Travoprost eye drops

Mechanism of Action - Travoprost free acid is a selective FP prostate receptor agonist. It is reported that FP prostate receptor agonists can reduce intraocular pressure by increasing the outflow of aqueous humor through the uveoscleral pathway. Its exact mechanism of action is still unclear. Carcinogenicity, mutagenesis, and impairment of fertility No mutagenic effects were found in a two-year carcinogenicity study in rats and mice given subcutaneously at 10, 30 or 100ug/kg/day. However, at a dose of 100ug/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was shown to be reached in mouse studies. Based on the effective drug amount in plasma, the high dose (100ug/kg) is equivalent to more than 400 times the exposure of the recommended maximum dose (MRHOD) of 0.04ug/kg for human eyes. Travoprost was not found to be mutagenic in the Ames test, the mouse micronucleus test, and the rat chromosome aberration test. In another mouse lymphoma study (one of two), high concentrations of travoprost were only slightly mutagenic in the presence of active rat S-9 enzyme. Travoprost was administered subcutaneously to male and female rats and mice at doses up to 10 μg/kg/day (250 times the maximum recommended dose for human ophthalmic use) without affecting mating or fertility indices. At this dose, the mean number of corpora lutea was reduced and post-implantation failure increased. However, there was no change in the number of corpora lutea at 3 μg/kg/day (75 times the maximum recommended dose for human ophthalmic use).

The main ingredient is: Travoprost. Chemical name: Structural formula: Molecular formula: Molecular weight:

Colorless to light yellow clear liquid.

To reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant to or have inadequate responses to other ocular hypotensive drugs (failure to reach target IOP after multiple doses).

The recommended dosage is 1 drop per night into the affected eye. The dosage should not exceed 1 time per day, because frequent use will reduce the intraocular pressure lowering effect of the drug. The intraocular pressure lowering effect of Suweitan begins to appear about 2 hours after medication and reaches its maximum at 12 hours. Suweitan can be used together with other topical eye medications to lower intraocular pressure. When using more than one eye drop at the same time, the time between drops of each drug should be at least 5 minutes apart.

In controlled clinical studies of Suweitan, the most common ocular adverse reaction observed was ocular hyperemia, which was seen in 35%-50% of patients. Approximately 3% of patients discontinued medication due to conjunctival hyperemia. 5-10% of ocular adverse reactions included decreased vision, ocular discomfort, foreign body sensation, pain, and itching. 1-4% of ocular adverse reactions included abnormal vision, blepharitis, blurred vision, cataracts, inflammatory cells, conjunctivitis, dry eyes, ocular discomfort, atrial flare, heterochromia iridis, keratitis, eyelid crusting, photophobia, subconjunctival hemorrhage, and tearing. Non-ocular adverse reactions accounted for 1~5%, including trauma, angina, anxiety, arthritis, back pain, bradycardia, tracheitis, chest pain, cold syndrome, depression, dyspepsia, gastrointestinal dysfunction, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate dysfunction, sinusitis, urinary incontinence, and urinary tract infection.

Patients with hypersensitivity to travoprost, benzalkonium chloride or any of the ingredients in this medicine are contraindicated.

Precautions for children: Safety and efficacy studies have not been conducted for children. Precautions for pregnancy and lactation: When 10ug/kg/day of travoprost was administered intravenously to rats (250 times the maximum recommended dose for human eye use), it caused malformations in rats, and increased incidence of skeletal malformations and external and visceral malformations in rat fetuses, such as fused fetuses, domed heads, and skull effusions. Travoprost did not cause malformations in rats when administered intravenously at doses as low as 3ug/kg/day (75 times the maximum recommended dose for human eye use) and subcutaneously in mice at doses as low as 1.0ug/kg/day (25 times the maximum recommended dose for human eye use). When travoprost was administered intravenously to rats at doses greater than 3ug/kg/day (7.5 times the maximum recommended dose for human eye use), it resulted in increased post-implantation failure and reduced fetal survival. From day 7 of pregnancy to day 21 of lactation, subcutaneous administration of travoprost to female rat offspring was observed in the elderly. Precautions for the elderly: There was no significant overall difference in efficacy and adverse reactions between elderly patients and adult patients.

Store at 2℃ - 25℃.

2.5 ml: 0.1 mg

18 months