Restasis eye drops 0.05%, 0.4ml No. 30

Locally. Invert the bottle several times before use until a homogeneous, opaque emulsion is obtained, white in color. One drop is instilled into the conjunctival sac 2 times / day with an interval of 12 hours.

Eye drops in the form of a homogeneous white emulsion, translucent or cloudy; when viewed through a microscope: oil droplets evenly distributed in the aqueous phase.

1 ml

cyclosporine 500 mcg

Excipients: castor oil - 12.5 mg, glycerol - 22 mg, polysorbate 80 - 10 mg, carbomer - 0.5 mg, sodium hydroxide - 4.09 mg, water - 950 mg.

• Acute infectious diseases of the eyes;

• pregnancy;

• lactation period;

• age under 18;

• hypersensitivity to the components of the drug.

  With caution: in patients with a history of herpetic keratitis.

pharmachologic effect

Cyclosporine is a substance that has an immunosuppressive effect when administered systemically. With the inhibition of tear production in patients with keratoconjunctivitis dry, 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 lower than the determined value - 0.1 ng / ml.

Side effect

When using the drug Restasis, most often (in 17% of cases), there was a burning sensation in the eye. The incidence of side effects: very frequent (> 10%), frequent (> 1%, <10%),. infrequent (> 0.1%, <1%); rare (> 0.01%, <0.1), very rare (<0.01%). Very common: burning in the eye. Frequent: eye irritation, conjunctival hyperemia, foreign body sensation in the eye, pain and itching in the eye, eye discharge, blurred vision, dry eye syndrome, photophobia, headache. Infrequent: keratitis with ulceration, edema and hyperemia of the eyelids, increased lacrimation, dizziness, nausea, rash. Frequency unknown: edema of the conjunctiva of the eye and eyelids, hypersensitivity reactions, urticaria.

Application during pregnancy and lactation

There have been no adequate and strictly controlled studies of Restasis in pregnant women. Restasis is not recommended for pregnant women. With systemic administration, cyclosporine passes into breast milk, excretion in breast milk with topical application has not been studied. When administered during lactation, breastfeeding should be discontinued.

Application in children

Contraindicated in children under 18 years of age.

special instructions

The emulsion contained in one bottle for individual use should be used immediately after opening the bottle - the remaining amount of the drug after instillation must be disposed of immediately after use. Do not allow the tip of the vial to touch the eyes or any surface to exclude the possibility of contamination of its contents. You should not use Restasis when wearing contact lenses. Contact lenses are generally not recommended for patients with decreased tear production. If the lenses are still used, they must be removed before using the drug and can be reinstalled 15 minutes after using the drug Restasis. Influence on the ability to drive vehicles and control mechanisms

Restasis has little effect on the ability to drive vehicles and mechanisms. If the patient's visual acuity temporarily decreases after using the drug, it is not recommended to drive a car and engage in activities that require increased attention until it is restored.

Overdose

No cases of overdose of the drug Restasis were reported. With local application of the drug in the form of eye drops, due to the low concentration of cyclosporine, an overdose is unlikely.