Bupro-D 45 mg+105 mg

INDICATIONS

This preparation tablet is indicated in major depressive disorder (MDD) in adults.

PHARMACOLOGY

This is a combined preparation of Dextromethorphan Hydrobromide and Bupropion Hydrochloride. Dextromethorphan is an uncompetitive antagonist of the NMDA receptor (an ionotropic glutamate receptor) and a sigma-1 receptor agonist. The mechanism of Dextromethorphan in the treatment of MDD is unclear. The mechanism of action of bupropion in the treatment of MDD is unclear; however, it may be related to noradrenergic and/or dopaminergic mechanisms. Bupropion increases plasma levels of Dextromethorphan by competitively inhibiting cytochrome P450 2D6, which catalyzes a major biotransformation pathway for Dextromethorphan. Bupropion is a relatively weak inhibitor of the neuronal reuptake of norepinephrine and dopamine and does not inhibit monoamine oxidase or the reuptake of serotonin.

DOSAGE & ADMINISTRATION

Starting dosage: One tablet once daily in the morning. After 3 days, increase to the maximum recommended dosage of one tablet twice daily, separated by at least 8 hours. Do not exceed two doses within the same day.Use in children & adolescents: The safety and effectiveness of this tablet have not been established. Antidepressants, including bupropion, increase the risk of suicidal thoughts and behaviors in pediatric patients.Moderate renal impairment: One tablet by mouth once daily in the morning.

INTERACTION

Strong CYP2D6 inhibitors: Recommended dosage is one tablet by mouthonce daily in the morning.Strong CYP2B6 inducers: Avoid use.CYP2D6 Substrates: Increases the exposures of drugs that are substrates of CYP2D6.Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.Drugs that lower seizure threshold: Coadministration may increase risk of seizure.Dopaminergic drugs: Central Nervous System (CNS) toxicity can occur with concomitant use.

SIDE EFFECTS

Dizziness, headache, somnolence
Diarrhea, dry mouth
Sexual dysfunction
Hyperhidrosis

PREGNANCY & LACTATION

The available clinical data on the use of this combination during pregnancy is insufficient to evaluate for a drug-associated risk of major birth malformations, miscarriage, or other adverse maternal or fetal outcomes. However, there are available data on one of the individual components of this combination, bupropion. Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall. There are risks to the mother associated with untreated depression in pregnancy. Data from published literature report the presence of bupropion and its metabolites in human milk. There are no data on the effects of bupropion or its metabolites on milk production. Limited data from post-marketing reports of bupropion use in lactating patients have not identified a clear association of adverse reactions in the breastfed infant.

PRECAUTIONS & WARNINGS

Seizure: Risk is dose-related. Discontinue if seizure occurs.
Increased Blood Pressure and Hypertension: this combination can increase blood pressure and cause hypertension. Assess blood pressure before initiating treatment and monitor periodically during treatment.
Activation of Mania or Hypomania: Screen patients for bipolar disorder.
Psychosis and Other Neuropsychiatric Reactions: Instruct patients to contact a healthcare provider if such reactions occur.

THERAPEUTIC CLASS

Combined anxiolytics & anti-depressant drugs

STORAGE CONDITIONS

Store at or below 30˚C temperature. Keep away from light and wet place. Keep out of reach of children. Do not store in wet place. Keep away from light. Keep out of reach of children.