Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
Aidarex Pharmaceuticals LLC
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. 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 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
Clonazepam Tablets, USP, for oral administration, are available as: 2 mg: Round, white, biconvex tablet, debossed “E” over “65” on one side and bisected on the other side and supplied as: 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. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880
Abbreviated New Drug Application
Aidarex Pharmaceuticals LLC ---------- MEDICATION GUIDE Clonazepam Tablets, USP CIV (kloe-NAZ-eh-pam) 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 affects 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 Lue koko asiakirja
CLONAZEPAM- CLONAZEPAM TABLET AIDAREX PHARMACEUTICALS LLC ---------- CLONAZEPAM TABLETS, USP CIV RX ONLY 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-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 mainly by reduction of the 7-nitro group to the 4-amino derivative. This derivative can be acetylated, hydroxylated and Lue koko asiakirja