SIGIDA crystal - instructions for use, dose, side effects, contraindications

Active substance:
Naphazoline nitrate (naphthysine)	0.5 mg
Excipients:
Boric acid	18.7 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 injections	up to 1 ml

Description:

Transparent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:Antitussive medication - alpha-adrenomimetic

ATX: & nbsp

A.01.A.A.08 Naphazoline

Pharmacodynamics:

Naphazoline stimulates alpha-2-adrenoceptors vessels, local application has vasoconstrictor effect that reduces the edema and hyperemia of the conjunctiva.

Pharmacokinetics:

The full local effect of nafazoline appears after only 5 minutes from the time of application. The action lasts for 6-8 hours.

Naphazoline can be absorbed from the mucous membranes, causing systemic effects, although such action in adults after administration of the drug into the conjunctival sac is unlikely.Systemic reactions occur mainly in elderly patients and in young children.

Indications:

Symptomatic temporary relief of secondary hyperemia (reddening) of the eyes due to moderate irritant effect and allergic conjunctivitis.

Contraindications:

- Hypersensitivity to the components of the drug;

- zacres of glaucoma;

- dEthnic age is up to 2 years.

Carefully:

Severe cardiovascular diseases (ischemic heart disease, arterial hypertension), pheochromocytoma, prostatic hyperplasia, hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma, joint use with monoamine oxidase inhibitors or other means that can raise blood pressure.

Pregnancy and lactation:

Application during pregnancy and during breastfeeding is possible only if the expected benefit for the mother exceeds the potential risk to the fetus and the baby.

There is no data on the excretion of naphazoline into breast milk. Care should be taken when applying during breastfeeding.

Dosing and Administration:

Locally, in the conjunctival sac.

Adults and children over 6 years of age: 1-2 drops in the conjunctival sac of the eye 2-3 times a day.

Children from 2 to 6 years old: 1 drop 1-2 times a day.

The drug should not be used for longer than 3-5 days.

The procedure for working with a tube-dropper:

1. Open the package, separate one tube-dropper, rest put back into the package.

2. Open the tube-dropper (making sure that the solution is in the bottom of the tube-dropper, rotate the movements and turn off the valve).

3. Inject the required amount of the drug into the eyes.

Do not touch the tip of the dispenser to the eye or other surfaces, as this can lead to contamination of the contents of the dropper.

After instillation of the drug, gently close the eye, do not blink and do not open your eyes for about 2 minutes, so that the drug is adsorbed. After instillation, gently press down on the inside corner of the closed eyelid for 1-2 minutes. This can prevent drops from entering the nasolacrimal canal into the nasal cavity and the occurrence of side effects of a systemic nature. Then you should wash your hands to remove the remnants of the drug, and close the bottle.

The dose contained in a tube-dropper is sufficient for one instillation in both eyes.After a single use, the tube-dropper should be discarded, even if the contents remain.

Side effects:

From the side of the organ of vision: burning, itching, pain in the eye area; reactive hyperemia of the conjunctiva, visual impairment, dryness of the nasal mucosa, mydriasis, increased intraocular pressure.

In children and patients of advanced age are possible: pallor of the skin, tachycardia, pain in the heart, increased blood pressure, increased sweating, tremors, headache, agitation, nausea, drowsiness, dizziness.

Overdose:

With topical application of the drug, an overdose is unlikely. There are no data on cases of an overdose of naphazoline in the dosage form of eye drops.

Overdose or accidental ingestion can lead to central nervous system depression, hypothermia, heart rhythm disturbance, sweating, long mydriasis, drowsiness and coma (the risk of overdose is higher in children and elderly patients), increased blood pressure with possible subsequent sharp lowering of blood pressure, tachycardia .

Treatment: symptomatic.

Interaction:

The use of naphazoline simultaneously with the administration of tricyclic antidepressants can potentiate the vasoconstrictive effect of naphazoline.

Simultaneous use of naphazoline with monoamine oxidase inhibitors and within 14 days after their cancellation can lead to the development of hypertensive crisis.

In the case of concomitant therapy with the use of other local ophthalmic drugs should adhere to a 15-minute interval between their use.

Special instructions:

The drug is intended for topical use only.

The use of the drug may cause mydriasis.

The drug should be discontinued and consult a doctor if no improvement occurs within 72 hours, or irritation or congestion continues or worsens, or pain in the eye or visual impairment occurs.

Avoid direct contact with contact lenses. It is recommended to remove contact lenses before using eye drops.

To prevent contamination, do not touch the top of the packing to any surfaces. In case of discoloration or cloudiness of the solution, the preparation is not suitable for use.

The use of drops for children from 2 to 6 years should be done with caution, only under the supervision of a doctor.

Patients with severe cardiovascular diseases, such as ischemic heart disease, hypertension, pheochromocytoma and metabolic disorders (hyperthyroidism, diabetes mellitus), as well as patients who receive monoamine oxidase inhibitors or other drugs that can raise blood pressure, the drug should be used only when the expected benefit exceeds the potential risk.

Very frequent use can lead to redness of the eyes.

It is advisable to use the crystal only in case of slight eye irritation.

The patient should know:

- if the condition does not improve within 48 hours or if irritation or redness persists or worsens, the drug should be discontinued;

- if irritation or redness is associated with serious eye diseases (eg, infection, foreign body or chemical injury of the cornea), it is recommended that you consult a doctor;

- if there is intense pain in the eyes, headache, rapid loss of vision, sudden appearance before the eyes of floating spots, red eyes,pain during the period of light or in the eyes begins to double, the doctor should be contacted immediately.

Do not use eye drops of SIGIDA crystal in patients with epidermal endothelial dystrophy of the cornea.

Effect on the ability to drive transp. cf. and fur:

In view of a possible visual impairment, one should refrain from driving vehicles and practicing other potentially hazardous activities immediately after application of the drug.

Form release / dosage:

Eye drops, 0.05%.

Packaging:

By 0,4 ml in a tube-dropper made of low-density polyethylene or polypropylene.

For 5 or 10 tubes of IV in a foil bag.

For 2, 4 or 6 packages of foil film with 5 tubes or 1, 2 or 3 foil bags with 10 tubes and instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.