ZALEPLON capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ZALEPLON (UNII: S62U433RMH) (ZALEPLON - UNII:S62U433RMH)

Dostopno od:

Teva Pharmaceuticals USA, Inc.

INN (mednarodno ime):

ZALEPLON

Sestava:

ZALEPLON 5 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Zaleplon Capsules are indicated for the short-term treatment of insomnia. Zaleplon Capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see CLINICAL PHARMACOLOGY , Clinical Trials ). They have not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment. Hypersensitivity to zaleplon or any excipients in the formulation (see also PRECAUTIONS ). Zaleplon is classified as a Schedule IV controlled substance by federal regulation. Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be prod

Povzetek izdelek:

Zaleplon Capsules, USP are available as: 5 mg - an opaque white body and opaque blue green cap, imprinted with “93” over “5268” on both the cap and the body in bottles of 100 (NDC 0093-5268-01). 10 mg - an opaque aqua blue body and opaque blue green cap, imprinted with “93” over “5269” on both the cap and the body in bottles of 100 (NDC 0093-5269-01). 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. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. G 8/2015

Status dovoljenje:

Abbreviated New Drug Application

Navodilo za uporabo

ZALEPLON- ZALEPLON CAPSULE
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
ZALEPLON (ZAL-e-plon) CAPSULES USP
CIV
Read this Medication Guide before you start taking zaleplon capsules
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. You and your doctor should
talk about zaleplon capsules when
you start taking them and at regular checkups.
What is the most important information I should know about zaleplon
capsules?
After taking zaleplon capsules, 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 zaleplon capsules. Reported
activities include:
•
driving a car (“sleep-driving”)
•
making and eating food
•
talking on the phone
•
having sex
•
sleep-walking
Important:
1. Take zaleplon capsules exactly as prescribed
•
Do not take more zaleplon capsules than prescribed.
•
Take zaleplon capsules right before you get in bed, not sooner.
2. Do not take zaleplon capsules if you:
•
drink alcohol
•
take other medicines that can make you sleepy. Talk to your doctor
about all of your medicines.
Your doctor will tell you if you can take zaleplon capsules with your
other medicines
•
cannot get a full night’s sleep
3. Call your doctor right away if you find out that you have done any
of the above activities after taking
zaleplon capsules.
What are zaleplon capsules?
Zaleplon capsules are a sedative-hypnotic (sleep) medicine. Zaleplon
capsules are used in adults for the
short-term treatment of the symptom of trouble falling asleep from
insomnia. Zaleplon capsules do not
treat other symptoms of insomnia which include waking up too early in
the morning and waking up often
during the night.
Zaleplon capsules are not fo

Lastnosti izdelka

ZALEPLON- ZALEPLON CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
ZALEPLON CAPSULES USP CIV
5268
5269
RX ONLY
DESCRIPTION
Zaleplon, USP is a nonbenzodiazepine hypnotic from the
pyrazolopyrimidine class. The chemical name
of zaleplon is
_N_-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-_N_-ethylacetamide.
The structural
formula is shown below.
C
H N O M.W. 305.34
Zaleplon, USP is a white to off-white powder that is practically
insoluble in water and sparingly soluble
in alcohol or propylene glycol. Its partition coefficient in
octanol/water is constant (log PC = 1.23) over
the pH range of 1 to 7.
Zaleplon Capsules, USP contain zaleplon, USP as the active ingredient,
and has the following inactive
ingredients: colloidal silicon dioxide, D&C yellow #10 aluminum lake,
FD&C blue #1 aluminum lake,
FD&C blue #2 aluminum lake, FD&C green #3, FD&C red #40 aluminum lake,
gelatin, iron oxide black,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized corn starch,
propylene glycol, shellac glaze, sodium lauryl sulfate, and titanium
dioxide. In addition, the 10 mg
capsule contains FD&C blue #1.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS AND MECHANISM OF ACTION
While zaleplon is a hypnotic agent with a chemical structure unrelated
to benzodiazepines, barbiturates,
or other drugs with known hypnotic properties, it interacts with the
gamma-aminobutyric acid-
benzodiazepine (GABA-BZ) receptor complex. Subunit modulation of the
GABA-BZ receptor chloride
channel macromolecular complex is hypothesized to be responsible for
some of the pharmacological
properties of benzodiazepines, which include sedative, anxiolytic,
muscle relaxant, and anticonvulsive
17
15
5
effects in animal models.
Other nonclinical studies have also shown that zaleplon binds
selectively to the brain omega-1 receptor
situated on the alpha subunit of the GABA /chloride ion channel
receptor complex and potentiates t-
butyl-bicyclophosphorothionate (TBPS) binding. Studies of binding of
zaleplon to recombinant GABA
receptors (α β γ