Vizofrin

General characteristics. Structure:

Active ingredient: Phenylephrinum a hydrochloride – 25 mg.

Excipients: a benzalkoniya chloride – 0,1 mg, dinatrium of an edetat a dihydrate – 1,0 mg, sodium hydroxide – 0,24 mg, sodium disulphite – 3,0 mg, citric acid – 1,0 mg, citrate sodium a dihydrate – 5,0 mg, water for injections – to 1 ml.

Description: the transparent colourless or slightly painted solution.

Pharmacological properties:

Pharmacodynamics. Fenilefrin – a-adrenomimetik, has the expressed non-selective a-adrenomimeticheskoye effect. At use in therapeutic doses does not make the considerable stimulating impact on the central nervous system. At topical administration in ophthalmology causes a mydriasis, improves outflow of intraocular liquid and narrows conjunctiva vessels. Poorly influences β-adrenoceptors, including hearts (does not render positive hrono-and inotropic action). Drug possesses vasoconstrictive action, similar to action of Norepinephrinum (noradrenaline). The angiotonic effect of Phenylephrinum is weaker, than at noradrenaline, but is longer. Causes vasoconstriction in 30-90 seconds after instillation, duration of 2-6 h. After instillation Phenylephrinum causes reduction of the muscle expanding a pupil, thereby, causing a mydriasis. The mydriasis comes within 10–60 minutes after single instillation. The mydriasis remains within 2 hours. The mydriasis caused by Phenylephrinum is not followed by a tsikloplegiya.

Pharmacokinetics. Fenilefrin easily gets into eye tissues, the maximum concentration in plasma is reached in 10–20 minutes after instillation in an eye. Preliminary instillation of local anesthetics can increase system absorption of Phenylephrinum and prolong a mydriasis. Fenilefrin is brought with urine in not changed look (<20 %) or in the form of inactive metabolites.

Indications to use:

Iridocyclitis (for prevention of emergence of back synechias and reduction of exudation from an iris of the eye). For a diagnostic mydriasis at the oftalmoskopiya and other diagnostic procedures necessary for control of a condition of a back piece of an eye. Carrying out the provocative test at patients with a narrow profile of a corner of an anterior chamber and suspicion of closed-angle glaucoma. Differential diagnosis of a superficial and deep injection of an eyeglobe. A syndrome of "a red eye" (for reduction of a hyperemia and annoyance of covers of an eye). Accommodation spasm.

Route of administration and doses:

At iridocyclites drug is used for prevention of development and a rupture of already formed back synechias; for decrease in exudation in an anterior chamber of an eye. For this purpose 1 drop of drug is dug in in a conjunctival sac of a sore eye (eyes) 2–3 times a day. When carrying out an oftalmoskopiya single instillation of drug is applied. As a rule, for creation of a mydriasis there is enough instillation of 1 drop of drug in a conjunctival sac. The maximum mydriasis is reached in 15–30 min. and remains during 1–3 h. In case of need maintenance of a mydriasis for a long time, in 1 h repeated instillation of drug is possible. Single instillation of drug is applied to holding diagnostic procedures: ·        as the provocative test at patients with a narrow profile of a corner of an anterior chamber of an eye and suspicion of closed-angle glaucoma. If the difference between values of intraocular pressure to an instillation of drug and after a mydriasis makes from 3 to 5  mm of mercury., the provocative test is considered positive; ·        for differential diagnosis like eyeglobe injection: if in 5 minutes after instillation of drug eyeglobe vasoconstriction is noted, then the injection is classified as superficial, at preservation of reddening of an eye it is necessary to inspect carefully the patient on existence of an iridocyclitis or sclerite as it demonstrates expansion of more deep-lying vessels. For an accommodation spasmolysis at children from 6 years and adults drug is instillirut on 1 drop in each eye for the night daily within 4 weeks.

Features of use:

Exceeding of the recommended dose of 2,5 % of solution at patients with injuries, diseases of an eye or its appendages, in the postoperative period or with a reduced slezoproduktion (anesthesia) can lead to increase in absorption of Phenylephrinum and development of system side effects. Influence on ability to control of mechanisms and vehicles: after use of drug owing to change of accommodation and width of a pupil, decrease in visual acuity therefore before its recovery it is not recommended to manage vehicles is possible and to be engaged in potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From an organ of sight Conjunctivitis, periorbital hypostasis. In certain cases patients note a burning sensation at the beginning of use, a sight zatumanennost, irritation, a sensation of discomfort in an eye, the raised dacryagogue, increase in intraocular pressure. Fenilefrin can cause a reactive miosis next day after use. Repeated instillations of drug during a short period can lead to less expressed mydriasis, than наблюдавшиемуся earlier. This effect is more often shown at elderly patients. Owing to considerable reduction of the muscle expanding a pupil in 30–45 minutes after instillation under the influence of Phenylephrinum in moisture of an anterior chamber of an eye parts of a pigment from a pigmental leaf of an iris of the eye can be found. The suspension in chamber moisture needs to be differentiated with manifestations of a front uveitis or with hit of uniform elements of blood in moisture of an anterior chamber. System reactions from skin and its appendages: contact dermatitis. From cardiovascular system: heart consciousness, tachycardia, arrhythmia, increase in arterial pressure, ventricular arrhythmia, reflex bradycardia, occlusion of coronary arteries, embolism of a pulmonary artery.

Interaction with other medicines:

The mydriatic effect of Phenylephrinum amplifies at its use in a combination with topical administration of atropine. Because of strengthening of angiotonic action development of tachycardia is possible. Use of Phenylephrinum with monoamine oxidase inhibitors, and also within 21 days after the termination of their use has to be carried out with care as in this case there is a possibility of uncontrollable rise in arterial pressure. Angiotonic action of a-adrenomimetikov can be also exponentiated at simultaneous use with tricyclic antidepressants, propranolol, Reserpinum, guanetidiny, metildopy and m-holinoblokatorami. Fenilefrin can exponentiate oppression of cardiovascular activity at an inhalation anesthesia. Simultaneous use with other adrenomimetika and sympathomimetics can strengthen influence of Phenylephrinum on cardiovascular system.

Contraindications:

Hypersensitivity to drug components. Narrow or closed-angle angle glaucoma. Advanced age. Serious cardiovascular or cerebrovascular illness. Disturbance of a slezoproduktion. Prematurity; children's age up to 6 years (at an accommodation spasm). Hyperthyroidism. Hepatic porphyria. Inborn deficit glyukozo-6-fosfatdegidrogenazy.

Overdose:

Symptoms: concern, nervousness, dizziness, perspiration, vomiting, heart consciousness, weak or shallow breathing.

Treatment: at emergence of systemic action of Phenylephrinum it is possible to stop the undesirable phenomena by administration of a-adrenoblockers, for example, of 5-10 mg of phentolamine intravenously. If necessary it is possible to repeat an injection.

Storage conditions:

To store in the place protected from light at a temperature not above 25 °C. To store in the places unavailable to children. Period of validity: 2 years. Not to use after the expiry date specified on packaging. After opening of a bottle a period of validity 1 month.

Issue conditions:

According to the recipe

Packaging:

Drops eye 2,5 %. On 5 ml in a bottle dropper polymeric with the screw mouth, a cover screwed, a stopper dropper and with a control ring of the first opening. 1 bottle dropper polymeric together with the application instruction in a pack from a cardboard.