Indication
- Inhibition of the development of intraoperative myositis during a cataract operation (Uniclophen has no characteristic midiraticheskih properties and does not replace the standard drugs that cause the enlargement of the pupil).
- Treatment of postoperative inflammatory process after removal of cataracts and other surgical interventions.
- Control of severity of pain and discomfort in ophthalmology associated with damage to the cornea epithelium after excimer-photorefraction therapy (CRF) or minor neuromuscular injury.
- Control of development of inflammation process after conduction of argon laser trabeculoplasty (ALT).
- Reduction of signs and symptoms of seasonal allergic conjunctivitis (SAC) in ophthalmology.
- Treatment of inflammation and discomfort after surgical treatment of strabismus.
- Treatment of pain syndrome and discomfort in ophthalmology after radial keratotomy.
Composition of the substance
active substance: diclofenac sodium; 1 ml of solution contains sodium diclofenac 1 mg; 1 ml contains 30 drops;
excipients: boric acid, sodium tetraborate, propylene glycol, hydroxypropylbetades, disodium edetate, benzalkonium chloride, water for injection.
Medicinal form
Eye drops, solution.
Pharmacological properties
Pharmacodynamics.
The drug Uniclophen contains diclofenac sodium – a non-steroidal compound with pronounced anti-inflammatory and analgesic effects. The inhibition of prostaglandin biosynthesis, which has been experimentally demonstrated, is considered to be a factor of importance in the mechanism of action of the drug. Prostaglandins play an important role in the etiology of the inflammatory process and pain.
It was found that the drug Uniclophen:
- inhibits the narrowing of the pupil during surgical cataract treatment;
- reduces inflammation after surgery;
- reduces the severity of pain and discomfort in ophthalmology associated with damage to the cornea epithelium after an excimer-photorefractional kerathectomy (VFR) or minor trauma;
- reduces the incidence of cystoid macular edema diagnosed with angiography after cataract surgery, but the clinical significance of this fact needs further study;
- reduces the intensity of the inflammatory process and discomfort that occurs after cataract surgery more effectively than steroids for local use, while preventing the development of undesirable effects typical of steroid drugs such as delayed wound healing of the conjunctiva and increased intraocular pressure;
- reduces the intensity of the inflammatory process, pain and discomfort in the eyes (photophobia, burning / stinging, feeling alien body, severe eye pain similar to headache and itching) more effectively than placebo eye drops after surgical surgery on the cornea, such as radial keratotomy .
An effective daily dose of Uniclophen (approximately 0.25 to 0.5 mg sodium diclofenac) is less than 1% of the recommended daily dose for rheumatic symptoms.
In the form of eye drops, Uniclophen includes cyclodextrin-hydroxypropyl-γ-cyclodextrin (GP-γ-CD). Cyclodextrins increase the water solubility of some lipophilic water-insoluble medicines. It is believed that cyclodextrins act as true carriers that hold molecules of hydrophobic drugs in the dissolved state and deliver them to the surface of biological membranes.
Pharmacokinetics.
The penetration of diclofenac in the anterior chamber of the eye has been confirmed in humans. After immersion of diclofenac sodium in the form of eye drops in the human body, it was not possible to identify the acceptable levels of diclofenac.
Producer
«UNIMED PHARMA Ltd».
Location of the manufacturer and the address of the place of its operation
Orieskova 11, 821 05 Bratislava, Slovak Republic