The instruction for medical use
of Polideksa medicine with Phenylephrinum
the Trade name
of Polidex with Phenylephrinum
the International unlicensed name
Is not present
the Dosage form
Spray nasal
Structure
100 ml of drug contain:
active agents: Neomycinum sulfate of 1.0 g (650,000 ME)
polymyxin In ME sulfate 1,000,000
dexamethasone sodium metasulfobenzoate of 0.025 g
Phenylephrinum a hydrochloride of 0.250 g,
excipients: methylparahydroxybenzoate, a lity chloride, citric acid monohydrate, a lity hydroxide, a macrogoal 4000, polysorbate 80, water purified.
The description
Transparent colourless liquid
Pharmacotherapeutic group
Glucocorticosteroids in a combination with antimicrobial drugs. Dexamethasone in a combination with the antimicrobial
drugs Code of Automatic Telephone Exchange S02CA06 Pharmacological Pharmacokinetics Due to Properties low system absorption of drug at topical administration the data on pharmacokinetics are not provided
the Pharmacodynamics
the Combined anti-inflammatory drug for topical administration in otolaryngology.
Neomycinum and polymyxin B have antibacterial effect. At a combination of the specified antibiotics the range of antibacterial action on the majority of the gram-positive and gram-negative microorganisms causing infectious and inflammatory diseases of a nasal cavity and adnexal bosoms extends.
Polymyxin In sulfate has bactericidal effect on gram-positive and gram-negative microorganisms. The most valuable feature of an antibiotic is its efficiency concerning a pyocyanic stick. Does not affect coccal aerobic (stafilo-, strepto-, pneumo - gono- and meningokokk) and anaerobic microorganisms and also the majority of strains of Proteus, causative agents of tuberculosis, diphtheria, clostridiums and mushrooms.
Neomycinum influences both gram-positive, and gram-negative microorganisms (staphylococcus, Proteus, Enterobacter, Klebsiella, Shigella, Haemophilus influenzae, Salmonella, Campilobacter, Cornebacterium, Listeria monocytogenes, Escherichia coli, etc.). Rezistenten concerning a mycoplasma, a pyocyanic stick, streptococci, anaerobic microorganisms.
Dexamethasone is a glucocorticosteroid, at topical administration has anti-inflammatory, antiallergic and anti-exudative effect.
Phenylephrinum the hydrochloride is a sympathomimetic, stimulates postsynaptic α-adrenoceptors and has vasoconstrictive property. As the vasoconstrictor reduces hypostasis and hyperaemia of mucous membranes of a nose and near-nasal bosoms, expressiveness of exudative manifestations, restores free breath.
Indications
Inflammatory and infectious diseases of a nasal cavity, adnexal bosoms of a nose:
- acute and chronic rhinitis
- sinusitis.
Route of administration and doses
Adult: on one injection in each nostril of 3-5 times a day.
To children 12 years are more senior: on one injection in each nostril 3 times a day.
Duration of treatment is 5-10 days.
You hold a bottle vertically, throw back the head back and press for injection.
Side effects
Local reactions:
- a syndrome of nasal dryness
- skin manifestations of allergic reaction
the General reactions: at prolonged use or in high doses:
- a headache, insomnia
- increase in arterial blood pressure, a cardiopalmus
- a shiver, pallor of skin
- the local or system hypersensitivity and a sensitization to the antibiotics which are a part of drug caused by systematic use of these antibiotics.
Contraindications
- hypersensitivity to drug components, especially to parabens or aminoglycosides
- suspicion of closed-angle glaucoma
- suspicion on the urination delay connected with uretroprostatichesky disturbances
- nasal localization of such infections as shingles, chicken pox, herpes
- pregnancy and the period of a lactation
- children's age up to 12 years.
Medicinal interactions
the Medicinal interactions caused by Phenylephrinum content
not recommended combinations of drugs:
Bromocriptinum - increases risk of vasoconstriction and/or hypertensive crisis.
Guanetidin and drugs of group of a guanetidin - increase hypertensive effect of Phenylephrinum, because of decrease in a sympathetic tone, the long mydriasis is possible.
Non-selective IMAO – can cause hypertensive crisis (suppression of amines of metabolism).
The combinations of drugs demanding caution at simultaneous use:
Selection IMAO (toloksaton and moklobemid) – data on medicinal interaction are absent, however, by analogy with non-selective IMAO, the doctor should be careful and to appoint the drug containing Phenylephrinum only when treatment requires drug only of this group, and the patient has to observe strictly established dosage.
Medicinal interactions
not recommended combinations of drugs caused by dexamethasone content:
The drugs causing piruetny ventricular tachycardia (astemizol, bepridit, erythromycin IV, halofantrin, pentamidine, sparfloksatsin, sultoprid, terfenadin, Vincaminum) increase risk of development of a hypopotassemia.
The combinations of drugs demanding caution at simultaneous use:
Acetylsalicylic acid and other salicylates - reduce a salitsilemiya during corticosteroid treatment and enhance risk of salicylate overdose after its cancellation, from communication with increase in discharge of salicylates from an organism corticosteroids. It is necessary to pick up the corresponding doses of salicylates at simultaneous use and after completion of treatment by corticosteroids.
Aminoglutetimid - reduces efficiency of dexamethasone in connection with increase in his hepatic metabolism. It is necessary to pick up the correct dosage of dexamethasone.
The anti-arrhythmic drugs causing piruetny ventricular tachycardia (Amiodaronum, a bretylium, Disopyramidum, V-quinine, derivatives, sotalol). For prevention of a hypopotassemia it is necessary to control QT an interval. In piruetny ventricular tachycardia the use of anti-arrhythmic drugs is not recommended.
Oral anticoagulants – enhance the risk of hemorrhage inherent in corticosteroid therapy (digestive mukoza, vascular weakness) in high doses or at long-term treatment (more than 10 days). At a justified combination of drugs the constant control of indicators of blood for the 8th day, then each 15 days during corticosteroid therapy and after its termination is necessary.
Other gipokaliyemichesky means (diuretics, depletive, B IV Amphotericinum) - increase risk of a hypopotassemia. It is necessary to control potassium level in blood.
Derivative foxgloves - the hypopotassemia strengthens toxic action of derivatives of a foxglove. It is necessary to control potassium level in blood.
Heparin at parenteral use - increases risk of the hemorrhage inherent in corticosteroid therapy (digestive mukoza, vascular weakness) in high doses or at the long-term treatment exceeding 10 days. The combination of drugs has to be justified and settled.
Enzymatic inductors (carbamazepine, phenobarbital, Phenytoinum, Primidonum, rifabutin, rifampicin) – reduce the level of blood plasma and efficiency of corticosteroids because of increase in hepatic metabolism. Consequences especially strongly affect patients with an addisonizm and at a transplant. Clinical and biological control, regulation of a corticosteroid dosage at simultaneous use of drugs and after cancellation of the enzymatic inductor is necessary.
Insulin, metformin, hypoglycemic sulphamides – increase a glycemia, sometimes accompanied with a ketosis. Constant control of indicators of blood and urine, especially in an initiation of treatment and also selection of an optimum dosage of antidiabetic drug is necessary during corticosteroid treatment and after its cancellation.
The isoniazid - reduces concentration of an isoniazid in blood plasma because of increase in hepatic metabolism of an isoniazid and reduction of metabolism of glucocorticosteroids. Clinical and biological control of a condition of the patient is necessary.
Local gastrointestinal means: magnesias, aluminum and calcic salts, oxides and hydroxides (it is described for Prednisolonum, dexamethasone) promote reduction of digestive absorption of glucocorticosteroids.
Combinations of the drugs taken into special account:
Antihypertensive drugs: simultaneous use promotes decrease in antihypertensive action.
The weakened live vaccines: increases risk of developing a general disease, the lethal outcome is possible. This risk increases at patients with the immunity weakened by a basic disease. In this case it is necessary to use inactive vaccines if those exists (poliomyelitis).
Praziquantel: reduction of concentration of a prazikvantel in blood plasma is possible.
Special instructions
not to swallow.
Not to apply to washing of adnexal bosoms of a nose.
Not to apply at patients with a renal failure.
Existence of a corticosteroid does not prevent local allergic reactions, but can change their clinical expression.
At presence of the corresponding general clinical symptoms the systematic course of treatment has to be considered.
With care to use drug at patients with arterial hypertension, an ischemic heart disease, a hyperthyroidism.
To attention of athletes: drug contains dexamethasone which can yield positive take when conducting doping control.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose
Due to low extent of absorption in a system blood stream does not influence the overdose is improbable.
A form of release and packing
On 15 ml of drug in a lightproof white bottle from polyethylene of low density, with a tip from white polyethylene of low density, a transparent colourless tube from polyethylene of low density and the screwing-up cover from polyethylene of low density. On a bottle paste the label from paper label.
The bottle together with the instruction for medical use in the state and Russian languages is placed in a box cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
SOFARTEX Producer
21 rue du Presso, 28500 of Vernuye, France
the Owner of the registration certificate
of "BUSHARA-REKORDATI Laboratory"
68 Rue Marzholen, 92300 of Levallua-Perre, France
to Develop
of Polideksa medicine with Phenylephrinum
the Trade name
of Polidex with Phenylephrinum
the International unlicensed name
Is not present
the Dosage form
Spray nasal
Structure
100 ml of drug contain:
active agents: Neomycinum sulfate of 1.0 g (650,000 ME)
polymyxin In ME sulfate 1,000,000
dexamethasone sodium metasulfobenzoate of 0.025 g
Phenylephrinum a hydrochloride of 0.250 g,
excipients: methylparahydroxybenzoate, a lity chloride, citric acid monohydrate, a lity hydroxide, a macrogoal 4000, polysorbate 80, water purified.
The description
Transparent colourless liquid
Pharmacotherapeutic group
Glucocorticosteroids in a combination with antimicrobial drugs. Dexamethasone in a combination with the antimicrobial
drugs Code of Automatic Telephone Exchange S02CA06 Pharmacological Pharmacokinetics Due to Properties low system absorption of drug at topical administration the data on pharmacokinetics are not provided
the Pharmacodynamics
the Combined anti-inflammatory drug for topical administration in otolaryngology.
Neomycinum and polymyxin B have antibacterial effect. At a combination of the specified antibiotics the range of antibacterial action on the majority of the gram-positive and gram-negative microorganisms causing infectious and inflammatory diseases of a nasal cavity and adnexal bosoms extends.
Polymyxin In sulfate has bactericidal effect on gram-positive and gram-negative microorganisms. The most valuable feature of an antibiotic is its efficiency concerning a pyocyanic stick. Does not affect coccal aerobic (stafilo-, strepto-, pneumo - gono- and meningokokk) and anaerobic microorganisms and also the majority of strains of Proteus, causative agents of tuberculosis, diphtheria, clostridiums and mushrooms.
Neomycinum influences both gram-positive, and gram-negative microorganisms (staphylococcus, Proteus, Enterobacter, Klebsiella, Shigella, Haemophilus influenzae, Salmonella, Campilobacter, Cornebacterium, Listeria monocytogenes, Escherichia coli, etc.). Rezistenten concerning a mycoplasma, a pyocyanic stick, streptococci, anaerobic microorganisms.
Dexamethasone is a glucocorticosteroid, at topical administration has anti-inflammatory, antiallergic and anti-exudative effect.
Phenylephrinum the hydrochloride is a sympathomimetic, stimulates postsynaptic α-adrenoceptors and has vasoconstrictive property. As the vasoconstrictor reduces hypostasis and hyperaemia of mucous membranes of a nose and near-nasal bosoms, expressiveness of exudative manifestations, restores free breath.
Indications
Inflammatory and infectious diseases of a nasal cavity, adnexal bosoms of a nose:
- acute and chronic rhinitis
- sinusitis.
Route of administration and doses
Adult: on one injection in each nostril of 3-5 times a day.
To children 12 years are more senior: on one injection in each nostril 3 times a day.
Duration of treatment is 5-10 days.
You hold a bottle vertically, throw back the head back and press for injection.
Side effects
Local reactions:
- a syndrome of nasal dryness
- skin manifestations of allergic reaction
the General reactions: at prolonged use or in high doses:
- a headache, insomnia
- increase in arterial blood pressure, a cardiopalmus
- a shiver, pallor of skin
- the local or system hypersensitivity and a sensitization to the antibiotics which are a part of drug caused by systematic use of these antibiotics.
Contraindications
- hypersensitivity to drug components, especially to parabens or aminoglycosides
- suspicion of closed-angle glaucoma
- suspicion on the urination delay connected with uretroprostatichesky disturbances
- nasal localization of such infections as shingles, chicken pox, herpes
- pregnancy and the period of a lactation
- children's age up to 12 years.
Medicinal interactions
the Medicinal interactions caused by Phenylephrinum content
not recommended combinations of drugs:
Bromocriptinum - increases risk of vasoconstriction and/or hypertensive crisis.
Guanetidin and drugs of group of a guanetidin - increase hypertensive effect of Phenylephrinum, because of decrease in a sympathetic tone, the long mydriasis is possible.
Non-selective IMAO – can cause hypertensive crisis (suppression of amines of metabolism).
The combinations of drugs demanding caution at simultaneous use:
Selection IMAO (toloksaton and moklobemid) – data on medicinal interaction are absent, however, by analogy with non-selective IMAO, the doctor should be careful and to appoint the drug containing Phenylephrinum only when treatment requires drug only of this group, and the patient has to observe strictly established dosage.
Medicinal interactions
not recommended combinations of drugs caused by dexamethasone content:
The drugs causing piruetny ventricular tachycardia (astemizol, bepridit, erythromycin IV, halofantrin, pentamidine, sparfloksatsin, sultoprid, terfenadin, Vincaminum) increase risk of development of a hypopotassemia.
The combinations of drugs demanding caution at simultaneous use:
Acetylsalicylic acid and other salicylates - reduce a salitsilemiya during corticosteroid treatment and enhance risk of salicylate overdose after its cancellation, from communication with increase in discharge of salicylates from an organism corticosteroids. It is necessary to pick up the corresponding doses of salicylates at simultaneous use and after completion of treatment by corticosteroids.
Aminoglutetimid - reduces efficiency of dexamethasone in connection with increase in his hepatic metabolism. It is necessary to pick up the correct dosage of dexamethasone.
The anti-arrhythmic drugs causing piruetny ventricular tachycardia (Amiodaronum, a bretylium, Disopyramidum, V-quinine, derivatives, sotalol). For prevention of a hypopotassemia it is necessary to control QT an interval. In piruetny ventricular tachycardia the use of anti-arrhythmic drugs is not recommended.
Oral anticoagulants – enhance the risk of hemorrhage inherent in corticosteroid therapy (digestive mukoza, vascular weakness) in high doses or at long-term treatment (more than 10 days). At a justified combination of drugs the constant control of indicators of blood for the 8th day, then each 15 days during corticosteroid therapy and after its termination is necessary.
Other gipokaliyemichesky means (diuretics, depletive, B IV Amphotericinum) - increase risk of a hypopotassemia. It is necessary to control potassium level in blood.
Derivative foxgloves - the hypopotassemia strengthens toxic action of derivatives of a foxglove. It is necessary to control potassium level in blood.
Heparin at parenteral use - increases risk of the hemorrhage inherent in corticosteroid therapy (digestive mukoza, vascular weakness) in high doses or at the long-term treatment exceeding 10 days. The combination of drugs has to be justified and settled.
Enzymatic inductors (carbamazepine, phenobarbital, Phenytoinum, Primidonum, rifabutin, rifampicin) – reduce the level of blood plasma and efficiency of corticosteroids because of increase in hepatic metabolism. Consequences especially strongly affect patients with an addisonizm and at a transplant. Clinical and biological control, regulation of a corticosteroid dosage at simultaneous use of drugs and after cancellation of the enzymatic inductor is necessary.
Insulin, metformin, hypoglycemic sulphamides – increase a glycemia, sometimes accompanied with a ketosis. Constant control of indicators of blood and urine, especially in an initiation of treatment and also selection of an optimum dosage of antidiabetic drug is necessary during corticosteroid treatment and after its cancellation.
The isoniazid - reduces concentration of an isoniazid in blood plasma because of increase in hepatic metabolism of an isoniazid and reduction of metabolism of glucocorticosteroids. Clinical and biological control of a condition of the patient is necessary.
Local gastrointestinal means: magnesias, aluminum and calcic salts, oxides and hydroxides (it is described for Prednisolonum, dexamethasone) promote reduction of digestive absorption of glucocorticosteroids.
Combinations of the drugs taken into special account:
Antihypertensive drugs: simultaneous use promotes decrease in antihypertensive action.
The weakened live vaccines: increases risk of developing a general disease, the lethal outcome is possible. This risk increases at patients with the immunity weakened by a basic disease. In this case it is necessary to use inactive vaccines if those exists (poliomyelitis).
Praziquantel: reduction of concentration of a prazikvantel in blood plasma is possible.
Special instructions
not to swallow.
Not to apply to washing of adnexal bosoms of a nose.
Not to apply at patients with a renal failure.
Existence of a corticosteroid does not prevent local allergic reactions, but can change their clinical expression.
At presence of the corresponding general clinical symptoms the systematic course of treatment has to be considered.
With care to use drug at patients with arterial hypertension, an ischemic heart disease, a hyperthyroidism.
To attention of athletes: drug contains dexamethasone which can yield positive take when conducting doping control.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
the Overdose
Due to low extent of absorption in a system blood stream does not influence the overdose is improbable.
A form of release and packing
On 15 ml of drug in a lightproof white bottle from polyethylene of low density, with a tip from white polyethylene of low density, a transparent colourless tube from polyethylene of low density and the screwing-up cover from polyethylene of low density. On a bottle paste the label from paper label.
The bottle together with the instruction for medical use in the state and Russian languages is placed in a box cardboard.
To Store storage conditions at a temperature not above 25 °C.
To store out of children's reach!
3 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
SOFARTEX Producer
21 rue du Presso, 28500 of Vernuye, France
the Owner of the registration certificate
of "BUSHARA-REKORDATI Laboratory"
68 Rue Marzholen, 92300 of Levallua-Perre, France
to Develop
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