Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: ophthalmologic, anti-inflammatory ATC Code: S01BC03 The active ingredient of Dicloftil is diclofenac sodium, a non-steroidal anti-inflammatory drug characterized by an intense antiphlogistic and analgesic activity.
In clinical studies, Dicloftil has been shown to inhibit miosis during cataract surgery, reduce inflammation following surgery and trauma or that present in other non-septic inflammatory states. In addition, a clinical trial demonstrated that Dicloftil administered prophylactically to patients who had undergone cataract lens extraction and intraocular lens implantation reduced the frequency of occurrence and intensity of cystoid macular edema.
Daily doses of Dicloftil that are effective by conjunctival instillation (approximately 0.25-0.5 mg diclofenac sodium) correspond to less than 1% of the recommended systemic daily dose recommended for rheumatic indications.

Pharmacokinetic Properties

5.2 Pharmacokinetic Properties
Peak concentrations in the cornea and conjunctiva were evident 30 minutes after instillation of 14C-labeled diclofenac in the rabbit; elimination was rapid and virtually complete after 6 hours. Penetration of diclofenac into the anterior chamber was also confirmed in humans.
No measurable plasma levels of diclofenac sodium were detected after ocular instillation of Dicloftil in humans.