TIMOPTIC Ophthalmic solution (2011)
Βιβλιογραφική αναφορά
Συγγραφείς
Aton Pharma, Inc.
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1. Description
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)1(<em>tert</em>-butylamino)3[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). ...
2. Clinical Pharmacology
Mechanism of Action Timolol maleate is a beta<sub>1</sub> and beta<sub>2</sub> (non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial ...
3. Indications and Usage
Preservative-free TIMOPTIC in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free TIMOPTIC in OCUDOSE may ...
4. Contraindications
Preservative-free TIMOPTIC in OCUDOSE is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease (see WARNINGS); (4) sinus ...
5. Warnings
As with many topically applied ophthalmic drugs, this drug is absorbed systemically. <b>The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical ...
6. Precautions
Angle-closure glaucoma In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil. Timolol maleate has little or no effect ...
6.1. General
Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms ...
6.2. Information for Patients
Patients should be instructed about the use of Preservative-free TIMOPTIC in OCUDOSE. Since sterility cannot be maintained after the individual unit is opened, patients should be instructed to use the ...
6.4. Drug Interactions
Although TIMOPTIC (timolol maleate ophthalmic solution) used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with TIMOPTIC (timolol maleate ophthalmic solution) ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
In a two-year oral study of timolol maleate administered orally to rats, there was a statistically significant increase in the incidence of adrenal pheochromocytomas in male rats administered 300 mg/kg/day ...
6.7. Pregnancy
Pregnancy Category C. Teratogenicity studies with timolol in mice, rats and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic ...
6.9. Nursing Mothers
Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from timolol in nursing infants, a decision should ...
6.10. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
6.11. Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
7. Adverse Reactions
The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients). The following additional adverse experiences have been reported ...
9. Overdosage
There have been reports of inadvertent overdosage with Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution) resulting in systemic effects similar to those seen with systemic beta-adrenergic ...
10. Dosage and Administration
Preservative-free TIMOPTIC in OCUDOSE 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 ...
11. How Supplied
Preservative-free Sterile Ophthalmic Solution TIMOPTIC in OCUDOSE is a clear, colorless to light yellow solution. No. 814 Preservative-free TIMOPTIC, 0.25% timolol equivalent, is supplied in OCUDOSE, ...
12. Storage and Handling
Store at room temperature, 15-30°C (59-86°F). Protect from freezing. Protect from light. Because evaporation can occur through the unprotected polyethylene unit dose container and prolonged exposure to ...