Monograph
S01FA56 - Tropicamide, Combinations |
Propably not porphyrinogenic |
PNP |
Important Information
Limitations: This safety classification applies only to preparations containing a combination of the two drugs tropicamide and phenylephrine. The same ATC code (S01FA56) can in some countries be used for different combinations of tropicamide and other drugs, which in theory may or may not be porphyrinogenic. Please refer to the classification and monograph of each individual substance.
Rationale
Administered locally in the eye and systemic exposure is insignificant.
Chemical description
Tropicamide is a phenylpropylamide.
Phenylephrine is a phenol derivative.
Therapeutic characteristics
Tropicamid in combination with phenylephrine is used to obtain pre-operative mydriasis (dilation of the pupil). It is administered as an ophthalmic insert.
Hepatic exposure
Very low concentrations of phenylephrine and tropicamide were found in eye chamber water, below 6 µg/ml and 3 µg/ml, respectively. Plasma levels of phenylephrine measured during 6 hours in healthy volunteers were not detectable (< 0.5 ng/ml) (SPC).
Plasma levels of phenylephedrine were well below 1 µM and hepatic exposure is therefore insignificant.
Metabolism and pharmacokinetics
In oral administration, phenylephrine is metabolized via monoamine oxidase and sulfotransferase and probably no CYP enzymes are involved. No data is found for the metabolism of tropicamide.
References
| # | Citation details | PMID |
|---|---|---|
| * | Drug interaction databases | |
| 1. | Lexi-Comp in UpToDate. Phenylephrine: Drug information.
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| * | Summary of Product Characteristics | |
| 2. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Mydriasert).
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