7 Interactions found for:

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

Professional Content

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: Zolpidem (found in Ambien)

Professional Content

This drug is only recommended for use during pregnancy when there are no alternatives and the benefit outweighs the risk.

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

Risk summary: The data do not report a clear association between use of this drug and major birth defects.

Comments:
-A syndrome of hypothermia, hypotonia, respiratory depression and difficulty feeding may occur in in infants of mothers administered this drug in the late phase of pregnancy or during childbirth.
-Withdrawal symptoms may occur in neonates whose mothers were taking sedative-hypnotics late in pregnancy.

Cases of severe neonatal respiratory depression have been reported when this drug was used at the end of pregnancy, especially when used with other central nervous system (CNS) depressants. Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may be at risk for developing physical dependence and withdrawal symptoms in the postnatal period. Additionally, neonatal flaccidity also has been reported in infants born to mothers who received sedative/hypnotic drugs during pregnancy.

Animal studies have revealed no evidence of teratogenicity or fertility impairment, but adverse effects including incomplete fetal skeletal ossification and increased embryo-fetal death.

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: Clonazepam (found in Klonopin)

Professional Content

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: Zolpidem (found in Ambien)

Professional Content

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts state that this drug should be used with caution.
-Due to the low levels of this drug in breastmilk and its short half-life, amounts ingested by nursing infants are small and would not be expected to cause any adverse effects in these infants.
-The American Academy of Pediatrics considers this drug to be compatible with breastfeeding.
-Some experts recommend monitoring breastfed infants for hypotonia, respiratory depression, and sedation.

After a single, 20 mg oral dose was administered to 5 nursing mothers (who were 3 to 4 days postpartum), breastmilk collected at 3 hours contained between 0.004% to 0.019% of the maternal dosage; the drug was undetectable (drug levels less than 0.5 mcg/L) in the breastmilk 13 to 16 hours after the dose was given.

In animal models, administration of this drug during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose tested.