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Timoptic in Ocudose

"Glaucoma is a group of diseases that damage the optic nerve, a cable at the back of each eye that connects it to the brain. It affects more than 2.7 million people in the United States and more than 60 million worldwide. There are many forms of t"...

Timoptic in Ocudose

Timoptic in Ocudose

INDICATIONS

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 be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

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 or both eyes. Since sterility cannot be guaranteed after the individual unit is opened, the remaining contents should be discarded immediately after administration.

Preservative-free TIMOPTIC in OCUDOSE is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Preservative-free TIMOPTIC in OCUDOSE in the affected eye(s) administered twice a day. Apply enough gentle pressure on the individual container to obtain a single drop of solution. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) administered twice a day.

Since in some patients the pressure-lowering response to Preservative-free TIMOPTIC in OCUDOSE may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Preservative-free TIMOPTIC in OCUDOSE.

If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Dosages above one drop of 0.5 percent TIMOPTIC (timolol maleate ophthalmic solution) twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted taking into consideration that the preparation(s) used concomitantly may contain one or more preservatives. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS: DRUG INTERACTIONS, Beta-adrenergic blocking agents.)

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, a clear low density polyethylene unit dose container. Each individual unit contains 0.2 mL of solution, and is available in a foil laminate overwrapped pouch as follows:

NDC 25010-814-66; 60 Individual Unit Doses.

No. 815- Preservative-free TIMOPTIC, 0.5% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.2 mL of solution, and is available in a foil laminate overwrapped pouch as follows:

NDC 25010-815-66; 60 Individual Unit Doses.

Storage

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 direct light can modify the product, the unit dose container should be kept in the protective foil overwrap and used within one month after the foil package has been opened.

Manuf. for: Aton Pharma, Lawrenceville NJ 08648 USA. By: Laboratories Merck Sharp & Dohme-Chibret 63963 Clermont-Ferrand Cedex 9, France. Issued February 2009

Last reviewed on RxList: 10/11/2011
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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