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Drug Interactions between berotralstat and PediaCare Children's Allergy & Cold

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

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Interactions between your drugs

Moderate

diphenhydrAMINE berotralstat

Applies to: PediaCare Children's Allergy & Cold (diphenhydramine / phenylephrine) and berotralstat

MONITOR: Coadministration with berotralstat may increase the plasma concentrations and effects of drugs that are substrates of CYP450 3A4 and/or 2D6. The mechanism is decreased clearance due to inhibition of CYP450 3A4 and 2D6 activity by berotralstat. Berotralstat is considered a moderate inhibitor of CYP450 3A4 and 2D6 and has been reported in drug interaction studies to increase the peak plasma concentration (Cmax) and systemic exposure (AUC) of sensitive CYP450 3A4 substrate midazolam by approximately 1.5-fold and 2.25-fold, respectively, and the Cmax and AUC of sensitive CYP450 2D6 substrate dextromethorphan by approximately 2.9-fold and 2.7-fold, respectively. Clinical data are not available.

MANAGEMENT: Caution is advised when berotralstat is coadministered with drugs that are substrates of CYP450 3A4 and/or 2D6, particularly those with a narrow therapeutic index including but not limited to thioridazine, pimozide, cyclosporine, and fentanyl. Clinical and laboratory monitoring are recommended following the initiation of berotralstat, and the individual dosage of the concomitant agents adjusted as needed.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2021) "Product Information. Orladeyo (berotralstat)." BioCryst Pharmaceuticals Inc

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Drug and food interactions

Moderate

diphenhydrAMINE food

Applies to: PediaCare Children's Allergy & Cold (diphenhydramine / phenylephrine)

GENERALLY AVOID: Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous. In addition, the potential for abuse may be increased with the combination. The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system. No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load. However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.

MANAGEMENT: Alcohol should generally be avoided during therapy with anticholinergic agents. Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.

References

  1. Linnoila M (1973) "Drug effects on psychomotor skills related to driving: interaction of atropine, glycopyrrhonium and alcohol." Eur J Clin Pharmacol, 6, p. 107-12

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Moderate

phenylephrine food

Applies to: PediaCare Children's Allergy & Cold (diphenhydramine / phenylephrine)

MONITOR: Coadministration of two or more sympathomimetic agents may increase the risk of adverse effects such as nervousness, irritability, and increased heart rate. Central nervous system (CNS) stimulants, particularly amphetamines, can potentiate the adrenergic response to vasopressors and other sympathomimetic agents. Additive increases in blood pressure and heart rate may occur due to enhanced peripheral sympathetic activity.

MANAGEMENT: Caution is advised if two or more sympathomimetic agents are coadministered. Pulse and blood pressure should be closely monitored.

References

  1. Rosenblatt JE, Lake CR, van Kammen DP, Ziegler MG, Bunney WE Jr (1979) "Interactions of amphetamine, pimozide, and lithium on plasma norepineophrine and dopamine-beta-hydroxylase in schizophrenic patients." Psychiatry Res, 1, p. 45-52
  2. Cavanaugh JH, Griffith JD, Oates JA (1970) "Effect of amphetamine on the pressor response to tyramine: formation of p-hydroxynorephedrine from amphetamine in man." Clin Pharmacol Ther, 11, p. 656
  3. (2001) "Product Information. Adderall (amphetamine-dextroamphetamine)." Shire Richwood Pharmaceutical Company Inc
  4. (2001) "Product Information. Tenuate (diethylpropion)." Aventis Pharmaceuticals
  5. (2001) "Product Information. Sanorex (mazindol)." Novartis Pharmaceuticals
  6. (2001) "Product Information. Focalin (dexmethylphenidate)." Mikart Inc
  7. (2002) "Product Information. Strattera (atomoxetine)." Lilly, Eli and Company
View all 7 references

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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

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