Zoladin Eye Drops

Brinzolamide + Brimonidine Tartrate eye prep

(10mg + 2mg)/ml

Aristopharma Limited

Pack size	5ml bot
Dispensing mode
Source
Agent
Retail Price	700.00 AED

Indications

Zoladin Eye Drops is used for: Open-angle glaucoma, Ocular hypertension

Adult Dose

Open-angle glaucoma, Ocular hypertension Brinzolamide 1% + Brimonidine Tartrate 0.2% eye prep Instill one drop in the affected eye(s) three times daily

Child Dose

<2 years: Safety and efficacy not established >2 years: Instill 1 drop in the affected eye(s) 2-3 times daily.

Renal Dose

Administration

Shake well before use If more than 1 ophthalmic drop is administered, the drugs should be administered at least 5 minutes apart

Contra Indications

Hypersensitivity to any component of this product. Neonates and infants (under the age of two years).

Precautions

Potential for sulfonamide hypersensitivity reactions because of the brinzolamide component Potential for corneal endothelium cell loss Severe renal impairment may limit the metabolism of the brinzolamide component

Pregnancy-Lactation

Pregnancy There are no adequate and well-controlled studies in pregnant women; therapy should be administered during pregnancy only if potential benefit justifies the potential risk to the fetus Animal data Developmental toxicity studies with brinzolamide in rabbits at oral doses of 1, 3, and 6 mg/kg/day (20, 60, and 120 times recommended human ophthalmic dose) produced maternal toxicity at 6 mg/kg/day and significant increase in the number of fetal variations, such as accessory skull bones, which was only slightly higher than historic value at 1 and 6 mg/kg In rats, statistically, decreased body weights of fetuses from dams receiving oral doses of 18 mg/kg/day (180 times the recommended human ophthalmic dose) during gestation were proportional to reduced maternal weight gain, with no statistically significant effects on organ or tissue development. Increases in unossified sternebrae reduced ossification of the skull, and unossified hyoid that occurred at 6 and 18 mg/kg were not statistically significant No treatment-related malformations were seen; following oral administration of 14C-brinzolamide 14Cbrinzolamide to pregnant rats, radioactivity was found to cross the placenta and was present in fetal tissues and blood Lactation There is no information regarding presence of dapagliflozin in human milk, effects on breastfed infants, or effects on milk production; dapagliflozin is present in milk of lactating rats Due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear; since human kidney maturation occurs in utero and during first 2 years of life when lactational exposure may occur, there may be risk to developing human kidney Because of potential for serious adverse reactions in breastfed infants, advise women that use of this medication is not recommended while breastfeeding

Interactions

Oral Carbonic Anhydrase Inhibitors High-dose Salicylate Therapy Central Nervous System Depressants Antihypertensives/Cardiac Glycosides Tricyclic Antidepressants Monoamine Oxidase (MAO) Inhibitors Contraindicated (9) isocarboxazid linezolid phenelzine procarbazine rasagiline selegiline selegiline transdermal thalidomide tranylcypromine Serious (19) alfentanil buprenorphine buprenorphine buccal buprenorphine subdermal implant buprenorphine transdermal buprenorphine, long-acting injection codeine fentanyl fentanyl intranasal fentanyl iontophoretic transdermal system fentanyl transdermal fentanyl transmucosal hydrocodone hydromorphone methadone morphine oxycodone oxymorphone remifentanil

Adverse Effects

Side effects of Brinzolamide + Brimonidine Tartrate eye prep : >10% (brimonidine) Somnolence in children (50-83%),Xerostomia (10-30%),Ocular hyperemia (10-30%),Burning and stinging (10-30%),Headache (10-30%),Blurring (10-30%),Foreign body sensation (10-30%),Fatigue/drowsiness (10-30%),Conjunctival follicles (10-30%),Ocular allergic reactions (10-30%),Ocular pruritus (10-30%) 1-10% (brinzolamide) Blurred vision (5-10%),Dysgeusia (5-10%),Blepharitis (1-5%),Dermatitis (1-5%),Dry eye (1-5%),Foreign body sensation (1-5%),Headache (1-5%),Hyperemia (1-5%),Ocular discharge (1-5%),Ocular discomfort (1-5%),Ocular keratitis (1-5%),Ocular pain (1-5%),Ocular pruritus (1-5%),Rhinitis (1-5%) 1-10% (brimonidine) Corneal staining/erosion (3-9%),Photophobia (3-9%),Eyelid erythema (3-9%),Ocular ache/pain (3-9%),Ocular dryness (3-9%),Tearing (3-9%),Upper respiratory symptoms (3-9%),Eyelid edema (3-9%),Conjunctival edema (3-9%),Dizziness (3-9%),Blepharitis (3-9%),Ocular (3-9%),Irritation (3-9%),Gastrointestinal symptoms (3-9%),Asthenia (3-9%),Conjunctival blanching (3-9%),Abnormal vision (3-9%) Muscular pain (3-9%),Lid crusting (<3%),Conjunctival hemorrhage (<3%),Abnormal taste (<3%),Insomnia (<3%),Conjunctival discharge (<3%),Depression (<3%),Hypertension (<3%),Anxiety (<3%),Palpitations/arrhythmias (<3%),Nasal dryness (<3%),Syncope (<3%) <1% (brinzolamide) Allergic reactions,Alopecia,Chest pain,Conjunctivitis,Diarrhea,Diplopia,Dizziness,Dry mouth,Dyspnea,Dyspepsia,Eye fatigue,Hypertonia,Keratoconjunctivitis,Keratopathy,Kidney pain,Lid margin crusting or sticky sensation,Nausea,Pharyngitis,Tearing,Urticaria

Mechanism of Action

Brinzolamide is a carbonic anhydrase inhibitor that decreases secretion of aqueous humor thus reducing intraocular pressure. Brimonidine is an alpha 2-adrenoceptor agonist which works to reduce aqueous humor production and increase uveoscleral flow.

Note

Zoladin (10mg + 2mg)/ml Eye Drops manufactured by Aristopharma Limited. Its generic name is Brinzolamide + Brimonidine Tartrate eye prep. Zoladin is availble in Bangladesh. Farmaco BD drug index information on Zoladin Eye Drops is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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