Midriaticum-stulln pu

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Mydriaticum-Stulln PU (Mydriaticum Stulln® UD)

Composition:

Active substance: tropicamide;

1 ml of solution contains 5 mg of tropicamide;

Excipients: sodium nitrate, nitric acid, water for injections.

Pharmaceutical form. Eye drops in a dropper bottle.

Main physicochemical properties: colorless transparent solution.

Pharmacotherapeutic group.

Agents used in ophthalmology. Mydriatic and cycloplegic agents. Anticholinergic agents.

ATC code S01FA06.

Pharmacological properties.

Pharmacodynamics.

Tropicamide has anticholinergic activity similar to that of atropine, but differs in its faster onset and relatively short duration of mydriasis. A 0.5% solution of the drug causes paralysis of ocular accommodation.

The mechanism of action of tropicamide is based on competitive antagonism toward acetylcholine. It causes paralysis of the muscles, resulting in pupil dilation (mydriasis).

Pupil dilation and paralysis occur within 5–8 minutes after instillation of the drug into the conjunctival sac. Maximum pupil dilation occurs 15–20 minutes after administration of tropicamide and lasts for approximately 2 hours. The pupil fully returns to normal within 3–5 hours, sometimes up to 8 hours.

Pharmacokinetics. After instillation into the conjunctival sac, the drug is absorbed and may penetrate into the systemic circulation in negligible amounts, particularly in children and elderly individuals.

Clinical characteristics.

Indications.

To achieve mydriasis and cycloplegia during ophthalmologic examinations.

Contraindications.

Hypersensitivity to tropicamide or to tropic acid derivatives, allergy to mercury or phenylmercuric nitrate or to other components of the drug.

• Primary glaucoma, especially angle-closure glaucoma.
• Dry rhinitis.

Interaction with other medicinal products and other forms of interaction.

The effect of tropicamide may be enhanced when used concomitantly with other medicinal products having antimuscarinic properties (central nervous system stimulants), such as amantadine, certain antihistamines (medicinal products used to treat allergies), antipsychotic agents – phenothiazine derivatives (for the treatment of psychiatric disorders), as well as tricyclic and tetracyclic antidepressants (for the treatment of depression), quinidine, disopyramide, and metoclopramide.

When using more than one ophthalmic medicinal product, they should be administered with an interval of 5 minutes.

Special precautions for use

Midriaticum-Stulln PU is intended for topical ocular use only and must not be used for injections or oral administration.

Use with special caution in the following conditions: tachycardia (increased heart rate), cardiac insufficiency, myasthenia gravis (excessive muscle weakness), hyperthyroidism, acute pulmonary edema, obstructive urological disorders, Down's syndrome, open-angle glaucoma (there is a risk of increased intraocular pressure following administration of tropicamide).

Neonates (especially premature infants), infants, patients aged 65 years and older, and individuals with Down's syndrome are particularly sensitive to tropicamide. This medication should be used with caution in such patients.

It should be noted that hypersensitivity to anticholinergic agents (medications that block acetylcholine receptors in the central and peripheral nervous systems) may lead to psychotic reactions and behavioral disturbances.

Tropicamide may cause an increase in intraocular pressure. The drug should be administered cautiously in elderly patients and in patients with elevated intraocular pressure. To prevent an acute attack of glaucoma due to angle closure, the physician must first assess intraocular pressure as well as the depth and angle of the anterior chamber of the eye before initiating treatment. Monitoring of intraocular pressure is recommended, especially in cases of repeated administration.

Anticholinergic drugs are generally used cautiously in patients with prostatitis. However, if the drug is administered only once, as in the case of a single examination, the likelihood of complications is very low.

After topical application of tropicamide, careful monitoring is required in patients with high arterial pressure, excessive production of thyroid hormones, elevated blood glucose levels, or cardiovascular disorders.

After instillation, it is recommended to press the lacrimal sac with a finger for 2–3 minutes to prevent excessive systemic absorption of the drug.

Some patients may experience increased sensitivity to light; therefore, when pupils are dilated, eyes should be protected from excessively bright light.

If you wear soft contact lenses, do not administer the drops without first removing them. Wait 15 minutes after instillation before reinserting the lenses.

Do not touch the tip of the dropper bottle. Before use, check the expiration date of the medication. Single-dose packages are intended for single use only.

Use during pregnancy or breastfeeding

There is insufficient data on the use of tropicamide during pregnancy and breastfeeding; therefore, the drug is not recommended during these periods.

Effect on ability to drive or operate machinery

After instillation of the drops, patients should wait at least 4 hours (or even longer in rare cases) before driving or operating complex machinery.

Method of Administration and Dosage

Midriaticum-Stulln PU drops are instilled into the conjunctival sac for diagnostic purposes.

For diagnostic purposes, instill 1 drop into the conjunctival sac 10–15 minutes prior to examination.

In isolated cases, systemic anticholinergic effects (such as bladder and intestinal dysfunction, bradycardia) have been observed in premature infants following administration of tropicamide, and these effects may be intensified with repeated dosing. These adverse effects can be prevented by diluting the solution (1:1).

Prolonged use is not recommended due to insufficient experience with long-term administration of the drug.

Children.

The drug should be used in infants only under medical supervision and on a physician's prescription.

Tropicamide may cause central nervous system disturbances, which can be dangerous in infants and children.

Excessive use in children may lead to symptoms of systemic intoxication. The drug must be used with extreme caution in infants, young children, and in children with increased muscle tone/spasms or cerebral disorders.

Patients should be advised that this medication must not be ingested by a child, and that hands of both the patient and the child must be washed after administration.

Overdose.

In case of local overdose, remove the excess medication from the eye by rinsing it with warm running water.

Systemic intoxication may occur after local administration, especially in children. Significant overdose may cause symptoms such as facial flushing, dryness of the skin and mucous membranes (rash may occur in children), blurred vision, rapid and irregular pulse, fever, abdominal distension in infants, seizures, psychiatric disturbances (hallucinations or psychotic behavior), loss of neuromuscular coordination, photophobia, more pronounced and prolonged mydriasis and cycloplegia, tachycardia, agitation, hyperactivity, hyperthermia. High doses of the drug may lead to coma and respiratory paralysis.

Treatment. If any of these symptoms occur, administration of the eye drops should be discontinued immediately and medical advice should be sought. Symptomatic and supportive therapy should be administered. It is necessary to keep the skin surface of infants and young children moist.

Treatment of local overdose: instillation of pilocarpine eye drops or prostigmine at doses adjusted according to their therapeutic effect.

Treatment of systemic intoxication: gastric lavage and administration of activated charcoal; intravenous physostigmine 1–2 mg, dose may be repeated hourly if necessary; in case of seizures – intravenous administration of 10–20 mg diazepam; in case of hyperthermia – physical measures.

Side effects.

Adverse effects are classified by frequency of occurrence as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), or not known (frequency cannot be estimated from available data).

Cardiovascular system: very rare – bradycardia, tachycardia, arrhythmia, facial flushing, pallor.

Psychiatric disorders: rare – psychotic disorders, hallucinations, abnormal behaviour, disorientation. Also reported are autonomic nervous system stimulation.

Nervous system: uncommon – headache; rare – coordination disturbances, somnolence; not known – dizziness.

Eye disorders: common – photophobia with or without transient corneal clouding, eye pain (burning sensation upon instillation), blurred vision, visual impairment, eye discomfort, accommodation disorder; uncommon – increased intraocular pressure, eye irritation, ocular hyperemia; rare – conjunctivitis, eye swelling, punctate keratitis, development of congestive glaucoma; not known – eye itching. With prolonged use, changes in lens colour and corneal opacity (keratopathy) may occur.

Respiratory system: rare – nasal dryness.

Gastrointestinal disorders: rare – vomiting, nausea, constipation, dry mouth, defecation disorder.

Skin and subcutaneous tissue disorders: rare – rash, dry skin, skin redness, contact dermatitis.

Renal and urinary disorders: rare – dysuria, urinary retention.

General and administration site conditions: not known – prolonged effect of the drug, increased body temperature; allergic reactions.

The above-mentioned adverse reactions are most pronounced in children, especially infants, as well as in elderly patients.

This medicinal product may cause central nervous system disturbances, which can be dangerous in children. It should be noted that hypersensitivity to anticholinergic agents may lead to psychotic reactions and behavioural disorders.

One case of acute hypersensitivity reaction has been reported in a 5-year-old child, characterized by muscle rigidity, opisthotonus, pallor, and cyanosis.

The drug should be used with particular caution in children and in patients sensitive to belladonna alkaloids due to an increased risk of systemic toxicity.

Skin rashes may occur in children, and abdominal distension may occur in infants. Psychotic reactions, behavioural disorders, and cardio-respiratory collapse have been reported in children receiving medicinal products of this group.

Shelf life.

2 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Unopened dropper tubes should be stored in the cardboard package.

After opening, any remaining contents of the dropper tube must not be used.

Packaging.

0.4 ml in a dropper tube; 5 dropper tubes connected into a block; 1 block (No. 5) in an aluminium package, or 6 blocks (No. 30, with every 2 blocks in an aluminium package), or 12 blocks (No. 60, with every 2 blocks in an aluminium package) in a cardboard box.

0.4 ml in a dropper tube; 5 dropper tubes connected into a block; 12 blocks (No. 60, with every 2 blocks in an aluminium package) in a cardboard box; 5 cardboard boxes in a thermoformed package.

Prescription status. Prescription only.

Manufacturer. Pharma Stulln GmbH.

Manufacturer's address and place of business.

Werksstrasse 3, 92551 Stulln, Germany.