7 Interactions found for:

The following applies to the ingredients: Bupropion (found in Wellbutrin Xl)

This drug should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Smoking cessation without the use of medications is advisable during pregnancy.

AU TGA pregnancy category: B2
US FDA pregnancy category: C

Comments:
-A pregnancy exposure registry is available.
-Neonates exposed to this drug late in the third trimester may require respiratory support, tube feeding, and/or prolonged hospitalization.
-Exposed neonates should be monitored after delivery for direct toxic effects of this drug, drug discontinuation syndrome, and serotonin syndrome (e.g.,. respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypo/hypertonia, hyperreflexia, tremor, jitteriness, irritability, constant crying).

High dose animal studies have failed to reveal evidence of specific teratogenic effects. Low dose animal studies in rabbits have reported a slightly increased incidence of fetal malformations and skeletal variations. Epidemiological studies of pregnant women exposed to bupropion in the first trimester show no increased risk of congenital malformations overall.

Data from the international bupropion pregnancy register (675 trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) and a case-control study from the National Birth Defects Prevention Study (6,853 infants with cardiovascular malformations and 5,763 with non-cardiovascular malformations) did not show an increased risk for malformations overall after bupropion exposure during the first trimester. A retrospective database of infants (n=7005) whose mothers were exposed to bupropion in the first trimester and outside of the first trimester also failed to reveal an increased risk for congenital malformation, especially cardiovascular malformation. Study findings on the risk for left ventricular outflow tract obstruction and ventricular septal defect after first trimester exposure to bupropion are inconclusive.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The following applies to the ingredients: Clonazepam

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: There are inconclusive data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Supplementation with folic acid is recommended before conception and during pregnancy.
-Pregnancy itself, and discontinuation of treatment, may result in exacerbation of epilepsy.
-The patient should be warned of the potential risks to the fetus prior to initiation; patients who become pregnant should continue treatment, and monotherapy should be used at the lowest effective dose (if possible).

Animal studies have revealed evidence of decreased number of pregnancies, lower number of surviving offspring until weaning, malformations, decreased maternal weight gain, and reduced fetal growth. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, irregular heart rate, and hypothermia in children born to mothers who have been taking benzodiazepines late in pregnancy. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (NAAED) Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: http://www.aedpregnancyregistry.org/

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The following applies to the ingredients: Bupropion (found in Wellbutrin Xl)

A decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother.
-Some experts recommend: Use with caution.

Excreted into human milk: Yes

Comment: Another drug may be preferred, particularly when breastfeeding a newborn or preterm infant.

There is limited information that maternal bupropion at oral doses up to 300 mg daily produces low levels in breastmilk. It is not generally expected to cause adverse effects in breastfed infants; however, there are case reports of possible seizure in partially breastfed 6-month-olds. Alternate drugs that may be considered in place of bupropion include nortriptyline, paroxetine, and sertraline.

One case report has suggested that bupropion accumulates in human breast milk in concentrations much greater than in maternal plasma. At least two metabolites of bupropion are also detectable in human milk. However, in the plasma of one nursing infant whose mother took bupropion, neither bupropion nor its metabolites could be detected.

Data from a lactation study in 10 women showed breastmilk levels of 45.2 mcg/L for bupropion, and 104.6 mcg/mL, 72.1 mcg/mL, and 459 mcg/mL for it metabolites hydroxybupropion, erythrohydroxybupropion, and threohydroxybupropion, respectively. The authors of this study estimated that an exclusively breastfed infant would receive an average of 0.2% of the maternal weight-adjusted dose of bupropion and an average of 2% of the maternal weight-adjusted dosage of bupropion plus metabolites.

The following applies to the ingredients: Clonazepam

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: This drug should be used only if clearly needed.

Excreted into human milk: Yes

Comments:
-Sedation, weight loss, and feeding difficulties have occurred in nursing infants.
-The WHO considers this drug compatible with breastfeeding when given at normal doses.
-Monitoring for drowsiness, weight gain, and developmental milestones should be considered in younger, exclusively breastfed infants and/or those exposed to combinations of psychotropic drugs.
-Some experts state that this drug may be an acceptable choice for refractory restless leg syndrome during lactation.