6 Interactions found for:

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

Professional Content

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: Lamotrigine (found in Lamictal)

Professional Content

Benefit should outweigh risk

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

Risk Summary: Several prospective pregnancy exposure registries and epidemiological studies have not detected an increased frequency of major congenital malformations or a consistent pattern of malformations among women exposed to lamotrigine compared with the general population; animal studies have shown developmental toxicities at doses administered clinically.

Comments:
-Women with epilepsy who are planning to become pregnant should receive pre-pregnancy counseling; folate supplementation should be considered before conception and for the first 12 weeks of pregnancy.
-Abrupt discontinuation of anti-epileptic therapy during pregnancy is not advised as this may lead to breakthrough seizures in mother and fetus.
-Physiologic changes during pregnancy may affect drug concentrations and/or therapeutic effect; dose adjustments may be necessary to maintain clinical response.
-Women should be advised to notify their healthcare provider if they plan to start or stop oral contraceptive use or other female hormonal preparations as this may significantly affect lamotrigine drug concentrations.
-A pregnancy registry is available to provide information on the effects of in utero exposure; pregnant patients should be encouraged to enroll: North American AED Pregnancy Registry: US toll free number: 1-888-233-2334; Website: http://www.aedpregnancyregistry.org/

Animal studies have shown developmental toxicity at doses estimated to be lower than those used clinically. Pregnant rats administered 3 doses (5, 10 or 20 mg/kg) during the latter part of gestation had increased offspring mortality (including stillbirths) at all doses. The lowest effect dose for peri/postnatal developmental toxicity was less than the human dose of 400 mg/day on mg/m2 basis. Maternal toxicity was observed at the 2 highest doses. Studies in rats have shown a decrease in folic acid during pregnancy, and since this drug is a weak inhibitor of dihydrofolate reductase, there is a theoretical risk of malformation due to folate deficiency. Anti-epileptic drugs should generally be continued during pregnancy with the goal of monotherapy at the lowest effective dose, however, the risk to the mother and fetus of uncontrolled epilepsy should be considered when deciding on treatment options. Data from several international pregnancy registries have not shown an increased risk for malformations overall. The frequency of major congenital malformations was similar to estimates from the general population. The North American Antiepileptic Drug Pregnancy (NAAED) Registry has reported an increased risk of isolated oral clefts, although this finding has not been observed in other large international pregnancy registries. Several meta-analyses have not reported an increased risk of major congenital malformations following lamotrigine exposure in pregnancy compared with healthy and disease-matched controls. No patterns of specific malformation types were observed. As with other antiepileptic drugs, decreased lamotrigine concentrations have been reported during pregnancy with a return to pre-pregnancy concentrations after delivery. Appropriate clinical management should include monitoring drug concentrations and adjusting doses as indicated. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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)

Professional Content

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: Lamotrigine (found in Lamictal)

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Adverse reactions have occasionally been reported in breastfed babies, but long-term exposure does not appear to affect infant growth and development.
-Breastfed infants should be carefully monitored for side effects; serum levels may be measured to rule out toxicity.
-If infant rash occurs, breastfeeding should be discontinued until cause can be established.

Drug concentrations in human milk may be as high as 50% of the maternal serum levels. Neonates are at risk for high plasma levels due to plasma protein binding being relatively low and decreased ability to clear drug (immaturity of glucuronidation capacity). Additionally, similar to other antiepileptic drugs, the maternal dose should generally be reduced after delivery to the pre-pregnancy dosage, and failure to reduce dose may lead to higher milk concentrations. Apnea, rash, drowsiness, and poor sucking have been reported in breastfed infants. If an adverse event occurs, a serum level can be measured to rule out toxicity. Consider monitoring platelet counts and liver function. Breastfeeding should be discontinued in infants with lamotrigine toxicity