7 Interactions found for:

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

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This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

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

Comments:
-A pregnancy exposure registry is available.
-Smoking cessation without the use of medications is advisable during pregnancy.
-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 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: Fluoxetine (found in Prozac)

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This drug should be used only if the potential benefit justifies the risk to the fetus, taking into account the risks of untreated depression.

AU TGA pregnancy category: C
US FDA pregnancy category:
-Tablets and capsules: C
-Oral solution and film coated tablets: Not assigned

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

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).

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

Results of several epidemiological studies assessing the risk of exposure of this drug in early pregnancy have been inconsistent and not provided conclusive evidence of an increased risk of congenital malformations. Some epidemiological studies suggest an increased risk of cardiovascular malformations; however, the mechanism is unknown. Overall, data suggest that the risk of having an infant with a cardiovascular defect following maternal exposure is approximately 2 in 100 compared with 1 in 100 for the general population.

Epidemiological data have suggested that the use of SSRIs, particularly in late pregnancy, may increase the risk of persistent pulmonary hypertension in the newborn. Data are not available for SNRIs.

The results of a cohort study indicated that 30% of neonates who had prolonged exposure to SSRIs in utero experienced symptoms, in a dose- response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high-pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth.

Data from animal studies has shown that fluoxetine may affect sperm quality. Human case reports from some SSRIs have shown this effect to be reversible. As the impact of this on human fertility has not been observed.

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 C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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)

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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: Fluoxetine (found in Prozac)

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Use of this drug is not recommended; however, if it is required by the mother, it is not considered a reason to discontinue breastfeeding

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for side effects such as colic, fussiness, sedation, and adequate weight gain.
-Mothers taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

The average amount of drug in breastmilk is higher with fluoxetine than with most other SSRIs, and the long-acting active metabolite, norfluoxetine, is detectable in the serum of most breastfed infants during the first 2 months postpartum and in a few thereafter. No adverse effects on development have been reported in a few infants followed for up to one year.

It has been suggested that fluoxetine therapy may be continued during breastfeeding if it was used during pregnancy or if other antidepressants were ineffective. Alternatively, medicines with a lower excretion into breastmilk may be preferred, particularly when nursing a newborn or preterm infant.

An infant breastfed by a mother receiving oral fluoxetine therapy developed crying, sleep disturbance, watery stools, and vomiting. The infants' plasma drug levels of fluoxetine and norfluoxetine on the second day of feeding were 340 ng/mL and 208 ng/mL, respectively.

A report of ten women nursing eleven infants found that less than 10% of the dose of fluoxetine (per kg of body weight) was delivered to the nursing infant during chronic maternal therapy. Other reports from two lactating women taking fluoxetine have described milk fluoxetine and norfluoxetine concentrations to be about one-fifth to one-quarter of the serum concentrations. No adverse effects were reported in these nursing infants.