REGISTRATION NUMBER
LP-001355 [ЛП-001355]
TRADE NAME
Visomitin®
INTERNATIONAL NON-PROPRIETARY NAME (INN)
Not assigned
DOSAGE FORM
Eye drops
COMPOSITION PER 1 ML
Active ingredient: Plastoquinonyl decyltriphenylphosphonium bromide (PDTF) – 0.155 mcg
Excipients: Benzalkonium chloride – 0.1 mg, hypromellose – 2 mg, sodium chloride – 9 mg, sodium dihydrogen phosphate dihydrate – 0.81 mg, sodium hydrogen phosphate dodecahydrate – 1.16 mg, sodium hydroxide 1 M solution to pH 6.3-7.3, water for injection to 1 ml.
DESCRIPTION
Clear or slightly opalescent colorless or slightly colored liquid.
PHARMACOLOGICAL GROUP
Keratoprotective agent. Antioxidant agent.
ATC CODE
S01XA
PHARMACOLOGICAL PROPERTIES
Pharmacodynamics
Plastoquinonyl decyltriphenylphosphonium bromide (PDTF) is a plastoquinone derivative linked to triphenylphosphine residue through a linker chain (C10). PDTF exhibits high antioxidant activity at low (nanomolar) concentrations. It also stimulates tear production and epithelialization, promoting tear film stability. One of the causes of age-related cataracts is the damaging effect of ultraviolet radiation, which initiates photooxidation processes leading to denaturation of crystallins, the main structural component of the lens.
The first line of defense for eye tissues against ultraviolet radiation is tear fluid, which absorbs ultraviolet light in the 240-320 nm range and neutralizes it through tear fluid antioxidant activity components. According to preclinical studies, Visomitin’s® anti-cataract action is associated with increased expression of main lens proteins α-crystallins, restoration of lens epithelium, and activation of energy processes within it.
Clinical studies in patients with age-related cataracts using Visomitin® showed increased antioxidant activity in tears.
Pharmacokinetics
No human pharmacokinetic studies have been conducted. In preclinical animal studies, PDTF distribution in organs and tissues occurred within 48 hours after intravenous and intragastric administration. PDTF was found in highest concentrations in kidney, liver, and heart tissues within 1-2 hours after administration. PDTF undergoes relatively rapid enzymatic degradation and covalent protein binding.
INDICATIONS
Dry eye syndrome. Initial stage of age-related cataract.
CONTRAINDICATIONS
Hypersensitivity to product components, age under 18 years.
PREGNANCY AND LACTATION
No adequate controlled studies in pregnant and nursing women have been conducted. Not recommended during pregnancy. If treatment is necessary during lactation, breastfeeding should be discontinued for the treatment period.
DOSAGE AND ADMINISTRATION
Dry eye syndrome: 1-2 drops into the conjunctival sac 3 times daily. Treatment duration is determined by physician depending on disease severity.
Initial stage of age-related cataract: 1-2 drops into the conjunctival sac 3 times daily. Treatment duration – 6 months. Ophthalmologist monitoring is required during treatment to assess disease progression and need for continued conservative therapy.
SIDE EFFECTS
Allergic reactions.
Sensory organs: possible temporary burning and stinging sensation in eyes after instillation.
OVERDOSE
No data available on local application overdose.
DRUG INTERACTIONS
Can be used simultaneously with other eye drops. Interval between instillations should be at least 5 minutes.
SPECIAL INSTRUCTIONS
Effect on ability to drive and use machinery
If temporary blurred vision occurs after application, avoid driving vehicles or operating machinery requiring increased attention until vision returns to normal.
FORM OF RELEASE
Eye drops 0.155 mcg/ml in 5 ml polyethylene bottles with dropper tips and screw caps. Each bottle with package insert in cardboard box.
STORAGE CONDITIONS
Store protected from light at 2-8°C. After opening, store protected from light at 2-8°C; use within 1 month.
Keep out of reach of children.
SHELF LIFE
2 years.
Do not use after expiration date shown on package.
Use opened bottle within 1 month.
DISPENSING CONDITIONS
Prescription only
MANUFACTURER
Mitotech LLC, Russia. https://skq.one/