit, d4T (stavudine) adverse (side) effects
>10%
Headache
Chills/fever
Malaise
Insomnia
Anxiety
Depression
Pain
Rash
Nausea
Vomiting
Diarrhea
Pancreatitis
Abdominal pain
Peripheral neuropathy
1-10%
Neutropenia
Thrombocytopenia
Incr hepatic transaminases
Incr bilirubin
Myalgia
Back pain
Weakness
Postmarketing Reports
Metabolic disorders: lipoatrophy, lipodystrophy
Warnings
Black box warnings
Fatal and nonfatal pancreatitis reported; suspend if pancreatitis suspected and discontinue if confirmed
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination
Fatal lactic acidosis reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Use the combination with caution in pregnant women
Contraindications
Hypersensitivity
Cautions
Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis, with use alone & especially with didanosine
Risk of potentially fatal pancreatitis when used with didanosine
Decr dose in renal impairment
Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs
Randomized controlled trials found lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir)
Pregnancy and lactation
Pregnancy category: C
Lactation: HIV+ women are advised not to breastfeed
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Zerit, d4T (stavudine)
Half-Life: 1-1.6 hr
Peak Plasma Time: 1 hr; 3 hr (XR)
Peak Plasma Concentration: (conventional) 228±62 ng/mL; (XR) 536±146 ng/mL
AUC: (conventional) 1966±629 ng.hr/mL; (XR) 2568±454 ng.hr/mL
Bioavailability: 86.4%
Vd: 0.5 L/kg
Clearance: 594±165 mL/min (total body); 237±98 mL/min (renal)
Excretion: urine
Mechanism of action
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
