Composition, form of production and packaging
Eye gel is colorless.
1 g
Ganciclovir 1.5 mg
Excipients: benzalkonium chloride - 75 Ојg, carbomer - 4.83 mg, sorbitol - 50 mg, sodium hydroxide - qs to pH 7.4, water purified to 1 g.
5 g - tubes with a tip, a screw cap and a removable stand for storing the tube upside down after opening (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Antiviral drug for topical application in ophthalmology. Ganciclovir is a nucleoside that inhibits the replication of human herpes simplex virus type 1 and type 2. In infected cells, ganciclovir is converted to the active form of ganciclovir - ganciclovirtriphosphate. Phosphorylation occurs predominantly in infected cells, and the concentration of ganciclovirtrisphosphate in uninfected cells is 10 times less.
The antiviral activity of ganciclovortriphosphate is to inhibit the synthesis of viral DNA using two mechanisms: competitive inhibition of viral DNA polymerase and direct incorporation into viral DNA in violation of chain termination and prevention of its replication.
PHARMACOKINETICS
After instillation of the drug in the eye 5 times / day for 11-15 days in the treatment of superficial herpetic keratitis, the concentrations of ganciclovir in plasma were very low: 0.013 Ојg / ml on average (0 = 0.037).
INDICATIONS
- Treatment of acute superficial keratitis caused by the herpes simplex virus.
DOSING MODE
The drug is instilled in the lower conjunctival sac of the affected eye 1 drop 5 times / day until complete corneal re-epithelialization, then 1 drop 3 times / day for 7 days.
The duration of treatment should not exceed 21 days.
SIDE EFFECT
From the side of the organ of vision: the most frequent side effects are blurred vision (60%), eye irritation (20%), point keratitis (5%) and conjunctival hyperemia (5%).
CONTRAINDICATIONS
- Pregnancy;
- the period of breastfeeding;
- children's age till 12 years;
- Hypersensitivity to ganciclovir, acyclovir or any of the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation.
For women of childbearing age , contraception is necessary.
Because of the genotoxicity found in animal experiments, men who use Zirgan В® are recommended to use reliable contraceptive methods during treatment and within three months after their completion.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
SPECIAL INSTRUCTIONS
This drug is not intended for the treatment of cytomegalovirus infection of the retina.
The efficacy against keratoconjunctivitis caused by other types of viruses has not been established.
No special studies have been conducted in patients with immunodeficiency.
Benzalkonium chloride can cause eye irritation and discoloration of soft contact lenses. Do not allow the drug to come into contact with soft contact lenses. Remove contact lenses before using the drug and re-install them no earlier than 15 minutes after instillation.
Impact on the ability to drive vehicles and manage mechanisms
The patient should refrain from driving a car or working with complex equipment in case of any visual impairment during drug treatment.
OVERDOSE
There is no information about overdose.
DRUG INTERACTION
Not found.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 3 years, after opening the tube - 4 weeks.
