Notify your doctor if chills, fever, sore throat, itch, rash, muscle aches, trouble sleeping, unusual bleeding or bruising, stomach pain, yellowing of the eyes and skin, dark urine or rapid breathing occur.

In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include rash, itching, swelling, dizziness or breathing trouble.

Precautions:

Before taking this medication tell your doctor of pre-existing kidney or liver diseases, pancreatitis, nerve disease, heart disease, major injury/surgery/infection, alcohol usage and of any allergies.

This medication should be used only if clearly needed during pregnancy.

Discuss the risks and benefits with your doctor.

It is not known if this medication appears in human breast milk.

Avoid breast-feeding in order to protect the newborn from possible HIV transmission.

For information on Medic Alert(TM) call 1-800-854-1166.

In Canada call 1-800-668-1507.

Related Drugs:

Zerit 15 mg Capsule - Prescription

Zerit 20 mg Capsule - Prescription

Zerit 30 mg Capsule - Prescription

Zerit 40 mg Capsule - Prescription

Zerit 1 mg/ml Solution, Reconstituted, Oral - Prescription ,

Generic Name: Stavudine

zerit_label_full

http://www.fda.gov/medwatch/SAFETY/2002/zerit_label_full.PDF

stavudine, ZERIT, administration, patients, didanosine, therapy, lactic acidosis, symptoms, reports, dose, peripheral neuropathy, zidovudine, recommend, dosage.

FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WHEN ZERIT WAS PART OF A COMBINATION REGIMEN THAT INCLUDED DIDANOSINE, WITH OR WITHOUT HYDROXYUREA, IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION (SEE WARNINGS).
ZERIT is the brand name for stavudine (d4T), a synthetic thymidine nucleoside analogue, active against the Human Immunodeficiency Virus (HIV).
In 2-year carcinogenicity studies in mice and rats, stavudine was noncarcinogenic at doses which produced exposures (AUC) 39 and 168 times, respectively, human exposure at the recommended clinical dose.
Use of stavudine in pediatric patients is supported by evidence from adequate and wellcontrolled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients.

zerit104week

XR/PRC, safety, stavudine, c/mL, treatment, efficacy, PNS, HIV RNA, patients, comparability, lipoatrophy, grade, dosing, lipodystrophy.

Week (wk) 48 efficacy and safety data demonstrated comparability, but the differing pharmacokinetics could result in clinically relevant differences in outcomes with longer dosing.
Methods: This analysis integrates results from two randomized, double-blind (through 1 year), studies of treatment-naive patients comparing XR/PRC versus IR, each with lamivudine (3TC) and efavirenz (EFV).
Conclusion: Overall two-year efficacy and safety for Stavudine XR/PRC are comparable to IR, with trends which favor XR for safety events of interest.
There are limited data available regarding intracellular stavudine triphosphate dynamics in samples from patients under treatment with stavudine.i.ii These limited data are consistent with previous in vitro information suggesting that stavudine enters and leaves cells rapidly by non-facilitated diffusion.iii Although the intracellular PK relationships between XR/PRC and IR remain to be explored, it is expected that the lower plasma peak and higher plasma trough of XR/PRC will persist qualitatively in clinical samples.

stavud

patients, Capsule, dispensing, SIGNATURE, highly specialised drugs, Expenditure, community patients, Stavudine, occasions, individual patients, CAMPUS, AUTHORISING SIGNATURE, Commonwealth, estimated average co-payment.

I certify that the Stavudine claimed was dispensed to community patients who met the Highly Specialised Drugs Program's criteria, including PBAC clinical indications and that the amount claimed is correct.
*Number of patients represents total number of individual patients who received supply of highly specialised drugs in quarter, NOT number of occasions of dispensing.