Vizofrin - instructions for use, dose, side effects, contraindications

Excipients: benzalkonium chloride 0.1 mg, disodium edetate dihydrate 1.0 mg, sodium hydroxide 0.24 mg, sodium disulfite 3.0 mg, citric acid 1.0 mg, sodium citrate dihydrate 5.0 mg, water for injection up to 1 ml .

Description:

Transparent colorless or slightly colored solution.

Pharmacotherapeutic group:Alpha-adrenomimetic

ATX: & nbsp

S.01.F.B.01 Ibopamine

Pharmacodynamics:

Phenylephrine - α-adrenomimetic, has a pronounced non-selective α-adrenergic effect.When used in therapeutic doses, it does not have a significant stimulating effect on the central nervous system.

With topical application in ophthalmology causes the dilatation of the pupil, improves the outflow of intraocular fluid and narrows the vessels of the conjunctiva.

Weakly affects β-adrenoreceptors, including the heart (does not have a positive chrono and inotropic effect). The drug has a vasoconstrictive action, similar to the action of norepinephrine (noradrenaline). The vasopressor effect of phenylephrine is weaker than that of norepinephrine, but is more prolonged. Causes vasoconstriction after 30-90 seconds after instillation, Duration 2-6 hours.

After instillation phenylephrine causes a contraction of the muscle that dilates the pupil, thereby causing a dilated pupil. Midriaz occurs within 10-60 minutes after a single Instillation. Mydriasis persists for 2 hours. Mydriaz, caused by phenylephrine, is not accompanied by cycloplegia.

Pharmacokinetics:

Phenylephrine easily penetrates the tissues of the eye, the maximum concentration in the plasma is reached in 10-20 minutes after instillation into the eye. The preliminary instillation of local anesthetics can increase the systemic absorption of phenylephrine and prolong the mydriasis.

Phenylephrine is excreted unchanged in urine (<20%) or in the form of inactive metabolites.

Indications:

Iridocyclitis (for the prevention of the appearance of posterior synechia and reduction of exudation from the iris).

For diagnostic dilatation of the pupil in ophthalmoscopy and other diagnostic procedures necessary for monitoring the state of the posterior segment of the eye.

Conducting a provocative test in patients with a narrow anterior chamber angle profile and suspicion of occlusive glaucoma.

Differential diagnosis of superficial and deep injection of the eyeball.

Syndrome of "red eye" (to reduce hyperemia and irritation of the membranes of the eye).

Spasm of accommodation.

Contraindications:

Hypersensitivity to the components of the drug.

Narrow-angle or angle-closure glaucoma.

Elderly age.

Severe cardiovascular or cerebrovascular disease.

Violation of tear production.

Prematurity; Children under 6 years of age (with accommodation spasm).

Hyperthyroidism.

Hepatic porphyria.

Congenital deficiency of glucose-6-phosphate dehydrogenase.

Carefully:

Diabetes mellitus (risk of increased blood pressure associated with a violation of autonomic regulation).

Elderly age in the absence of concomitant severe cardiovascular or cerebrovascular diseases (increased risk of reactive miosis).

Simultaneous use with monoamine oxidase inhibitors (including within 21 days after discontinuation of their use).

Sickle-cell anemia, wearing contact lenses, after surgical interventions (reduction of healing due to hypoxia of the conjunctiva).

Pregnancy and lactation:

The effect of phenylephrine in pregnant women and breast-feeding is not well understood, therefore, the use of the drug in these categories of patients is possible only if the expected benefit for the mother exceeds the potential risk in the fetus or the child.

It is not known whether the drug is excreted in breast milk. When appointing during lactation, breastfeeding should be stopped for the duration of treatment.

Dosing and Administration:

When iridotsiklitah the drug is used to prevent the development and rupture of the already formed rear synechia; to reduce exudation in the anterior chamber of the eye. To this end, 1 drop of the drug is buried in the conjunctival sac of the diseased eye (eye) 2-3 times a day.

When conducting ophthalmoscopy, a single instillation of the drug is used. Typically, to create mydriasis, enough instillation of 1 drop of the drug in the conjunctival sac. The maximum mydriasis is reached after 15-30 minutes and persists for 1-3 hours.

If you need to maintain mydriasis for a long time, after 1 hour, you can re-instillate the drug.

For diagnostic procedures, a single instillation of the drug is used:

- as a provocative test in patients with a narrow angle profile of the anterior chamber of the eye and suspected of a closed-angle glaucoma. If the difference between the values of intraocular pressure before instillation of the drug and after dilating the pupil is from 3 to 5 mm Hg. the provocative test is considered positive;

- for differential diagnosis of the type of injection of the main apple: if, after 5 minutes after the drug has been installed, the narrowing of the vessels of the eyeball is noted, the injection is classified as superficial, while maintaining the redness of the eye, it is necessary to carefully examine the patient for the presence of iridocyclitis or scleritis, since this indicates the expansion of deeper vessels.

To remove the spasm of accommodation in children from 6 years of age and adults, the drug is instilled by 1 drop in each eye at night every day for 4 weeks.

Side effects:

From the side of the organ of vision

Conjunctivitis, periorbital edema.

In some cases, patients note a burning sensation at the beginning of the application, blurred vision, irritation, a feeling of discomfort in the eye, increased lacrimation, increased intraocular pressure.

Phenylephrine may cause a reactive miosis the next day after application. Repeated instillations of the drug for a short period of time may lead to a less pronounced mydriasis than observed earlier. This effect is more common in elderly patients.

Due to a significant contraction of the muscle that dilates the pupil, after 30-45 minutes after instillation under the influence of phenylephrine in the moisture of the anterior chamber of the eye, pigment particles from the iris pigment sheet can be detected. The suspension in the chamber moisture must be differentiated with the manifestations of anterior uveitis or with the ingress of the formed elements of blood into the moisture of the anterior chamber.

Systemic reactions

From the skin and its appendages: contact dermatitis.

From the side of the cardiovascular system: palpitation, tachycardia, arrhythmia, increased blood pressure, ventricular arrhythmia, reflex bradycardia, coronary artery occlusion, pulmonary embolism.

Overdose:

Symptoms: anxiety, nervousness, dizziness, sweating, vomiting, palpitations, weak or shallow breathing.

Treatment: when the systemic effect of phenylephrine is suppressed Adverse events can be caused by the administration of α-blockers, for example 5-10 mg of phentolamine intravenously. If necessary, you can repeat the injection.

Interaction:

The mydriatic effect of phenylephrine is enhanced when it is used in combination with topical application of atropine. Because of the increased vasopressor effect, tachycardia can develop.

The use of phenylephrine with monoamine oxidase inhibitors, and also during 21 days after discontinuation of their use should be carried out with caution, since in this case there is the possibility of an uncontrolled rise in blood pressure.

Vasopressor action α-adrenomimetics can also be potentiated when used simultaneously with tricyclic antidepressants, propranolol, reserpine, guanethidine, methyldopa, and m-holinoblokatorami.

Phenylephrine can potentiate the inhibition of cardiovascular activity with inhalation anesthesia.

Simultaneous use with other adrenomimetics and sympathomimetics can enhance the effect of phenylephrine on the cardiovascular system.

Special instructions:

Exceeding the recommended dose of 2.5% solution in patients with trauma, eye disease or its appendages, in the postoperative period or with reduced tear production (anesthesia) can lead to an increase in the absorption of phenylephrine and the development of systemic side effects.

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

After applying the drug due to a change in accommodation and the width of the pupil, visual acuity can be reduced, so it is not recommended to drive vehicles and engage in potentially dangerous activities requiring increased attention and speed of psychomotor reactions until recovery.

Form release / dosage:

Eye drops, 2.5%.

Packaging:

5 ml per bottle of dropper polymer with a screw neck, cap screwed, stopper-dropper and with a control ring of the first opening.

1 bottle-dropper polymer together with instructions for use in a pack of cardboard.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

After opening the bottle, the expiration date is 1 month.

Terms of leave from pharmacies:On prescription

Registration number:LP-001556

Date of registration:01.03.2012

Expiration Date:01.03.2017

The owner of the registration certificate:LEKKO, ZAO LEKKO, ZAO Russia

Manufacturer: & nbsp

Pharmaceutical firm LEKKO, ZAO Russia

Information update date: & nbsp13.02.2017

Illustrated instructions

Instructions

Visofrin (Vizofrin)