Timolol eye drops are formulated with the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. Updated If you are a consumer or patient please visit When suggestions are available use up and down arrows to review and ENTER to select. Timolol Maleate Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Timolol maleate has been detected in human milk following oral and ophthalmic drug administration.Because of the potential for serious adverse reactions from Timolol Maleate Ophthalmic Solution in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.Safety and effectiveness in pediatric patients have not been established.No overall differences in safety or effectiveness have been observed between elderly and younger patients.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: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.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 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: 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 Overdosage has been reported with timolol maleate tablets.
None of the patients received concomitant local or oral drugs. Registration Status . The mean peak plasma concentration following morning dosing was 0.46 ng/mL and following afternoon dosing was 0.35 ng/mL.In controlled multiclinic studies in patients with untreated intraocular pressures of 22 mmHg or greater, Timolol Maleate Ophthalmic Solution 0.25 percent or 0.5 percent administered twice a day produced a greater reduction in intraocular pressure than 1, 2, 3, or 4 percent pilocarpine solution administered four times a day or 0.5, 1, or 2 percent epinephrine hydrochloride solution administered twice a day.In these studies, Timolol Maleate Ophthalmic Solution was generally well tolerated and produced fewer and less severe side effects than either pilocarpine or epinephrine. Patients should also be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.Unit 6 Fulcrum1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FETo bookmark a medicine you must sign up and log in.To view the changes to a medicine you must sign up and log in. To reduce the systemic absorption, see section 4.2. 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) 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). Dosage Form/Route Marketing Status TE Code RLD RS; TIMOLOL MALEATE: TIMOLOL MALEATE: EQ 0.25% BASE: SOLUTION/DROPS;OPHTHALMIC: Prescription: AT: No: No: TIMOLOL MALEATE: TIMOLOL MALEATE: EQ 0.5% BASE: SOLUTION/DROPS;OPHTHALMIC: Prescription : AT1: No: No: Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078771. Peyronie's disease.Reporting suspected adverse reactions after authorisation of the medicinal product is important. In the assays with tester strain TA100, no consistent dose-response relationship was observed, nor did the ratio of test to control revertants reach 2. August 21, 2020