Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)
PharmPak, Inc.
ORAL
PRESCRIPTION DRUG
Lorazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The effectiveness of lorazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Lorazepam is contraindicated in patients with - hypersensitivity to benzodiazepines or to any components of the formulation. - acute narrow-angle glaucoma.
Lorazepam Tablets, USP are available in the following dosage strengths: 0.5 mg: white, scored, round flat faced beveled edge, debossed with 240 over 0.5 on one side and WATSON on the other side, supplied in bottles of 1. 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. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised: May 2017 220239-2
Abbreviated New Drug Application
LORAZEPAM- LORAZEPAM TABLET PharmPak, Inc. ---------- MEDICATION GUIDE Lorazepam (lor azʹ e pam) Tablets, USP C-IV What is the most important information I should know about lorazepam tablets? • Lorazepam 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. • Lorazepam tablets can make you sleepy or dizzy, and can slow your thinking and motor skills. • Do not drive, operate heavy machinery, or do other dangerous activities until you know how lorazepam tablets affect you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking lorazepam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, lorazepam tablets may make your sleepiness or dizziness much worse. • Do not take more lorazepam tablets than prescribed. What are lorazepam tablets? • Lorazepam tablets are a prescription medicine used: • to treat anxiety disorders • for the short-term relief of the symptoms of anxiety or anxiety that can happen with symptoms of depression • Lorazepam tablets are a federal controlled substance (C-IV) because they can be abused or lead to dependence. Keep lorazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away lorazepam tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if lorazepam tablets are safe and effective in children less than 12 years of age. • It is not known if lorazepam tablets are safe and effective for use for longer than 4 months. Do not take lorazepam tablets if you: • are allergic to lorazepam, other benzodiazepines, or any of the ingredients in lorazepam tablets. See the end of this Medication Guide for a complete list of ingredien Pročitajte cijeli dokument
LORAZEPAM- LORAZEPAM TABLET PHARMPAK, INC. ---------- LORAZEPAM TABLETS, USP REVISED: MAY 2017 RX ONLY C-IV 220239-2 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; PRECAUTIONS, CLINICALLY SIGNIFICANT 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 Lorazepam, USP, an antianxiety agent, has the chemical formula, 7-chloro-5-( _o_-chlorophenyl)-1,3- dihydro-3-hydroxy-2 _H_-1,4-benzodiazepin-2-one: It is a nearly white powder almost insoluble in water. Each lorazepam tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose, magnesium stearate, microcrystalline cellulose, and polacrilin potassium. CLINICAL PHARMACOLOGY Studies in healthy volunteers show that in single high doses lorazepam has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems. Lorazepam is readily absorbed with an absolute bioavailability of 90 percent. Peak concentrations in plasma occur approximately 2 hours following administration. The peak plasma level of lorazepam from a 2 mg dose is approximately 20 ng/mL. The mean half-life of unconjugated lorazepam in human plasma is about 12 hours and for its major metabolite, lorazepam glucuronide, about 18 hours. At clinically relevant concentrations, lorazepam is approximately 85% bound to plasma proteins. Lorazepam is rapidly conjugated at its 3-hydroxy group into lorazepam glucuronide which is then excreted in the urine. Lorazepam glucuronide has no demonstrable CNS activity in animals. The plasma levels of lorazepam are proportional to the dose given. There is no evidence of accumulation of lor Pročitajte cijeli dokument