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Restasis Eye Drops |
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Restasis Structure
- 0.05% - cyclosporine ophthalmic emulsion;
Restasis Indications
Restasis eye drops are indicated to increase tear production in patients whose tear production is presumed to be suppressed
due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not
seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
Restasis Contraindications
Restasis eye drops are contraindicated in patients with active ocular
infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
Restasis and Pregnancy
No evidence of teratogenicity was observed in rats or rabbits receiving oral doses of cyclosporine
up to 300 mg/kg/day during organogenesis. These doses in rats and rabbits are approximately 300,000 times greater than
the daily human nose of one drop (28 ml) 0.05% Restasis eye drops BID into each eye of a 60 kg person (0.001 mg/kg/day),
assuming that the entire dose is absorbed.
Side effects were seen in reproduction studies in rats and rabbits only at dose levels
toxic to dams At toxic doses (rats at 30 mg/kg/day and rabbits
at 100 mg/kg/day), cyclosporine oral solution, USP, was
embryo and fetotoxic as indicated by increased pre- and
postnatal mortality and reduced fetal weight together with
related skeletal retardaiions.
Restasis and Nursing Mothers
Restasis eye drops are known to be excreted in human milk
following systematic administration but excretion in milk after
topical treatment has not been investigated. Although blood
concentrations are undetectable after topical administration
of Restasis eye drops, caution should be exercised when Restasis eye drops
are administered to a nursing woman,
Restasis Side Effects
The most common adverse event following the use of Restasis eye drops was ocular burning (17%).
Other events reported in 1% to 5% of patients included:
- Visual disturbance (most often blurring);
- Stinging;
- Pruritus;
- Foreign body sensation;
- Eye pain;
- Epiphora;
- Discharge;
- Conjunctival hyperemia;
Restasis Dosage
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of
Restasis eye drop twice a day in each eye approximately 12 hours apart. Restasis eye drop can be prescribed concomitantly
with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
Restasis Form
Restasis eye drops are packaged in single use vials.
Each vial contains 0.4 mL fill in a 0.9 mL LOPE vial: 32 vials are packaged
in a polypropylene tray with an aluminium peelable lid.
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