Description
Latin name
Restasis
Release form
eye drops.
Packaging
In 1 bottle of 0.4 ml eye drops. In a plastic package of 30 bottles.
Pharmacological action
Cyclosporine – a substance that has an immunosuppressive effect with systemic administration.
When suppressing tear production in patients with dry keratoconjunctivitis, topical cyclosporin has an anti-inflammatory and immunomodulatory effect.
Pharmacokinetics
The concentration of cyclosporine after topical administration in adults at a concentration of 0.05% 2 times a day below the defined value – 0.1 ng / ml.
Indications
Decreased tear production due to dry keratoconjunctivitis.
Contraindications
acute infectious eye diseases
pregnancy
lactation period
age under 18
hypersensitivity to the components of the drug.
Caution: Patients with a history of herpetic keratitis.
Use during 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, cyclosporine passes into breast milk, topical milk excretion has not been studied. If prescribed during lactation, breast-feeding should be discontinued.
Composition of
In 1 ml of eye drops contains:
Active ingredient
Cyclosporin 500 mcg.
Excipients
Castor oil, glycerol, carbomer, polysorbate-80, sodium hydroxide, water.
Dosage and Administration
Topically. Before use, turn the bottle over several times until a homogeneous, opaque, white emulsion is obtained. One drop is instilled into the conjunctival sac 2 times / day. with an interval of 12 hours
Side effects
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 often (> 10%).
Often (> 1%, <10%). Infrequently (> 0.1%, <1%). Rarely (> 0.01%, <0.1%). Very rare (<0.01%). On the part of the organ of vision Very often – burning in the eye. Often – eye irritation, conjunctival hyperemia of the eye, foreign body sensation in the eye, pain and itching in the eye, discharge from the eye, blurred vision, dry eye syndrome. Infrequently – keratitis with ulceration, edema and hyperemia of the eyelids, increased lacrimation. Frequency unknown – conjunctival edema of the eye and eyelids, hypersensitivity reactions. Other Photophobia, headache, dizziness, nausea, rash, urticaria. Overdose No cases of overdose with Restasis have been reported. Topical use of the drug in the form of eye drops due to the low concentration of cyclosporine overdose is unlikely. Storage conditions Keep out of the reach and sight of children at temperatures not exceeding 25 ° C. Shelf life 2 years. Conditions of release from drugstores Prescription dosage form eye drops Possible product names RESTASIS 0.05% 0.4ML N30 FLAC GL DROPS Restasis 0.05% eye drops 0.4ml Php./ X30 RESTASIS DROPS GL. 0.05% FL. 0.4 ML No. 30 Restasis eye drops 0.05% vial 0.4ml x 30 RESTASIS DROPS EYE. FLAC 0.05% 0, 4ML N30 Allergan, USA
