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5 Interactions found for:

Xarelto and gabapentin
Interactions Summary
  • 4 Major
  • 1 Moderate
  • 0 Minor
  • Xarelto
  • gabapentin

Drug Interactions

No drug interactions were found for selected drugs: Xarelto, gabapentin.

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

Drug and Food Interactions

Moderate
Gabapentin + Food

The following applies to the ingredients: Gabapentin

Alcohol can increase the nervous system side effects of gabapentin such as dizziness, drowsiness, and difficulty concentrating. Some people may also experience impairment in thinking and judgment. You should avoid or limit the use of alcohol while being treated with gabapentin. Do not use more than the recommended dose of gabapentin, and avoid activities requiring mental alertness such as driving or operating hazardous machinery until you know how the medication affects you. Talk to your doctor or pharmacist if you have any questions or concerns.

Drug and Pregnancy Interactions

The following applies to the ingredients: Gabapentin

Professional Content

Benefits should clearly outweigh risks

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

Risk Summary: There are no data on the developmental risks associated with use of this drug in pregnant women; in animal studies, developmental toxicity was observed at doses estimated to be similar or lower than those used clinically.

Comments:
-The risk of having a child with a congenital defect as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy; folic acid supplementation (5 mg) should be started 4 weeks prior to and continued for 12 weeks after conception.
-Women of childbearing potential should receive counseling on the risk of fetal abnormalities with use of antiepileptic drugs (AEDs) during pregnancy; AEDs should generally be continued during pregnancy utilizing monotherapy at the lowest effective dose as this has been shown to minimize risks of fetal abnormalities compared to combination AED therapy.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of developmental toxicity (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered at doses similar to, or lower than expected clinical doses. In rats, an increased incidence of hydroureter and/or hydronephrosis have been observed in offspring at all doses, the lowest dose being similar to the maximum recommended human dose on a mg/m2 basis. This drug crosses the human placenta. From the limited amount of data in human pregnancy, it is not possible to inform an associated increased risk of congenital malformations because epilepsy itself and the presence of concomitant antiepileptic medicinal products have their own risks. There are no controlled data in human pregnancy.

To provide information regarding the effects of in utero exposure to this drug, pregnant patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 and must be done by patients themselves. Information on the registry can also be found at the website 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.

References

  1. "Product Information. Neurontin (gabapentin)." Parke-Davis PROD (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Horizant (gabapentin)." GlaxoSmithKline (2021):
  5. "Product Information. Gralise (gabapentin)." Depomed Inc (2021):

The following applies to the ingredients: Rivaroxaban (found in Xarelto)

Professional Content

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; caution is recommended.
-According to some authorities: Use is contraindicated.

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

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

Comments:
-This drug should be used with caution in pregnant patients due to the potential for pregnancy-related hemorrhage and/or emergent delivery; the anticoagulant effect of this drug cannot be reliably monitored with standard laboratory testing.
-The benefits and risks for the mother and possible risks to the fetus should be considered when prescribing this drug during pregnancy.
-Disease-associated maternal and/or embryofetal risk, fetal/neonatal adverse reactions, and risks during labor/delivery should be considered.
-Patients of childbearing potential who require anticoagulation should discuss pregnancy planning with their physician; the risk of clinically significant uterine bleeding (potentially requiring gynecological surgical interventions) seen with oral anticoagulants (including this drug) should be assessed in patients of childbearing potential and those with abnormal uterine bleeding.
---According to some authorities: This drug should be used in patients of childbearing potential only with effective contraception; patients of childbearing potential should avoid becoming pregnant during therapy.

Animal studies have revealed evidence of fetotoxicity. After pregnant rabbits were given oral doses of at least 10 mg/kg (dose corresponds to about 4 times the human exposure of unbound drug, based on AUC comparisons at the recommended human dose of 20 mg/day) during organogenesis, increased fetal toxicity (increased resorptions, decreased number of live fetuses, decreased fetal body weight) was observed. Fetal body weights decreased after pregnant rats were give oral doses of 120 mg/kg (dose corresponds to about 14 times the human exposure of unbound drug) during organogenesis; peripartal maternal bleeding and maternal and fetal death occurred at 40 mg/kg (about 6 times maximum human exposure of unbound drug at the human dose of 20 mg/day). This drug crosses the placenta in animals; in an in vitro placenta perfusion model, unbound drug was rapidly transferred across the human placenta. There are no controlled data in human pregnancy.

Pregnancy is a risk factor for venous thromboembolism; that risk is increased in women with inherited/acquired thrombophilias. Pregnant women with thromboembolic disease have an increased risk of maternal complications (including preeclampsia); maternal thromboembolic disease increases the risk for intrauterine growth restriction, placental abruption, and pregnancy loss (early and late).

Based on the pharmacologic activity of factor Xa inhibitors and the potential to cross the placenta, bleeding may occur at any site in the fetus and/or neonate.

All patients receiving anticoagulants (including pregnant patients) are at risk for bleeding; this risk may be increased during labor or delivery. The bleeding risk should be balanced with the risk of thrombotic events when considering the use of this drug in this setting.

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.

References

  1. "Product Information. Xarelto (rivaroxaban)." Janssen Pharmaceuticals SUPPL-39 (2022):
  2. "Product Information. Xarelto (rivaroxaban)." Bayer Australia Ltd XARELTO PI XV2.0; CC (2020):
  3. "Product Information. Xarelto (rivaroxaban)." Bayer Plc (2022):

Drug and Breastfeeding Interactions

The following applies to the ingredients: Gabapentin

Professional Content

Benefits should clearly outweigh risks

Excreted into human milk: Yes

Comments:
-Breastfed infants should be monitored for drowsiness, adequate weight gain, and developmental milestones, especially when used in combination with other anticonvulsant or psychotropic drugs and in younger, exclusively breastfed infants.
-Some authorities suggest discontinuing nursing or discontinuing use of this drug while breastfeeding due to the potential for serious adverse reactions in the breastfed infant.

With maternal doses up to 2.1 g/day, estimated doses for fully breastfed infants are 0.2 to 1.3 mg/kg/day (equivalent to 1.3 to 3.8% of the maternal weight-adjusted dose). An expert panel has deemed this drug is an acceptable choice for refractory restless leg syndrome during lactation. Until more data becomes available, 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.

References

  1. "Product Information. Neurontin (gabapentin)." Parke-Davis PROD (2001):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  5. "Product Information. Horizant (gabapentin)." GlaxoSmithKline (2021):
  6. "Product Information. Gralise (gabapentin)." Depomed Inc (2021):

The following applies to the ingredients: Rivaroxaban (found in Xarelto)

Professional Content

If this drug is required by the mother, it is not a reason to discontinue nursing; because data are limited, preterm or newborn infants should be monitored for signs of bleeding.
-According to some authorities: Use is contraindicated; a decision should be made to discontinue breastfeeding or discontinue the drug.

Excreted into human milk: Yes

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

Several case reports consistently showed that maternal doses of 15 to 30 mg/day produced low levels in milk that were considerably below doses required for anticoagulation in infants.

A 40-year-old woman developed bilateral pulmonary embolism and peripartum cardiomyopathy after cesarean section; after initially receiving enoxaparin, she was switched to this drug (15 mg orally twice a day) after 2 days. On the third day of this drug, complete milk collections from both breasts were obtained before and at 3, 6, and 10 hours after the morning dose; blood samples were collected at the same times. According to author calculation, a fully breastfed infant would receive 2.4 mcg/kg over the 10-hour period, which would be 1.3% of the maternal weight-adjusted dosage.

A 38-year-old woman with antiphospholipid syndrome began 15 mg/day (0.19 mg/kg/day) at 5 days postpartum for prophylaxis of deep vein thrombosis; she partially breastfed her infant (at least 50%). On 2 separate days, 7 samples of milk were collected over a 24-hour period; values were similar at the same times on each day. A mean peak value of 53.9 mcg/L occurred at 6 hours after dosing and the milk level averaged 22.7 mcg/L; the half-life in milk was 4.7 hours. A fully breastfed infant would receive 3.4 mcg/kg/day (estimated), which corresponded to 1.8% of the maternal weight-adjusted dosage. No apparent evidence of bleeding was noted in the infant at 1- and 3-month checkups and development was normal at 18 months of age.

This drug was prescribed to 2 postpartum women, 1 for stroke and the other for pulmonary embolism; each began therapy with 15 mg twice a day for 21 days, then 20 mg once a day. Both patients provided several steady-state milk samples over the dosage interval during each regimen. After the 15 mg dose, a mean peak value of 300 mcg/L occurred 1 hour after dosing and the milk level averaged 160 mcg/L; a fully breastfed infant would receive 10 mcg/kg every 12 hours (estimated), which corresponded to 5% of the maternal weight-adjusted dosage. After the 20 mg dose, a mean peak value of 260 mcg/L occurred 2 hours after dosing and the milk level averaged 70 mcg/L; a fully breastfed infant would receive 10 mcg/kg/day (estimated), which corresponded to 4% of the maternal weight-adjusted dosage.

At 8 months postpartum, 2 nursing mothers received a single 20 mg oral dose; blood and milk samples were collected before the dose and at 2.5, 6, 10, 12, and 24 hours after the dose. The peak drug milk level of about 90 mcg/L occurred at 2.5 hours after the dose. The milk level over 24 hours averaged 28.9 mcg/L, which corresponded to an infant dosage of 4.3 mcg/kg/day and a relative infant dose of 1.63% of the maternal weight-adjusted dosage. The daily dosage of this drug in milk was about 0.7% of the estimated infant daily dosage required for anticoagulation.

References

  1. "Product Information. Xarelto (rivaroxaban)." Janssen Pharmaceuticals SUPPL-39 (2022):
  2. National Library of Medicine (US), National Center for Biotechnology Information "Rivaroxaban - Drugs and Lactation Database (LactMed) https://www.ncbi.nlm.nih.gov/books/NBK500742/"
  3. "Product Information. Xarelto (rivaroxaban)." Bayer Australia Ltd XARELTO PI XV2.0; CC (2020):
  4. "Product Information. Xarelto (rivaroxaban)." Bayer Plc (2022):

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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