Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
Alembic Pharmaceuticals Inc.
ORAL
PRESCRIPTION DRUG
Seizure Disorders: Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. In some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. In some cases, dosage adjustment may reestablish efficacy. Panic Disorder: Clonazepam orally disintegrating tablet is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of clonazepam orally disintegrating tablets was established in two
Clonazepam orally disintegrating tablets, USP are available as follows: 0.125 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 523’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each NDC 62332-364-06 0.25 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 524’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each NDC 62332-365-06 0.5 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 525’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each NDC 62332-366-06 1 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 526’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each NDC 62332-367-06 2 mg: White to off white, round, flat-faced, beveled edge tablets, debossed with ‘L 527’ on one side and plain on other side, available in: Cartons of 60 - 10 blisters of 6 tablets each NDC 62332-368-06 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Medication Guide available at http://www.alembicusa.com/medicationguide.aspx or call 1-866-210-9797. Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division), Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Revised: 11/2022
Abbreviated New Drug Application
Alembic Pharmaceuticals Inc. ---------- MEDICATION GUIDE Clonazepam (kloe NAZ e pam) Orally Disintegrating Tablets, USP What is the most important information I should know about clonazepam orally disintegrating tablets? • Clonazepam orally disintegrating tablet is 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: o shallow or slowed breathing o breathing stops (which may lead to the heart stopping) o excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking clonazepam orally disintegrating tablets with opioids affects you. • Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including clonazepam orally disintegrating tablet, which can lead to overdose and serious side effects including coma and death. o Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including clonazepam orally disintegrating tablets. These serious side effects may also include delirium, paranoia, suicidal thoughts oractions, 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. o You can develop an addiction even if you take clonazepam orally disintegrating tablets exactly as prescribed by your healthcare provider. o Take clonazepam orally disintegrating tablets exactly as your healthcare provider prescribed. o Do not share your clonazepam orally disintegrating tablets with other people. o Keep clonazepam orally disintegrating tablets in a safe place and away from children. • Physical dependence and withdrawal reactions. Clonazepam orally disintegrating tablets can cause physical dependence and withdrawal react Perskaitykite visą dokumentą
CLONAZEPAM - CLONAZEPAM TABLET, ORALLY DISINTEGRATING ALEMBIC PHARMACEUTICALS INC. ---------- CLONAZEPAM ORALLY DISINTEGRATING TABLETS, USP 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 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 CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 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 CLONAZEPAM ORALLY DISINTEGRATING TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). • THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM ORALLY DISINTEGRATING TABLETS, 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 CLONAZEPAM ORALLY DISINTEGRATING TABLETS 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 CLONAZEPAM ORALLY DISINTEGRATING TABLETS OR REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION AND WARNINGS). DESCRIPTION Clonazepam, USP a benzodiazepine, is available as an orally disintegrating tablet containing 0.125 mg, 0.25 mg, 0.5 mg, 1 mg or 2 mg clonazepam, USP. Each orally disintegrating table Perskaitykite visą dokumentą