Friday, September 13, 2013

BETOPTIC (rest of pamphlet)

BETOPTIC (rest of pamphlet)
34453-E 
Pulmonary; BETOPTIC® OPHTHALMIC SOLUTION, a cardioselective beta-blocker, has produced only minimal effects in patients with reactive airway disease. However, caution should be exercised in the treatment of patients with excessive restriction of pulmonary function. 
Drug Interactions: Although BETOPTIC OPHTHALMIC SOLUTION used alone has little or no effect on pupil size, mydriasis resulting from concomitanttherapy with BETOPTIC OPHTHALMIC SOLUTION and epinephrine has been reported occasionally. 
Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholaminedepleting drugs such as reserpine. because of-possible additive effect and the production of hypotension and/or bradycardia. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs. 
Ocular: In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent. Betaxolol has no effect on the pupil therefore, BETOPTIC OPHTHALMIC SOLUTION should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma. 
As with the use of other anti-glaucoma drugs, diminished responsiveness to BETOPTIC OPHTHALMIC SOLUTION after prolonged therapy has been reported in some patients. However, in one long-term study in which 250 patients have been followed for up to three years, no significant difference in mean-intraocular pressure has been observed after initial stabi lization 
- Usage in Pregnancy and Nursing Mothers: As with any drug, BETOPTIC OPHTHALMIC SOLUTION should be used by women who are pregnant or nursing only when the anticipated benefits outweigh the risks. 
Usage in Children: Clinical studies to establish the safety and efficacity in children have not been performed. 
I 
ADVERSE REACTIONS: 
The following adverse reactions have been reported in clinical trials of up to 4 years of patient experience with BETOPTIC 
OPHTHALMIC SOLUTION. 
Ocular: BETOPTIC OPHTHALMIC SOLUTION has been well tolerated. Discomfort of short duration may be experienced in some patients upon instillation and occasional tearing has been reported. Rare instances of decreased corneal sensitivity, erythema, itching sensation, corneal punctate staining, keratitis, anisocoria and photophobia have been reported. Systemic: Systemic reactions following topical administration of BETOPTIC OPHTHALMIC SOLUTION have been reported rarely (e.g. insomnia and depressive neurosis) 
DOSAGE AND ADMINISTRATION: The usual dose is one drop of BETOPTIC OPHTHALMIC SOLUTION in the affected eye(s) twice daily. In some patients, the intraocularpressure lowering response to BETOPTIC OPHTHALMIC SOLUTION may require a fewweeks to stabilize. Clinical follow up should include a determination of the intraocular pressure during the first month of treatment with BETOPTIC OPHTHALMIC SOLUTION. Thereafter, intraocular pressures should be determined on an individual basis at 
thejudgementofthephysician. 
-- - When a patient is transferred from a single anti-glaucoma agent, continue the agent already used and add drop BETOPTIC OPHTHALMIC SOLUTION in theaffected eye(s) twice a day. On thefollowing day, discontinue the previous anti-glaucoma agent completely and continue with BETOPTIC OPHTHALMIC SOLUTION. 
If the intraocular pressure of the patient is not adequately controlled on this regimen, concomitant therapy with pilocarpine, other miotics, epinephrine or systemically administered carbonic anhydrase inhibitors can be instituted. 
When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. Adjustment should involve one agent ala lime made at intervals of not less than one week. 
STORAGE: Store at room temperature. 
Keep out of reach of children. 
Discard one month after opening. 
HOW SUPPLIED: In 5 ml white opaque plastic ophthalmic DROPTAINER® Dispensers. 
Alcon ALCON-COUVREUR B-2870 PUUrS (Belgium) i096 34453-E