Source: FDA, National Drug Code (US) Revision Year: 2011
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. Its chemical name is (-)1(tert-butylamino)3[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is:
| [α] | 25° 405 nm | in 1.0N HCl (C = 5%) = –12.2° (–11.7° to –12.5°). |
Its molecular formula is C13H24N4O3S•C4H4O4 and its structural formula is:
Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature.
Timolol maleate ophthalmic solution is supplied in two formulations: Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution), which contains the preservative benzalkonium chloride; and Ophthalmic Solution TIMOPTIC (timolol maleate ophthalmic solution), the preservative-free formulation.
Preservative-free Ophthalmic Solution TIMOPTIC is supplied in OCUDOSE, a unit dose container, as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths: Each mL of Preservative-free TIMOPTIC in OCUDOSE 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). The pH of the solution is approximately 7.0, and the osmolarity is 252-328 mOsm. Each mL of Preservative-free TIMOPTIC in OCUDOSE 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate).
Inactive ingredients: monobasic and dibasic sodium phosphate, sodium hydroxide to adjust pH, and water for injection.
| How Supplied |
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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. Manuf. for: ATON PHARMA, Lawrenceville, NJ 08648, USA By: Laboratories Merck Sharp & Dohme-Chibret, 63963 Clermont-Ferrand Cedex 9, France |
| Drug | Countries | |
|---|---|---|
| TIMOPTIC | Austria, Canada, Poland, United States |
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