Indocollir, eye drops 0.1%, 5 ml

Composition

Eye drops 0.1% in the form of a clear solution of pale yellow color.

1 mlIndometacin 1 mg.

Auxiliary substances:

thiomersal,

arginine,

hydroxypropyl betacyclodextrin,

hydrochloric acid,

purified water.

Pharmacological action

It is intended for topical use in ophthalmology. It has analgesic and anti-inflammatory effects.

The main effect of the drug is to inhibit the synthesis of prostaglandins, which play an important role in the pathogenesis of inflammation and pain.

Pharmacokinetics

There are confirmed data that the drug penetrates into the anterior chamber of the eye. With a single instillation, the Active ingredient of the drug is detected in the moisture of the anterior chamber for several hours.

With topical application of Indocollir, systemic absorption is low.

Indications

• Inhibition of miosis during cataract surgery.
• Treatment and prevention of inflammatory processes after surgical interventions on the eyeball.
• Treatment and prevention of post-traumatic inflammatory process in penetrating and non-penetrating eyeball wounds (as an adjunct to local antimicrobial therapy).
• Prevention of cystic macular edema after cataract surgery.
• Treatment of non-infectious conjunctivitis.

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy and lactation have not been conducted.

However, the drug can be used in the first five months of pregnancy if the intended benefit of therapy for the mother exceeds the potential risk to the fetus.

Starting from the sixth month of pregnancy, the drug should not be prescribed, because this can lead to impaired function of the vascular system and kidneys in the fetus.

Indometacin is excreted in breast milk, so if it is necessary to use the drug during lactation, you should decide whether to stop breastfeeding or avoid its use during breastfeeding.

Contraindications

• Hypersensitivity to the components of the drug.
• Hypersensitivity to acetylsalicylic acid or other NSAIDs, manifested by attacks of bronchial asthma, urticaria, acute rhinitis.

Use Indocollir with caution when:

• Epithelial herpetic keratitis (including in the anamnesis).
• Diseases that cause blood clotting disorders (including hemophilia, prolonged bleeding time, and a tendency to bleed).

Side effects

 From the side of the organ of vision: rarely-mild or moderate burning sensation and / or temporary loss of clarity of vision immediately after instillation of eye drops.

Local allergic reactions: rarely-itching and redness of the skin around the eyes.

With prolonged use of Indocollir, systemic side effects of Indometacin may develop.

Interaction

It can be used, if necessary, simultaneously with other eye drops, including those containing corticosteroids. The interval between applications should be at least 5 minutes to prevent the active substances from being washed out by subsequent doses.

Indocollir may enhance the effects of indirect anticoagulants, lithium preparations.

Concomitant use of this drug with diflunisalum (possible gastrointestinal bleeding) and other NSAIDs, including acetylsalicylic acid in high doses (3 g/day or more) is not recommended.

Concomitant use of Indometacin with beta-blockers and saluretics may weaken the effects of the latter.

How to take, course of administration and dosage

To inhibit intraoperative miosis, the drug is instilled 1 drop into the conjunctival sac for 2 hours with an interval of 30 minutes (4 times) before surgery.

To prevent cystic edema of the macula, the drug is instilled in 1 drop 3-4 times a day for 1 month after surgery.

For other indications,1 drop is prescribed 3-4 times a day, depending on the severity of the condition. The course of treatment can last from 1 to 4 weeks.

Overdose

Accidental ingestion of Indocollir does not pose a risk of side effects.

Special instructions

Before instillation of the drug, it is necessary to remove contact lenses; they can be installed 15 minutes after instillation.

The bottle must be closed after each use of the drug. Do not touch the tip of the pipette to the eye.

Influence on the ability to drive motor vehicles and manage mechanisms

Patients who temporarily lose clear vision after applying the drug are advised not to drive a car or work with complex machinery, machines, or any other complex equipment that requires clear vision immediately after instillation of the drug.

Form of production

Eye drops.

Storage conditions

In a dark place, at a temperature not exceeding 25 °C.

Shelf

life 1.5 years

Active ingredient

Indometacin

Conditions of release from pharmacies

By prescription

Dosage form

of eye drops

Weight

Weight: 16 gr.