TEMAZEPAM capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)

Tilgjengelig fra:

Bryant Ranch Prepack

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day resulted in increasing nursling mortality. Teratology studies in rats demonstrated increased fetal resorptions at doses of 30 and 120 mg/kg in one study and increased occurrence of rudimentary ribs, which are considered skeletal variants, in a second study at doses of 240 mg/kg or higher. In rabbits, occasional abnormalities such as exencephaly and fusion or asymmetry of ribs were reported without dose relationship. Although these abnormalities were not found in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg or higher, there was an increased incidence of the 13th rib variant when compared to the incidence in concurrent and historical controls. Temazepam is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. 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 adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects. Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common. Controlled Substance Temazepam is a controlled substance in Schedule IV. Abuse and Dependence Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal, and muscle cramps, vomiting, and sweating), have occurred following abrupt discontinuance of benzodiazepines. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy at doses higher than 15 mg, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. As with any hypnotic, caution must be exercised in administering temazepam to individuals known to be addiction-prone or to those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeated prescriptions without adequate medical supervision.

Produkt oppsummering:

Temazepam Capsules USP 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 500 NDC 63629-1057-1 Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage : Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

TEMAZEPAM- TEMAZEPAM CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
TEMAZEPAM (tem az' e pam) Capsules, C-IV
What is the most important information I should know about TEMAZEPAM?
•
TEMAZEPAM is a benzodiazepine medicine. Taking benzodiazepines with
opioid medicines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death.
•
After taking TEMAZEPAM, 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 TEMAZEPAM.
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
Call your healthcare provider right away if you find out that you have
done any of the above activities
after taking TEMAZEPAM.
• Do not take TEMAZEPAM unless you are able to stay in bed a full
night (7 to 8 hours) before you must
be active again.
• Do not take more TEMAZEPAM than prescribed.
What is TEMAZEPAM?
• TEMAZEPAM is a prescription sleep medicine. TEMAZEPAM is used in
adults for the short-term
(usually 7 to 10 days) treatment of a sleep problem called insomnia.
Symptoms of insomnia include
trouble falling asleep and waking up often during the night.
• TEMAZEPAM is a federal controlled substance (C-IV) because it can
be abused or lead to dependence.
Keep TEMAZEPAM in a safe place to prevent misuse and abuse. Selling or
giving away TEMAZEPAM
may harm others, and is against the law. Tell your healthcare provider
if you have ever abused or been
dependent on alcohol, prescription medicines or street drugs.
• It is not known if TEMAZEPAM is safe and effective in children.
• It is not known if TEMAZEPAM is safe and effective for use longer
than 2 weeks.
Do not take TEMAZEPAM i

Preparatomtale

TEMAZEPAM- TEMAZEPAM CAPSULE
BRYANT RANCH PREPACK
----------
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death (see WARNINGS and Drug
Interactions).
• Reserve concomitant prescribing of these drugs for use in patients
for whom
alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression
and sedation.
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro-1,3-
dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and
the structural
formula is:
C
H
ClN O MW = 300.74
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly
soluble in alcohol USP.
16
13
2
2
Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral
administration.
_7.5 MG, 15 MG, 22.5 MG AND 30 MG CAPSULES _
Active Ingredient: temazepam USP
_7.5 MG CAPSULES _
_Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Red #40 and titanium dioxide.
_May also include: _sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium
hydroxide, propylene
glycol, and black iron oxide.
_15 MG CAPSULES_
_Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide.
_May also include: _sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium
hydroxide, propylene
glycol, and black iron oxide.
_22.5 MG CAPSULES_
_Inactive Ingredients: _Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide.
_May also include: _sodium lauryl sulfate. Imprinting ink may contain
ammonium
hydroxide, ethanol, isopropyl a