TEMAZEPAM capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

McKesson Corporation dba SKY Packaging

INN（国際名）:

temazepam

構図:

temazepam 7.5 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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. Controlled Substance Temazepam is a Schedule IV controlled substance. Abuse Temazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS, Abuse, Misuse, and Addiction). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Dependence Physical Dependence Temazepam may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use ( see WARNINGS, Dependence and Withdrawal Reactions ). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue Temazepam or reduce the dosage ( see DOSAGE and ADMINISTRATION, Discontinuation or Dosage Reduction of Temazepam and WARNINGS, Dependence and Withdrawal Reactions). Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality. Protracted Withdrawal Syndrome Protracted withdrawal syndrome with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance Tolerance to Temazepam may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of Temazepam may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

製品概要:

Temazepam Capsules USP 7.5 mg Pink opaque cap and white opaque body, imprinted “7.5 mg” on cap and “Novel 120” on the body in black ink. Box of 3 x 10 UD 30 NDC 63739-003-33 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]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Distributed by: McKesson Corporation dba SKY Packaging Memphis, TN 38133 Rev. 04/2022 21359-1

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

TEMAZEPAM- TEMAZEPAM CAPSULE
McKesson Corporation dba SKY Packaging
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MEDICATION GUIDE
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 (CNS) depressants (including street drugs) can
cause severe drowsiness, breathing problems (respiratory
depression), coma and death. Get emergency help right away if any
of the following happens:
° shallow or slowed breathing
° breathing stops (which may lead to the heart stopping)
° excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
temazepam and opioids affects you.
° Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines including temazepam
which can lead to overdose and serious side effects including
coma and death. Serious side effects including coma and death
have happened in people who have abused or misused
benzodiazepines, including temazepam. These serious side
effects may also include delirium, paranoia, suicidal thoughts or
actions, seizures, and difficulty breathing. Call your healthcare
provider or go to the nearest hospital emergency room right
away if you get any of these serious side effects.
° You can develop an addiction even if you take temazepam as
prescribed by your healthcare provider
° Take temazepam exactly as your healthcare provider
prescribed.
° Do not share your temazepam with other people.
° Keep temazepam in a safe place and away from children.
• Physical dependence and withdrawal reactions. temazepam can
cause physical dependence and withdrawal reactions.
° Do not suddenly stop taking temazepam. Stopping temazepam
suddenly can cause serious and life-threatening side effects,
including, unusual movements, responses, or expressions,
seizures, sudden and severe mental or nervous system changes,
depression, seeing or hearing t

製品の特徴

TEMAZEPAM- TEMAZEPAM CAPSULE
MCKESSON CORPORATION DBA SKY PACKAGING
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MCK - TEMAZEPAM - ASCEND
TEMAZEPAM 7.5MG-HEADER
RX ONLY
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.
Temazepam Capsules, USP 7.5 mg, are for oral administration.
_7.5 MG CAPSULES_
_Active Ingredient:_ temazepam USP
_7.5 MG CAPSULES _
16
13
2
2
_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.
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, formation of the major
metabolite is the rate
limiting step in the biodisposition of Temazepam. There is no
accumulation of
metabolites. A dose-proportional relationship has been established for
the area under
the plasma concentration/time curve over the 15 to 30 mg dose range.
Temazepam was completely metabolized through conjugation prior to
excre