Release form and composition
The drug is available in the form of eye drops 0.05%: transparent liquid, colorless or yellowish (0.4 ml in polyethylene tube-droppers: 5 tube-droppers per bag, in a cardboard pack 2, 4 or 6 bags; 10 tube droppers in a bag, in a cardboard box 1, 2 or 3 bags and instructions for use of Sigida crystal).
1 ml drops contain:
- active ingredient: naphazoline nitrate (naphthyzin) – 0.5 mg;
- auxiliary components: disodium edetate dihydrate (Trilon B), boric acid, sodium hyaluronate, macrogol 300, sodium hydroxide solution 1 M or nitric acid solution 0.1 M, water for injection.
Pharmacological properties
Pharmacodynamics
Sigida crystal is an alpha-adrenergic agonist, a drug for topical use in ophthalmology. The mechanism of its action is due to the property of the active substance, naphazoline, to stimulate alpha2-adrenergic receptors of blood vessels and have a vasoconstrictor effect. Which helps reduce hyperemia and swelling of the conjunctiva.
Pharmacokinetics
After administration of naphazoline into the conjunctival sac, the therapeutic effect occurs quickly. The vasoconstrictor effect on the mucous membranes of the eye lasts from 6 to 8 hours.
Absorption of naphazoline into the systemic circulation is possible; this often occurs when treating children and elderly patients.
Contraindications
Absolute:
- angle-closure glaucoma;
- age up to two years;
- hypersensitivity to the components of the drug.
Sigida crystal eye drops should be used with caution in case of glaucoma, keratoconjunctivitis sicca, severe cardiovascular diseases (including coronary heart disease, arterial hypertension), prostatic hyperplasia, pheochromocytoma, diabetes mellitus, hyperthyroidism, porphyria, dry rhinitis, concomitant therapy with monoamine oxidase inhibitors or medications that cause an increase in blood pressure (BP), as well as during pregnancy and breastfeeding.
Will eye drops work as well as glasses?
Recent research suggests that the effects of miotic drops begin in about 30 minutes and last between three and seven hours. After the corrective effect wears off, you need to put drops into your eyes again. On the other hand, the effect of eye drops to soften the lens can last several years. Patients using any type of these drops are able to see the 7th line at close range - approximately the same results are achieved when using glasses. Some patients using eye drops began to experience headaches, decreased night vision, or problems visually distinguishing an object from the surrounding background.
Some patients using drops used a combination of miotic drops and lens softening drops. Others have been able to benefit more from one type of drop than another.
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Sigida crystal, instructions for use: method and dosage
Sigida Crystal eye drops are intended for topical use by injection into the conjunctival sac.
To carry out the procedure, you should take the dropper tube in your hand and, holding it in a vertical position, turn and separate the valve. After instilling the required amount of the drug into the conjunctival sac, the eyes should be carefully closed (without blinking) for several minutes so that the drug is completely absorbed into the mucous membrane. To prevent drops from entering the nasal cavity through the nasolacrimal duct, it is necessary to press the inner corner of the closed eyelid with the bend of your finger.
Do not touch the tip of the dropper to the eye or other surfaces to prevent infection of its contents.
The procedure is carried out in compliance with antiseptic rules.
The amount of the drug in the dropper tube is sufficient for one instillation procedure in both eyes. Remains of the drug and the tube after administration of the drug should be disposed of.
Recommended dosage:
- children 2–6 years old: 1 drop 1–2 times a day;
- children and adolescents over 6 years of age, adult patients: 1-2 drops 2-3 times a day.
The duration of treatment is 3–5 days.
If after two days of using the drug Sigida Crystal there is no improvement in the condition or there is a worsening of symptoms of irritation or hyperemia, pain in the eye, blurred vision, you should immediately stop the procedure and consult a doctor.
Sigida Crystal eye drops 0.05% tube-drops 0.4ml No. 10
Compound
1 ml of the drug contains: Active ingredients: Diphenhydramine hydrochloride Naphazoline nitrate (naphthyzin) 1.0 mg 0.33 mg Excipients: Boric acid 16.0 mg Macrogol 300 1.125 mg Sodium hyaluronate 1.0 mg Disodium edetate dihydrate (Trilon B) 0 .5 mg 1 M solution of sodium hydroxide or nitric acid 0.1 M solution to pH 4.0 - 7.0 Water for injection up to 1 ml
Pharmacokinetics
The full local effect of naphazoline appears within 5 minutes from the moment of application. The action lasts 6-8 hours. Naphazoline can be absorbed from the mucous membranes, causing systemic effects, although such an effect in adults after administration of the drug into the conjunctival sac is unlikely. Systemic reactions occur mainly in elderly patients and young children. Systemic effects of diphenhydramine are unlikely.
Indications for use
Exacerbation of seasonal or year-round allergic conjunctivitis; ? inflammatory conditions associated with irritation of the conjunctiva as a result of the use of contact lenses, exposure to sunlight, cigarette smoke, contact with water in a swimming pool, etc.
Contraindications
Hypersensitivity to any component of the drug (including sympathomimetic amines); ? pregnancy; ? breast-feeding; ? angle-closure glaucoma; ? children's age (up to 2 years). 3
Carefully. Drops should not be used in case of prolonged conjunctivitis; they can be used for a short time during exacerbation of a chronic disease. The systemic effect of the components of the drug after administration into the conjunctival sac is unlikely, but it should be used with caution in patients with hypertension and arrhythmia; atherosclerosis, chronic rhinitis, bronchial asthma, with hypersensitivity to sympathomimetic amines, hyperthyroidism, as well as prostatic hyperplasia and old age. These patients should be warned that if any systemic reactions indicating absorption of naphazoline occur, the drug should be discontinued. It is not recommended to use the drug in newborns and children under 6 years of age due to the possible occurrence of potentially dangerous side effects. The patient should be warned that persistence of symptoms of irritation or eye pain for more than 72 hours is an indication for discontinuation of the drug. The use of the drug for more than 5 days or at intervals of less than 3 hours is contraindicated, due to the risk of developing a syndrome leading to a secondary increase in edema and hypersecretion, as well as the possibility of developing persistent changes in the epithelium.
Directions for use and doses
Locally, into the conjunctival sac. Adults and children over 6 years of age: 1-2 drops into the conjunctival sac, if necessary, every 6-8 hours. The drug should not be used for longer than 3-5 days. Procedure for working with a dropper tube: 4 1. Open the bag, separate one dropper tube, and place the rest back into the bag. 2. Open the dropper tube (making sure that the solution is at the bottom of the dropper tube, turn with a rotating motion and separate the valve). 3. Drop the required amount of the drug into the eyes. The dose contained in the dropper tube is sufficient for one instillation into both eyes. After one use, the dropper tube should be thrown away, even if the contents remain.
Storage conditions
Store at a temperature not exceeding 25? C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiration date!
special instructions
The drug is intended for topical use only: instillation into the conjunctival sac
Description
Transparent colorless or slightly colored liquid.
Conditions for dispensing from pharmacies
Dispensed by prescription.
Dosage form
Eye drops
Manufacturer and organization accepting consumer complaints
LLC "Grotex" Russia, 195279, St. Petersburg Industrialny pr., 71, building 2, lit. A Tel. Fax: +7 812 385 47 88 www.solopharm.com
Pharmacodynamics
A combined drug with antihistamine (diphenhydramine) and vasoconstrictor (naphazoline) effects. Diphenhydramine is a histamine H1 receptor antagonist. By competitively blocking histamine H1 receptors, it reduces allergic symptoms, especially those associated with histamine release, such as increased permeability and vasodilation. Naphazoline stimulates vascular alpha-adrenergic receptors, its local application leads to a narrowing of dilated blood vessels and a reduction in the symptoms of the inflammatory condition.
Side effects
Burning, itching, hyperemia, irritation of the conjunctiva, pain in the eyes, visual disturbances, dryness of the nasal mucosa, mydriasis, increased intraocular pressure. A single case of corneal opacification has been described (when used for 7 days at least 10 times a day), which disappeared after stopping treatment. Long-term use may lead to local changes in the epithelium associated with hypoxia (worsening prognosis).
Use during pregnancy and breastfeeding
During pregnancy, the use of the drug is not recommended. If it is necessary to use the drug during lactation, it is recommended to stop breastfeeding.
Interaction
The use of a drug containing naphazoline simultaneously with tricyclic antidepressants may potentiate the vasoconstrictor effect of naphazoline. The simultaneous use of naphazoline with monoamine oxidase inhibitors can lead to the development of a hypertensive crisis.
Overdose
Symptoms: prolonged or too frequent use in children under 6 years of age can lead to inhibition of the central nervous system, hypothermia (lowering body temperature), prolonged mydriasis, increased blood pressure, tachycardia, coma.
Treatment: symptomatic.
Impact on the ability to drive vehicles and operate machinery
Due to possible visual impairment, it should be used with caution in persons driving vehicles and servicing machinery.
special instructions
Mydriasis may develop during the use of Sigida crystal.
Before using the drug, it is recommended to consult a doctor, especially when treating children and the elderly.
If a visual inspection of the solution reveals turbidity or a change in color, the tube with drops should be discarded.
Direct contact of eye drops with contact lenses should not be allowed, therefore, before each procedure, it is recommended to remove contact lenses and after 15 minutes put them back on the cornea.
In case of coronary heart disease, arterial hypertension and other severe cardiovascular diseases, pheochromocytoma, metabolic disorders (diabetes mellitus, hyperthyroidism), concomitant therapy with monoamine oxidase inhibitors and other drugs that can increase blood pressure, before using Sigida crystal, patients should compare the expected benefit and potential risk from therapy.
Violation of the recommended dosage regimen may cause redness of the eyes.
If irritation or redness of the eyes is caused by such serious diseases of the organ of vision as chemical injury to the cornea, infections, foreign bodies, then you should consult a doctor.
Immediate consultation with a doctor is required if intense pain in the eyes, redness of the eyes, sudden appearance of floating spots in front of the eyes, headache, rapid loss of vision, pain or double vision in bright light appear during the use of Sigida Crystal.
For epidermal endothelial corneal dystrophy (Fuchs' dystrophy), eye drops should not be used.
Impact on the ability to drive vehicles and complex mechanisms
Immediately after the administration of the drops, temporary visual disturbances are possible; during this period, you should avoid driving vehicles and performing other potentially hazardous activities.
Two types of eye drops
Farsightedness occurs when the lenses of the eyes become stiffer and less flexible over time. This makes it difficult to focus our vision, which we need to read words on a page or on a smartphone screen. To solve this problem, two types of eye drops are being developed today, each of which has its own unique mechanism of action. Miotic drops cause pupil constriction, limiting out-of-focus information. Drops to soften the lens help restore its flexibility. Both types of drops are currently undergoing clinical trials to test their safety and effectiveness in humans. Experts predict that at least one type of eye drop could soon get the green light—maybe within the next two years.
Miotic drops
Miotic drops change the size of the pupil. By creating a "small hole" effect, this type of drops improves eye focusing for near and far vision. This is reminiscent of the action of a camera before the invention of photographic lenses. Miotic drops are being developed by Allergan, Presbyopia Therapies and Orasis Pharmaceuticals.
Drops for softening the lens
Drops of this type soften the lenses of aging eyes. When the lens regains flexibility, the eye can better focus on nearby objects. Drops of this type cannot completely restore near vision. But they are able to “turn the clock back” ten years. This type of drop may be best suited for people in the early stages of developing farsightedness, which includes almost half of all patients diagnosed with this condition. The first eye drops that soften the lens were developed by Novartis. They are now undergoing the second stage of clinical trials.
Drug interactions
With the simultaneous use of Sigid Crystal with tricyclic antidepressants, the vasoconstrictor effect of naphthyzine may be enhanced.
It should be taken into account that when combined with monoamine oxidase inhibitors or using the drug within the first 14 days after their discontinuation, there is a risk of developing a hypertensive crisis.
When concomitant therapy with other local ophthalmic agents is recommended, an interval of 15 minutes between procedures is recommended.
