Trusopt漆素得

Trusopt

dorzolamide

Manufacturer:

Santen

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Contents
Dorzolamide HCl.
Action
Trusopt (dorzolamide HCl ophthalmic solution, MSD) is a novel carbonic anhydrase inhibitor formulated for topical ophthalmic use. Unlike oral carbonic anhydrase inhibitors, Trusopt, which is administered topically, exerts its effects directly in the eye.
Indications/Uses
Treatment of elevated intraocular pressure in patients with ocular hypertension, open-angle glaucoma, pseudoexfoliative glaucoma and other secondary open-angle glaucomas.
Dosage/Direction for Use
When used as monotherapy, the dose is 1 drop of Trusopt in the affected eye(s) 3 times daily.
When used as adjunctive therapy with an ophthalmic β-blocker, the dose is 1 drop of Trusopt in the affected eye(s) 2 times daily.
When substituting Trusopt for another ophthalmic antiglaucoma agent, discontinue the other agent after proper dosing on 1 day, and start Trusopt on the next day.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least 10 min apart.
Overdosage
Treatment should be symptomatic and supportive. Electrolyte imbalance, development of an acidotic state and possible central nervous system effects may occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
Contraindications
Patients who are hypersensitive to any component of Trusopt.
Special Precautions
Trusopt has not been studied in patients with severe renal impairment (CrCl <30 mL/min). Because dorzolamide HCl and its metabolite are excreted predominantly by the kidney, Trusopt is not recommended in such patients.
The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. Trusopt has not been studied in patients with acute angle-closure glaucoma.
Trusopt has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients.
Dorzolamide HCl is a sulfonamide and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of Trusopt.
In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of Trusopt. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of drug therapy. If such reactions are observed, discontinuation of treatment with Trusopt should be considered.
There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition in patients receiving an oral carbonic anhydrase inhibitor and Trusopt. The concomitant administration of Trusopt and oral carbonic anhydrase inhibitors has not been studied and is not recommended.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (eg, dorzolamide) after filtration procedures.
Trusopt contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Therefore, Trusopt should not be administered while wearing soft contact lenses. The contact lenses should be removed before application of the drops and not be reinserted earlier than 15 min after use.
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Trusopt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Trusopt is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Trusopt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Trusopt is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects
In long-term clinical studies of 1108 patients treated with Trusopt alone or as adjunctive therapy with ophthalmic β-blockers, the most frequently reported drug-related adverse effects and local symptoms were bitter taste, burning and stinging, blurred vision, eye itching, tearing, headache, conjunctivitis, eyelid inflammation, nausea, eyelid irritation and asthenia/fatigue. The most frequent cause of discontinuation (approximately 3%) from treatment with Trusopt was drug-related ocular adverse effects, primarily conjunctivitis and lid reactions. Iridocyclitis and rash were each reported rarely. There was one report of urolithiasis.
In a double-blind, active treatment controlled, multiple dose, 2-period crossover, randomized multiclinic study, the safety profile of preservative-free Trusopt was similar to that of Trusopt ophthalmic solution.
The following adverse reactions have been reported in post-marketing experience: Hypersensitivity: Signs and symptoms of local reactions including palpebral reactions and systemic allergic reactions including angioedema, bronchospasm, urticaria and pruritus.
Nervous System: Dizziness and paresthesia.
Ocular: Pain, redness, superficial punctate keratitis, transient myopia (which resolved upon discontinuation of therapy), eyelid crusting, choroidal detachment following filtration surgery.
Skin/Mucous Membranes: Contact dermatitis, throat irritation, dry mouth.
Urogenital: Urolithiasis.
Laboratory Findings: Trusopt was not associated with clinically meaningful electrolyte disturbances.
Drug Interactions
Specific drug interaction studies have not been performed with Trusopt. In clinical studies, Trusopt was used concomitantly with the following medications without evidence of adverse interactions: Timolol ophthalmic solution, betaxolol ophthalmic solution and systemic medications, including ACE inhibitors, calcium-channel blockers, diuretics, NSAIDs including aspirin, and hormones (eg, estrogen, insulin, thyroxine).
Trusopt is a carbonic anhydrase inhibitor and although administered topically, is absorbed systemically. In clinical studies, Trusopt was not associated with acid-base disturbances. However, these disturbances have been reported with oral carbonic anhydrase inhibitors and have in some instances, resulted in drug interactions (eg, toxicity associated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving Trusopt.
Storage
Store at 15-30°C (59-86°F). Protect from light.
ATC Classification
S01EC03 - dorzolamide ; Belongs to the class of carbonic anhydrase inhibitors. Used in the treatment of glaucoma.
Presentation/Packing
Eye drops 2% (clear, colorless to nearly colorless, slightly viscous soln) x 5 mL.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in