STAVUDINE capsule

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

STAVUDINE (UNII: BO9LE4QFZF) (STAVUDINE - UNII:BO9LE4QFZF)

Commercializzato da:

Rising Pharmaceuticals, Inc.

INN (Nome Internazionale):

STAVUDINE

Composizione:

STAVUDINE 15 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Stavudine capsules, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14) ]. Stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. Co-administration of stavudine capsules with didanosine is contraindicated due to the potential for serious and/or life-threatening events notably lactic acidosis, hepatotoxicity, peripheral neuropathy, and pancreatitis [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4 ) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to stavudine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Fatal lactic acidosis has been reported in pregnant individuals who received

Dettagli prodotto:

Capsules  Stavudine Capsules USP, 15 mg are dark red opaque/light yellow opaque size ‘4’ hard gelatin capsule filled with white to off white granular powder and imprinted with ‘E’ on dark red opaque cap and ‘76’ on light yellow opaque body with black ink. Bottle of 60 Capsules                             NDC 64980-354-06 Stavudine Capsules USP, 20 mg are light brown opaque/light brown opaque size ‘3’ hard gelatin capsule filled with white to off white granular powder and imprinted with ‘E’ on light brown opaque cap and ‘77’ on light brown opaque body with black ink. Bottle of 60 Capsules                             NDC 64980-355-06 Stavudine Capsules USP, 30 mg are dark orange opaque/light orange opaque size “2” hard gelatin capsule filled with white to off white granular powder and imprinted with “C” on dark orange opaque cap and “36” on light orange opaque body with black ink. Bottle of 60 Capsules                             NDC 64980-356-06 Stavudine Capsules USP, 40 mg are dark orange opaque/dark orange opaque size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “C” on dark orange opaque cap and “37” on dark orange opaque body with black ink. Bottle of 60 Capsules                         NDC 64980-357-06 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Foglio illustrativo

Rising Pharmaceuticals, Inc.
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MEDICATION GUIDE
Stavudine Capsules, USP
(stav' ue deen)
What is the most important information I should know about stavudine
capsules?
Stavudine capsules can cause serious side effects, including:
Build-up of an acid in your blood (lactic acidosis). Lactic acidosis
can happen in some people who take
stavudine capsules or similar medicines (nucleoside analogues). Lactic
acidosis is a serious medical
emergency that can lead to death. Do not take stavudine capsules with
didanosine.
Call your healthcare provider right away if you get any of the
following symptoms which could be signs of
lactic acidosis:
•
feel very weak or tired
•
have unusual (not normal) muscle pain
•
have trouble breathing
•
have stomach pain with nausea and vomiting
•
feel cold, especially in your arms and legs
•
feel dizzy or lightheaded
•
have a fast or irregular heartbeat
•
weight loss
•
Severe liver problems . Severe liver problems, including liver failure
can happen in people who take
stavudine capsules. In some cases, these liver problems can lead to
death. Your liver may become
large (hepatomegaly) and you may develop fat in your liver
(steatosis). Taking stavudine capsules
with medicines that contain didanosine or hydroxyurea may increase
your risk for liver problems.
Call your healthcare provider right away if you have any of the
following symptoms of liver problems:
•
your skin or the white part of your eyes turns yellow (jaundice)
•
nausea
•
light colored stools (bowel movements)
•
loss of appetite
•
dark or “tea-colored” urine
•
pain, aching, or tenderness on the right side of your stomach area
You may be more likely to get lactic acidosis or severe liver problems
if you are female, are very
overweight (obese), or have been taking nucleoside analogue medicines
for a long time.
•
Neurologic problems including weakness of your legs, feet, arms, or
hands (motor weakness) and
numbness, tingling or pain in your hands or feet (peripheral
neuropathy). Peripheral neu

Scheda tecnica

STAVUDINE - STAVUDINE CAPSULE
RISING PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STAVUDINE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR STAVUDINE CAPSULES.
STAVUDINE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1994
WARNING: LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS; PANCREATITIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES. FATAL LACTIC ACIDOSIS HAS
BEEN REPORTED IN PREGNANT INDIVIDUALS WHO RECEIVED THE COMBINATION OF
STAVUDINE AND DIDANOSINE.
COADMINISTRATION OF STAVUDINE WITH DIDANOSINE IS CONTRAINDICATED. (4,
5.1) FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED WHEN STAVUDINE WAS PART
OF A COMBINATION REGIMEN THAT
INCLUDED DIDANOSINE. COADMINISTRATION OF STAVUDINE WITH DIDANOSINE IS
CONTRAINDICATED. (4, 5.4)
INDICATIONS AND USAGE
Stavudine is a nucleoside reverse transcriptase inhibitor for use in
combination with other antiretroviral agents for the
treatment of human immunodeficiency virus (HIV)-1 infection. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage for adults:
less than 60 kg: 30 mg every 12 hours (2.1)
at least 60 kg: 40 mg every 12 hours (2.1)
Recommended dosage for pediatric patients:
newborns from birth to 13 days old: 0.5 mg/kg every 12 hours (2.2)
at least 14 days old and weighing less than 30 kg: 1 mg/kg every 12
hours (2.2)
weighing at least 30 kg: adult dose (2.2)
Renal impairment:_ _Dose adjustment is recommended for CrCl ≤50
mL/min. (2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg, 20 mg, 30 mg, 40 mg (3, 16)
CONTRAINDICATIONS
Stavudine capsules are contraindicated in patients with clinically
significant hypersensitivity to stavudine or to any of the
components of this product. (4)
Coadministration of stavudine capsules with didanosine is
contraindicated. (4)
WARNINGS AND PRECAUTIONS
Hepatic toxicity: May be severe, fatal. Consider interruption or
discontinuation. Avoid us