ZOLPIDEM TARTRATE tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Lupin Pharmaceuticals,Inc.

INN (Jina la Kimataifa):

ZOLPIDEM TARTRATE

Tungo:

ZOLPIDEM TARTRATE 1.75 mg

Njia ya uendeshaji:

SUBLINGUAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Zolpidem Tartrate Sublingual Tablet is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Limitations of Use : Zolpidem Tartrate Sublingual Tablet is not indicated for the treatment of middle-of-the-night insomnia when the patient has fewer than 4 hours of bedtime remaining before the planned time of waking. Zolpidem Tartrate Sublingual Tablets are contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Sublingual Tablets [see Warnings and Precautions (5.1) ] Zolpidem Tartrate Sublingual Tablets are contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema [see Warnings and Precautions (5.3)]. Pregnancy Category C There are no adequate and well-controlled studies of zolpidem in pregnant women. Studies in children to assess the effects of prenatal ex

Bidhaa muhtasari:

Each Zolpidem Tartrate Sublingual Tablet is individually packaged in a blister inside a unit-dose pouch. Zolpidem Tartrate Sublingual Tablets 1.75 mg are white to off white, round, flat faced beveled edged debossed with "N2" on one side and plain on the other side and supplied as: NDC 43386-762-30: Carton of 30 unit-dose pouches Zolpidem Tartrate Sublingual Tablets 3.5 mg are white to off white, round, flat faced beveled edged debossed with "NP" on one side and plain on the other side and supplied as: NDC 43386-761-30: Carton of 30 unit-dose pouches Storage and Handling Store between 20°C to 25°C (68°F to 77°F), [see USP Controlled Room Temperature]. Protect from moisture. The patient should be instructed not to remove the blister from the unit-dose pouch until the patient is ready to consume the sublingual tablet inside. Do not use if blister seal is broken or missing.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
Lupin Pharmaceuticals,Inc.
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MEDICATION GUIDE
Zolpidem Tartrate ((zol' pi dem tar' trate)) Sublingual Tablet CIV
Phenylketonurics
Phenylalanine is a component of aspartame. Each 3.5 mg and 1.75 mg
Zolpidem Tartarate Sublingual
Tablets contains 4.48 mg and 2.24 mg of phenylalanine.
Read the Medication Guide that comes with Zolpidem Tartrate Sublingual
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 doctor about your medical condition or
treatment.
What is the most important information I should know about Zolpidem
Tartrate Sublingual Tablet?
Follow the Instructions for Use at the end of this Medication Guide
when you take Zolpidem Tartrate
Sublingual Tablet. If you do not follow the Instructions for Use, you
might be drowsy in the morning
without knowing it.
•
Only take one Tablet a night, if needed.
•
Only take Zolpidem Tartrate Sublingual Tablet if you have at least 4
hours of bedtime left.
Zolpidem Tartrate Sublingual Tablet may cause serious side effects,
including:
•
Complex sleep behaviors that have caused serious injury and death .
After taking Zolpidem
Tartrate Sublingual 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 Sublingual Tablets whether or not you drink alcohol
or take other medicines
that make you sleepy
Reported activities include:
•
driving a car ("sleep-driving")
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Stop taking Zolpidem Tartrate Sublingual Tablet and call your
healthcare provider right away if you find
out that you have done any of the above activities after taking
Zolpidem Tartrate Sublingual Tablet.
Important:
1.
Take Zolpidem Tartrate Sublingual Table

Tabia za bidhaa

ZOLPIDEM TARTRATE- ZOLPIDEM TARTRATE TABLET
LUPIN PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZOLPIDEM TARTRATE SUBLINGUAL
TABLETS.
ZOLPIDEM TARTRATE SUBLINGUAL TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1992
WARNING: COMPLEX SLEEP BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOX WARNING._
Complex sleep behaviors including sleep-walking, sleep-driving, and
engaging in other activities while not fully awake
may occur following use of Zolpidem Tartrate Sublingual Tablets. Some
of these events may result in serious
injuries, including death. Discontinue Zolpidem Tartrate Sublingual
Tablets immediately if a patient experiences a
complex sleep behavior (4, 5.1).
RECENT MAJOR CHANGES
Box 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) 08/2019
INDICATIONS AND USAGE
Zolpidem Tartrate is a GABA
agonist indicated for use as needed for the treatment of insomnia when
a middle-of-the-
night awakening is followed by difficulty returning to sleep ( 1)
Limitation of Use: Not indicated for the treatment of middle-of-the
night awakening when the patient has fewer than 4 hours
of bedtime remaining before the planned time of waking ( 1)
DOSAGE AND ADMINISTRATION
Take only if 4 hours of bedtime remain before the planned time of
waking ( 2.1, 5.1)
Zolpidem Tartrate Sublingual Tablets should be placed under the tongue
and allowed to disintegrate completely before
swallowing. The tablet should not be swallowed whole. ( 2.1)
The effect of Zolpidem Tartrate Sublingual Tablets may be slowed if
taken with or immediately after a meal ( 2.1)
Recommended dose is 1.75 mg for women and 3.5 mg for men, taken only
once per night if needed ( 2.2)
Lower doses of CNS depressants may be necessary when taken
conc