ZOLPIDEM TARTRATE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Proficient Rx LP

INN (nume internaţional):

ZOLPIDEM TARTRATE

Compoziție:

ZOLPIDEM TARTRATE 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Zolpidem Tartrate Tablets USP are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets USP 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 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem tartrate is 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 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 when zolpidem was used at the end of pregnancy, especially when taken with

Rezumat produs:

Zolpidem tartrate tablets USP are available as follows: 5 mg: pink, film-coated, round, unscored tablets, debossed "TEVA" on one side of the tablet and “73” on the other. They are available in bottles of 15, 30, 60 and 90. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
Proficient Rx LP
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MEDICATION GUIDE
ZOLPIDEM TARTRATE (zol PI dem tar trate) Tablets USP CIV
Read the Medication Guide that comes with zolpidem tartrate tablets
before you start taking them 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 know about zolpidem
tartrate tablets?
•
Do not take more zolpidem tartrate tablets than prescribed.
•
Do not take zolpidem tartrate tablets unless you are able to stay in
bed a full night (7 to 8 hours)
before you must be active again.
•
Take zolpidem tartrate tablets right before you get in bed, not
sooner.
Zolpidem tartrate tablets may cause serious side effects, including:
•
After taking zolpidem tartrate tablets, you may get up out of bed
while not being fully awake and do
an activity that you do not know you are doing. The next morning, you
may not remember that you
did anything during the night. You have a higher chance for doing
these activities if you drink
alcohol or take other medicines that make you sleepy with zolpidem
tartrate tablets. Reported
activities include:
•
driving a car (“sleep-driving”)
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking zolpidem tartrate tablets.
Do not take zolpidem tartrate tablets if you:
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep
What is zolpidem tartrate?
Zolpidem tartrate is a sedative-hypnotic (sleep) medicine. Zolpidem
tartrate is used in adults for the short-
term treatment of a sleep problem called insomnia (trouble falling
asleep).
It is not known if zolpidem tartrate is safe and effective in children
under the age of 18 years.
Zolpidem tartrate is a federally controlled

Caracteristicilor produsului

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, FILM COATED
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE TABLETS USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLPIDEM TARTRATE
TABLETS USP.
ZOLPIDEM TARTRATE TABLETS, FOR ORAL USE CIV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Warnings and Precautions, Severe Injuries (5.8)
10/2014
INDICATIONS AND USAGE
Zolpidem Tartrate Tablets USP, a gamma-aminobutyric acid (GABA) A
agonist, are indicated for the short-term treatment
of insomnia characterized by difficulties with sleep initiation.
Zolpidem Tartrate Tablets USP have been shown to decrease
sleep latency for up to 35 days in controlled clinical studies. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Known hypersensitivity to zolpidem (4)
WARNINGS AND PRECAUTIONS
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•
•
•
•
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ADVERSE REACTIONS
Most commonly observed adverse reactions were:
Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea
Long-term (28 to 35 nights): Dizziness and drugged feelings (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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Use the lowest dose effective for the patient (2.1)
Recommended initial dose is 5 mg for women and 5 or 10 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 5 mg for men and women (2.2)
Lower doses of CNS depressants may be necessary when taken
concomitantly with zolpidem tartrate tablets (2.3)
The effect of zolpidem tartrate tablets may be slowed if taken with or
immediately after a meal (2.4)
CNS depressant effects: Impairs alertness and motor coordination.
Instruct