Country: United States
Language: English
Source: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
NuCare Pharmaceuticals,Inc.
CLONAZEPAM
CLONAZEPAM 0.5 mg
ORAL
PRESCRIPTION DRUG
Clonazepam 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 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. Clonazepam 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 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
Clonazepam tablets USP 0.5 mg are orange, round, flat faced, beveled edge, scored, debossed with “1” and “2” on one side and plain on other. They are supplied as follows: NDC 68071-4021-3 Bottles of 30 NDC 68071-4021-5 Bottles of 45 NDC 68071-4021-6 Bottles of 60 NDC 68071-4021-9 Bottles of 90 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Manufactured For: Accord Healthcare, Inc., 1009, Slater Road, Suite 210-B, Durham, NC 27703, USA. Manufactured By: Intas Pharmaceuticals Limited, Plot No. : 457, 458, Village – Matoda, Bavla Road, Ta.- Sanand, Dist.- Ahmedabad – 382 210. India. 10 0533 0 667114 Issued April 2016
Abbreviated New Drug Application
NuCare Pharmaceuticals,Inc. ---------- Medication Guide Clonazepam Tablets, USP (kloe-NA-za-pam) CIV Read this Medication Guide before you start taking clonazepam tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Clonazepam tablets can cause serious side effects. Because stopping clonazepam tablets suddenly can also cause serious problems, do not stop taking clonazepam tablets without talking to your healthcare provider first. What is the most important information I should know about clonazepam tablets? Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems. Clonazepam tablets can cause serious side effects, including: 1. Clonazepam tablets can slow your thinking and motor skills • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you. • 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. 2. Like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a 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 • attempt to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood How can I watch for earl Read the complete document
CLONAZEPAM- CLONAZEPAM TABLET NUCARE PHARMACEUTICALS,INC. ---------- CLONAZEPAM TABLETS, USP CIV RX ONLY DESCRIPTION Clonazepam, a benzodiazepine, is available as scored tablets debossed with “1” and “2” containing 0.5 mg of clonazepam and unscored tablets debossed with “C 1” on 1 mg tablets and “C 2” on 2 mg tablets containing 1 mg or 2 mg of clonazepam. Each tablet contains anhydrous lactose, lactose monohydrate, magnesium stearate, microcrystalline cellulose and starch (corn), with the following colorants: 0.5 mg-FD&C Yellow No. 6 Lake and 1 mg- FD&C Blue No.2 Lake. Chemically, clonazepam is 5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2 _H_-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. Convulsions produced in rodents by pentylenetetrazol or, to a lesser extent, electrical stimulation are antagonized, as are convulsions produced by photic stimulation in susceptible baboons. A taming effect in aggressive primates, muscle weakness and hypnosis are also produced. In humans, clonazepam is capable of suppressing the spike and wave discharge in absence seizures (petit mal) and decreasing the frequency, amplitude, duration and spread of discharge in minor motor seizures. 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 m Read the complete document