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5 Interactions found for:

Flexeril and omeprazole
Interactions Summary
  • 2 Major
  • 1 Moderate
  • 2 Minor
  • Flexeril
  • omeprazole

Drug Interactions

No drug interactions were found for selected drugs: Flexeril, omeprazole.

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

Drug and Food Interactions

Moderate
Flexeril + Food

The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)

GENERALLY AVOID: Alcohol may potentiate some of the pharmacologic effects of CNS-active agents. Use in combination may result in additive central nervous system depression and/or impairment of judgment, thinking, and psychomotor skills.

MANAGEMENT: Patients receiving CNS-active agents should be warned of this interaction and advised to avoid or limit consumption of alcohol. Ambulatory patients should be counseled to avoid hazardous activities requiring complete mental alertness and motor coordination until they know how these agents affect them, and to notify their physician if they experience excessive or prolonged CNS effects that interfere with their normal activities.

References

  1. Warrington SJ, Ankier SI, Turner P "Evaluation of possible interactions between ethanol and trazodone or amitriptyline." Neuropsychobiology 15 (1986): 31-7
  2. Gilman AG, eds., Nies AS, Rall TW, Taylor P "Goodman and Gilman's the Pharmacological Basis of Therapeutics." New York, NY: Pergamon Press Inc. (1990):
  3. "Product Information. Fycompa (perampanel)." Eisai Inc (2012):
  4. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc (2015):

Drug and Pregnancy Interactions

The following applies to the ingredients: Omeprazole

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

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

Risk Summary: Epidemiologic studies have demonstrated that major malformative risks with use in pregnant patients are unlikely.

Comment: Some experts recommend that use is considered acceptable.

Animal models have revealed evidence of dose-related increases in embryolethality, fetal resorptions, and pregnancy disruptions when animal models were given this drug during organogenesis. Major fetal malformations were not frequently observed in animal models. Embryofetal and postnatal developmental toxicities were observed in offspring of parents given at least 3.4 times an oral human dose of 40 mg.

Embryofetal toxicity is associated with maternally toxic doses given throughout gestation as well as in high doses given to males prior to mating.

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. PriLOSEC (omeprazole)." Merck & Co., Inc (2022):
  2. "Product Information. Omeprazole (omeprazole)." Mylan Pharmaceuticals Inc (2003):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)

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

  1. "Product Information. Flexeril (cyclobenzaprine)." Merck & Co., Inc PROD (2001):
  2. "Product Information. Amrix (cyclobenzaprine)." A-S Medication Solutions (2016):

Drug and Breastfeeding Interactions

The following applies to the ingredients: Omeprazole

Use is not recommended.

Excreted into human milk: Yes

Comments:
-This drug is associated with tumorigenicity in animal models, and may suppress gastric acid secretion in the nursing infant.
-The American Academy of Pediatrics state that this drug should be avoided until additional studies can confirm the safe use of this drug during breastfeeding.

In animal models, decreased postpartum offspring growth rates were observed when this drug was administered during late gestation and throughout lactation at oral doses of at least 138 mg/kg/day and IV doses of 3.2 mg/kg/day.

References

  1. "Product Information. PriLOSEC (omeprazole)." Merck & Co., Inc (2022):
  2. "Product Information. Omeprazole (omeprazole)." Mylan Pharmaceuticals Inc (2003):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation." Philadelphia, PA: Wolters Kluwer Health (2015):

The following applies to the ingredients: Cyclobenzaprine (found in Flexeril)

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

  1. 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
  2. "Product Information. Flexeril (cyclobenzaprine)." Merck & Co., Inc PROD (2001):
  3. "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: Consumer 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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