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SANDOZ TIMOLOL is a brand name for Timolol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Timolol is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with: • Chronic open glaucoma. • Ocular hypertension. • Aphakic patients with glaucoma, including those wearing contact lenses. • Narrow angles and a history of spontaneous or iatrogenically-induced narrow-angle…
Verbatim from this product's HC label. Tap a section to expand.
25% Sandoz Timolol in the affected eye(s) twice a day. 5% Sandoz Timolol twice a day if the clinical response is not adequate. 25% Sandoz Timolol in each affected eye(s) twice a day. On the following day, discontinue the previously used anti-glaucoma agent completely and continue with Sandoz Timolol.
5% solution in each affected eye(s) twice a day. When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other anti- glaucoma agents.
Adjustments should involve one agent at a time. 25% solution in the affected eye(s) twice a day. 5% solution in each affected eye(s) twice a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with Sandoz Timolol.
Other topically applied medications should be administered at interval of not less than 10 minutes. Since in some patients the IOP-lowering response to Sandoz Timolol Solution may require a few weeks to stabilize, evaluation should include a determination of IOP after approximately 4 weeks of treatment with Sandoz Timolol.
If IOP is maintained at satisfactory levels, the dosage schedule may be changed to one drop a day in the affected eye(s). Because of naturally occurring diurnal variations in IOP, satisfactory response to the once-a-day dose is best determined by measuring IOP at different times during the day.
4 Administration Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events.
To avoid contamination, patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. The contents should not be used for more than one month after the date on which the container is first opened.
If using another eye medication, use it at least 10 minutes before or after the use of Sandoz Timolol. 5 Missed Dose Patients who miss a dose, should be advised to apply it as soon as possible. However, if it is almost time for the next dose, patients are advised to skip the missed dose and go back to regular dosing schedule to avoid doubling the dose.
4%). Other ocular adverse reactions occurring with a frequency of at least 1% were eye pain, ocular discomfort, and vision blurred. Timolol ophthalmic solution is usually well tolerated. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the adverse reaction rates observed in the clinical trials, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
, anxiety, confusion, disorientation, hallucinations, nervousness, somnolence and other psychic disturbances), dry mouth, dyspepsia, hypertension, macular edema, nasal congestion, and retroperitoneal fibrosis. Adverse reactions reported in clinical experience with oral timolol may be considered potential side effects of ophthalmic timolol.
5 Post-Market Adverse Reactions Eye disorders: choroidal detachment (following filtration surgery), eyelid ptosis. Cardiac disorders: cardiac arrest, atrioventricular block (complete, lower degree or aggravation), arrhythmia, palpitations.
Sandoz Timolol Page 11 of 25 Gastrointestinal disorders: vomiting, diarrhea, nausea. Immune system disorders: angioedema, hypersensitivity. Metabolism and nutrition disorders: hypoglycemia. Musculoskeletal and connective tissue disorders: arthropathy.
Nervous system disorders: cerebrovascular accident, syncope, paresthesia. Psychiatric disorders: insomnia, amnesia, nightmares. Reproductive system and breast disorders: sexual dysfunction. Skin and subcutaneous tissue disorders: urticaria, psoriasis, rash, alopecia.
Vascular disorders:
Raynaud’s phenomenon.
, ophthalmologic). 1 Pediatrics Sandoz Timolol is not recommended for use in children or adolescents. The safety and effectiveness of Sandoz Timolol in pediatric patients < 18 years of age have not been established.
Pediatrics (< 18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
2 CONTRAINDICATIONS Sandoz Timolol is contraindicated in patients with: • Hypersensitivity to timolol or any ingredient in the formulation or component of the container (see 6 Dosage forms, Strengths, Composition and Packaging). • Hypersensitivity to other beta-blockers.
• Bronchospasm, including bronchial asthma, a history of bronchial asthma, or chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sinoatrial block, second and third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
25% Sandoz Timolol in the affected eye(s) twice a day. 5% Sandoz Timolol twice a day if the clinical response is not adequate. 25% Sandoz Timolol in each affected eye(s) twice a day. On the following day, discontinue the previously used anti-glaucoma agent completely and continue with Sandoz Timolol.
5% solution in each affected eye(s) twice a day. When a patient is transferred from several concomitantly administered anti-glaucoma agents, individualization is required. The physician may be able to discontinue some or all of the other anti- glaucoma agents.
Adjustments should involve one agent at a time. 25% solution in the affected eye(s) twice a day. 5% solution in each affected eye(s) twice a day. If the patient’s IOP is still not at a satisfactory level on this regimen, concomitant therapy with miotics, epinephrine and systemically administered carbonic anhydrase inhibitors may be instituted with Sandoz Timolol.
Sandoz Timolol is contraindicated in patients with: • Hypersensitivity to timolol or any ingredient in the formulation or component of the container (see 6 Dosage forms, Strengths, Composition and Packaging). • Hypersensitivity to other beta-blockers.
• Bronchospasm, including bronchial asthma, a history of bronchial asthma, or chronic obstructive pulmonary disease. • Sinus bradycardia, sick sinus syndrome, sinoatrial block, second and third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Timolol in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Sandoz timolol Page 6 of 25
Other topically applied medications should be administered at interval of not less than 10 minutes. Since in some patients the IOP-lowering response to Sandoz Timolol Solution may require a few weeks to stabilize, evaluation should include a determination of IOP after approximately 4 weeks of treatment with Sandoz Timolol.
If IOP is maintained at satisfactory levels, the dosage schedule may be changed to one drop a day in the affected eye(s). Because of naturally occurring diurnal variations in IOP, satisfactory response to the once-a-day dose is best determined by measuring IOP at different times during the day.
4 Administration Nasolacrimal occlusion or gently closing the eyelid for 2 minutes after instillation is recommended. This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic adverse events.
To avoid contamination, patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures. The contents should not be used for more than one month after the date on which the container is first opened.
If using another eye medication, use it at least 10 minutes before or after the use of Sandoz Timolol. 5 Missed Dose Patients who miss a dose, should be advised to apply it as soon as possible. However, if it is almost time for the next dose, patients are advised to skip the missed dose and go back to regular dosing schedule to avoid doubling the dose.
Sandoz timolol Page 6 of 25 5 OVERDOSAGE No data are available in regard to overdosage in humans. The most common signs and symptoms to be expected with overdosage with administration of a systemic beta-adrenergic receptor blocking agent are symptomatic bradycardia, hypotension, bronchospasm, and acute cardiac failure.
The following therapeutic measures should be considered: 1) Gastric lavage: if ingested. 25 mg to 2 mg to induce vagal blockade. If bradycardia persists, intravenous isoproterenol hydrochloride should be administered cautiously. In refractory cases the use of a transvenous cardiac pacemaker may be considered.
3) Hypotension: use sympathomimetic pressor drug therapy, such as dopamine, dobutamine or levarterenol. In refractory cases the use of glucagon hydrochloride has been reported to be useful. 4) Bronchospasm: use isoproterenol hydrochloride.
Additional therapy with aminophylline may be considered. 5) Acute cardiac failure: conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases the use of intravenous aminophylline is suggested.
This may be followed if necessary by glucagon hydrochloride which has been reported to be useful. ] 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging For management of a suspected drug overdose, contact your regional poison control centre.
Route of Administration Dosage Form / Strength/Composition Non-medicinal […]