Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)
Amneal Pharmaceuticals LLC
LORAZEPAM
LORAZEPAM 2 mg in 1 mL
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 contains lorazepam, a Schedule IV controlled substance. Lorazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug
Lorazepam Oral Concentrate USP, 2 mg per mL , is available as a clear, colorless solution. It is supplied as follows: NDC 65162-687-84: Bottles of 30 mL with calibrated dropper (graduations of 0.25 mL [0.5 mg], 0.5 mL [1 mg], 0.75 mL [1.5 mg] and 1 mL [2 mg] on the dropper). PROTECT FROM LIGHT Keep bottles tightly closed. Keep out of reach of children. Store at cold temperature. Refrigerate at 2° to 8°C (36° to 46°F). Dispense only in the bottle and only with the calibrated dropper provided. Discard opened bottle after 90 days. Manufactured by: Amneal Pharmaceuticals LLC Branchburg, NJ 08876 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 07-2023-04
Abbreviated New Drug Application
Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE Lorazepam (lor az’ e pam) Oral Concentrate USP, CIV What is the most important information I should know about lorazepam? • 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. 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 lorazepam with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines including lorazepam 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 lorazepam. 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 lorazepam exactly as prescribed by your healthcare provider. • Take lorazepam exactly as your healthcare provider prescribed. • Do not share your lorazepam with other people. • Keep lorazepam in a safe place and away from children. • Physical dependence and withdrawal reactions. Lorazepam can cause physical dependence and withdrawal reactions. • Do not suddenly stop taking lorazepam. Stopping lorazepam suddenly can cause serious and life- threatening side effects, including, unusual movements, responses or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or Læs hele dokumentet
LORAZEPAM- LORAZEPAM CONCENTRATE AMNEAL PHARMACEUTICALS LLC ---------- LORAZEPAM ORAL CONCENTRATE USP, 2 MG PER ML, CIV 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. RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR 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 LORAZEPAM, 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 LORAZEPAM AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM 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 LORAZEPAM 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 LORAZEPAM OR REDUCE THE DOSAGE (DOSAGE AND ADMINISTRATION AND WARNINGS). DESCRIPTION Lorazepam USP, an antianxiety agent, has the chemical formula, 2_H_-1,4-benzodiazepin- 2-one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-: C H C N O M.W. 321.16 Lorazepam, USP is a white to almost white powder, practically insoluble in water. Each mL of lorazepam oral concentrate, USP contains 2 mg of lorazepam. The inactive ingredients are polyethylene glycol, propyle Læs hele dokumentet