ZOLPIDEM TARTRATE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Cardinal Health 107, LLC

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 tablets are contraindicated in patients Zolpidem tartrate tablets are contraindicated in patients Risk Summary Neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data] . Published data on the use of zolpidem during pregnancy have not reported a clear association with zolpidem and major bi

পণ্য সারাংশ:

Zolpidem tartrate 5 mg tablets, USP are red colored, capsule shaped tablets with the Torrent logo debossed on one side and '5 MG' debossed on the other side and supplied as: Overbagged with 10 tablets per bag, NDC 55154-1398-0 Store at 20º to 25°C (68º to 77°F); excursions permitted to 15° to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

তথ্য লিফলেট

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
Cardinal Health 107, LLC
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MEDICATION GUIDE
Zolpidem Tartrate (zole-PI-dem TAR-trate) Tablets, USP C-IV
Read the Medication Guide that comes with zolpidem tartrate 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 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:
•
complex sleep behaviors that have caused serious injury and death.
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 (complex sleep behaviors). The next morning, you may not
remember that you did
anything during the night. These activities may occur with zolpidem
tartrate tablets whether or not you
drink alcohol or take other medicines that make you sleepy. Reported
activities include:
o driving a car ("sleep-driving")
o making and eating food
o talking on the phone
o having sex
o sleep-walking
Stop taking zolpidem tartrate tablets and 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:
•
have ever experienced a complex sleep behavior (such as driving a car,
making and eating food, talking
on the phone , or having sex while not being fully awake) after taking
zolpidem tartrate tablets.
•
drank alcohol that evening or before bed
•
took another medicine to help you sleep
What are zolpidem tartrate tablets?
Zolpidem

পণ্য বৈশিষ্ট্য

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
CARDINAL HEALTH 107, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE
TABLETS.
ZOLPIDEM TARTRATE (USP-CIV) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992.
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND
ENGAGING IN OTHER
ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF ZOLPIDEM
TARTARE TABLETS.
SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH.
DISCONTINUE
ZOLPIDEM TARTARE TABLETS IMMEDIATELY IF A PATIENT EXPERIENCES A
COMPLEX SLEEP
BEHAVIOR ( 4, 5.1).
RECENT MAJOR CHANGES
Boxed Warning 08/2019
Contraindications ( 4) 08/2019
Warnings and Precautions, Complex Sleep Behaviors ( 5.1) 08/2019
Warnings and Precautions, CNS Depressant Effects and Next-day
Impairment ( 5.2)
02/2019
INDICATIONS AND USAGE
Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A
receptor positive modulator, is
indicated for the short-term treatment of insomnia characterized by
difficulties with sleep initiation. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3)
CONTRAINDICATIONS
Patients who have experienced complex sleep behaviors after taking
zolpidem tartare tablets ( 4)
Known hypersensitivity to zolpidem ( 4)
WARNINGS AND PRECAUTIONS
•
•
•
•
Use the lowest dose effective for the patient and must not exceed a
total of 10 mg daily ( 2.1)
Recommended initial dose is a single dose of 5 mg for women and a
single dose of 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 mild to moderate hepatic
impairment: Recommended dose is 5
mg for men and women ( 2.2)
Lower doses of CNS de