7 Interactions found for:
Drug Interactions
Major
Flexeril
+ Tramadol
The following applies to the ingredients: Cyclobenzaprine (found in Flexeril) and Tramadol
Using narcotic pain or cough medications together with other medications that also cause central nervous system depression can lead to serious side effects including respiratory distress, coma, and even death. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Do not drink alcohol or self-medicate with these medications without your doctor's approval, and do not exceed the doses or frequency and duration of use prescribed by your doctor. Also, you should avoid driving or operating hazardous machinery until you know how these medications affect you. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.
Drug and Food Interactions
Moderate
Flexeril
+ Food
The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)
Alcohol can increase the nervous system side effects of cyclobenzaprine 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 cyclobenzaprine. Do not use more than the recommended dose of cyclobenzaprine, 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.
Moderate
Tramadol
+ Food
The following applies to the ingredients: Tramadol
Alcohol can increase the nervous system side effects of traMADol 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 traMADol. Do not use more than the recommended dose of traMADol, 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
Major
Tramadol
+ Pregnancy
The following applies to the ingredients: Tramadol
Professional Content
Use is not recommended
AU TGA pregnancy category: C
US FDA pregnancy category: Not Assigned
Risk Summary: There is insufficient data in humans to inform a drug-associated risk for major birth defects and miscarriage; prolonged use of opioids during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth.
Comments:
-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.
This drug has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83. Animal studies have shown at very high doses, this drug has an effect on organ development, bone growth, and mortality rate. Prolonged maternal use of opioid analgesics during pregnancy may result in respiratory depression and physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. There have been postmarketing reports of neonatal seizures, neonatal withdrawal syndrome, fetal death, and still births. There are no adequate and well-controlled studies in pregnant women.
Chronic use of opioids may cause reduced fertility; 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.
References
- "Product Information. Ultram (tramadol)." McNeil Pharmaceutical PROD (2001):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Ultram ER (tramadol)." PriCara Pharmaceuticals (2015):
Minor
Flexeril
+ Pregnancy
The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)
Professional Content
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
Embryofetal development in rats and rabbits given approximately 3 and 15 times, respectively, the maximum recommended human dose (MRHD) was not adversely effected. Dams receiving this drug at doses 3 times or more the MRHD during pregnancy and lactation, had pups with decreased body weight and survival. There are no adequate and controlled studies in pregnant women.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
adversely
References
- "Product Information. Flexeril (cyclobenzaprine)." Merck & Co., Inc PROD (2001):
- "Product Information. Amrix (cyclobenzaprine)." A-S Medication Solutions (2016):
Drug and Breastfeeding Interactions
Major
Tramadol
+ Breastfeeding
The following applies to the ingredients: Tramadol
Professional Content
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.
References
- "Product Information. Ultram (tramadol)." McNeil Pharmaceutical PROD (2001):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
- "Product Information. Ultram ER (tramadol)." PriCara Pharmaceuticals (2015):
- US Food and Drug Administration (FDA) "FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women. https://www.fda.gov/Drugs/DrugSafety/ucm549679.htm" (2017):
Minor
Flexeril
+ Breastfeeding
The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)
Professional Content
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
The effects in the nursing infant are unknown.
This drug has been shown to be excreted in rat milk and achieve concentrations in the milk which are 50% of those in the rat maternal plasma. As this drug is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, use caution especially when other drugs that cause sedation are used simultaneously.
References
- Hucker HB, Stauffer SC, Balletto AJ, White SD, Zacchei AG, Arison BH "Physiological disposition and metabolism of cyclobenzaprine in the rat, dog, rhesus monkey, and man." Drug Metab Dispos 6 (1978): 659-72
- "Product Information. Flexeril (cyclobenzaprine)." Merck & Co., Inc PROD (2001):
- "Product Information. Amrix (cyclobenzaprine)." A-S Medication Solutions (2016):
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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