Mio-Chol (Solution) Instructions for Use

Marketing Authorization Holder

Vartamana Pharma, LLC (Russia)

Manufactured By

Appasamy Ocular Devices (P) Ltd. (Pharma Division) (India)

ATC Code

S01EB02 (Carbachol)

Active Substance

Carbachol (Rec.INN registered by WHO)

Dosage Form

Mio-Chol

Solution for intraocular administration 0.1 mg/1 ml: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intraocular administration in the form of a clear, colorless liquid.

Excipients: sodium chloride – 9 mg, water for injection – 1 ml.

1 ml – glass bottles (10) – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug and miotic – m-, n-cholinomimetic

Pharmacotherapeutic Group

M- and n-cholinomimetic

Pharmacological Action

M, n-cholinomimetic, a synthetic derivative of choline. With topical application, it causes pupil constriction, accompanied by a decrease in intraocular pressure.

This effect is partly explained by the fact that when the pupil constricts and the iris flattens, the spaces of Fontana (trabecular meshwork) and the canal of Schlemm (scleral venous sinus) widen, which improves the outflow of fluid from the internal media of the eye. It causes accommodative spasm.

Unlike acetylcholine, it is not hydrolyzed by cholinesterases and has a more pronounced and prolonged effect. When instilled into the eye, pupil constriction is noted after 15-20 minutes and lasts 4-8 hours; the decrease in intraocular pressure occurs after 20-30 minutes and reaches a maximum after 2 hours. When administered intraocularly, the action of carbachol begins within 2-5 minutes and lasts for 24 hours.

Pharmacokinetics

Metabolized to form choline. Excreted by the kidneys.

Indications

Surgical interventions in ophthalmology: cataract extraction with (without) intraocular lens implantation.

ICD codes

Dosage Regimen

Administer intraocularly as a single dose into the anterior chamber of the eye.

Perform administration before the start of the ophthalmic surgical procedure.

Use a recommended single dose of no more than 50 mg of carbachol.

Ensure the solution is a clear, colorless liquid without visible particles prior to use.

Do not administer intravenously, intramuscularly, or via any other route.

Avoid contact with uninvolved ocular tissues to minimize systemic exposure.

Discontinue use immediately if signs of hypersensitivity occur.

Adverse Reactions

From the organ of vision: rarely – retinal detachment, corneal degeneration, uveitis, iritis, corneal opacity, corneal edema; very rarely – anterior chamber inflammation, eye hyperemia, eye edema, blurred vision.

From the digestive system: very rarely – epigastric discomfort, nausea, vomiting.

Contraindications

Hypersensitivity to carbachol; children and adolescents under 18 years of age.

With caution: cicatricial changes of the iris, obliteration of the fundus vessels, bronchial asthma, chronic heart failure, hyperthyroidism, urinary tract obstruction, gastric or duodenal ulcer (in history), Parkinson’s disease; pregnancy, lactation period (breastfeeding).

Use in Pregnancy and Lactation

During pregnancy, use is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated (efficacy and safety have not been established).

Special Precautions

The use of carbachol may enhance surgery-induced intraocular inflammation. In case of identified hypotension, the risk of an additional decrease in intraocular pressure should be assessed.

Drug Interactions

The use of carbachol may enhance the effectiveness of depolarizing muscle relaxants and increase the chronotropic effect of cardiac glycosides.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.