ZOLPIDEM TARTRATE- zolpidem tartrate tablet, film coated, extended release

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ZOLPIDEM TARTRATE (UNII: WY6W63843K) (ZOLPIDEM - UNII:7K383OQI23)

Tillgänglig från:

American Health Packaging

INN (International namn):

ZOLPIDEM TARTRATE

Sammansättning:

ZOLPIDEM TARTRATE 6.25 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Zolpidem tartrate extended-release tablets, USP are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see Clinical Studies (14)]. Zolpidem tartrate extended-release tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release tablets in pregnant women. Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported wh

Produktsammanfattning:

Zolpidem tartrate extended-release tablets, USP 6.25 mg, are composed of two portions* and are coated, white, round, bi-convex, debossed with A2 on one side and supplied as: Unit dose packages of 30 (3 x 10) NDC 68084-889-21 Each tablet contains 6.25 mg of zolpidem tartrate, USP. Zolpidem tartrate extended-release tablets, USP 12.5 mg, are composed of two portions* and are coated, yellow, round, bi-convex, debossed with A1 on one side and supplied as: Unit dose packages of 30 (3 x 10) NDC 68084-523-21 Each tablet contains 12.5 mg of zolpidem tartrate, USP. *Portions are covered by the coating and are indistinguishable. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

These highlights do not include all the information
needed to use zolpidem tartrate extended-release tablets safely
and effectively. See full prescribing information for zolpidem
tartrate extended-release tablets.
ZOLPIDEM tartrate extended-release tablets, USP for oral use C-IV
Initial U.S. Approval: 1992

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ZOLPIDEM TARTRATE- zolpidem
tartrate tablet, film coated, extended
release  American Health Packaging
----------

MEDICATION GUIDE
ZOLPIDEM (zole-PI-dem)
TARTRATE EXTENDED-RELEASE TABLETS, USP
C-IV
Rx Only
Read the Medication Guide that comes with zolpidem tartrate
extended-release tablets before you start taking it and each time
you get a refill. There may be new information. This Medication
Guide does not take the place of talking to your healthcare
provider about your medical condition or treatment.
What is the most important information
I should kn

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Produktens egenskaper

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED, EXTENDED
RELEASE
AMERICAN HEALTH PACKAGING
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM
TARTRATE EXTENDED-RELEASE TABLETS.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP FOR ORAL USE C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries ( 5.8) 10/2014
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablets, USP a gamma-aminobutyric
acid (GABA) A agonist are indicated for the
treatment of insomnia characterized by difficulties with sleep onset
and/or sleep maintenance. ( 1)
DOSAGE AND ADMINISTRATION
Use the lowest dose effective for the patient ( 2.1)
Recommended initial dose is 6.25 mg for women, and 6.25 or 12.5 mg for
men, immediately before bedtime with at
least 7 to 8 hours remaining before the planned time of awakening (
2.1)
Geriatric patients and patients with hepatic impairment: Recommended
dose is 6.25 mg for men and women ( 2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate extended-release
tablets ( 2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed (
2.4)
The effect of zolpidem tartrate extended-release tablets may be slowed
if taken with or immediately after a meal ( 2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 6.25 mg and 12.5 mg extended-release tablets. Tablets not
scored. ( 3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem ( 4)
WARNINGS AND PRECAUTIONS
CNS depressant effects: Impaired alertness and motor coordination,
including risk of morning impairment. Caution
patients against driving and other activities requiring complete
mental alertness the morning after use. ( 5.1)
Need to evaluate for co-morbid diagnoses: Revaluate if insomnia
persists after 7 to 10 days of use ( 5.2)
Severe anaphylactic/anaphylactoid reactions: Angioedema and