Timolol Maleate Ophthalmic Gel Forming Solution 0.25%
Generic Name: timolol maleate ophthalmic gel forming solution, 0.25%
Brand Names:
Timolol Maleate Ophthalmic Gel Forming Solution 0.25%, Timolol Maleate Ophthalmic Gel Forming Solution 0.5%
DESCRIPTION Timolol maleate ophthalmic gel forming solution 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: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°).
Overview
DESCRIPTION Timolol maleate ophthalmic gel forming solution 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: 25° [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°).
Uses
INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevatedintraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage
DOSAGE AND ADMINISTRATION Patients should be instructed to invert the closed container and shake once before each use. It is not necessary to shake the container more than once. Other topically applied ophthalmic medications should be administered at least 10 minutes before timolol maleate ophthalmic gel forming solution [see PRECAUTIONS, Information for Patients and accompanying INSTRUCTIONS FOR USE ]. Timolol maleate ophthalmic gel forming solution is available in concentrations of 0.25% and 0.5%.
Side Effects
ADVERSE REACTIONS In clinical trials, transient blurred vision upon instillation of the drop was reported in approximately one in three patients (lasting from 30 seconds to 5 minutes). Less than 1% of patients discontinued from the studies due to blurred vision.The frequency of patients reporting burning and stinging upon instillation was comparable between timolol maleate ophthalmic gel forming solution and TIMOPTIC (approximately one in eight patients). Adverse experiences reported in 1 to 5% of patients were: Ocular: Pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing; Systemic: Headache, dizziness, and upper respiratory infections.
Interactions
Drug Interactions Beta-Adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent orally and timolol maleate ophthalmic gel forming solution should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended. Calcium Antagonists Caution should be used in the coadministration of beta-adrenergic blocking agents, such as timolol maleate ophthalmic gel forming solution, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension. In patients with impaired cardiac function, coadministration should be avoided.
Warnings
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 ophtalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patient with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophtalmic administration of timolol maleated [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. CONTRAINDICATIONS Timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS ,Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure[see WARNINGS , Cardiac Failure ]; (7) cardio...
Pregnancy
Pregnancy Teratogenic Effects Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring.
Storage
HOW SUPPLIED Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous solution. Timolol maleate ophthalmic gel forming solution, 0.25% timolol equivalent, is supplied in a white low density polyethylene (LDPE) bottle with a controlled drop tip and a yellow high density polyethylene (HDPE) screw cap with tamper-evident ring as fol...
Frequently Asked Questions
What is Timolol Maleate Ophthalmic Gel Forming Solution 0.25% used for?▼
INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevatedintraocular pressure in patients with ocular hypertension or open-angle glaucoma.
What are the side effects of Timolol Maleate Ophthalmic Gel Forming Solution 0.25%?▼
ADVERSE REACTIONS In clinical trials, transient blurred vision upon instillation of the drop was reported in approximately one in three patients (lasting from 30 seconds to 5 minutes). Less than 1% of patients discontinued from the studies due to blurred vision.The frequency of patients reporting burning and stinging upon instillation was comparable between timolol maleate ophthalmic gel forming solution and TIMOPTIC (approximately one in eight patients). Adverse experiences reported in 1 to 5% of patients were: Ocular: Pain, conjunctivitis, discharge (e.g., crusting), foreign body sensation, itching and tearing; Systemic: Headache, dizziness, and upper respiratory infections.
Can I take Timolol Maleate Ophthalmic Gel Forming Solution 0.25% during pregnancy?▼
Pregnancy Teratogenic Effects Teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring.
What are the important warnings for Timolol Maleate Ophthalmic Gel Forming Solution 0.25%?▼
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 ophtalmic administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patient with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophtalmic administration of timolol maleated [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. CONTRAINDICATIONS Timolol maleate ophthalmic gel forming solution is contraindicated in patients with (1) bronchial asthma; (2) a history of bronchial asthma; (3) severe chronic obstructive pulmonary disease [see WARNINGS ,Obstructive Pulmonary Disease ]; (4) sinus bradycardia; (5) second or third degree atrioventricular block; (6) overt cardiac failure[see WARNINGS , Cardiac Failure ]; (7) cardio...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.