Label: TIMOLOL MALEATE solution

  • NDC Code(s): 82260-496-05
  • Packager: Bausch & Lomb Americas Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application Authorized Generic

Drug Label Information

Updated March 5, 2025

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    PRESERVATIVE-FREE STERILE - OPHTHALMIC SOLUTION - in a Sterile Ophthalmic - Unit Dose Dispenser
  • DESCRIPTION
    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 ...
  • CLINICAL PHARMACOLOGY
    Mechanism of Action - Timolol maleate is a beta - 1and beta - 2(non-selective) adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial ...
  • INDICATIONS AND USAGE
    Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle ...
  • CONTRAINDICATIONS
    Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive ...
  • WARNINGS
    As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur ...
  • PRECAUTIONS
    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 ...
  • 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 ...
  • OVERDOSAGE
    There have been reports of inadvertent overdosage with Timolol Maleate Ophthalmic Solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as ...
  • DOSAGE AND ADMINISTRATION
    Preservative-free Timolol Maleate Ophthalmic Solution in OCUDOSE is a sterile solution that does not contain a preservative. The solution from one individual unit is to be used immediately after ...
  • HOW SUPPLIED
    Preservative-free Sterile Timolol Maleate Ophthalmic Solution in OCUDOSE - ®is a clear, colorless to light yellow solution. Preservative-free Timolol Maleate Ophthalmic Solution, 0.5% timolol ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    NDC82260-496-05 - Timolol Maleate Ophthalmic Solution in OCUDOSE - ® 0.5% (DISPENSER) Timolol Equivalent (Timolol Maleate 6.8 mg/mL) [Eye Image] Rx only - FOR TOPICAL ...
  • INGREDIENTS AND APPEARANCE
    Product Information