6 Interactions found for:

The following applies to the ingredients: Topiramate (found in Topamax)

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This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated unless there are no alternatives for epilepsy.

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

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. Data from pregnancy registries indicate that infants exposed in utero have increased risk of major congenital malformations.

Comments:
-Inform women of childbearing potential of the potential risk to a fetus from exposure to this drug. Alternative treatment options may be advisable. According to some authorities, use is contraindicated in women of childbearing potential (the manufacturer product information should be consulted).
-Advise women of childbearing potential to use effective contraception during treatment. Estrogen-containing birth control may be less effective when used with this drug. According to some authorities, pregnancy testing should be performed prior to starting treatment, and contraception should be used throughout treatment and for at least 4 weeks after stopping this drug.
-A pregnancy exposure registry is available.
-Monitor pregnant patients and newborns of mothers exposed to this drug for metabolic acidosis and treat as appropriate. The effect of metabolic acidosis induced by this drug has not been studied in pregnancy; however, metabolic acidosis due to other causes in pregnancy can elicit decreased fetal oxygenation and growth as well as fetal death.
-According to some authorities, antiepileptic therapy should be continued during pregnancy using monotherapy at the lowest effective dose whenever possible. Folic acid supplementation (5 mg) should be commenced four weeks prior to and continued for twelve weeks after conception. Women should be followed by a specialist and offered detailed mid-trimester ultrasound.

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data in human pregnancy; however, data from pregnancy registries have shown that infants exposed in utero have increased risk of cleft lip and/or cleft palate (oral clefts) and of being small for gestational age (SGA). SGA has been observed at all doses and appears to be dose-dependent.

To monitor the outcomes of pregnant women exposed to this drug, The North American Antiepileptic Drug in Pregnancy Registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by visiting https://www.aedpregnancyregistry.org/join-our-study/.

Based on limited data, this drug has been associated with pre-term labor and premature delivery. In addition, metabolic acidosis induced by this drug may affect the ability of the fetus to tolerate labor.

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: Metformin

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Benefit should outweigh risk

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

Risk Summary: Data are not sufficient to inform a drug-associated risk for major birth defects or miscarriage; published studies have not reported an increased risk. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy.

Comments:
-Maternal glucose levels should be well controlled prior to conception and throughout pregnancy to avoid maternal and fetal diabetes-associated risks.
-Premenopausal women should understand the potential for unintended pregnancy with use of this drug as ovulation may occur in some anovulatory women.

Animal studies do not indicate harmful effects with respect to pregnancy, embryo or fetal development, birth or postnatal development. Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. Poorly controlled maternal diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. Published evidence suggests this drug has a good safety profile in women with no increased long-term effects in offspring up to 18 months; however, much of the evidence is from observational, small, and/or nonrandomized studies, and therefore data must be interpreted cautiously.

Many experts continue to recommend insulin as the drug of choice for type 1, type 2, and gestational diabetes when diet alone is unsuccessful in controlling blood sugars. The estimated background risk for major birth defects in women with pre-gestational diabetes mellitus with an HbA1C greater than 7 is 6% to 10% and for women with a HbA1C greater than 10, this risk has been reported to be as high as 20% to 25%. In the US, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated risk of miscarriage for pregnant women with diabetes is unknown. There are no adequate and well-controlled studies in pregnant women.

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 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: Topiramate (found in Topamax)

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Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-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.
-If this drug is used during breastfeeding, monitor breastfed infant for diarrhea, drowsiness, adequate weight gain, and developmental milestones, especially younger, exclusively breastfed infants.
-Some authorities recommend avoiding breastfeeding during therapy with this drug.

Limited data in women with epilepsy have shown drug levels in milk similar to those in maternal plasma. The excretion of topiramate has not been evaluated in controlled studies.

The following applies to the ingredients: Metformin

Professional Content

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Available data have not reported adverse effects in breastfed infants, however, this data is limited.
-Due to this limited data, product manufacturers recommend a decision should be made to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.
-Published data suggest this drug is compatible with breastfeeding; they recommend caution when nursing a newborn or premature infant, and those with renal impairment.

Drug levels are expected to be 0.5% (range 0.11% to 1%) of the mother's weight-adjusted dosage and milk/plasma ratio range between 0.13 and 1. Since milk levels are expected to be relatively constant, timing of breastfeeding with drug administration is expected to be of little benefit. One large prospective study found no adverse effects in breastfed infants. Low detectable serum levels were found in some breastfed infants.