Bupro-D ER Tablet
Dextromethorphan + Bupropion
45mg + 105mg
Square Pharmaceuticals PLC.
| Pack size | 30's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.00 AED |
Indications
Bupro-D ER Tablet is used for:
Major Depressive Disorders
Adult Dose
Major Depressive Disorders
Indicated for major depressive disorder (MDD)
1 tablet PO once daily in morning for 3 days, then increase to 1 tablet BID given at least 8 hr apart
Maximum recommended dose: 1 tablet BID; do not exceed 2 doses/24 hr
Child Dose
Renal Dose
Renal impairment
Mild (eGFR ?60 mL/min/1.73 m2): No dose adjustment is required
Moderate (eGFR 30-59 mL/min/1.73 m2): 1 tablet PO qAM (do not increase the initial dose)
Severe (eGFR 15-29 mL/min/1.73 m2): Not recommended
Administration
May administer with or without food
Contra Indications
Seizure disorder.
Current or prior diagnosis of bulimia or anorexia nervosa.
Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
Use with an MAOI or within 14 days of stopping treatment with Dextromethorphan + Bupropion.
Do not use Dextromethorphan + Bupropion within 14 days of discontinuing an MAOI.
Known hypersensitivity to bupropion, dextromethorphan, or other components of Dextromethorphan + Bupropion
Precautions
Antidepressants increased risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies
Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors
Not approved for use in pediatric patients
Seizure: Risk is dose-related. Discontinue if a seizure occurs.
Increased Blood Pressure and Hypertension: Dextromethorphan + Bupropion 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.
Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
Dizziness: Dextromethorphan + Bupropion may cause dizziness. Take precautions to reduce falls and use caution when operating machinery.
Serotonin Syndrome: Use of Dextromethorphan + Bupropion with selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants increases the risk. Discontinue if this occurs.
Embryo-fetal Toxicity: May cause fetal harm. Advise pregnant females of the potential risk to a fetus. Discontinue treatment in pregnant females and use alternative treatment for females who are planning to become pregnant
Pregnancy-Lactation
Pregnancy
Not recommended during pregnancy
Based on animal studies, may cause fetal harm when administered during pregnancy
Clinical considerations
A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy
Women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants
Consider maternal risks of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum
Lactation
Owing to the potential for neurotoxicity, advise patients that breastfeeding is not recommended during treatment and for 5 days after the final dose
Dextromethorphan
Neurotoxicity was observed in juvenile rats treated with dextromethorphan/quinidine on postnatal day 7, which corresponds to the third trimester of gestation through the first few months of life and may extend through the first 3 years of human life
Unknown if dextromethorphan is present in human milk; data are not available regarding effects on breastfed infants or on milk production
Bupropion
There are no data on the effects of bupropion or its metabolites on milk production
Data from postmarketing reports are limited; use in lactating patients has not identified a clear association of adverse reactions in the breastfed infant
Interactions
Strong CYP2D6 inhibitors: The recommended dosage is one tablet by mouth once daily in the morning.
Strong CYP2B6 inducers: Avoid use.
CYP2D6 Substrates: Increases the exposure of drugs that are substrates of CYP2D6.
Digoxin: May decrease plasma digoxin levels. Monitor digoxin levels.
Drugs that lower seizure threshold: Coadministration may increase the risk of seizure.
Dopaminergic drugs: Central Nervous System (CNS) toxicity can occur with concomitant use.
Drug-laboratory test interactions: AU
Contraindicated (11)
eliglustat
isocarboxazid
phenelzine
pimozide
procarbazine
rasagiline
safinamide
selegiline
selegiline
selegiline transdermal
tranylcypromine
Adverse Effects
Side effects of Dextromethorphan + Bupropion :
>10%
Dizziness (16%)
Nausea (13%)
1-10%
Headache (8%)
Diarrhea (7%)
Somnolence (7%)
Dry mouth (6%)
Sexual dysfunction (6%)
Hyperhidrosis (5%)
Anxiety (4%)
Constipation (4%)
Decreased appetite (4%)
Insomnia (4%)
Arthralgia (3%)
Fatigue (3%)
Paresthesia (3%)
Vision blurred (3%)
Mechanism of Action
Dextromethorphan: Uncompetitive N-methyl-D-aspartate receptor (NMDA) receptor antagonist (glutamate receptor modulator) with multimodal activity; also is an agonist of sigma-1 receptor
Bupropion: Serves to increase bioavailability of dextromethorphan; also inhibits norepinephrine and dopamine reuptake
Note
Bupro-D ER 45mg + 105mg Tablet manufactured by Square Pharmaceuticals PLC.. Its generic name is Dextromethorphan + Bupropion. Bupro-D ER is availble in Bangladesh.
Farmaco BD drug index information on Bupro-D ER Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.