ZOLPIDEM TARTRATE tablet, extended release

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

INN (Alþjóðlegt nafn):

ZOLPIDEM TARTRATE

Samsetning:

ZOLPIDEM TARTRATE 12.5 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Zolpidem tartrate extended-release tablet, USP is 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) ]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem tartrate extended-release 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 en

Vörulýsing:

Zolpidem tartrate extended-release tablets, USP are available as follows: 12.5 mg, light pink, round, biconvex film-coated tablets debossed with SZ on one side and 229 on the other side. NDC 63187-114-30, bottles of 30 tablets The tablets are to be swallowed whole and should not be crushed, chewed, or divided. Storage Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant, child-resistant container.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
Proficient Rx LP
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MEDICATION GUIDE
Zolpidem Tartrate Extended-Release Tablets, USPC-IV
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 know about zolpidem
tartrate extended-release tablets?
•
Do not take more zolpidem tartrate extended-release tablets than
prescribed.
•
Do not take zolpidem tartrate extended-release 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 extended-release tablets right before you get
in bed, not sooner.
Zolpidem tartrate extended-release tablets may cause serious side
effects that you may not know are
happening to you. These side effects include:
•
sleepiness during the day
•
not thinking clearly
•
act strangely, confused, or upset
•
"sleep-walking" or doing other activities when you are asleep like:
•
eating
•
talking
•
having sex
•
driving a car
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking zolpidem tartrate extended-release tablets.
You should not drive a car or do things that require clear thinking
the day after you take zolpidem tartrate
extended-release tablets.
Do not take zolpidem tartrate extended-release tablets if you:
•
drank alcohol that evening or before bed
•
take other medicines that can make you sleepy. Taking zolpidem
tartrate extended-release tablets
with other drugs can cause side effects. Talk to your healthcare
provider about all of your
medicines. Your healthcare provider will tell you if you can take
zolpidem tartrate extended-release
tablets with your other medicines.
•
cannot get a full night's sleep
What is zolpidem ta

Vara einkenni

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET, EXTENDED RELEASE
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS,
USP.
ZOLPIDEM TARTRATE EXTENDED-RELEASE TABLETS, USP C-IV
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Dosage and Administration (2)
4/2013
Dosage and Administration, Dosage in Adults (2.1)
4/2013
Warnings and Precautions (5)
4/2013
INDICATIONS AND USAGE
Zolpidem tartrate extended-release tablet, USP a gamma-aminobutyric
acid (GABA) A agonist, is indicated for the
treatment of insomnia characterized by difficulties with sleep onset
and/or sleep maintenance. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
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
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most commonly observed adverse reactions (> 10% in either elderly or
adult patients) are: headache, next-day
somnolence and dizziness (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT
1-800-525-8747 OR FDA AT 1-800-FDA-
1088 OR HTTP://WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
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, USP (2.3)
Tablets to be swallowed whole, not to be crushed, divided or chewed
(2.4)
The effect of zolpidem tartrate extended-release tablets, USP may be
slowed if taken with or immedi