Trusopt 20mg Ophthalmic Solution

TRUSOPT u00ae 2 % 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
• and in the short term treatment of paediatric glaucomas as adjunctive therapy to beta-blockers and for monotherapy

When used as monotherapy, the dose is one drop of TRUSOPT u00ae 2 % Ophthalmic Solution in the affected eye(s) 3 times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of TRUSOPT u00ae 2 % in the affected eye(s) 2 times daily. When substituting TRUSOPT u00ae 2 % for another ophthalmic anti-glaucoma agent, discontinue the other agent after proper dosing in one day, and start TRUSOPT u00ae 2 % on the next day. If more than one topical ophthalmic medicine is being used, the medicines should be administered at least 10 minutes apart.

TRUSOPT u00ae 2 % is contra-indicated in patients who are hypersensitive to any component of this product. TRUSOPT u00ae 2 % has not been studied in patients with moderate progressing to severe renal impairment (CrCl < 30 ml/min). Because TRUSOPT u00ae 2 % and its metabolite are excreted predominantly by the kidney, TRUSOPT u00ae 2 % is not recommended in such patients. TRUSOPT u00ae 2 % has not been studied in patients with hepatic impairment and should therefore be used with caution in such patients. TRUSOPT u00ae 2 % has not been studied in patients wearing contact lenses. TRUSOPT u00ae 2 % Ophthalmic Solution contains the preservative, benzalkonium chloride, which may be absorbed by soft contact lenses. Therefore, TRUSOPT u00ae 2 % should not be administered while wearing soft contact lenses.

As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease. The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. TRUSOPT u00ae 2 % has not been studied in patients with acute angle-closure glaucoma. TRUSOPT u00ae 2 % is a sulphonamide and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulphonamides may occur with TRUSOPT u00ae 2 %. Fatalities have occurred, although rarely, due to severe reactions to sulphonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Sensitisation may recur when a sulphonamide is re-administered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of TRUSOPT u00ae 2 %. In clinical studies, local ocular adverse effects, primarily conjunctivitis and lid reactions, were reported with chronic administration of TRUSOPT u00ae 2 %. Some of these reactions had the clinical appearance and course of an allergic-type reaction that resolved upon discontinuation of therapy. If such reactions are observed, treatment with TRUSOPT u00ae 2 % should be discontinued and the patient evaluated before considering restarting the medicine. 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 u00ae 2 %. The concomitant administration of TRUSOPT u00ae 2 % and oral carbonic anhydrase inhibitors has not been studied and is not recommended. There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing TRUSOPT u00ae 2 % to this group of patients. Choroidal detachment has been reported with the administration of TRUSOPT u00ae 2 % after filtration procedures. Use in the Elderly: Of the total number of patients in clinical studies of TRUSOPT u00ae 2 %, 44 % were 65 years of age and over, while 10 % were 75 years of age and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals to the product cannot be ruled out.

Specific interaction studies have not been performed with TRUSOPT u00ae 2 % Ophthalmic Solution. In clinical studies, TRUSOPT u00ae 2 % 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, non-steroidal anti-inflammatory drugs including aspirin, and hormones (e.g. oestrogen, insulin, thyroxine). TRUSOPT u00ae 2 % is a carbonic anhydrase inhibitor and although administered topically, is absorbed systemically. In clinical studies, TRUSOPT u00ae 2 % 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 interactions (e.g. toxicity associated with high-dose salicylate therapy). Therefore, the potential for such interactions should be considered in patients receiving TRUSOPT u00ae 2 %.

Pregnancy: There are not adequate and well-controlled studies in pregnant women. TRUSOPT u00ae 2 % should not be used during pregnancy. In rabbits given maternotoxic doses associated with metabolic acidosis u2265 2,5 mg/kg/day, malformation of the vertebral bodies were observed. Lactation: Safety during breast-feeding has not been established.

There are side effects associated with this product that may affect your ability to drive or operate machinery (see u201cPOSSIBLE SIDE EFFECTSu201d).

TRUSOPT u00ae 2 % was evaluated in more than 1 400 individuals in controlled and uncontrolled clinical studies. In long term studies of 1 108 patients treated with TRUSOPT u00ae 2 % as monotherapy or as adjunctive therapy with an ophthalmic beta-blocker, the most frequent cause of discontinuation (approximately 3 %) from treatment with TRUSOPT u00ae 2 % was drug-related ocular adverse effects, primarily conjunctivitis and lid reactions. Paediatric Patients: The most frequent adverse events associated with TRUSOPT u00ae 2 % in patients younger than 2 years of age were ocular injection (5,4 %) and eye discharge (3,6 %). In patients older than 2 years of age, but younger than 6 years the most frequent adverse events associated with TRUSOPT u00ae 2 % were burning/stinging in the eye (12,1 %), ocular injection (7,6 %), eye pain (3 %) and eyelid inflammation (3 %). The following adverse reactions have been reported in post-marketing experience: Very common (u2265 1/10), Common (u2265 1/100, < 1/10), Uncommon (u2265 1/1 000, < 1/100) and Rare (u2265 1/10 000, < 1/1 000) Nervous system and psychiatric disorders: Common: Headache; Rare: Dizziness, paraesthesia. Eye Disorders: Very common: Burning and stinging eyes; Common: Superficial punctuate keratitis, tearing, conjunctivitis, eyelid inflammation, eye itching, eyelid irritation, blurred vision; Uncommon: Iridocyclitis; Rare: Irritation including redness, pain, eyelid crusting, transient myopia (which resolved upon discontinuation of therapy), corneal oedema, ocular hypotony, choroidal detachment following filtration surgery. Respiratory, thoracic and mediastinal disorders: Rare: Epistaxis. Gastrointestinal disorders: Common: Nausea, bitter taste; Rare: Dry mouth. Renal disorders: Rare: Urolithiasis. Immune system disorders: Rare: Hypersensitivity: Signs and symptoms of local reactions (palpebral reactions) and systemic allergic reactions including angioedema, urticaria and pruritus, rash, shortness of breath, rarely bronchospasm. General disorders and administration site conditions: Common: Asthenia/fatigue. Skin disorders: Rare: Stevens-Johnson syndrome, toxic epidermal necrolysis. Laboratory Findings: TRUSOPT u00ae 2 % was not associated with clinically meaningful electrolyte disturbances.

Limited data are available in humans in regard to overdosage by accidental or deliberate ingestion. 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.