Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
CLONAZEPAM
CLONAZEPAM 0.5 mg
ORAL
PRESCRIPTION DRUG
Seizure Disorders: 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 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 tablets, USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. 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
Clonazepam Tablets, USP are available as follows: 0.5 mg — Each pink, round tablet imprinted and 33 on one side and scored on the other side contains 0.5 mg of clonazepam USP. 1 mg — Each yellow, round tablet imprinted and 34 on one side and scored on the other side contains 1 mg of clonazepam USP. 2 mg — Each white, round tablet imprinted and 35 on one side and scored on the other side contains 2 mg of clonazepam USP. Store at 25(C (77(F); excursions permitted to 15( to 30(C (59( to 86(F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA 40-9148 Revised — June 2011
Abbreviated New Drug Application
CLONAZEPAM- CLONAZEPAM TABLET Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC ---------- MEDICATION GUIDE CLONAZEPAM TABLETS, USP CIV Rx only Read this Medication Guide before you start taking clonazepam 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 can cause serious side effects. Because stopping clonazepam suddenly can also cause serious problems, do not stop taking clonazepam without talking to your healthcare provider first. What is the most important information I should know about clonazepam? Do not stop taking clonazepam without first talking to your healthcare provider. Stopping clonazepam suddenly can cause serious problems. Clonazepam can cause serious side effects, including: 1. Clonazepam can slow your thinking and motor skills • Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam affects you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam may make your sleepiness or dizziness worse. 2. Like other antiepileptic drugs, clonazepam 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 early symptoms of suicidal thoughts and actions? Les hele dokumentet
CLONAZEPAM- CLONAZEPAM TABLET LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC ---------- CLONAZEPAM TABLETS, USP CIV 40-9148 Revised — June 2011 RX ONLY DESCRIPTION Clonazepam, USP a benzodiazepine, is available for oral administration as scored tablets containing 0.5 mg, 1 mg or 2 mg of clonazepam. In addition, each tablet also contains the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 0.5 mg tablet also contains D&C Red #30 aluminum lake. The 1 mg tablet also contains D&C Yellow #10HT aluminum lake. Chemically, clonazepam is 5-(_o_-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. Biotransformati Les hele dokumentet