TEMAZEPAM capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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 30       NDC 71205-914-30 Bottle of 60       NDC 71205-914-60 Bottle of 90       NDC 71205-914-90 Bottle of 100       NDC 71205-914-00 Bottle of 120       NDC 71205-914-72 Bottle of 500       NDC 71205-914-55 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 71205-915-30 Bottle of 60       NDC 71205-915-60 Bottle of 90       NDC 71205-915-90 Bottle of 100       NDC 71205-915-00 Bottle of 120       NDC 71205-915-72 Bottle of 500       NDC 71205-915-55   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 PDR Network, LLC Manufactured by: Novel Laboratories Inc. Somerset, NJ 08873 Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 Repackaged and Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

TEMAZEPAM- temazepam capsule
Proficient Rx LP
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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 if yo

Fitxa tècnica

TEMAZEPAM- TEMAZEPAM CAPSULE
PROFICIENT RX LP
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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.
Temazepam capsules, 15 mg and 30 mg are for oral administration.
16
13
2
2
_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
H 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 w