Bupropion hydrochloride tablet

Pregnancy

Teratogenic Effects


Pregnancy category C

When rats were administered bupropion at oral doses of up to 300 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis) prior to mating and throughout pregnancy and lactation, there were no apparent adverse effects on offspring development.
One study has been conducted in pregnant women. This retrospective, managed-care database study assessed the risk of congenital malformations overall and cardiovascular malformations specifically, following exposure to bupropion in the first trimester compared to the risk of these malformations following exposure to other antidepressants in the first trimester and bupropion outside of the first trimester. This study included 7,005 infants with antidepressant exposure during pregnancy, 1,213 of whom were exposed to bupropion in the first trimester. The study showed no greater risk for congenital malformations overall or cardiovascular malformations specifically, following first trimester bupropion exposure compared to exposure to all other antidepressants in the first trimester, or bupropion outside of the first trimester. The results of this study have not been corroborated. Bupropion should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ingredients and appearance - Product information

Bupropion hydrochloride tablet- Bupropion hydrochloride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 49349-704
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Bupropion hydrochloride ( UNII: ZG7E5POY8O)( Bupropion - UNII: 01ZG3TPX31 ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Fd&c blue no. 2 ( UNII: L06K8R7DQK)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Glutamic acid hydrochloride ( UNII: M0C2SP444T)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Hydroxypropyl cellulose ( UNII: RFW2ET671P)
Hypromelloses ( UNII: 3NXW29V3WO)
Magnesium stearate ( UNII: 70097M6I30)
Maleic acid ( UNII: 91XW058U2C)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Polyethylene glycol 6000 ( UNII: 30IQX730WE)
Talc ( UNII: 7SEV7J4R1U)
Titanium dioxide ( UNII: 15FIX9V2JP)

Product Characteristics

Color pink Score 1
Shape ROUND (TABLET) Imprint Code 93;290
Size 11 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 49349-704-02 30 in 1 BLISTER PACK 2011/04/11

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA075310 USA 2011/04/11

Labeler - REMEDYREPACK INC.( 829572556)