Medication info

Restain Eye Drops 0.05% (Cyclosporine) (Single Use)

Prescription medicationEye dropsEye drops
Ingredient · strength
Cyclosporine›0.5mg / 1mL
Manufacturer / importer
Genewon Science Co., Ltd.
Appearance
A colorless or pale white transparent liquid in a colorless transparent plastic single-use container
Packaging
0.4mL/tube × 30 tubes
Approval status
Active

MFDS item code 201800839 · Approved 2018.02.14 · Insurance code 671705551

Summary

Main use
Improvement of tear production suppressed by ocular inflammation associated with keratoconjunctivitis sicca
Who applies the drops
Adults
Adult eye dose
Instill 1 drop into each eye twice daily, approximately 12 hours apart. If using this medicine at the same time as artificial tears, allow an interval of 15 minutes between administrations. Discard any remaining solution and the container after instillation.

Ingredients

Manufacturer
Genewon Science Co., Ltd.

Efficacy & effects

Improvement of tear production suppressed by ocular inflammation associated with keratoconjunctivitis sicca

  • Dry eye syndrome
  • inflammation of the eye
View approved original text

This medication helps to relieve dry eyes by increasing tear production in patients with suppressed tear synthesis. It is especially used for improving inflammation of the eye related to dry eye syndrome.

How to apply drops

Adult eye dose

Instill 1 drop into each eye twice daily, approximately 12 hours apart. If using this medicine at the same time as artificial tears, allow an interval of 15 minutes between administrations. Discard any remaining solution and the container after instillation.

Precautions

This medication should be used with caution in patients with a history of herpes keratitis, as sufficient research has not been conducted. The effect of increased tear production has not been observed in patients using topical anti-inflammatory agents or tear plugs. Patients with active ocular infections or known or suspected allergic reactions to this medication should not use it. The most common side effect is a burning sensation in the eyes, while conjunctival hyperemia, discharge, eye pain, foreign body sensation, itching, and vision disturbances may occur rarely. In severe cases, serious allergic reactions such as eye swelling, angioedema, and difficulty breathing may occur, and in such instances, immediate consultation with healthcare professionals is required. This medication is for ophthalmic use only, and care should be taken to prevent infection or damage by avoiding direct contact of the tip of the container with the eye. There is insufficient safety data on its use during pregnancy; therefore, it should be used cautiously only when necessary, and caution is also required during breastfeeding. Safety and efficacy in pediatric patients under 16 years have not been established, so its use is not recommended. The product should be used immediately after opening, and any remaining solution and container should be discarded. When wearing contact lenses, they should be removed before application and can be reinserted at least 15 minutes later. Keep this product out of reach of children to prevent accidental ingestion. Some trends in cancer occurrence were reported in long-term high-dose oral administration studies; however, the local dosage of this medication is much lower, generally posing a low risk. No special harmful effects were found in mutagenicity or genotoxicity tests, but the possibility of adverse reactions should always be kept in mind during use.

Side effects

  • burning sensation in the eyes
  • conjunctival hyperemia
  • discharge
  • epiphora
  • ocular pain
  • foreign body sensation
  • itching
  • pain in the eye
  • visual disturbances
  • blurred vision
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  • ocular swelling
  • hypersensitivity reaction
  • severe angioedema
  • facial swelling
  • tongue swelling
  • pharyngeal edema
  • difficulty breathing
  • ocular surface damage
  • pruritus
  • urticaria
  • dry eyes
  • eye pain
  • abnormal sensations in the eye
  • eye fatigue
  • eye irritation
  • corneal erosion
  • sticky eyes
  • edema of the eyes

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to avoid exposure to air or moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius to safely preserve the effectiveness of the medication.

Appearance and packaging

Appearance

A colorless or pale white transparent liquid in a colorless transparent plastic single-use container

Package unit

0.4mL/tube × 30 tubes

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.