Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Preservative-free Sterile Ophthalmic Solution TIMOPTIC ® in OCUDOSE ® is a clear, colorless to light yellow solution. Preservative-free TIMOPTIC, 0.25% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 24208-498-34; 60 Individual Unit Doses. Preservative-free TIMOPTIC, 0.5% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 24208-499-68; 60 Individual Unit Doses. Storage Store at room temperature, 15°C to 30°C (59°F to 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. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Laboratoire Unither 1 rue de l’Arquerie 50200 Coutances France TIMOPTIC and OCUDOSE are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates Revised: 01/2022 65NOT8556/D 9390305; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-498-34 Rx only TIMOPTIC ® in OCUDOSE ® (timolol maleate ophthalmic solution) (DISPENSER) 0.25% Timolol Equivalent (Timolol Maleate 3.4 mg/mL) 60 x 0.3 mL UNIT DOSES FOR TOPICAL APPLICATION IN THE EYE PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION Keep out of reach of children. BAUSCH + LOMB carton25; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-499-68 Rx only TIMOPTIC ® in OCUDOSE ® (timolol maleate ophthalmic solution) (DISPENSER) 0.5% Timolol Equivalent (Timolol Maleate 6.8 mg/mL) 60 x 0.3 mL UNIT DOSES FOR TOPICAL APPLICATION IN THE EYE PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION Keep out of reach of children. BAUSCH + LOMB carton5
- HOW SUPPLIED Preservative-free Sterile Ophthalmic Solution TIMOPTIC ® in OCUDOSE ® is a clear, colorless to light yellow solution. Preservative-free TIMOPTIC, 0.25% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 24208-498-34; 60 Individual Unit Doses. Preservative-free TIMOPTIC, 0.5% timolol equivalent, is supplied in OCUDOSE, a clear low density polyethylene unit dose container. Each individual unit contains 0.3 mL of solution, and is available in a foil laminate overwrapped pouch as follows: NDC 24208-499-68; 60 Individual Unit Doses. Storage Store at room temperature, 15°C to 30°C (59°F to 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. Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Laboratoire Unither 1 rue de l’Arquerie 50200 Coutances France TIMOPTIC and OCUDOSE are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2022 Bausch & Lomb Incorporated or its affiliates Revised: 01/2022 65NOT8556/D 9390305
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-498-34 Rx only TIMOPTIC ® in OCUDOSE ® (timolol maleate ophthalmic solution) (DISPENSER) 0.25% Timolol Equivalent (Timolol Maleate 3.4 mg/mL) 60 x 0.3 mL UNIT DOSES FOR TOPICAL APPLICATION IN THE EYE PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION Keep out of reach of children. BAUSCH + LOMB carton25
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 24208-499-68 Rx only TIMOPTIC ® in OCUDOSE ® (timolol maleate ophthalmic solution) (DISPENSER) 0.5% Timolol Equivalent (Timolol Maleate 6.8 mg/mL) 60 x 0.3 mL UNIT DOSES FOR TOPICAL APPLICATION IN THE EYE PRESERVATIVE-FREE STERILE OPHTHALMIC SOLUTION Keep out of reach of children. BAUSCH + LOMB carton5
Overview
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: Its molecular formula is C 13 H 24 N 4 O 3 S•C 4 H 4 O 4 , and its structural formula is: Timolol maleate has a molecular weight of 432.49. It is a white, odorless, crystalline powder which is soluble in water; sparingly soluble in ethanol; slightly soluble in chloroform; practically insoluble in ether. 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. chem structure formula
Indications & 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 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 & 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%. The usual starting dose is one drop of 0.25% 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% 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% 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 ).
Warnings & Precautions
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 with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate (see CONTRAINDICATIONS ). Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In Patients without a History of Cardiac Failure continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Preservative-free TIMOPTIC in OCUDOSE should be discontinued. Obstructive Pulmonary Disease Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which TIMOPTIC in OCUDOSE is contraindicated [see CONTRAINDICATIONS ]) should, in general, not receive beta-blockers, including Preservative-free TIMOPTIC in OCUDOSE. Major Surgery The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists. Diabetes Mellitus Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. Thyrotoxicosis Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
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 bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure (see WARNINGS ); (7) cardiogenic shock; or (8) hypersensitivity to any component of this product.
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 less frequently with ocular administration of this or other timolol maleate formulations: Body as a Whole Headache, asthenia/fatigue, and chest pain. Cardiovascular Bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet. Digestive Nausea, diarrhea, dyspepsia, anorexia, and dry mouth. Immunologic Systemic lupus erythematosus. Nervous System/Psychiatric Dizziness, increase in signs and symptoms of myasthenia gravis, paresthesia, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including depression, confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss. Skin Alopecia and psoriasiform rash or exacerbation of psoriasis. Hypersensitivity Signs and symptoms of systemic allergic reactions including anaphylaxis, angioedema, urticaria, and localized and generalized rash. Respiratory Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections. Endocrine Masked symptoms of hypoglycemia in diabetic patients ( see WARNINGS ). Special Senses Signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery (see PRECAUTIONS , General ); and tinnitus. Urogenital Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie’s disease. The following additional adverse effects have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents, and may be considered potential effects of ophthalmic timolol maleate: Allergic : Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole : Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular : Worsening of arterial insufficiency, vasodilatation; Digestive : Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; Endocrine : Hyperglycemia, hypoglycemia; Skin : Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal : Arthralgia; Nervous System/Psychiatric : Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory : Rales, bronchial obstruction; Urogenital : Urination difficulties. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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