Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ESTAZOLAM (UNII: 36S3EQV54C) (ESTAZOLAM - UNII:36S3EQV54C)
Actavis Pharma, Inc.
ESTAZOLAM
ESTAZOLAM 1 mg
ORAL
PRESCRIPTION DRUG
Estazolam tablets, USP are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. Both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see CLINICAL PHARMACOLOGY ). Because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. Since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. There is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see CLINICAL PHARMACOLOGY ). Estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by CYP3A (see WARNIN
Estazolam Tablets, USP 1 mg are white, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 744 on the left side of the score and 1 on the right side of the score, supplied in bottles of 100 (NDC 0591-0744-01). Estazolam Tablets, USP 2 mg are dark pink, scored, diamond shaped compressed tablets imprinted with WATSON on one side of the tablet and on the other side with 745 on the left side of the score and 2 on the right side of the score, supplied in bottles of 100 (NDC 0591-0745-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. F 11/2022
Abbreviated New Drug Application
Actavis Pharma, Inc. ---------- MEDICATION GUIDE Estazolam (es taz'oh lam) Tablets, USP C-IV What is the most important information I should know about estazolam? • Estazolam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (CNS) (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 estazolam with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including estazolam, 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 estazolam. 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 estazolam exactly as prescribed by your healthcare provider. • Take estazolam exactly as your healthcare provider prescribed. • Do not share your estazolam with other people. • Keep estazolam in a safe place and away from children. • Physical dependence and withdrawal reactions. Estazolam can cause physical dependence and withdrawal reactions, especially if you continue to take estazolam for several days to several weeks. • Do not suddenly stop taking estazolam. Stopping estazolam suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system read_full_document
ESTAZOLAM- ESTAZOLAM TABLET ACTAVIS PHARMA, INC. ---------- ESTAZOLAM TABLETS, USP C-IV 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 (SEE WARNINGS). 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 ESTAZOLAM, 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 ESTAZOLAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING ESTAZOLAM, 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 ESTAZOLAM 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 ESTAZOLAM OR REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND WARNINGS). DESCRIPTION Estazolam, USP, a triazolobenzodiazepine derivative, is an oral hypnotic agent. Estazolam occurs as a fine, white, odorless powder that is soluble in alcohol and practically insoluble in water. The chemical name for estazolam is 8-chloro-6-phenyl- 4_H_-_s_-triazolo[4,3-α][1,4]benzodiazepine. The structural formula is represented as follows: C H ClN M. W. 294.75 Each tablet, for oral administrat read_full_document