6 Interactions found for:

The following applies to the ingredients: Tramadol

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According to some authorities: Use is not recommended.

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

Risk Summary: Insufficient data are available in humans to inform a drug-related risk; however, prolonged use of opioids during pregnancy for medical or nonmedical purposes can result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.

Comments:
-Use is not recommended in pregnant women immediately prior to or during labor when other analgesic techniques are more appropriate.
-If prolonged use is required in a pregnant woman, advise the patient of the risk for neonatal opioid withdrawal syndrome, which could be life-threatening if not recognized and treated, and ensure appropriate monitoring and treatment will be available.
-Monitor newborns exposed to this drug for signs of excess sedation, respiratory depression, and neonatal opioid withdrawal syndrome and manage accordingly. An opioid overdose reversal agent must be available for reversal of opioid-induced respiratory depression in the neonate.

Animal studies have revealed decreased fetal weights, reduced ossification, and structural abnormalities in the brains of fetuses. This drug has been shown to cross the placental barrier with an umbilical vein to maternal vein serum concentration ratio of 0.83. There are no controlled data in human pregnancy; however, there have been postmarketing reports of neonatal seizures, neonatal withdrawal syndrome, fetal death, and still birth.

Chronic use of opioids may cause reduced fertility in females and males; however, it is unknown whether these effects are reversible.

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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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: Tramadol

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Use is not recommended

Excreted into human milk: Yes

Comments:
-The US FDA recommends against the use of tramadol during breastfeeding due to risks of serious adverse reactions in breastfed infants; this drug is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.
-If infants are exposed through breastmilk, they should be monitored for excess sedation and respiratory depression.

Serious adverse reactions in breastfed infants may include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death. Newborns have limited capacity to metabolize the active 0-desmethyltramadol.

A study in 75 mothers reported an average milk concentration of 748 mcg/L; this translates to an average infant dose of 112 mcg/kg and a maternal weight-adjusted dose of 2.24% and 0.64% for the drug and its metabolite, respectively. Reanalysis of the data using a population pharmacokinetic model showed a maternal weight adjusted dose of 2.2% for extensive metabolizers and 2.6% for poor metabolizers. The amount of drug present in breast milk represents a maximum of 2.6% of the proposed IV newborn dose. This drug can increase prolactin levels; however, the prolactin level in a mother with established lactation may not affect her ability to breastfeed.

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.