7 Interactions found for:

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: Citalopram (found in Celexa)

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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: C
US FDA Pregnancy Category: C

Comments:
-Newborns should be monitored if the maternal use of this drug continues into the later stages of pregnancy, particularly the third trimester.
-Abrupt discontinuation should be avoided during pregnancy.

Animal studies have revealed evidence of embryofetal toxicity and effects on postnatal development, including teratogenicity, at doses greater than human therapeutic doses, which were also maternally toxic. There are no controlled data in human pregnancy.

Published data on pregnant women, with more than 2,500 exposed outcomes, indicate no malformative feto/neonatal toxicity. The results of a prospective comparative study (n=396 pregnant women) indicate that citalopram use during embryogenesis is not associated with an apparent major teratogenic risk in humans; however, human spontaneous abortion has been reported.

Neonates exposed to SSRIs and SNRIs late in the third trimester have uncommonly reported clinical findings including respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These effects have mostly occurred either at birth or within a few days of birth. These features are consistent with either a direct toxic effect of SSRIs and SNRIs, or possibly a drug discontinuation syndrome; in some cases, the clinical picture is consistent with serotonin syndrome.

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.

Data from animal studies has shown that citalopram 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.

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

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.

The following applies to the ingredients: Citalopram (found in Celexa)

Professional Content

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for drowsiness
-Mothers taking an SSRI during pregnancy and postpartum may have difficulty breastfeeding and may require additional breastfeeding support.

Cases of minor behavioral side effects such as drowsiness or fussiness have been reported; however no adverse effects on development have been observed in infants followed for up to 1 year.

It has been suggested that citalopram therapy may be continued during breastfeeding if it was used during pregnancy or if other antidepressants were ineffective. Escitalopram, the S-enantiomer of citalopram, may be preferred during breastfeeding as its usual dose is about 25% that of citalopram and has a lower infant exposure.

One study has reported that the relative dose to a suckling infant is similar to that reported for fluoxetine, and higher than that reported for fluvoxamine, paroxetine, or sertraline.

Two cases have been reported of infants experiencing excessive somnolence, decreased feeding, and weight loss in relation to breast-feeding from a mother receiving citalopram. Milk/serum concentration ratios based on single pairs of samples from the two patients ranged from 1.16 to 1.88. Based on this, the absolute dose a suckling infant may ingest would be in the range of 4.3 to 17.6 micrograms/kg. The relative dose would be 0.7% to 5.9% of the weight- adjusted maternal dose. In one case the infant was reported to have recovered completely once the infants mother discontinued the citalopram.

According to another case report, the relative infant citalopram dose from breast milk is approximately 9% of the weight- adjusted maternal dose.

A study of seven women taking citalopram and their infants has reported that the plasma concentrations of citalopram and demethylcitalopram in the infants were very low or absent and there were no adverse effects.