Instructions for use: Cirelax eye drops, solution 10 mg/ml, dropper bottle 5 ml
Composition
active ingredient: cyclopentolate hydrochloride;
1 ml of solution contains 10 mg of cyclopentolate hydrochloride;
excipients: boric acid, benzalkonium chloride, potassium chloride, disodium edetate, hydrochloric acid or sodium carbonate solution, purified water.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent colorless solution.
Pharmacotherapeutic group
Mydriatics and cycloplegics. Anticholinergics. ATX code S01F A04.
Pharmacological properties
Pharmacodynamics.
Cyclopentolate, by blocking M-cholinergic receptors, prevents the action of the mediator of cholinergic synapses - acetylquinoline.
As a result of blocking cholinergic synapses located in the sphincter of the pupil and in the ciliary muscle, the pupil dilates due to the predominance of the tone of the muscle that dilates the pupil and the relaxation of the muscle that constricts the pupil. At the same time, accommodation paralysis (cycloplegia) occurs due to the relaxation of the ciliary (accommodative) muscle.
Mydriasis occurs within 15–30 minutes after a single instillation. Mydriasis persists for 6–12 hours, in particularly sensitive patients, mild mydriasis may persist much longer. Residual cycloplegia persists for 6–24 hours. The drug has a weak antispasmodic effect, reduces the secretion of salivary, gastric, bronchial, sweat glands and pancreas; increases intraocular pressure; reduces the tone of the vagus nerve, which leads to an increase in heart rate with a slight increase in blood pressure.
Penetrates the blood-brain barrier; in medium therapeutic doses, it has a moderate stimulating effect on the central nervous system and stimulates respiration.
Pharmacokinetics.
Cyclopentolate is well absorbed through the conjunctiva. Significant levels in the central nervous system are reached after 0.5–1 hour. Plasma protein binding is moderate. The half-life is 2 hours.
Indication
The drug is used to achieve mydriasis and cycloplegia.
Contraindication
Hypersensitivity to the active substance or to any of the other components of the drug; angle-closure glaucoma; anatomically narrow angle of the anterior chamber of the eye.
Interaction with other medicinal products and other types of interactions
The effects of cyclopentolate may be enhanced when used concomitantly with anticholinergic agents such as amantadine, some antihistamines, phenothiazines, neuroleptics, and tricyclic antidepressants.
The antiglaucoma effect of carbacholine, pilocarpine and the antiglaucoma and miotic effects of ophthalmic cholinesterase inhibitors may be attenuated when used concomitantly with cyclopentolate.
Application features
Full recovery of accommodation occurs within 24 hours, but in some cases recovery is possible within several days.
Individuals with dark iris pigment and/or dark skin are less sensitive to the effects of cyclopentolate, so the dose of the drug should be adjusted accordingly.
To reduce systemic absorption and the risk of systemic adverse reactions, it is recommended to apply pressure to the nasolacrimal punctum during the procedure and for 2–3 minutes afterwards (especially when used in children). Children should be observed for at least 45 minutes after the procedure.
Hands should be washed thoroughly after use as there is a risk of systemic toxicity if accidentally ingested. In case of accidental ingestion, seek medical attention.
Parents should prevent the medicine from getting into the child's mouth and wash the child's hands after using it.
To prevent contamination of the solution, do not touch other surfaces with the dropper tip.
During the use of cyclopentolate, increased sensitivity to light is possible, so the eyes should be protected from bright light.
When using cyclopentolate, psychotic reactions, behavioral disorders and other neurological disorders may develop in patients with hypersensitivity to anticholinergic drugs. These disorders can occur at any age, but young children (up to 3 years) are most sensitive.
Patients with a predisposition to increased intraocular pressure and elderly patients are at increased risk of developing provoked angle-closure glaucoma. The drug should be used with caution in such patients and in patients with Down syndrome. Before using the drug, the depth of the anterior chamber should be assessed, especially if prolonged or intensive therapy is required.
The drug should be used with caution in patients with prostatic hypertrophy, intestinal obstruction, coronary insufficiency, heart failure, ataxia due to the possibility of atropine-like reactions, and in patients with hypersensitivity to belladonna alkaloids and debilitated patients due to the risk of developing systemic toxic effects.
The drug should be used with caution in patients with eye inflammation, as hyperemia significantly increases the rate of systemic absorption through the conjunctiva.
Cyclopentolate may cause seizures and psychotic reactions, especially in children. The drug should be used with caution in children with epilepsy.
Application to children.
Hypersensitivity to cyclopentolate has been reported in infants, young children (up to 3 years of age), children with Down syndrome, spastic paralysis or brain damage. Due to systemic absorption of cyclopentolate in such patients, its toxic effects on the central nervous system, cardiovascular and respiratory systems are manifested.
The drug should not be used in children under 1 year of age and should be used with extreme caution in younger children (under 3 years of age), children with Down syndrome, spastic paralysis, or brain damage.
In the presence of semi-persistent or persistent accommodation spasm in cycloplegia, it is better to use a course of atropine sulfate instillations.
Light-skinned children with blue eyes are at increased risk of developing adverse reactions.
Use in elderly patients.
Elderly patients are at increased risk of developing provoked glaucoma, increased intraocular pressure, psychotic and behavioral disorders. The drug should be used with caution in such patients and intraocular pressure should be monitored.
Use in patients with impaired renal and/or hepatic function.
No studies have been conducted on the use of cyclopentolate in such patients.
The medicine contains a preservative - benzalkonium chloride, which can be absorbed by soft contact lenses, discolor them or cause eye irritation. If you wear contact lenses, they must be removed before instillation. You can put on lenses no earlier than 15 minutes after using the medicine.
In case of simultaneous use of other eye drops, the interval between instillations of these medicines should be at least 15 minutes.
Use during pregnancy or breastfeeding
There is currently insufficient data on the safety of cyclopentolate use in pregnant women. It is not known whether cyclopentolate passes into breast milk. The drug should be used during pregnancy or breastfeeding only if the expected benefit to the woman outweighs the potential risk to the fetus/child. Food intolerance may develop in infants when using cyclopentolate. When using the drug, it is recommended to refrain from breastfeeding for 4 hours after its use.
Ability to influence reaction speed when driving vehicles or other mechanisms
Cyclopentolate may cause temporary blurred vision. Patients should refrain from driving or operating machinery until vision clears.
Method of administration and doses
The drug is intended for ophthalmic use only. Eye drops should be instilled into the conjunctival sac of the eye.
Adults: 1–2 drops of the solution should be instilled. If necessary, the instillation can be repeated after 5–10 minutes.
Children over 1 year of age: 1–2 drops of the solution should be instilled. If necessary, the instillation can be repeated after 5–10 minutes.
The maximum effect of the drug is achieved 30–60 minutes after its use.
It is also recommended to apply pressure to the nasolacrimal punctum during the procedure and for 2–3 minutes afterwards (especially in children) to reduce systemic absorption and the risk of systemic adverse reactions. Children should be observed for at least 45 minutes after the procedure.
Hands should be washed thoroughly after using the medicine. Parents should avoid putting the medicine in the child's mouth and wash the child's hands after using it.
Children.
The drug should not be used in children under 1 year of age and should be used with extreme caution in younger children (under 3 years of age), children with Down syndrome, spastic paralysis, or brain damage.
Hypersensitivity to cyclopentolate has been reported in infants, young children (up to 3 years of age), children with Down syndrome, spastic paralysis or brain damage. Due to systemic absorption of cyclopentolate in such patients, its toxic effects on the central nervous system, cardiovascular and respiratory systems are manifested.
Overdose
Increased manifestations of adverse reactions. Systemic adverse reactions may also occur after topical application of cyclopentolate, especially in children, and include redness and dryness of the skin and mucous membranes, rash (in children), blurred vision, tachycardia, fever, abdominal distension in infants, convulsions, hallucinations, agitation, impaired mental reactions (incoherent speech, increased fatigue, impaired recognition of close objects and disorientation in space, change in emotional state) and impaired neuromuscular coordination. Significant overdose can cause central nervous system depression, coma, cardiovascular and respiratory failure, cerebral palsy, and death. Symptoms appear 20–30 minutes after instillation of cyclopentolate and last up to 12–24 hours.
Treatment.
In case of local overdose, the eyes should be washed with warm water. In case of symptoms of overdose, the drug should be discontinued and symptomatic and supportive therapy should be carried out. In case of severe manifestations, intravenous administration of a specific antidote, physostigmine, is indicated. Adults should be administered the antidote at a dose of 2 mg, if there is no effect within 20 minutes, the administration is repeated at a dose of 1–2 mg. Children should be administered the antidote at a dose of 0.5 mg, if there is no effect within 5 minutes, the administration is repeated (the total dose should not exceed 2 mg).
Adverse reactions
Local reactions (ophthalmological disorders): increased intraocular pressure, transient burning sensation, irritation, conjunctival hyperemia, photophobia, blurred vision, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae, edema, eye pain, mydriasis, lacrimation.
From the side of the central nervous system and psyche: psychotic reactions and behavioral disorders, including ataxia, speech incoherence, anxiety, hallucinations, hyperactivity, seizures, disorientation, prosopagnosia, confusion, agitation; retrograde amnesia, dizziness, headache, drowsiness. Children may experience ataxia, epileptic seizures, speech disorders, agitation, incoherent speech, hallucinations, disorientation in time and space, impaired recognition of people around them, amnesia, dysarthria, cerebral manifestations or dysfunctions, increased activity, anxiety, fear, central anticholinergic syndrome, drowsiness, tearfulness.
From the cardiovascular system: tachycardia, bradycardia alternating with tachycardia, arterial hypotension or hypertension, tachyarrhythmia, arrhythmia, vasodilation, flushing of the face and extremities, feeling of heartbeat (palpitations).
On the part of the digestive tract: nausea, vomiting, dry mouth, decreased gastrointestinal motility, bloating (in young children), indigestion, intestinal obstruction, food intolerance, necrotizing enterocolitis, constipation, drooling.
Immune system, skin and subcutaneous tissue disorders: hypersensitivity reactions, including severe anaphylactic reactions, respiratory failure; rash, erythema, urticaria (including contact), contact dermatitis, feeling of heat and dryness of the skin.
On the part of the urinary system: urinary retention, urgency to urinate, difficulty urinating.
Others: fever, gait disturbance, fatigue, decreased secretion of salivary and sweat glands, pharynx, bronchi, and nasal passages.
Reporting of suspected adverse reactions.
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
3 years. After opening the bottle, the medicine can be used for 28 days.
Storage conditions
Store at 2–8°C, protected from light and out of reach of children. After opening, store at a temperature not exceeding 25°C.
Packaging
5 ml of solution in a dropper bottle; 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
K.O. Rompharm Company S.R.L., Romania /
SC Rompharm Company SRL, Romania.
Location of the manufacturer and its business address.
Otopeni, Eroilor St. No. 1A, 075100, Ilfov County /
Otopeni city, Eroilor str. No. 1A, 075100, jud. Ilfov.
Applicant.
LLC "WORLD MEDICINE", Ukraine /
WORLD MEDICINE, LLC, Ukraine.
