Monograph
S01GX09 - Olopatadine |
Not porphyrinogenic |
NP |
Rationale
Olophatadine is administered locally in the eye and the hepatic exposure is insignificant.
Chemical description
Selective histamine H1-receptor antagonist
Therapeutic characteristics
Olophatadine eye drops are antihistamines used in the treatment of ocular signs and symptoms in seasonal allergic conjunctivitis. One drop is administered in the eye twice daily for a period of up to four months.
Hepatic exposure
Plasma concentrations are well below 1 µM (SPC).
Metabolism and pharmacokinetics
In oral administration the drug is mainly excreted in the urine as unchanged drug.
In vitro studies indicate that olopatadine is a substrate of CYP3A4 and that it has no inhibitory effects on CYP 1A2, 2C8/2C9, CYP2C19, CYP2D6, CYP2E1 and CYP3A4 (Ohmori 2002, SPC)
IPNet drug reports
Uneventful use reported in 1 patient with acute porphyria.
References
| # | Citation details | PMID |
|---|---|---|
| * | Scientific articles | |
| 1. | Ohmori K, Pharmacological, Pharmacokinetic and Clinical Properties of Olopatadine Hydrochloride, a New Antiallergic Drug, 2002, Jpn. J. Pharmacol. 88, 379 – 397
|
|
| * | Summary of Product Characteristics | |
| 2. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Opatanol.
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