7 Interactions found for:

The following applies to the ingredients: Clonazepam (found in Klonopin)

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.

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

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

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Supplementation with folic acid is recommended before conception and during pregnancy.
-Pregnancy itself, and discontinuation of treatment, may result in exacerbation of epilepsy.
-The patient should be warned of the potential risks to the fetus prior to initiation; patients who become pregnant should continue treatment, and monotherapy should be used at the lowest effective dose (if possible).

Animal studies have revealed evidence of decreased number of pregnancies, lower number of surviving offspring until weaning, malformations, decreased maternal weight gain, and reduced fetal growth. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, irregular heart rate, and hypothermia in children born to mothers who have been taking benzodiazepines late in pregnancy. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcome of pregnant women exposed to antiepileptic drugs, the North American Antiepileptic Drug (NAAED) Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: 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)

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: Clonazepam (found in Klonopin)

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: This drug should be used only if clearly needed.

Excreted into human milk: Yes

Comments:
-Sedation, weight loss, and feeding difficulties have occurred in nursing infants.
-The WHO considers this drug compatible with breastfeeding when given at normal doses.
-Monitoring for drowsiness, weight gain, and developmental milestones should be considered in younger, exclusively breastfed infants and/or those exposed to combinations of psychotropic drugs.
-Some experts state that this drug may be an acceptable choice for refractory restless leg syndrome during lactation.

The following applies to the ingredients: Fluoxetine (found in Prozac)

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.