TEMAZEPAM capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

PD-Rx Pharmaceuticals, Inc.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 r

Resumo do produto:

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 30       NDC 55289-660-30 Bottle of 60       NDC 55289-660-60 Bottle of 90       NDC 55289-660-90 Bottle of 100     NDC 55289-660-01 Bottle of 500     NDC 55289-660-82 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].

Status de autorização:

Abbreviated New Drug Application

Folheto informativo - Bula

TEMAZEPAM- TEMAZEPAM CAPSULE
PD-Rx Pharmaceuticals, Inc.
----------
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.Get
emergency help right away if
any of the following happens:
•
o shallow or slowed breathing
•
o breathing stops (which may lead to the heart stopping)
o excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
temazepam and opioids affects you.
•
o 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.
o You can develop an addiction even if you take temazepam as
prescribed by your healthcare
provider
o Take temazepam exactly as your healthcare provider prescribed.
o Do not share your temazepam with other people.
o Keep TEMAZEPAM in a safe place and away from children.
• Physical dependence and withdrawal reactions. temazepam can cause
physical dependence and
withdrawal reactions.
o 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 things that
others do not see or h

Características técnicas

TEMAZEPAM- TEMAZEPAM CAPSULE
PD-RX PHARMACEUTICALS, INC.
----------
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
Concomitant use of benzodiazepines and opioids may result in profound
sedation,
respiratory depression, coma, and death. Reserve concomitant
prescribing of
these drugs 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.
The use of benzodiazepines, including temazepam, exposes users to
risks of
abuse, misuse, and addiction, which can lead to overdose or death.
Abuse and
misuse of benzodiazepines commonly involve concomitant use of other
medications, alcohol, and/or illicit substances, which is associated
with an increased
frequency of serious adverse outcomes. Before prescribing temazepam
and
throughout treatment, assess each patient’s risk for abuse, misuse,
and addiction
(see WARNINGS).
The continued use of benzodiazepines, including Temazepam, may lead to
clinically
significant physical dependence. The risks of dependence and
withdrawal increase
with longer treatment duration and higher daily dose. Abrupt
discontinuation or
rapid dosage reduction of temazepam after continued use may
precipitate acute
withdrawal reactions, which can be life-threatening. To reduce the
risk of
withdrawal reactions, use a gradual taper to discontinue temazepam or
reduce the
dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).
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, 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: tema