TRUSOPT Ophthalmic Solution is indicated in the treatment of elevated intraocular
pressure in patients with:
ocular hypertension
open-angle glaucoma
 pseudoexfoliative glaucoma and other secondary open-angle glaucomas

When used as monotherapy, the dose is one drop of TRUSOPT Ophthalmic Solution in the
affected eye(s) three times daily.
When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of
TRUSOPT in the affected eye(s) two times daily.
When substituting TRUSOPT for another ophthalmic antiglaucoma agent, discontinue the
other agent after proper dosing on one 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 ten minutes apart.
Preservative-Free TRUSOPT is a sterile solution that does not contain a preservative. The
solution from one individual unit is to be used immediately after opening for administration
to one or both eyes. Since sterility cannot be maintained after the individual unit is opened,
any remaining contents should be discarded immediately after administration.

TRUSOPT is contraindicated in patients who are hypersensitive to any component of this
product.

TRUSOPT has not been studied in patients with severe renal impairment (CrCl < 30
mL/min). Because TRUSOPT 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.

TRUSOPT 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 this preparation.

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 (e.g., dorzolamide) after filtration procedures.

TRUSOPT Ophthalmic Solution 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 minutes after use.

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.

It is not known whether this drug 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.

Safety and effectiveness in children have not been established.

Specific drug interaction studies have not been performed with TRUSOPT Ophthalmic
Solution. In clinical studies, TRUSOPT was used concomitantly with the following
medications without evidence of adverse interactions: timolol ophthalmic solution, betaxolo lophthalmic solution and systemic medications, including ACE-inhibitors, calcium channelblockers, diuretics, non-steroidal anti-inflammatory drugs including aspirin, and hormones (e.g. 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 (e.g. toxicit yassociated with high-dose salicylate therapy). Therefore, the potential for such drug interactions should be considered in patients receiving TRUSOPT.

In the previous long-term clinical studies of 1108 patients treated with TRUSOPT
Ophthalmic Solution alone or as adjunctive therapy with ophthalmic beta-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, two-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, 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, epistaxis, throat irritation, dry mouth
Urogenital: urolithiasis.

TRUSOPT was not associated with clinically meaningful electrolyte disturbances.

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.

[To be filled in locally.]
TRUSOPT Ophthalmic Solution is a clear, colorless to nearly colorless, slightly viscous
solution.
For patients who may be sensitive to the preservative benzalkonium chloride or when use of a preservative-free topical medication is advisable, a formulation of TRUSOPT without the preservative benzalkonium chloride is available. This formulation is packaged in individual unit dose containers.

TRUSOPT Ophthalmic Solution:
Store at 15-30.... ........F). Protect from light.

Preservative-Free TRUSOPT Ophthalmic Solution:
Store at 15-30.... ........F). Protect from light. Store in protective foil pouch.tored.