Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Estazolam (UNII: 36S3EQV54C) (Estazolam - UNII:36S3EQV54C)
Mayne Pharma
Estazolam
Estazolam 1 mg
ORAL
PRESCRIPTION DRUG
Estazolam is 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 ). Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepox
Estazolam tablets 1 mg are available as white, oval, biconvex, double-scored tablets debossed "93"–"129" on one side. Packaged in bottles of 100 (NDC 51862-069-01). Estazolam tablets 2 mg are available as pale orange, oval, biconvex, single-scored tablets debossed "93"–"130" on the scored side. Packaged in bottles of 100 (NDC 51862-070-01). 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).
Abbreviated New Drug Application
Mayne Pharma ---------- MEDICATION GUIDE ESTAZOLAM (ES-TAZE-OH-LAM) TABLETS, C-IV This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: September/2016 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 (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. • After taking estazolam, 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 estazolam. Reported activities include: • driving a car ("sleep-driving") • making and eating food • talking on the phone • having sex • sleep-walking Call your healthcare provider right away if you find out that you have done any of the above activities after taking estazolam. • Do not take estazolam 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 estazolam than prescribed. What is estazolam? • Estazolam is a prescription medicine used short-term to treat certain types of insomnia including difficulty falling asleep, waking up often during the night, or waking up early in the morning. • Estazolam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep estazolam in a safe place to prevent misuse and abuse. Selling or giving away estazolam 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 estazolam is safe and effective in children. • It is not known if estazolam is safe and effective when used to treat insomnia for lon read_full_document
ESTAZOLAM- ESTAZOLAM TABLET MAYNE PHARMA ---------- ESTAZOLAM TABLETS CIV 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, 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 Estazolam, 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 Each tablet, for oral administration, contains either 1 mg or 2 mg of estazolam. In addition, each tablet contains the following inactive ingredients: 1 mg tablets - corn starch, lactose monohydrate, pregelatinized starch, and stearic acid; 2 mg tablets - corn starch, FD&C Red #40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, pregelatinized starch, and stearic acid. CLINICAL PHARMACOLOGY PHARMACOKINETICS _Absorption_ Estazolam tablets have been found to be equivalent in absorption to an orally administered solution of estazolam. In healthy subjects who received up to three times the recommended dose of estazolam, peak estazolam plasma concentrations occurred within two hours after dosing (range 0.5 to 6.0 hours) and were proportional to the administered dose, suggesting linear pharmacokinetics over the dosage range tested. _Distribution_ 16 11 4 _Distribution_ Independent of concentration, estazolam in plasma is 93% protein bound. _Metabolism_ Estazolam is extensively metabolized. Only two metabolites (1-oxo-estazolam & 4-hydroxy-estazolam) were detected in human plasma up to 18 hrs. The pharmacologic activity of estaz read_full_document