Country: United States
Language: English
Source: NLM (National Library of Medicine)
TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)
Preferred Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Temazepam is 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 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 nu
Temazepam capsules, USP are available as follows: 15 mg — Each #3 capsule with green opaque cap and white opaque body, imprinted with 076 in black ink on both cap and body contains 15 mg of temazepam, USP. Capsules are supplied: Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 10/2021 Repackaged By: Preferred Pharmaceuticals Inc.
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Temazepam (tem az' e pam) Capsules CIV What is the most important information I should know about temazepam capsules? • Temazepam capsules are 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) NaN Do not drive or operate heavy machinery until you know how taking temazepam capsules and opioids affect you. Call your healthcare provider right away if you find out that you have done any of the above activities after taking temazepam capsules. What are temazepam capsules? • Temazepam capsules are a prescription sleep medicine. Temazepam capsules are 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 capsules are a federal controlled substance (CIV) because they contain temazepam that can be abused or lead to dependence. Keep temazepam capsules in a safe place to prevent misuse and abuse. Selling or giving away temazepam capsules 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 capsules are safe and effective in children. • It is not known if temazepam capsules are safe and effective for use longer than 2 weeks. Do not take temazepam capsules if you: • are allergic to temazepam or any of the ingredients in temazepam capsules. See the end of this Medication Guide for a complete list of ingredients in temaz Read the complete document
TEMAZEPAM- TEMAZEPAM CAPSULE PREFERRED PHARMACEUTICALS INC. ---------- TEMAZEPAM CAPSULES, USP CIV RX ONLY WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS • • • DESCRIPTION Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name is 7-chloro- 1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2_H_-1,4-benzodiazepin-2-one, and the structural formula is: 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 (_SEE _WARNINGS _AND _PRECAUTIONS). 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). Temazepam, USP is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol, USP. Temazepam capsules USP, 15 mg and 30 mg, are for oral administration. _Active Read the complete document