Instructions for Cyclomed eye drops 1% dropper bottle 5 ml
Composition
active ingredient: cyclopentolate;
1 ml contains 10 mg of cyclopentolate hydrochloride;
Excipients: benzalkonium chloride, sodium hydroxide, disodium edetate, sodium chloride, water for injections.
Dosage form
Eye drops.
Main physicochemical properties: transparent, colorless solution.
Pharmacotherapeutic group
Agents used in ophthalmology. Mydriatic and cycloplegic agents. Anticholinergic agents. Cyclopentolate.
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.
Pupil dilation 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 12–24 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
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
Suspected glaucoma, angle-closure glaucoma.
Intestinal obstruction.
Hypersensitivity to any components of the drug.
Organic lesions of the central nervous system in children.
Interaction with other medicinal products and other types of interactions
The effect of the drug may be enhanced by sympathomimetics (mezaton), and weakened by M-cholinomimetics (pilocarpine). Drugs with M-cholinomimetic properties when used simultaneously with Cyclomed may enhance the manifestations of its side effects. Cyclopentolate may affect the ocular antihypertensive effect of carbachol or cholinesterase inhibitors for ophthalmic use.
Application features
Reservation.
FOR OPHTHALMIC USE ONLY. NOT FOR INJECTION.
This drug may cause central nervous system (CNS) disturbances. This is particularly true in younger children, but can occur in patients of any age, especially when higher concentrations are used.
Mydriatics may cause a temporary increase in intraocular pressure.
General requirements. To reduce absorption and the risk of systemic effects when using the drug, it is necessary to carefully pinch the inner edges of the eyes (near the bridge of the nose) with clean fingers for two to three minutes after instillation, this will minimize the passage of the drug with tears through the nasolacrimal duct to the nasopharynx and nasal cavity. This is especially necessary when using the drug in children. Caution should be exercised regarding the possibility of using this drug in patients with Down syndrome and prone to angle-closure glaucoma. Children should be observed for at least 45 minutes after use.
The drug is less effective in young children, people with dark skin and/or darkly pigmented irises. In these people, when using the drug, residual accommodation can reach 2–4 diopters. If it is necessary to use the drug in this category of patients, the necessary dose should be selected. Use with caution in children, debilitated or elderly people, as well as in the presence of eye hyperemia (possible increased absorption and manifestations of systemic reactions).
In children with semi-persistent and persistent accommodation spasm, it is better to use a course of atropine sulfate instillations for cycloplegia.
When using the drug in elderly patients, there is a need to monitor intraocular pressure.
Use the drug with caution in young children (under 3 years old), patients over 60 years old, and those with prostatic hyperplasia.
Use with caution in patients with coronary disease, heart failure, ataxia.
Use with extreme caution in children and patients with sensitivity to belladonna derivatives, as the risk of systemic toxicity is increased.
Accommodation is restored within 24 hours.
The drug contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses, discoloring them or causing eye irritation. If you wear contact lenses, they must be removed before instillation. Lenses can be put on no earlier than 15 minutes after using the drug.
Children.
The use of cyclopentolate in children may be associated with psychotic reactions and behavioral disturbances. Increased susceptibility to cyclopentolate is observed in newborns, young children, and children with spastic paralysis or brain damage. Such disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation in time and space, and failure to recognize people. Food intolerance may occur in newborns if they are breastfed after ophthalmic use of this drug.
It is recommended to refrain from breastfeeding for 4 hours after the procedure.
Elderly patients. Overall, no differences in safety or effectiveness have been observed between elderly and younger patients. Cyclopentolate should be used with caution in elderly patients due to the possible presence of undiagnosed angle-closure glaucoma.
If you use other eye drops, you must wait at least 15 minutes before using the next medication.
After using the drug, hands must be washed thoroughly, as there is a risk of systemic toxicity if the drug is accidentally ingested orally.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug reduces visual acuity and affects reaction speed, so you should refrain from driving and working with other mechanisms during the period of drug use.
Use during pregnancy or breastfeeding
Pregnancy.
The drug can be used during pregnancy or breastfeeding only in urgent cases, provided that the expected benefit to the woman outweighs the possible risk to the fetus/child.
Breast-feeding.
It is not known whether cyclopentolate is excreted in human milk. However, the drug may enter the systemic circulation and infants whose mothers receive cyclopentolate topically may be at increased risk of toxicity.
Reproductive function.
Animal studies on the effects of cyclopentolate on reproductive function have not been conducted. It is not known whether cyclopentolate can cause adverse effects on the fetus when administered to pregnant women or whether it can affect reproductive function.
Method of administration and doses
Eye drops should be used with maximum hygiene, do not touch the tip of the dropper to any surfaces or fingers. Keep the bottle closed after each use. Pull the lower eyelid back while instilling.
Adults. Instill 1–2 drops into the conjunctival sac. The maximum effect occurs after 30–60 minutes. If necessary, instillation can be repeated after 5–10 minutes.
Children from 3 months of age and adolescents: 1–2 drops should be instilled at intervals of 15–20 minutes, 2–3 times a day.
Children
The drug is contraindicated for use in children under 3 months of age and children with organic lesions of the central nervous system, including epilepsy.
Overdose
Treatment: intravenous administration of a specific antidote – physostigmine. Children – at a dose of 0.5 mg, if there is no effect within 5 minutes, repeat the dose (the maximum dose should not exceed 2 mg). Adults, administer the antidote at a dose of 2 mg, if there is no effect within 20 minutes, repeat the administration at a dose of 1–2 mg.
Adverse reactions
Local reactions (ophthalmological disorders).
Short-term burning sensation, conjunctival redness, visual acuity disorders, increased intraocular pressure in patients with narrow-angle or open-angle glaucoma, photophobia, edema, irritation, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae.
Systemic reactions.
From the side of the central nervous system: inappropriate behavior, hallucinations (visual or auditory), unclear and inadequate speech, delusions, generalized/widespread epileptic seizures, disorientation in time and space, memory impairment, excitement, acute psychotic reactions, psychosis, agitation, dizziness, weakness, asthenia, fatigue, cerebellar manifestations or cerebellar dysfunction, confusion, ataxia, anxiety, causeless fear, change in sensations, increased fatigue, delirium, acute progressive midbrain hemorrhage, medullary paralysis, coma, death.
Manifestations of central nervous system toxicity in children: ataxia, generalized seizures, speech disorders, agitation, incoherent speech, inappropriate conversations, hallucinations, disorientation in time and space, impaired recognition of people around them, amnesia, dysarthria, cerebral manifestations or dysfunctions, increased activity, anxiety, fear, delirium, central anticholinergic syndrome, drowsiness, tearfulness may be observed.
3 sides of the cardiovascular system: cardiac arrhythmias (tachycardia, tachyarrhythmia); bradycardia alternating with tachycardia; arterial hypotension or hypertension, flushing of the face and extremities, vasodilation, feeling of heartbeat (palpitations).
Skin: urticaria (including contact), contact dermatitis, feeling of heat and dryness of the skin, unprovoked sweating.
3. Digestive system: nausea, bloating (especially in young children), increased gastric aspirate, indigestion, transient paralytic ileus, vomiting, food intolerance, necrotizing enterocolitis, constipation, lacrimation, drooling, decreased secretion of the pharynx and salivary glands (dry mouth).
Immune system disorders: severe anaphylactic reactions, respiratory failure.
On the part of the urinary system: urinary retention, urgency to urinate, difficulty urinating.
Others: fever, redness of the cheeks, decreased secretion in the bronchi, nasal passages, and sweat glands.
Effects caused by the preservative content: corneal edema, damage to the corneal endothelium, cytotoxic effect on corneal cells.
Expiration date
2 years.
The shelf life after opening the bottle is 1 month.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature not exceeding 25 °C in a place protected from light. Do not freeze! Keep out of the reach of children.
Packaging
5 ml in a dropper bottle, one bottle in a pack.
Vacation category
According to the recipe.
Producer
SENTISS PHARMA PVT. LTD.
Location of the manufacturer and its business address
Village Khera Nihla, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, 174 101, India.
