DESCRIPTION
id: 7eb20c50-341d-4b04-aad5-3c493983fe97
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake.
Chemically, clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
CONTRAINDICATIONS
id: ba6cc381-da8b-49d7-8edc-8fad5336dd05
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Clonazepam should not be used in patients with a history of sensitivity to benzodiazepines, nor in patients with clinical or biochemical evidence of significant liver disease. It may be used in patients with open angle glaucoma who are receiving appropriate therapy but is contraindicated in acute narrow angle glaucoma.
ADVERSE REACTIONS
id: e6df2416-9bfa-42cf-bea9-e40d675a6de0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
DOSAGE AND ADMINISTRATION
id: f9b753c0-4715-46f7-ac02-e2dc15a9dcb3
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Clonazepam tablets USP should be administered with water by swallowing the tablet whole.
HOW SUPPLIED
id: 149ba058-9c68-4c11-9d41-8dddd4b3c62c
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Clonazepam tablets USP 0.5 mg are available as yellow, round, flat beveled, single-scored tablets debossed “832” above the scored line and “TEVA” on the unscored side. Packaged in bottles of 30 and 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 Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. Q 9/2012
Repackaged By:
KAISER FOUNDATION HOSPITAL
Livermore, CA 94551
PRINCIPAL DISPLAY PANEL
id: a479d8f2-3925-437d-be13-b89002168868
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
PRINCIPAL DISPLAY PANEL
id: 6a029fd3-4b80-4e17-a9a1-e9ffd7e919c9
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
