Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
CLONAZEPAM (UNII: 5PE9FDE8GB) (CLONAZEPAM - UNII:5PE9FDE8GB)
Rebel Distributors
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-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 category of panic disorder (see CLINICAL PHARMACOLOGY , Clinical
Clonazepam tablets 0.5 mg are available as yellow, round, single-scored tablets debossed “93” – “832” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 30, 60, 90, 100 and 120. Clonazepam tablets 1 mg are available as mottled green, round, single-scored tablets debossed “93” – “833” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 30, 60, 90, 100 and 120. Clonazepam tablets 2 mg are available as white to off-white, round, single-scored tablets debossed “93” – “834” on the unscored side. Packaged in bottles of 100 with a child-resistant closure, in bottles of 60. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Canada By: NOVOPHARM LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960
Abbreviated New Drug Application
CLONAZEPAM - CLONAZEPAM TABLET REBEL DISTRIBUTORS ---------- CLONAZEPAM TABLETS, USP CIV 0832 0833 0834 RX ONLY DESCRIPTION Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, a benzodiazepine. Each tablet also contains lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, purified water, and corn starch. Clonazepam tablets 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 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 the following structural formula: C H ClN O M.W. 315.72 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 15 10 3 3 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 Lue koko asiakirja