Medication info

Restaporin Eye Drops 0.05% (Cyclosporine) (Single-use)

Prescription medicationEye dropsEye drops
Ingredient · strength
Cyclosporine›0.5mg / 1mL
Manufacturer / importer
International Pharmaceutical Co., Ltd.
Appearance
Colorless, transparent eye drops in a transparent plastic container
Packaging
0.4 milliliters per unit [[0.4mL/box × 30EA]]
Approval status
Active

MFDS item code 201110343 · Notified 2011.11.24 · Insurance code 643703441

Summary

Main use
Improvement of reduced tear production due to ocular inflammation associated with keratoconjunctivitis sicca
Who applies the drops
Adults
Adult eye dose
Instill 1 drop in each eye twice daily, approximately 12 hours apart. If this medicine is used at the same time as artificial tears, administer them 15 minutes apart. Discard any remaining solution and the container after instillation.

Ingredients

Manufacturer
International Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of reduced tear production due to ocular inflammation associated with keratoconjunctivitis sicca

  • Dry keratoconjunctivitis
  • inflammatory eye disease
View approved original text

This medicine helps to increase tear production in patients whose tear production is suppressed, alleviating the symptoms related to dry keratoconjunctivitis and inflammatory eye disease. It is used to improve discomfort caused by dry eyes and maintain eye health.

How to apply drops

Adult eye dose

Instill 1 drop in each eye twice daily, approximately 12 hours apart. If this medicine is used at the same time as artificial tears, administer them 15 minutes apart. Discard any remaining solution and the container after instillation.

Precautions

This medication has not been adequately studied for use in patients with a history of herpetic keratitis, so caution is advised. An increase in tear production has not been observed in patients using topical anti-inflammatory medications or tear plugs. Patients with active eye infections or a known or suspected allergy to this medication should not use this product. This medication contains Propylene Glycol and should be used with caution in patients with allergies or hypersensitivity to this ingredient. Using this medication may commonly cause a burning sensation in the eyes, and various eye-related side effects such as conjunctival hyperemia, discharge, eye pain, foreign body sensation, itching, and visual disturbances have been reported. Rarely, hypersensitivity reactions such as eye swelling, severe angioedema, and breathing difficulties may occur, so if any unusual symptoms arise, immediate consultation with a healthcare professional is advised. This product is for ophthalmic use only and caution should be taken to avoid direct contact of the container with the eye. Vision may be temporarily blurred after instillation, so it is advisable to avoid driving or operating hazardous machinery until vision clears. Women who are pregnant or breastfeeding should use this medication with caution, and it should only be administered when the benefits outweigh the risks due to insufficient safety data for pregnant individuals. The safety and efficacy of this medication in children under 16 years of age have not been established, so its use is not recommended. Opened containers should be used only once, and any leftover liquid or container should be discarded immediately, ensuring that the tip of the container does not contact the eye or other surfaces. If wearing contact lenses, remove the lenses prior to instillation and reinsert them 15 minutes after instillation. This medication should be stored out of reach of children, and expired medications should be discarded. In systemic carcinogenicity studies of this medication, trends for certain cancers were observed in animal studies, but the risk in humans is unclear. This medication has not been reported to cause mutagenicity or genotoxicity, and there are also no reports of reproductive toxicity related to infertility.

Side effects

  • burning sensation in the eyes
  • conjunctival hyperemia
  • discharge
  • epiphora
  • eye pain
  • foreign body sensation
  • itching
  • ocular pain
  • visual impairment
  • ocular swelling
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  • hypersensitivity reaction
  • severe angioedema
  • facial swelling
  • tongue swelling
  • pharyngeal edema
  • dyspnea
  • ocular surface damage
  • pruritus
  • urticaria
  • dry eye
  • eye pain
  • abnormal sensation in the eye
  • eye fatigue
  • eye irritation
  • corneal erosion
  • sticky eyes
  • eyelid swelling

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature to ensure the effectiveness of the medicine.

Appearance and packaging

Appearance

Colorless, transparent eye drops in a transparent plastic container

Package unit

0.4 milliliters per unit [[0.4mL/box × 30EA]]

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.