terminology and guidelines for glaucoma ii - Kwaliteitskoepel
terminology and guidelines for glaucoma ii - Kwaliteitskoepel
terminology and guidelines for glaucoma ii - Kwaliteitskoepel
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3.3.1.5 - Category: PROSTAGLANDIN DERIVATIVES AND PROSTAMIDES 47,53-73<br />
Generics<br />
Tradenames<br />
Topical: Bimatoprost 0.03% Lumigan<br />
Latanoprost 0.005% Xalatan<br />
Travoprost 0.004% Travatan<br />
Unoprostone 0.12%, 0.15% Rescula<br />
Lumigan ® Xalatan ® Travatan ® Rescula ®<br />
Active ingredient* Bimatoprost Latanoprost Travoprost Unoprostone<br />
Category Prostamide Prostagl<strong>and</strong>in Prostagl<strong>and</strong>in Docosanoid<br />
Formulation 0.03% 0.005% 0.004% 0.12%, 0.15%<br />
Preservative BAC 0.05 mg/ml BAC 0.2 mg/ml BAC 0.15 mg/ml BAC 0.1 mg/ml<br />
0.005% 0.002% 0.015% 0.01%<br />
Dosage Once daily Once daily Once daily Twice daily<br />
*in alphabetic order<br />
Action<br />
For bimatoprost, latanoprost <strong>and</strong> travoprost the most evident action is the increase of the uveo-scleral outflow, reducing<br />
IOP 20% - 35%.<br />
The IOP lowering effect of unoprostone is up to 18% from baseline. Unoprostone 0.12% has been available in Japan<br />
since 1994.<br />
Pressure lowering effect: 53-61 Bimatoprost 7-8 mmHg (baseline 26 mmHg)<br />
Latanoprost 6-8 mmHg (baseline 24-25 mmHg)<br />
Travoprost 7-8 mmHg (baseline 25-27 mmHg)<br />
Unoprostone 3-4 mmHg (baseline 24-25 mmHg)<br />
Reduction of the intraocular pressure starts approximately 2-4 hours after the first administration with peak effect<br />
reached within approximately 8 to 12 hours. Maximum IOP lowering is often achieved 3 to 5 weeks from commencement<br />
of treatment<br />
Dosage <strong>and</strong> administration<br />
Bimatoprost 0.03%, latanoprost 0.005% or travoprost 0.004% solution: once daily, preferably in the evening.<br />
Unoprostone 0.12% <strong>and</strong> 0.15% BID.<br />
Indications<br />
Latanoprost has received European (EMEA) <strong>and</strong> FDA approval as first line drug <strong>for</strong> reducing intraocular pressure<br />
(IOP) in patients with open-angle <strong>glaucoma</strong> or ocular hypertension. A similar application as first-line treatment <strong>for</strong><br />
bimatoprost <strong>and</strong> travoprost have now also been made to the European regulatory agencies. The CPMP extended<br />
the indication <strong>for</strong> travoprost to first-line treatment in April 2003.<br />
There are only few published clinical trials with bimatoprost, latanoprost, travoprost <strong>and</strong> unoprostone in treating<br />
angle-closure <strong>glaucoma</strong>, inflammatory or neovascular <strong>glaucoma</strong>. Most of the large clinical trials of unoprostone are<br />
on the Japanese population.<br />
The prostagl<strong>and</strong>in analogues <strong>and</strong> prostamides (bimatoprost, latanoprost, travoprost <strong>and</strong> unoprostone) appear to be<br />
effective, well-tolerated agents <strong>for</strong> the reduction of intraocular pressure (IOP) in patients with primary open-angle<br />
<strong>glaucoma</strong> <strong>and</strong> ocular hypertension; most of the long-term data are published on latanoprost.<br />
This drug class offers potential as first choice drugs or an alternative <strong>for</strong> patients who do not achieve control the target<br />
IOP with another topical anti<strong>glaucoma</strong> agent or <strong>for</strong> those with a contraindication to initial therapy with beta-<br />
Ch. 3 - 18 EGS