Polideksa with Phenylephrinum

General characteristics. Structure:

Active agents: Neomycinum sulfate of 1 g (650 000 PIECES); polymyxin B sulfate of 1 000 000 PIECES; dexamethasone metasulfosodium benzoate of 25 mg; Phenylephrinum hydrochloride of 250 mg

Excipients: methylparahydroxybenzoate - 100 mg, a lity chloride - 340 mg, citric acid - 280 mg, a lity hydroxide - 100 mg, a macrogoal of 400 - 5, polysorbate of 80 - 200 mg, the water purified - to 100 ml.

Pharmacological properties:

Pharmacodynamics. The therapeutic effect of drug of Polideks with Phenylephrinum is caused by antiinflammatory effect of dexamethasone on a mucous membrane of a nasal cavity, antimicrobic action of antibiotics of Neomycinum and polymyxin B and vasoconstrictive action of Phenylephrinum. At a combination of the specified antibiotics the range of antimicrobic action on the majority of the gram-positive and gram-negative microorganisms causing infectious and inflammatory diseases of a nasal cavity and okolonosovy bosoms extends. Thanks to vasoconstrictive action of Phenylephrinum the congestion of a nose decreases and nasal breath is facilitated.

Pharmacokinetics. The research of pharmacokinetics of drug was not conducted in connection with low system absorption.

Indications to use:

Inflammatory and infectious diseases of a nasal cavity, including acute rhinitis, acute sinusitis.

Route of administration and doses:

The adult appoint on 1 injection of 3-5 times a day in each nasal course, to children 12 years — on 1 injection 3 times a day in each nasal course within 5–10 days are aged more senior.
Injection is carried out by means of pressing a bottle. At use of drug it is necessary to hold a bottle vertically, and slightly to incline the head forward to inject into the nasal course solution in the form of spray, but not streams of liquid. If for 10 days of treatment the therapeutic effect is absent, administration of drug needs to be stopped.

Features of use:

It is not necessary to swallow of drug. It is impossible to apply this medicine longer than an established period (10 days) because of possible risk of emergence of a withdrawal and iatrogenic rhinitis. The repeated and/or long inhalations can cause essential absorption of active ingredients.
Existence of a corticosteroid as a part of drug does not prevent local symptoms of an allergy, but can change their current.
At deterioration in the general state in connection with an infectious and inflammatory disease if necessary appoint antibiotics for system use.
With care appoint to patients with AG, IBS, a hyper thyroidism in connection with existence in composition of drug of a sympathomimetic.
Drug contains dexamethasone which can yield a positive take when carrying out a drug test.
Despite topical administration of medicine, it is necessary to consider that at long therapy or at use in the dose considerably exceeding recommended drug can have systemic action.
At systemic action of active components of drug their interaction with other medicines is possible.
After opening of a bottle and since first day of use of drug there is a possibility of its microbic infection.
Use during pregnancy and feeding by a breast
Efficiency and safety of use of drug during pregnancy and feeding by a breast were not studied therefore it is not recommended to use drug during pregnancy and feeding by a breast.
Children. Drug is not used at children aged <12 years.
Ability to influence speed of response at control of vehicles or work with other mechanisms. Cases of influence on speed of response at control of vehicles are noted.

Side effects:

Local: the feeling of dryness in a nose, such local allergic reactions as a small tortoiseshell, an itch, skin rash is in some cases possible. System side effects are possible only on condition of long treatment (more established period) or at use in the dose considerably exceeding recommended.
System: headache, sleeplessness, increase in the ABP, tachycardia, tremor, pallor of integuments.
System or local allergic reactions (reddening, swelled) and sensitization to the antibiotics which are a part of drug that can complicate the following reception of these or related antibiotics are possible.

Interaction with other medicines:

The features of interaction with medicines arising at system absorption of active components of drug are included below.
Interactions characteristic of Phenylephrinum
Inadmissible combinations: with Bromocriptinum — risk of emergence of a vasospasm (vasomotor spasm) and/or increase in the ABP; with guanetidiny or substances, similar on chemical structure (a possibility of strengthening of hypertensive effect of Phenylephrinum and due to decrease in a sympathetic tone guanetidiny a possibility of a long mydriasis); MAO inhibitors (development of hypertensive crisis owing to weakening of metabolism of pressor amines is possible). Due to long effect of MAO inhibitors interaction is possible for 2 weeks after cancellation of MAO inhibitors.
The combinations demanding use with care: MAO selection inhibitors (толоксатон and моклобемид): because of insufficient data existence of interaction between α-sympathomimetic vasoconstrictors and the MAO selection inhibitors was not estimated, unlike interaction of these means with the MAO non-selective inhibitors. But, by analogy with the MAO non-selective inhibitors, it is necessary to be careful and appoint Phenylephrinum only in case of emergency, observing the recommended doses.
Interactions characteristic of dexamethasone
Inadmissible combinations: with drugs which can cause polymorphic ventricular tachycardia like pirouette (астемизол, bepridit, erythromycin in/in, галофантрин, pentamidine, спарфлоксацин, султоприд, терфенадин and Vincaminum). The hypopotassemia, bradycardia and increase in an interval of Q-T can be adverse factors.
Combinations which use demands extra care: long system use of acetylsalicylic acid and other salicylates (decrease in level of salicylates in blood serum at use is possible GKS and risk of overdose of salicylates after cancellation of GKS); antiarrhytmic means which are capable to cause polymorphic ventricular tachycardia on type a pirouette (Amiodaronum, a bretylium, Disopyramidum, quinidine, соталол) — possibly development of a hypopotassemia, bradycardia and increase in an interval of Q-T at an ECG; аминоглутетимид: increase in activity of dexamethasone (increase in his metabolism in a liver). Dexamethasone dose adjustment is necessary; peroral anticoagulants (a possibility of influence of GKS on metabolism of indirect anticoagulants and blood-coagulation factors that can increase risk of development of the bleedings specific to system therapy of GKS — gastrointestinal due to fragility of vessels). When such association is justified, it is necessary to strengthen actions for monitoring: to repeatedly carry out laboratory analyses for the 8th day of treatment, and then each 2 weeks throughout treatment by drug and after its termination; drugs which reduce potassium level in a blood plasma (diuretics, purgatives, Amphotericinum in/in) result in the increased risk of development of a hypopotassemia. It is necessary to carry out monitoring of level of potassium in blood serum and to adjust it if necessary, especially in case of treatment by foxglove drugs; foxglove drugs (the hypopotassemia strengthens toxic effects of drugs of a foxglove); parenteral heparins: heparin increases risk of development of bleedings, specific to GKS (a mucous membrane of a GIT due to fragility of vessels); the substances influencing synthesis of enzymes (carbamazepine, phenobarbital, Phenytoinum, Primidonum, рифабутин and rifampicin): reduce concentration in a blood plasma and action of corticosteroids by strengthening of their metabolism in a liver. Especially it is shown at patients with Addison's disease and in case of organ transplantation. Monitoring of clinical and laboratory indicators, and also dose adjustment of corticosteroids is necessary during a combination therapy and after the treatment termination by substances which influence synthesis of enzymes; insulin, metformin (decrease in efficiency of gipoglikemiziruyushchy drugs that can lead to development of a ketosis owing to the induced GKS of decrease in portability of glucose); an isoniazid (decrease in level of an isoniazid in a blood plasma); salts, oxides and magnesium hydroxides, aluminum and calcium: decrease in extent of absorption of GKS in a GIT.
Combinations which use demands care: antihypertensives (possible easing of hypotensive effect) — deduction in an organism of salt and water thanks to influence of corticosteroids; the weakened live vaccines (risk of generalization of a disease up to a lethal outcome), such risk is connected with the immunity easing connected with other diseases; a praziquantel (decrease in concentration of a prazikvantel in a blood plasma is possible).

Contraindications:

Hypersensitivity to any of drug components in particular, to parabens and aminoglycosides; existence of the infections of nasal localization caused by a virus of the simple or surrounding herpes, chicken pox;
suspicion of closed-angle glaucoma; suspicion on an urination delay during uretro-prostatic disturbances; period of pregnancy and feeding by a breast; simultaneous use with guanetidiny or similar medicines, Bromocriptinum, MAO inhibitors and drugs which can cause polymorphic ventricular tachycardia on type a pirouette (see INTERACTIONS); age up to 12 years.

Overdose:

On condition of long treatment (more established period) or at use in a dose which considerably exceeds recommended drug can cause systemic action.

Storage conditions:

At a temperature not above 25 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

100 ml of spray for a nose contain Neomycinum of sulfate 1 g (650000 PIECES), polymyxin B of sulfate of 1000000 PIECES, dexamethasone of sodium of metasulfobenzoate of 25 mg and Phenylephrinum of a hydrochloride of 250 mg; in a bottle with the sprayer of 15 ml.