Stavir-30 Capsules
Stavir-40 Capsules
Warning
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS,
INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE
OF ANTIRETROVIRAL NUCLEOSIDE ANALOGUES ALONE OR IN
COMBINATION, INCLUDING
STAVUDINE (See Warnings and Precautions).
Composition
Stavir-30 Capsules
Each capsule contains Stavudine 30 mg
Stavir-40 Capsules
Each capsule contains Stavudine 40 mg
Description
Stavudine (formerly called d4T) is a synthetic thymidine
nucleoside analogue that possesses virustatic activity
against human immunodefi-ciency virus type 1 (HIV-1) and
type 2 (HIV-2).
Indications
Stavir is indicated for the treatment of HIV-infected
patients who have received prolonged prior zidovudine
therapy.
Dosage and Administration
Adults: The interval between oral doses should
be 12 hours. Stavudine may be taken without regard to
meals. The recommended starting dose based on body weight
is as follows:
40 mg twice daily for patients 60 kg
30 mg twice daily for patients < 60 kg
Paediatrics: The recommended starting dose for
paediatric patients weighing less than 30 kg is 1 mg/kg/dose,
given every 12 hours. Paediatric patients weighing 30
kg or greater should receive the recommended adult dose.
Dosage adjustment: Patients should be monitored
for the development of peripheral neuropathy, which is
usually characterised by numbness, tingling or pain in
the feet or hands. If these symptoms develop on treatment,
stavudine therapy should be interrupted. Symptoms may
resolve if therapy is withdrawn promptly. In some cases,
symptoms may worsen temporarily following discontinuation
of therapy. If symptoms resolve completely, resumption
of treatment may be considered using the following dosage
schedule.
Schedule
20 mg twice daily for patients >60 kg
15 mg twice daily for patients < 60 kg
For paediatric patients, resumption of treatment may be
considered at one-half the recommended dose.
Renal Impairment
Stavudine may be administered to adult patients with impaired
renal function. The following schedule is recommended:
|
Creatinine Clearance (mL/min
)
|
Recommended Stavudine Dose
by patient weight
|
|
< 60 kg
|
< 60 kg
|
| >50 |
40 mg every 12 hours |
30 mg every 12 hours |
| 26-50 |
20 mg every 12 hours |
15 mg every 12 hours |
| 10-25 |
20 mg every 24 hours |
15 mg every 24 hours |
Paediatrics: There are insufficient data to
recommend a specific dose adjustment of stavudine in
children with renal impairment. A reduction in the dose
and/or an increase in the interval between doses should
be considered.
Hemodialysis Patients
The recommended dose is 20 mg every 24 hours (>60
kg) or 15 mg every 24 hours (< 60 kg), administered
after the completion of hemodialysis and at the same
time of day on non-dialysis hours.
Contraindications
Stavir is contraindicated in patients with clinically
significant hypersensitivity to stavudine or to any
of the components contained in the formulation. It should
not be used in combination with zidovudine.
Warnings and Precautions
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS
Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use
of antiretroviral nucleoside analogues alone or in combination,
including stavudine. A majority of these cases have
been in women. Caution should be exercised when administering
stavudine to any patient and particularly to those with
known risk factors for liver disease. Treatment with
stavudine should be discontinued in any patient who
develops clinical or laboratory findings suggestive
of lactic acidosis or hepatotoxicity.
PERIPHERAL NEUROPATHY
Stavudine therapy can be associated with severe peripheral
neuropathy which is dose-related and occurs more frequently
in patients with advanced HIV infection or who have
previously experienced peripheral neuropathy.
LABORATORY TESTS
Mild to moderate increases in AST (SGOT) and (SGPT)
occurred commonly in clinical trials.
PREGNANCY
There are no adequate and well-controlled studies in
pregnant women. Because animal reproduction studies
are not always predictive of human response, stavudine
should be used during pregnancy only if clearly needed.
NURSING MOTHERS
It is recommended that HIV-infected mothers do not breast
feed their infants to avoid risking postnatal transmission
of HIV infection. It is not known whether stavudine
is excreted in human milk and because of the potential
for adverse reactions from stavudine in nursing infants,
mothers should be instructed not to nurse if they are
receiving stavudine.
PAEDIATRIC USE
Use of stavudine in paediatric patients is supported
by evidence from adequate and well-controlled studies
in adults with additional safety data in 115 paediatric
patients.
RENAL INSUFFICIENCY
It is recommended that the dosage of stavudine be modified
in patients with reduced creatinine clearance. (See
Dosage and Administration).
Side Effects
The major clinical toxicity of stavudine is peri-pheral
neuropathy, which is dose related. Modest elevation
of hepatic transaminases was observed commonly in controlled
trials. Other adverse events that occurred in adult
patients included headache, chills/fever, diarrhoea,
rash, nausea and vomiting, abdominal pain, pancreatitis,
myalgia and insomnia.
Overdosage
Experience with adults treated with 12 to 24 times the
recommended daily dosage revealed no acute toxicity.
Complications of chronic overdosage include peripheral
neuropathy and hepatic toxicity. It is not known whether
stavudine is eliminated by peritoneal dialysis or hemodialysis.
Presentation
Stavir-30
Blister strip of 10 capsules
Container of 60 capsules
Stavir-40
Blister strip of 10 capsules
Container of 60 capsules
|
