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4 Interactions found for:

Topamax and Vitamin D3
Interactions Summary
  • 2 Major
  • 0 Moderate
  • 2 Minor
  • Topamax
  • Vitamin D3

Drug Interactions

No drug interactions were found for selected drugs: Topamax, Vitamin D3.

This does not necessarily mean no interactions exist. Always consult your healthcare provider.

Drug and Food Interactions

No food interactions were found for selected drugs: Topamax, Vitamin D3.

This does not necessarily mean no interactions exist. Always consult your healthcare provider.

Drug and Pregnancy Interactions

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

Professional Content

Use only if clearly needed and benefit outweighs potential risk

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

Risk Summary: This drug can cause fetal harm when administered to pregnant women. Data from a pregnancy registry and several epidemiologic studies have shown that infants exposed in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age; in multiple animal species, this drug has demonstrated developmental toxicity, including increased incidences of fetal malformations at clinically relevant doses.

Comments:
-If a patient becomes pregnant during therapy, she should be informed of the potential hazard to her fetus; women of childbearing potential should be counseled on the use effective contraception.
-Women of childbearing potential on antiepileptic drug therapy should receive pregnancy counseling regarding the risk of fetal abnormalities. Generally, antiepileptic therapy should be continued during pregnancy, with monotherapy at the lowest effective dose whenever possible. Folic acid supplementation (5 mg) should be commenced four weeks prior to and continued for 12 weeks after conception. Women should be followed by a specialist and offered detailed mid-trimester ultrasound.
-Pregnancy Registry: The North American Antiepileptic Drug (NAAED) Pregnancy Registry collects information about the safety of antiepileptic drugs during pregnancy; enrollment information: toll-free 1-888-233-2334 or http://www.aedpregnancyregistry.org/

Animal studies in multiple species of animals have revealed evidence of developmental toxicity. Topiramate has shown teratogenicity in mice, rats, and rabbits. In humans, clinical data from a pregnancy registry and several epidemiologic studies have shown infants exposed during the first trimester have an increased incidence of major congenital malformations compared with a reference group not taking antiepileptic drugs (AED). Infants exposed in utero have an increased risk for cleft lip and/or cleft palate (oral clefts) and for being small for gestational age (SGA). SGA has been observed at all doses and appears to be dose-dependent. The prevalence of SGA is greater in infants of women who received higher doses of topiramate during pregnancy. In addition, the prevalence of SGA in infants of women who continued topiramate use until later in pregnancy is higher compared to the prevalence in infants of women who stopped before the third trimester. This drug can cause metabolic acidosis. The effect of topiramate-induced metabolic acidosis has not been studied in pregnancy; however, metabolic acidosis in pregnancy (due to other causes) can cause decreased fetal growth, decreased fetal oxygenation, and fetal death, and may affect the ability of the fetus to tolerate labor. There are no controlled data in human pregnancy.

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.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Qudexy XR Sprinkle (topiramate)." Upsher-Smith Laboratories Inc (2017):
  4. "Product Information. Trokendi XR (topiramate)." Supernus Pharmaceuticals Inc (2017):
  5. "Product Information. Topiramate (topiramate)." Cipla USA Inc. (2017):

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Professional Content

Use is not recommended unless there is a deficiency.

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

Comments:
-Vitamin D supplementation should begin a few months prior to pregnancy.

Animal studies at high doses have shown teratogenicity. There are no controlled data in human pregnancy. Because vitamin D raises calcium levels, it is suspect in the pathogenesis of supravalvular aortic stenosis syndrome, which is often associated with idiopathic hypercalcemia of infancy, but excessive vitamin D intake or retention has not been found consistently in these mothers. A study of 15 patients with maternal hypoparathyroidism, treated with high dose vitamin D during pregnancy (average 107,000 international units per day) to maintain normal calcium levels, produced all normal children. Vitamin D deficiency is associated with reduced fetal growth, neonatal hypocalcemia (with and without convulsions), rickets, and defective tooth enamel.

AU TGA pregnancy category Exempt: Medicines exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.

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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm" (2010):
  4. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):

Drug and Breastfeeding Interactions

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

Professional Content

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.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  4. "Product Information. Qudexy XR Sprinkle (topiramate)." Upsher-Smith Laboratories Inc (2017):
  5. "Product Information. Trokendi XR (topiramate)." Supernus Pharmaceuticals Inc (2017):
  6. "Product Information. Topiramate (topiramate)." Cipla USA Inc. (2017):

The following applies to the ingredients: Cholecalciferol (found in Vitamin D3)

Professional Content

Use is not recommended unless the clinical condition of the woman requires treatment.

Excreted into human milk: Yes

Comments:
-Make allowance for any maternal dose if prescribing this product to a breast fed infant.
-Consider monitoring the infant's serum calcium if the mother is receiving pharmacologic doses of vitamin D.
-Vitamin D supplementation is recommended in exclusively breast fed infants.

The required dose of vitamin D during lactation has not been adequately studied; doses similar to those for pregnant women have been suggested.

Chronic ingestion of large doses of vitamin D by the mother may lead to hypercalcemia in the breastfed infant.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):
  4. IOM (Institute of Medicine). "Dietary Reference Intakes for Calcium and Vitamin D." Washington, DC: The National Academies Press (2011):

Therapeutic Duplication Warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

Switch to: Professional Interactions

Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

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