Tropikamid-SOLOpharm (Drops) Instructions for Use

Marketing Authorization Holder

Grotex, LLC (Russia)

ATC Code

S01FA06 (Tropicamide)

Active Substance

Tropicamide (Rec.INN WHO registered)

Dosage Forms

	Tropicamide-SOLOpharm	Eye drops 0.5%: 5 ml, 10 ml or 15 ml bottle 1 pc.
		Eye drops 1%: 5 ml, 10 ml or 15 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye drops in the form of a transparent, colorless or slightly brownish solution.

Excipients: benzalkonium chloride – 0.1 mg, sodium chloride – 8 mg, disodium edetate dihydrate (Trilon B) – 0.1 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 4.0-5.8, water for injections – up to 1 ml.

5 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene terephthalate bottles (1) with a dropper – foil film bag (1) – cardboard packs.
15 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
15 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.

Eye drops in the form of a transparent, colorless or slightly brownish solution.

Excipients: benzalkonium chloride – 0.1 mg, sodium chloride – 8 mg, disodium edetate dihydrate (Trilon B) – 0.1 mg, 1M hydrochloric acid solution or 1M sodium hydroxide solution – to pH 4.0-5.8, water for injections – up to 1 ml.

5 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
10 ml – polyethylene terephthalate bottles (1) with a dropper – foil film bag (1) – cardboard packs.
15 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
15 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

M-Cholinoreceptor blocker for topical use in ophthalmology (mydriatic)

Pharmacotherapeutic Group

Agents used in ophthalmology; mydriatic and cycloplegic agents; anticholinergic agents

Pharmacological Action

Mydriatic. It blocks m-cholinergic receptors of the iris sphincter and ciliary muscle, causing mydriasis and cycloplegia. The action occurs quickly and is relatively short-lived. The tendency to increase intraocular pressure is less pronounced than with atropine. Pupil dilation is observed 5-10 minutes after instillation; maximum mydriasis and cycloplegia are noted after 20-45 minutes and last for 1-2 hours. The original pupil width is restored after 6 hours. The level of absorption of the active substance entering the nose through the lacrimal canals is relatively high, and side effects due to systemic action are possible.

Pharmacokinetics

After instillation into the conjunctival sac, Tropicamide undergoes systemic absorption to a small extent (especially in children and the elderly).

Indications

For diagnostic purposes when mydriasis and cycloplegia are necessary, including for fundus examination and refraction determination. As part of complex therapy for inflammatory processes and synechiae.

ICD codes

Dosage Regimen

For fundus examination, instill 1-2 drops of the 0.5% solution into the conjunctival sac of each eye 15-20 minutes before the procedure.

For refraction determination, instill 1-2 drops of the 1% solution into each eye; repeat the instillation after 5 minutes. Conduct the examination after 30-45 minutes.

For inflammatory processes and synechiae, use the 0.5% solution as part of complex therapy; instill 1-2 drops up to 3-4 times daily.

In pediatric patients, use only the 0.5% solution; instill 1 drop per eye 15-20 minutes before examination. Do not use the 1% solution in children without specific medical direction.

To minimize systemic absorption, apply pressure to the lacrimal sac (at the inner corner of the eye) for 2-3 minutes immediately after instillation.

Avoid allowing the dropper tip to contact the eye or any other surface to prevent contamination.

Wait at least 15 minutes before inserting soft contact lenses after instillation.

Adverse Reactions

Local reactions: possible – blurred vision, photophobia, eye pain, eye irritation, hyperemia, conjunctival edema, increased intraocular pressure.

Nervous system disorders: dizziness, headache.

Cardiovascular system disorders: fainting, arterial hypotension, tachycardia.

Gastrointestinal system disorders: nausea, dry mouth, decreased gastrointestinal motility, constipation.

Skin and subcutaneous tissue disorders: rash, skin redness.

Other: mydriasis, allergic reactions, dryness of mucous membranes, decreased secretion of sweat glands, urinary retention, decreased secretion of nasal, bronchial and lacrimal glands.

Use in pediatrics: rash; possible development of mental reactions and behavioral disorders; in newborns – abdominal distension.

Contraindications

Hypersensitivity to tropicamide; glaucoma (especially closed-angle form), increased intraocular pressure; children’s age – depending on the dosage form.

With caution

In case of increased intraocular pressure, shallow anterior chamber of the eye. In case of eye inflammation, as hyperemia significantly increases the level of systemic absorption through the conjunctiva.

Use in Pregnancy and Lactation

Use during pregnancy is not recommended. During breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the infant.

Pediatric Use

It is possible to use in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the tropicamide drug leaflets regarding contraindications for the use of specific tropicamide dosage forms in children of different ages.

Geriatric Use

The possibility of undiagnosed glaucoma in elderly patients should be considered.

Special Precautions

Tropicamide may cause an increase in intraocular pressure. The possibility of undiagnosed glaucoma in some categories of patients, such as the elderly, should be considered. Before starting treatment, it is necessary to measure intraocular pressure and assess the depth of the anterior chamber angle.

In patients with hypersensitivity to anticholinergic drugs, Tropicamide-induced psychotic reactions and behavioral disorders may develop. Particular caution is necessary in individuals with sensitivity to belladonna alkaloids, which is associated with an increased risk of general toxic effects on the body.

To reduce the risk of systemic side effects, it is recommended to compress the nasolacrimal duct by pressing the point at the inner corner of the eye for several minutes after instillation.

Do not wear soft contact lenses during the period of use.

Effect on ability to drive vehicles and mechanisms

After using tropicamide, driving vehicles and engaging in other activities requiring high concentration and speed of psychomotor reactions should be avoided until vision is completely restored.

Drug Interactions

The effect of m-cholinoblockers may be enhanced when used concomitantly with drugs possessing antimuscarinic properties – amantadine, some antihistamines, butyrophenones, phenothiazines, antipsychotics, tricyclic antidepressants.

When using more than one topical ophthalmic medicinal product, the drugs should be applied with an interval of at least 5 minutes.

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.