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Drug Interactions between Pep-Back Ultra and ramelteon

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

caffeine ramelteon

Applies to: Pep-Back Ultra (caffeine) and ramelteon

MONITOR: Coadministration with inhibitors of CYP450 1A2 may increase the plasma concentrations and pharmacologic effects of ramelteon, which is primarily metabolized by the isoenzyme. In healthy volunteers, administration of a single 16 mg dose of ramelteon following pretreatment with the potent CYP450 1A2 inhibitor fluvoxamine (100 mg orally twice daily for 3 days) resulted in a 70-fold increase in ramelteon peak plasma concentration (Cmax) and a 190-fold increase in systemic exposure (AUC) compared to administration of ramelteon alone. However, fluvoxamine is known to also inhibit CYP450 2C9 and 3A4, both of which contribute significantly to the metabolism of ramelteon. Concomitant administration of ramelteon with less potent CYP450 1A2 inhibitors has not been evaluated.

MANAGEMENT: Caution is advised when ramelteon is used with CYP450 1A2 inhibitors. A reduction in the ramelteon dosage may be necessary in patients who experience excessive sedation or other adverse effects.

References

  1. "Product Information. Rozerem (ramelteon)." Takeda Pharmaceuticals America (2005):

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Drug and food interactions

Moderate

ramelteon food

Applies to: ramelteon

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

ADJUST DOSING INTERVAL: Administration of ramelteon with or immediately after a high-fat/heavy meal may delay the onset of hypnotic effects. In study subjects, administration of a 16 mg dose of ramelteon with a high-fat meal decreased the peak plasma drug concentration (Cmax) by 22% and delayed the median time to reach peak plasma drug concentration (Tmax) by approximately 45 minutes compared to administration in a fasted state.

MANAGEMENT: Patients receiving ramelteon should be advised to avoid the consumption of alcohol. For faster sleep onset, ramelteon should not be administered with or immediately after a high-fat/heavy meal.

References

  1. "Product Information. Rozerem (ramelteon)." Takeda Pharmaceuticals America (2005):

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Minor

caffeine food

Applies to: Pep-Back Ultra (caffeine)

The effect of grapefruit juice on the pharmacologic activity of caffeine is controversial. One report suggests that grapefruit juice increases the effect of caffeine. The proposed mechanism is inhibition of cytochrome P-450 metabolism of caffeine. However, a well-conducted pharmacokinetic/pharmacodynamic study did not demonstrate this effect. The clinical significance of this potential interaction is unknown.

References

  1. "Grapefruit juice interactions with drugs." Med Lett Drugs Ther 37 (1995): 73-4
  2. Maish WA, Hampton EM, Whitsett TL, Shepard JD, Lovallo WR "Influence of grapefruit juice on caffeine pharmacokinetics and pharmacodynamics." Pharmacotherapy 16 (1996): 1046-52

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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.

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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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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