7 Interactions found for:

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: 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).

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 yet, 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.

The following applies to the ingredients: Gabapentin

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Benefits should clearly outweigh risks

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

Risk Summary: There are no data on the developmental risks associated with use of this drug in pregnant women; in animal studies, developmental toxicity was observed at doses estimated to be similar or lower than those used clinically.

Comments:
-The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy; folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception.
-Women of childbearing potential should receive counseling on the risk of fetal abnormalities with use of antiepileptic drugs (AEDs) during pregnancy; AEDs should generally be continued during pregnancy utilizing monotherapy at the lowest effective dose as this has been shown to minimize risks of fetal abnormalities compared to combination AED therapy.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of developmental toxicity (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered at doses similar to, or lower than expected clinical doses. In rats, an increased incidence of hydroureter and/or hydronephrosis have been observed in offspring at all doses, the lowest dose being similar to the maximum recommended human dose on a mg/m2 basis. This drug crosses the human placenta. From the limited amount of data in human pregnancy, it is not possible to inform an associated increased risk of congenital malformations because epilepsy itself and the presence of concomitant antiepileptic medicinal products have their own risks. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, pregnant patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. Information on the registry can also be found at the website 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: 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.

The following applies to the ingredients: Gabapentin

Professional Content

Benefits should clearly outweigh risks

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially when used in combination with other anticonvulsant or psychotropic drugs and in younger, exclusively breastfed infants.
-Some authorities suggest discontinuing nursing or discontinuing use of this drug while breastfeeding due to the potential for serious adverse reactions in the breastfed infant.

With maternal doses up to 2.1 g/day, estimated doses for fully breastfed infants are 0.2 to 1.3 mg/kg/day (equivalent to 1.3 to 3.8% of the maternal weight-adjusted dose). An expert panel has deemed this drug is an acceptable choice for refractory restless leg syndrome during lactation. Until more data becomes available, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.