USA - engelsk - NLM (National Library of Medicine)

apotex corp. - brimonidine tartrate (unii: 4s9cl2dy2h) (brimonidine - unii:e6gnx3hhte), timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (iop) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled iop; the iop-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see warnings and precautions (5.1, 5.3)] . brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see warnings and precautions (5.2)] ; cardiogenic shock. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in neonates and infants (under the age of 2 years). local hypersensitivity reactions have occurred following the use of different components of brimonidine tartrate/timolol maleate ophthalmic solution. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past. teratogenicity studies have been performed in animals. brimonidine tartrate was not teratogenic when given orally during gestation days 6 through 15 in rats and days 6 through 18 in rabbits. the highest doses of brimonidine tartrate in rats (2.5 mg/kg/day) and rabbits (5 mg/kg/day) achieved auc exposure values 580 and 37-fold higher, respectively, than similar values estimated in humans treated with brimonidine tartrate/timolol maleate ophthalmic solution, 1 drop in both eyes twice daily. teratogenicity studies with timolol in mice, rats, and rabbits at oral doses up to 50 mg/kg/day [4,200 times the maximum recommended human ocular dose of 0.012 mg/kg/day on a mg/kg basis (mrhod)] 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. doses of 1,000 mg/kg/day (83,000 times the mrhod) were maternotoxic in mice and resulted in an increased number of fetal resorptions. increased fetal resorptions were also seen in rabbits at doses 8,300 times the mrhod without apparent maternotoxicity. there are no adequate and well-controlled studies in pregnant women; however, in animal studies, brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. because animal reproduction studies are not always predictive of human response, brimonidine tartrate/timolol maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. timolol has been detected in human milk following oral and ophthalmic drug administration. it is not known whether brimonidine tartrate is excreted in human milk, although in animal studies, brimonidine tartrate has been shown to be excreted in breast milk. because of the potential for serious adverse reactions from brimonidine tartrate/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. brimonidine tartrate/timolol maleate ophthalmic solution is contraindicated in children under the age of 2 years [see contraindications (4.3)] . during post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. the safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in children below the age of 2 years. the safety and effectiveness of brimonidine tartrate/timolol maleate ophthalmic solution have been established in the age groups 2 – 16 years of age. use of brimonidine tartrate/timolol maleate ophthalmic solution in these age groups is supported by evidence from adequate and well-controlled studies of brimonidine tartrate/timolol maleate ophthalmic solution in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). in this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. the most commonly observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. in pediatric patients 7 years of age or older (>20 kg), somnolence appears to occur less frequently (25%). approximately 16% of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence. no overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Canada - fransk - Health Canada

micro labs limited - timolol (maléate de timolol); dorzolamide (chlorhydrate de dorzolamide) - solution - 5mg; 20mg - timolol (maléate de timolol) 5mg; dorzolamide (chlorhydrate de dorzolamide) 20mg

Belgia - fransk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - maléate de timolol 6,83 mg/ml - eq. timolol 5 mg/ml; travoprost 0,04 mg/ml - collyre en solution - 40 µg/ml - 5 mg/ml - travoprost 0.04 mg/ml; maléate de timolol 6.83 mg/ml - timolol, combinations

Frankrike - fransk - ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé)

viatris up - latanoprost 50 microgrammes; timolol base 5 mg sous forme de : maléate de timolol 6 - collyre - 50 microgrammes - pour 1 ml > latanoprost 50 microgrammes > timolol base 5 mg sous forme de : maléate de timolol 6,80 mg - bêta-bloquant ophtalmique – timolol - classe pharmacothérapeutique : bêta-bloquant ophtalmique-timolol, en association.xalacom contient deux principes actifs : le latanoprost et le timolol. le latanoprost appartient à une famille de médicaments appelés analogues des prostaglandines. le timolol appartient à une famille de médicaments appelés bêta-bloquants. le latanoprost agit en augmentant la quantité de liquide évacué de l’œil. le timolol agit en ralentissant la production de liquide dans l’œil.xalacom est indiqué pour faire baisser la pression intraoculaire chez les patients atteints de glaucome à angle ouvert ou d’hypertonie intraoculaire. ces deux pathologies sont liées à une augmentation de la pression à l’intérieur de l’œil qui risque éventuellement d’endommager la vue. votre médecin prescrira xalacom quand d’autres médicaments n’auront pas agi de manière adéquate.

Belgia - nederlandsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - timololmaleaat 6,83 mg/ml - eq. timolol 5 mg/ml; dorzolamidehydrochloride 22,26 mg/ml - eq. dorzolamide 20 mg/ml - oogdruppels, oplossing - 20 mg/ml - 5 mg/ml - timololmaleaat 6.83 mg/ml; dorzolamidehydrochloride 22.26 mg/ml - timolol, combinations

Belgia - fransk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

eg sa-nv - maléate de timolol 6,83 mg/ml - eq. timolol 5 mg/ml; latanoprost 0,05 mg/ml - collyre en solution - 50 µg/ml - 5 mg/ml - latanoprost 0.05 mg/ml; maléate de timolol 6.83 mg/ml - timolol, combinations

Belgia - fransk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

pharmathen s.a. - maléate de timolol 6,83 mg/ml - eq. timolol 5 mg/ml; latanoprost 50 µg/ml - collyre en solution - 50 µg/ml - 5 mg/ml - latanoprost 50 µg/ml; maléate de timolol 6.83 mg/ml - timolol, combinations

Australia - engelsk - Department of Health (Therapeutic Goods Administration)

apotex pty ltd - dorzolamide hydrochloride,timolol maleate -

USA - engelsk - NLM (National Library of Medicine)

sandoz inc - timolol maleate (unii: p8y54f701r) (timolol anhydrous - unii:5jky92s7br) - timolol anhydrous 5 mg in 1 ml - timolol gfs 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. timolol gfs is contraindicated in patients with: • bronchial asthma • history of bronchial asthma • severe chronic obstructive pulmonary disease • sinus bradycardia • second or third degree atrioventricular block • overt cardiac failure • cardiogenic shock • hypersensitivity to any component of this product. teratogenic effects pregnancy category c: 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. doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in

USA - engelsk - NLM (National Library of Medicine)

akorn - timolol (unii: 817w3c6175) (timolol anhydrous - unii:5jky92s7br) - preservative-free timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. preservative-free timolol maleate ophthalmic solution may be used when a patient is sensitive to the preservative in timolol maleate ophthalmic solution, benzalkonium chloride, or when use of a preservative-free topical medication is advisable. preservative-free timolol maleate ophthalmic solution 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.