Composition, form of production and packaging
Eye drops 0.05% 1 ml
cyclosporine 500 Ојg
0.4 ml - bottles (1) of LDPE single-dose - packages (30) polypropylene, sealed with aluminum foil and closed with a lid of polystyrene - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Ciclosporin - a substance that has an immunosuppressive effect in systemic administration. When oppression of the production of tears in patients with dry keratoconjunctivitis, cyclosporine, applied topically, has an anti-inflammatory and immunomodulatory effect.
PHARMACOKINETICS
The concentration of cyclosporine after topical application in adults at a concentration of 0.05% 2 times / day is below the determined value of 0.1 ng / ml.
INDICATIONS
- decreased tear production due to dry keratoconjunctivitis.
DOSING MODE
Locally. Before use, flip the bottle several times until a homogeneous opaque emulsion, white. One drop is instilled in the conjunctival sac 2 times / day with an interval of 12 hours.
SIDE EFFECT
When using the drug Restasis most often (in 17% of cases) there was a burning sensation in the eye.
Frequency of occurrence of side effects: very frequent (> 10%), frequent (> 1%, <10%),. infrequent (> 0.1%, <1%); rare (> 0.01%, <0.1), very rare (<0.01%).
Very frequent: burning in the eye.
Frequent: eye irritation, conjunctival eye hyperemia, foreign body sensation in the eye, pain and itching in the eye, discharge from the eye, blurred vision, dry eye syndrome, photophobia, headache.
Infrequent: keratitis with ulceration, edema and hyperemia of the eyelids, increased lacrimation, dizziness, nausea, rash.
The frequency is unknown: edema of the conjunctiva of the eye and eyelids, reactions of hypersensitivity, urticaria.
CONTRAINDICATIONS
- acute infectious diseases of the eyes;
- Pregnancy;
- lactation period;
- age up to 18 years;
- Hypersensitivity to the components of the drug.
With caution: in patients with herpetic keratitis in the anamnesis.
PREGNANCY AND LACTATION
Adequate and strictly controlled studies of the drug Restasis in pregnant women have not been conducted. Restasis is not recommended for pregnant women. With systemic administration of cyclosporine penetrates into breast milk, excretion with breast milk with topical application has not been studied. When appointing during lactation, breast-feeding should be discontinued.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
SPECIAL INSTRUCTIONS
The emulsion contained in one bottle for individual use should be used immediately after opening the vial - the remaining amount of the drug after instillation is to be disposed of immediately after use.
Do not allow the tip of the bottle to touch the eyes and any surface to prevent the possibility of infection of its contents.
Do not use Restasis when wearing contact lenses. Patients with reduced tears production are usually not recommended to use contact lenses. If the lenses are still used, they must be removed before the drug is applied and can be re-installed 15 minutes after using the drug Restasis.
Impact on the ability to drive vehicles and manage mechanisms
Restasis has little influence on the ability to drive vehicles and mechanisms.
If the patient after the application of the drug temporarily reduces visual acuity, until it is restored, it is not recommended to drive the car and engage in activities that require increased attention.
OVERDOSE
No cases of an overdose of the drug Restasis were reported. When topical application of the drug in the form of eye drops due to low concentrations of cyclosporine, an overdose is unlikely.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a place inaccessible to children at a temperature not exceeding 25 В° РЎ. The shelf life is 2 years.
Do not use after the expiration date printed on the package.
