Restasis - instructions for use, doses, side effects, contraindications

A translucent or turbid homogeneous emulsion of white color. When viewed through a microscope: droplets of oil, evenly distributed in the water phase.

Pharmacotherapeutic group:Immunosuppressive remedy.

ATX: & nbsp

Pharmacodynamics:

Ciclosporin - a substance that has an immunosuppressive effect in systemic administration. With oppression of production, tears in patients with dry keratoconjunctivitis, ciclosporin, 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:

Reduced tear production due to dry keratoconjunctivitis.

Contraindications:Hypersensitivity to the components of the drug, acute infectious diseases of the eyes, pregnancy, the period of breastfeeding, age to 18 years.

Carefully:

In patients with herpetic keratitis in history.

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 a systemic introduction ciclosporin penetrates into breast milk, excretion with breast milk with topical application has not been studied. When appointing during lactation, breast-feeding should be discontinued.

Dosing and Administration:

Locally. Before use, flip the bottle several times until a homogeneous opaque emulsion, white.One drop is instilled in the conjunctival sac twice a day at intervals of 12 hours.

Side effects:

With the use of the drug Restasis®, the burning sensation in the eye was most often (in 17% of cases).

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.

Overdose:

No cases of overdose of 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.

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 the application of the drug Restasis®.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:Eye drops 0.05%.

Packaging:

0.4 ml of the drug in a single-dose vial of LDPE with a capacity of 0.9 ml. For 30 bottles in a package of polypropylene sealed with a membrane of aluminum foil and a closed lid made of polystyrene. Instructions for use are inserted between the lid of polystyrene and the membrane of aluminum foil.

Storage conditions:

At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:PL-000583

Date of registration:16.09.2011

The owner of the registration certificate:Allergen, Inc.Allergen, Inc. USA

Manufacturer: & nbsp

ALLERGAN SALES, LLC Germany

Representation: & nbspAllergen of CIS SARL. LtdAllergen of CIS SARL. LtdRussia

Information update date: & nbsp14.10.2015

Illustrated instructions

Instructions

Restasis® (Restasis®)