zolpidem tartrate- Zolpidem tartrate tablet, film coated for oral use - CIV

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Zolpidem tartrate (UNII: WY6W63843K) (Zolpidem - UNII:7K383OQI23)

Tilgjengelig fra:

Synthon Pharmaceuticals, Inc.

INN (International Name):

Zolpidem tartrate

Legemiddelform:

TABLET, FILM COATED

Sammensetning:

5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)] . The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. Teratogenic effects: Pregnancy Category C Zolpidem tartrate was administered to pregnant Sprague-Dawley rats by oral gavage during the period of organogenesis at doses of 4, 20, or 100 mg based/kg/day. Adverse maternal and embryo/fetal effects occurred at doses of 20 mg base/kg and higher, manifesting as dose-related lethargy and ataxia in pregnant rats while examination of fetal skull bones revealed a dose

Produkt oppsummering:

Zolpidem tartrate tablets, 5 mg: Pink, round, film-coated tablets, debossed with "ZIM" on one side and "5" on the other side. Bottles of 100's .................................... NDC 63672-3005-1 Bottles of 500's .................................... NDC 63672-3005-2 Zolpidem tartrate tablets, 10 mg : White, round, film-coated tablets, debossed with "ZIM" on one side and "10" on the other side. Bottles of 100's ....................................... NDC 63672-3010-1 Bottles of 500's ....................................... NDC 63672-3010-2 Store at controlled room temperature 20°–25° C (68°–77°F).

Preparatomtale

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
SYNTHON PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
RECENT MAJOR CHANGES
Indications and Usage (1) 03/2007
Warnings and Precautions (5) 03/2007
INDICATIONS AND USAGE
Zolpidem tartrate tablets are indicated for the short-term treatment
of insomnia characterized by difficulties with sleep
initiation. Zolpidem tartrate tablets have been shown to decrease
sleep latency for up to 35 days in controlled clinical
studies. (1)
DOSAGE AND ADMINISTRATION
Adult dose: 10 mg immediately before bedtime (2.1)
Elderly/Debilitated patients/Hepatic Impairment: Initial dose of 5 mg
(2.2)
Downward dosage adjustment may be necessary when used with CNS
depressants (2.3)
Total daily dose should not exceed 10 mg (2.4)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets (3)
CONTRAINDICATIONS
Hypersensitivity to zolpidem tartrate or inactive ingredients (4.1)
WARNINGS AND PRECAUTIONS
Reevaluate if insomnia persists after 7 to 10 days of use (5.1)
Severe anaphylactic and anaphylactoid reactions have been reported
(5.2)
Abnormal thinking, behavior changes and complex behaviors such as
sleep-driving have been reported (5.3)
Pediatric patients with attention-deficit/hyperactivity disorder
(ADHD): Hallucinations (7.4%) and other psychiatric and
/or nervous system adverse events were observed frequently (5.6, 8.4)
Depression: Worsening of depression or, suicidal thinking may occur.
Prescribe the least amount feasible to avoid
intentional overdose (5.3, 5.6)
Withdrawal symptoms may occur with rapid dose reduction or
discontinuation (5.4)
CNS depressant effects, additive effects with CNS depressants (2.3,
5.5)
Potential impairment of activities requiring complete mental alertness
such as operating machinery or driving a motor
vehicle, after ingesting the drug and the following day (5.5)
Additive effects with alcohol; should not be taken with alcohol (5.5)
Elderly/debilitated patients: Impaired motor, cognitive performance
after repeated exposure, increased sensitivit