ZOLPIDEM TARTRATE tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 - who have experienced complex sleep behaviors after taking zolpidem tartrate tablets [see Warnings and Precautions ( 5.1)]. who have experienced complex sleep behaviors after taking zolpidem tartrate tablets

Ապրանքի ամփոփագիր:

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: NDC Number Size 70934-700-30 bottle of 30 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].

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

ZOLPIDEM TARTRATE- zolpidem tartrate tablet
Denton Pharma, Inc. dba Northwind Pharmaceuticals
----------
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 ta

Ապրանքի հատկությունները

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
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
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 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)
DOSAGE FORMS AND STRENGTHS
5 mg and 10 mg tablets. Tablets not scored. (3