7 Interactions found for:

The following applies to the ingredients: Bupropion

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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: Lisdexamfetamine (found in Vyvanse)

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Benefit should outweigh risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Comments:
-The active metabolite of this drug, dexamphetamine, crosses the placenta.
-Premature delivery, low birth weight, and other adverse pregnancy outcomes have been seen in infants born to mothers dependent on amphetamines.
-Monitor infants born to mothers taking amphetamines for symptoms of withdrawal such as feeding difficulties, irritability, agitation, and excessive drowsiness.

There are no controlled data of this drug in human pregnancy, but there are some available data for amphetamines in pregnant women. Two case control studies of over a thousand patients exposed to amphetamines at different gestational ages did not show an increase in congenital abnormalities. Additionally, animal studies have revealed no effects on embryofetal morphological development and survival, nor on fertility.

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 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: Bupropion

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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: Lisdexamfetamine (found in Vyvanse)

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Use should be avoided during breastfeeding.

Excreted into human milk: Yes

Comments:
-This drug is a prodrug of dextroamphetamine. The effect of dextroamphetamine in milk on the neurological development of a breastfed infant has not been well studied.
-Large dosages of this drug might interfere with milk production, especially in women whose lactation is not well established.

-Blood levels of dextroamphetamine in 3 breastfed infants were up to 14% of the maternal plasma level.
-Four breastfed infants whose mothers took an average dose of 18 mg/day of dextroamphetamine had no adverse effects and showed normal progress with weights between the 10th and 75th percentiles.
-In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose produced a sustained suppression of serum prolactin by 40%.