Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
REMEDYREPACK INC.
ORAL
PRESCRIPTION DRUG
Clonazepam tablets, USP are 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 tablets, USP may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect). Clonazepam tablets, USP are 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 tablets, USP was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials). Panic disorder (
Clonazepam Tablets, USP, for oral administration, are available as: 0.5 mg : Round, light yellow, bi-convex tablet, debossed “ E ” over “63” on one side and bisected on the other side and supplied as: NDC 0185-0063-01 bottles of 100 NDC 0185-0063-05 bottles of 500 NDC 0185-0063-10 bottles of 1000 0.5 mg : Round, light yellow, flat-faced beveled edge, debossed “ E ” over “63” on one side and bisected on the reverse side and supplied as: NDC 0781-8018-01 bottles of 100 NDC 0781-8018-05 bottles of 500 NDC 0781-8018-10 bottles of 1000 1 mg : Round, light blue, bi-convex tablet, debossed “ E ” over “64” on one side and bisected on the other side and supplied as: NDC 0185-0064-01 bottles of 100 NDC 0185-0064-05 bottles of 500 NDC 0185-0064-10 bottles of 1000 1 mg : Round, light blue, bi-convex tablet, debossed “ E ” over “64” on one side and plain on the reverse side and supplied as: NDC 0781-5567-01 bottles of 100 NDC 0781-5567-05 bottles of 500 NDC 0781-5567-10 bottles of 1000 2 mg : Round, white, bi-convex tablet, debossed “ E ” over “65” on one side and bisected on the other side and supplied as: NDC 0185-0065-01 bottles of 100 NDC 0185-0065-05 bottles of 500 NDC 0185-0065-10 bottles of 1000 2 mg : Round, white, bi-convex tablet, debossed “ E ” over “65” on one side and plain on the reverse side and supplied as: NDC 0781-5569-01 bottles of 100 NDC 0781-5569-05 bottles of 500 NDC 0781-5569-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP, with a child-resistant closure, as required. KEEP TIGHTLY CLOSED. KEEP OUT OF THE REACH OF CHILDREN. Manufactured by Sandoz Inc. Princeton, NJ 08540
Abbreviated New Drug Application
CLONAZEPAM- CLONAZEPAM TABLET REMEDYREPACK INC. ---------- MEDICATION GUIDE Clonazepam Tablets, USP CIV (kloe-NAZ-eh-pam) What is the most important information I should know about clonazepam tablets? • Clonazepam tablets are a benzodiazepine medicine. Benzodiazepines can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines. • Clonazepam tablets can make you sleepy or dizzy and can slow your thinking and motor skills. This may get better over time. • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you. • Clonazepam tablets may cause problems with your coordination, especially when you are walking or picking things up. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse. • Like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • new or worse anxiety • trouble sleeping (insomnia) • acting on dangerous impulses • attempts to commit suicide • feeling agitated or restless • new or worse irritability • an extreme increase in activity and talking (mania) • new or worse depression • panic attacks • acting aggressive, being angry, or violent • other unusual changes in behavior or mood How can I watch for early symptoms of suicidal thoughts and actions? • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, esp Prečítajte si celý dokument
CLONAZEPAM- CLONAZEPAM TABLET REMEDYREPACK INC. ---------- CLONAZEPAM TABLETS, USP CIV 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 AND PRECAUTIONS). 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 Clonazepam tablets, USP, for oral administration, contain 0.5 mg, 1 mg or 2 mg clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose anhydrous, magnesium stearate and microcrystalline cellulose with the following colorants: 0.5 mg - D&C yellow No. 10 aluminum lake; 1 mg - FD&C blue No. 1 aluminum lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1, 3-dihydro-7-nitro-2H-1, 4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has a molecular weight of 315.72 and the following structural formula: CLINICAL PHARMACOLOGY PHARMACODYNAMICS The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system. PHARMACOKINETICS Clonazepam is rapidly and completely absorbed after oral administration. The absolute bioavailability of clonazepam is about 90%. Maximum plasma concentrations of clonazepam are reached within 1 to 4 hours after oral administration. Clonazepam is approximately 85% bound to plasma proteins. Clonazepam is highly metabolized, with less than 2% unchanged clonazepam being excreted in the urine. Biotransformation occurs mainly by reduction of the 7-nitro group to the 4-amino derivative. This derivative can be acetylated, hydroxylated and glucuronidated. Cytochrome P-450, including Prečítajte si celý dokument