CLONAZEPAM TABLETS, USP CIV, Rx only

/CLONAZEPAM TABLETS, USP CIV, Rx only
CLONAZEPAM TABLETS, USP CIV, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

CLONAZEPAM TABLETS, USP CIV, Rx only

ID:

34410165-09ca-46bb-82d0-433b0fdf6e89

Code:

34391-3

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