ZERIT- stavudine capsule, gelatin coated ZERIT- stavudine capsule, gelatin coated ZERIT- stavudine powder, for solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

stavudine (UNII: BO9LE4QFZF) (stavudine - UNII:BO9LE4QFZF)

Tilgængelig fra:

E.R. Squibb & Sons, L.L.C.

INN (International Name):

stavudine

Sammensætning:

stavudine 15 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

ZERIT® , in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)]. ZERIT is contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. Co-administration of ZERIT 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 ZERIT 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 the combination of stavudine and didanosine with other antiretroviral ag

Produkt oversigt:

Capsules ZERIT® (stavudine) Capsules are available in the following strengths and configurations of plastic bottles with child-resistant closures: 15 mg Light yellow & dark red BMS 1964 15 60 0003-1964-01 20 mg Light brown BMS 1965 20 60 0003-1965-01 30 mg Light orange & dark orange BMS 1966 30 60 0003-1966-01 40 mg Dark orange BMS 1967 40 60 0003-1967-01 Oral Solution ZERIT® (stavudine) for oral solution is a dye-free, fruit-flavored powder that provides 1 mg of stavudine per mL of solution upon constitution with water. Directions for solution preparation are included on the product label and in the Dosage and Administration (2) section of this insert. ZERIT for oral solution (NDC No. 0003-1968-01) is available in child-resistant containers that provide 200 mL of solution after constitution with water. Storage ZERIT Capsules should be stored in tightly closed containers at 25°C (77°F). Excursions between 15°C and 30°C (59°F and 86°F) are permitted (see USP Controlled Room Temperature). ZERIT for oral solution should be protected from excessive moisture and stored in tightly closed containers at 25°C (77°F). Excursions between 15°C and 30°C (59°F and 86°F) are permitted (see USP Controlled Room Temperature). After constitution, store tightly closed containers of ZERIT for oral solution in a refrigerator, 2°C to 8°C (36°F to 46°F). Discard any unused portion after 30 days.

Autorisation status:

New Drug Application

Indlægsseddel

ZERIT- STAVUDINE CAPSULE, GELATIN COATED
ZERIT- STAVUDINE POWDER, FOR SOLUTION
E.R. Squibb & Sons, L.L.C.
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Medication Guide
ZERIT® (Zair-it)
(stavudine)
capsules
ZERIT® (Zair-it)
(stavudine)
for oral Solution
What is the most important information I should know about ZERIT?
ZERIT 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 ZERIT or similar medicines (nucleoside analogues). Lactic
acidosis is a serious medical
emergency that can lead to death. Do not take ZERIT 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
•
feel cold, especially in your arms and legs
•
have unusual (not normal) muscle pain
•
feel dizzy or lightheaded
•
have trouble breathing
•
have a fast or irregular heartbeat
•
have stomach pain with nausea and vomiting
•
weight loss
•
Severe liver problems. Severe liver problems, including liver failure
can happen in people who
take ZERIT. 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 ZERIT 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)
•
loss of appetite
•
nausea
•
dark or "tea-colored" urine
•
light colored stools (bowel movements)
•
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 o

Produktets egenskaber

ZERIT- STAVUDINE CAPSULE, GELATIN COATED
ZERIT- STAVUDINE POWDER, FOR SOLUTION
E.R. SQUIBB & SONS, L.L.C.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZERIT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZERIT.
ZERIT (STAVUDINE) CAPSULES, FOR ORAL USE
ZERIT (STAVUDINE) FOR ORAL SOLUTION
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
ZERIT AND
DIDANOSINE. COADMINISTRATION OF ZERIT WITH DIDANOSINE IS
CONTRAINDICATED (4, 5.1) FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED WHEN ZERIT WAS PART OF
A COMBINATION REGIMEN THAT
INCLUDED DIDANOSINE. COADMINISTRATION OF ZERIT WITH DIDANOSINE IS
CONTRAINDICATED (4,5.4)
INDICATIONS AND USAGE
ZERIT (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)
For oral solution: Requires preparation by a pharmacist. (2.4)
DOSAGE FORMS AND STRENGTHS
Capsules: 15 mg, 20 mg, 30 mg, 40 mg (3, 16)
For oral solution: 1 mg/mL following constitution (3, 16)
CONTRAINDICATIONS
• ZERIT is contraindicated in patients with clinically significant
hypersensitivity to stavudine or to any of the components of
this product. (4)
• Coadministration