TEMAZEPAM capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

temazepam (UNII: CHB1QD2QSS) (temazepam - UNII:CHB1QD2QSS)

Available from:

Quality Care Products LLC

INN (International Name):

temazepam

Composition:

temazepam 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 perinatalpostnatal 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. Pediatric Use Safety and effectiveness in pediatric patients have not been established. 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. 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.

Product summary:

Temazepam Capsules USP 15 mg Blue opaque cap and white opaque body, imprinted “15 mg” on cap and “Novel 121” on the body in black ink. Bottle of 100........NDC 67877-146-01 Bottle of 500........NDC 67877-146-05 30 mg White opaque cap and body, imprinted “30 mg” on cap and “Novel 123” on the body in black ink. Bottle of 100........NDC 67877-147-01 Bottle of 500........NDC 67877-147-05 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]. *Romazicon is the registered trademark of Hoffman-LaRoche Inc. **Trademark of Medical Economics Company, Inc. Manufactured by:                                          Distributed by: Novel Laboratories, Inc.                                 ASCEND Laboratories, LLC Somerset, NJ 08873                                      Montvale, NJ 07645

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Quality Care Products LLC
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MEDICATION GUIDE
MEDICATION GUIDE
TEMAZEPAM Capsules, USP C-IV
(temazepam)
Read the Medication Guide that comes with TEMAZEPAM 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 TEMAZEPAM?
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:
• driving a car (“sleep-driving”)
• making and eating food
• talking on the phone
• having sex
• sleep-walking
Call your doctor right away if you find out that you have done any of
the above activities after taking
TEMAZEPAM.
Important:
1. Take TEMAZEPAM exactly as prescribed
• Do not take more TEMAZEPAM than prescribed.
• Take TEMAZEPAM right before you get in bed, not sooner.
2. Do not take TEMAZEPAM 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 TEMAZEPAM with your other
medicines
• cannot get a full night’s sleep
What is TEMAZEPAM?
TEMAZEPAM is a sedative-hypnotic (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
• waking up often during the night
TEMAZEPAM is not for children.
TEMAZEPAM is a federally 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
doctor if yo

Summary of Product characteristics

TEMAZEPAM- TEMAZEPAM CAPSULE
QUALITY CARE PRODUCTS LLC
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RX ONLY
Enter section text here
DESCRIPTION
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro1,3-
dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one, and
the structural
formula is:
C16H13ClN2O2 MW = 300.74
Temazepam is a white, crystalline substance, very slightly soluble in
water and sparingly
soluble in alcohol USP.
Temazepam capsules, 15 mg and 30 mg, are for oral administration.
_15 MG AND 30 MG CAPSULES_
Active Ingredient: temazepam USP
_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.
_30 MG CAPSULES_
_Inactive Ingredients:_ Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl
sulfate, 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.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
In a single and multiple dose absorption, distribution, metabolism,
and excretion (ADME)
study, using 3H labeled drug, temazepam was well absorbed and found to
have minimal
(8%) first pass metabolism. There were no active metabolites formed
and the only
significant metabolite present in blood was the O-conjugate. The
unchanged drug was
96% bound to plasma proteins. The blood level decline of the parent
drug was biphasic
with the short half-life ranging from 0.4 to 0.6 hours and the
terminal half-life from 3.5
to 18.4 hours (mean 8.8 hours), depending on the study population and
method of
determination. Metabolites were formed with a half-life of 10 hours
and excreted with a
half-life of approximately 2 hours. Thus, forma