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.
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.
Nausea, diarrhea, dyspepsia, anorexia, and dry mouth.
Systemic lupus erythematosus.
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.
Alopecia and psoriasiform rash or exacerbation of psoriasis.
Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and localized and generalized rash.
Bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections.
Masked symptoms of hypoglycemia in diabetic patients (see WARNINGS).
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.
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.
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 dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest (see also ADVERSE REACTIONS).
Overdosage has been reported with timolol maleate tablets. A 30-year-old female ingested 650 mg of timolol maleate tablets (maximum recommended oral daily dose is 60 mg) and experienced second and third degree heart block. She recovered without treatment but approximately two months later developed irregular heartbeat, hypertension, dizziness, tinnitus, faintness, increased pulse rate, and borderline first degree heart block.
An in vitro hemodialysis study, using 14 C timolol added to human plasma or whole blood, showed that Timolol was readily dialyzed from these fluids; however, a study of patients with renal failure showed that Timolol did not dialyze readily.
Timolol Maleate Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Timolol Maleate Ophthalmic Solution in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be change to one drop of 0.5 percent solution in the affected eye(s) twice a day.
Since in some patients the pressure-lowering response to Timolol Maleate Ophthalmic Solution may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Timolol Maleate Ophthalmic Solution.
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 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. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. (See PRECAUTIONS, Drug Interactions, Beta-adrenergic blocking agents.)
Sterile ophthalmic solution of timolol maleate is a clear, colorless solution.
Timolol maleate ophthalmic solution USP, 0.25% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap
NDC 67877-228-55 5 mL in a 5 mL bottle
NDC 67877-228-11 10 mL in a 10 mL bottle
NDC 67877-228-15 15 mL in a 15 mL bottle
Timolol maleate ophthalmic solution USP, 0.5% timolol equivalent, is supplied in a translucent LDPE plastic ophthalmic dispenser with a yellow polystyrene cap
NDC 67877-229-55 5 mL in a 5 mL bottle
NDC 67877-229-11 10 mL in a 10 mL bottle
NDC 67877-229-15 15 mL in 15 mL bottle
Store at 25° (77°F); excursions permitted 15°C to 30°C (59°F to 86°F) [See USP controlled room temperature]
Protect from freezing. Protect from light.
B-8, M.I.D.C. Waluj,
Dist. Aurangabad 431 136
Maharashtra State, India
Ascend Laboratories, LLC
Montvale, NJ 07645
STERILE OPHTHALMIC SOLUTION USP
(Timolol Maleate 6.8 mg/mL)
Application In The Eye
Manufactured by: FDC Limited
At: B-8, M.I.D.C., Waluj
Dist. Aurangabad 431 136. India
Manufactured for: Ascend Laboratories, LLC
Montvale, NJ 07645
Each mL contains: Timolol maleate equivalent to 5mg timolol.
See accompanying Package Insert
Protect from freezing.
Protect from light.
Retain in carton until time of use.Mfg. Lic. No. 1032
|TIMOLOL MALEATE timolol maleate solution|
|Labeler — Ascend Laboratories, LLC (141250469)|
|FDC Limited||862267994||manufacture (67877-229)|
Revised: 12/2018 Ascend Laboratories, LLC
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