Polydexa with phenylephrine spray naz 15 ml fl/pack card x1

Composition and release form

The drug is dispensed in the following forms:

1. ​Drops - used in the fight against smart pathologies. This is a liquid base, packaged in a 10 ml glass bottle and secondary paper packaging. The kit includes a pipette for convenience.
2. ​Spray is a colorless, odorless, completely transparent liquid. Designed for instillation into the nose. Sold in a 15 ml bottle. The set includes a sprayer. One cardboard box contains 1 bottle and instructions for use are included.

The active substances in the drops are: neomycin sulfate, polymyxidine sulfate, sodium dexamethasone methylsulfobenzoate.

The active ingredients of the spray are the same and additionally includes phenylephrine hydrochloride.

Polydex auxiliary compounds: citric acid, pure water, lithium chloride, macrogol, methylparaben, polysorbate, thiomersal.

What Polydexa contains and how it works

A common cold during pregnancy can lead to the development of an infectious process, which requires the use of antibacterial agents. These drugs include Polydexa. The product is available in two forms:

• nasal spray;
• ear drops.

The drug in the appropriate form is capable of inhibiting the vital activity of gram-positive and gram-negative bacteria in the nasal cavity or in the ear canal. This combination remedy is often used in otolaryngology and is considered quite effective.

Polydexa can relieve nasal congestion

The therapeutic effect is provided by the active ingredients of the drug. Common active ingredients include:

• neomycin sulfate;
• polymyxin B sulfate;
• dexamethasone sodium metasulfobenzoate.

The nasal spray contains another active component - phenylephrine, which has a vasoconstrictor effect on the nasal mucosa, relieving nasal congestion.

Polydexa is available in the form of ear drops and nasal spray.

Neomycin and polymyxin B are antibiotics. Thanks to the combination of two types of antibiotics in one medicine, a broad antibacterial effect is provided. At the same time, the drug does not affect the microorganisms Streptococcus spp. Dexamethasone complements these components, providing an anti-inflammatory effect.

Common auxiliary components:

• lemon acid;
• macrogol;
• polysorbate;
• purified water.

The composition of the ear drops is supplemented with thiomersal and sodium hydroxide solution. The nasal spray contains methylparaben, lithium chloride, lithium hydroxide.

Indications for Polydex

The ear medication is used in the following cases:

1. ​Eczema of the ear canal due to infections.
2. ​Inflammatory lesion of the middle ear, if there are no abnormalities of the eardrum.
3. As a nasal administration, the drug is indicated for the treatment of:
4. ​Rhinitis in acute and chronic form.
5. ​Adenoiditis.
6. Damage to the paranasal sinuses (sinusitis, sinusitis, sinusitis).
7. Treatment and prevention of diseases of the nasopharynx and sinuses after surgery.

Indications during pregnancy

Treatment with the drug is only relevant for bacterial infections, since the active substance does not affect viruses. Typically, the drug is prescribed by doctors for the following diagnoses:

• otitis without compromising the integrity of the eardrum;
• eczema of the external auditory canal with signs of infection.

In some cases, treatment of otitis media without an antibiotic is impossible.
Polydex in the form of a nasal spray can be prescribed to expectant mothers with the following diagnoses:

• sinusitis (inflammation of the mucous membrane of the maxillary (maxillary) sinus, can be unilateral or bilateral, accompanied by damage to other paranasal sinuses);
• adenoiditis (inflammation of the adenoids - pathologically enlarged pharyngeal tonsil);
• rhinopharyngitis (simultaneous inflammation of the mucous membranes of the nasal cavity and pharynx);
• purulent rhinitis (runny nose with complications accompanied by the discharge of pus);
• sinusitis (inflammation of the mucous membrane of one or more paranasal sinuses).

The effect of the drug components on the fetus

The instructions prohibit the use of nasal spray while pregnant. The prohibition on use during pregnancy is due to the vasoconstrictor effect of the phenylephrine component. Vessels can narrow not only in the nose, but also in the placenta, which makes it difficult for the supply of oxygen and nutrients. With long-term treatment, ototoxic effects on the fetus are also possible. This nasal spray, however, is sometimes prescribed by doctors to expectant mothers when the risk of negative consequences of the disease is higher than the risk of harming the intrauterine baby. The medicine is almost not absorbed into the bloodstream and acts locally.

Polydex in the form of ear drops is allowed to be used during pregnancy at any stage. However, the instructions contain a warning that if used for too long, ototoxic effects of the components on the fetus cannot be ruled out.

According to FDA (Food and Drag Administration) standards, the safety of components is assessed as follows:

1. Dexamethasone is category C. This means that during studies of its effect on animals, a negative effect on the fetus was identified. In particular, the drug caused hearing impairment, pathology of the heart and blood vessels. Dexamethasone is a glucocorticosteroid that can provoke adrenal insufficiency in the fetus, even when applied topically.
2. Neomycin is category D. It has a proven toxic effect on the intrauterine baby when it enters the systemic bloodstream. This substance is especially dangerous in the first trimester of pregnancy.
3. Polymyxin B - category not defined. It is not recommended for the treatment of expectant mothers; it is prescribed in case of urgent need after a doctor has assessed all the risks.
4. Phenylephrine - category C. Experts allow taking medications containing this component only if the risk of complications of the disease for the mother is higher than the consequences for the child.

Use at different stages of pregnancy

The likelihood of negative consequences for the fetus after using the drug largely depends on the duration of pregnancy:

1. First trimester. During this period, the baby is most vulnerable to the effects of the active components of the drug. Its organs and systems are being formed, and the medication can cause the development of pathologies, hearing organs, kidneys, and adrenal glands. The likelihood of negative consequences increases when the dosage is exceeded and the medication is used for a long time.
2. Second trimester. It is considered a safer period than the early months of pregnancy. The intrauterine baby has already formed, and if the rules of caution are followed, it is unlikely that the drug will have a negative effect on it. However, negative effects cannot be excluded with a long course of treatment or individual sensitivity of the body.
3. Third trimester. The risk of harm to the baby is assessed in the same way as in the second trimester. However, it must be taken into account that when treated with the drug before childbirth, it can accumulate in the body and then pass to the newborn baby through breast milk, and this is extremely undesirable.

Polydex ear drops and Polydex spray with Phenylephrine are used during pregnancy only if the therapeutic effect for the mother outweighs the potential risk to the fetus.

Valentina Lyapunova, general practitioner

https://mirmam.pro/polideksa-pri-beremennosti/

Contraindications

General contraindications to the use of the drug are:

1. ​Individual intolerance to active and auxiliary substances.
2. Damage to the eardrum due to various injuries and infections.
3. ​Time of bearing a child and breastfeeding.
4. ​Children under 2 years old.
5. Glaucoma.
6. Viral pathologies - herpes and chickenpox.
7. ​Serious kidney disease, urinary retention and albuminuria.
8. ​Tachycardia due to the use of pharmacological agents.

It is necessary to use the drug with extreme caution in case of hypertension, ischemic conditions and the presence of symptoms of hyperthyroidism.

Interactions of Polydex with phenylephrine

Below are the features of drug interactions that occur during systemic absorption of the active components of the drug. Interactions specific to phenylephrine Inadmissible combinations: with bromocriptine (risk of developing hypertension (arterial hypertension)); with guanethidine or substances similar in chemical structure (the possibility of enhancing the hypertensive effect of phenylephrine and, by reducing the sympathetic tone with guanethidine, the possibility of prolonged mydriasis); MAO inhibitors (possible development of hypertensive crisis due to weakening of the metabolism of pressor amines). Due to the prolonged action of MAO inhibitors, interaction is possible for 2 weeks after discontinuation of MAO inhibitors. Interactions specific to dexamethasone Inadmissible combinations: with drugs that can cause ECG changes (astemizole, bepridil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, sultopride, terfenadine and vincamine). Hypokalemia, bradycardia and prolongation of the QT may be unfavorable factors. Combinations, the use of which requires special caution: prolonged systemic use of acetylsalicylic acid and other salicylates (a decrease in the level of salicylates in the blood serum is possible when using GCS and the risk of overdose of salicylates after discontinuation of GCS); antiarrhythmic drugs that can cause changes in the ECG (amiodarone, bretylium, disopyramide, quinidine, sotalol) - the development of hypokalemia, bradycardia and an increase in the QT on the ECG is possible; indirect anticoagulants (the possibility of GCS influencing the metabolism of indirect anticoagulants and blood clotting factors, which may increase the risk of bleeding specific to systemic GCS therapy - gastrointestinal, due to vascular fragility); drugs that reduce serum potassium levels (diuretics, laxatives, IV amphotericin B) lead to an increased risk of hypokalemia; digitalis preparations (hypokalemia enhances the toxic effects of digitalis preparations); heparin (increases the risk of developing hemorrhagic complications characteristic of GCS); insulin, metformin (reduced effectiveness of hypoglycemic drugs, which can lead to the development of ketosis due to a GCS-induced decrease in glucose tolerance); isoniazid (decreasing the level of isoniazid in the blood plasma). Combinations the use of which requires caution: antihypertensive drugs (possible weakening of the hypotensive effect); weakened live vaccines (risk of generalization of the disease, including death); praziquantel (a decrease in the concentration of praziquantel in blood plasma is possible).

Side effects

As a rule, side effects rarely occur after taking Polydex ear drops. The only condition that the drug can provoke is allergic reactions. Skin rashes, itching, rarely hyperemia and urticaria are observed.

The nasal spray contains a larger number of active ingredients, therefore it has a wide range of side effects, these are:

1. ​Headache.
2. ​Sleep disturbance.
3. Signs of tachycardia.
4. ​Increased pressure level.
5. Tremor of the limbs.
6. ​Pale or redness of the skin.
7. ​Allergy symptoms - itching, rash, hives.

Special instructions for the use of Polydex with phenylephrine

The drug should not be swallowed. This medicine should not be used for longer than the prescribed period (10 days). The presence of a corticosteroid in the drug does not prevent local allergy symptoms, but may change their course. If the general condition worsens due to an infectious-inflammatory disease, antibiotics for systemic use are prescribed, if necessary. Prescribe with caution to patients with hypertension (arterial hypertension), coronary artery disease, hyperthyroidism due to the presence of a sympathomimetic in the drug. The drug contains dexamethasone, which may give a positive result during doping control. Despite the local use of the drug, it should be noted that with long-term therapy or when used in a dose significantly higher than the recommended one, the drug may have a systemic effect. With systemic action of the active components of the drug, it is possible that they interact with other drugs.

Instructions for use of Polydex

Ear drops are convenient to use to treat various conditions in adults and children. The duration of the course and therapeutic dose depend on the diagnosis and severity of clinical signs.

As a rule, 1-2 drops are instilled into the ears twice a day. In complicated conditions, it is permissible to increase the dosage to 5 drops. Before using the product, it needs to be warmed up a little.

The duration of the course of treatment is no more than 10 days.

Polydex nasal spray has a similar application regimen as ear drops. Before spraying, Aeroflot should be shaken and holding the bottle vertically, irrigate the nasal cavity.

Spray dose 1 press in each pass up to 3 times a day. Depending on the age and nature of the disease, the therapeutic dosage can be increased up to 5 times a day.

The course of spray treatment is 5-10 days.

Polydexa with phenylephrine nasal spray fl 15ml

Active substance

neomycin

ATX code

R01AX30 (Combination drugs)

Release form, packaging and composition of the drug

Nasal spray

in the form of a clear, colorless liquid.

[PRING] methyl parahydroxybenzoate - 0.1 g, lithium chloride - 0.34 g, citric acid monohydrate - 0.28 g, lithium hydroxide - 0.1 g, macrogol 400 - 5 g, polysorbate 80 - 0.2 g, purified water - up to 100 ml.

15 ml - lightproof polyethylene bottles (1) with a spray tip - cardboard packs.

Clinical and pharmacological group

A drug with antibacterial, anti-inflammatory and vasoconstrictor effects for topical use in ENT practice

Pharmacotherapeutic group

Glucocorticosteroid for local use + antibiotics (aminoglycoside and cyclic polypeptide) + alpha-adrenergic agonist

pharmachologic effect

Data on the pharmacokinetics of the drug are not provided.

Indications for use

Inflammatory and infectious diseases of the nasal cavity, pharynx, paranasal sinuses:

• acute and chronic rhinitis;
• acute and chronic nasopharyngitis;
• sinusitis.

Dosage

For adults

Prescribe 1 injection into each nostril 3-5 times a day.

Children aged 2.5 to 18 years

- 1 injection into each nostril 3 times a day.

The duration of treatment is 5-10 days.

When injecting the drug, the bottle should be held in a vertical position with the sprayer facing up.

Contraindications

• suspicion of angle-closure glaucoma;
• simultaneous use of MAO inhibitors;
• viral diseases;
• kidney diseases accompanied by albuminuria, renal failure;
• pregnancy;
• lactation (breastfeeding);
• children's age up to 2.5 years;
• hypersensitivity to the components of the drug.

Carefully

The drug is used in patients with arterial hypertension, coronary artery disease, and hyperthyroidism.

Overdose

Due to the low degree of absorption into the systemic circulation, an overdose is unlikely.

Side effects

Possible

local allergic reactions.

If unusual reactions occur, the patient should consult a doctor about the advisability of further use of the drug.

Overdose

Drug interactions are due to the content of phenylephrine.

Phenylephrine reduces the hypotensive effect of diuretics and antihypertensive drugs (including methyldopa, mecamylamine, guanadrel, guanethidine). If such a combination cannot be avoided, medical supervision is necessary.

No clinically significant interactions of the drug with other drugs have been identified.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. Shelf life: 3 years. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Special Instructions

Do not use for rinsing the paranasal sinuses.

Avoid contact of the drug with the eyes. If the drug accidentally gets into the eyes or other mucous membranes, rinse immediately with plenty of water.

It should be borne in mind that the drug contains components that can give a positive result during doping control in athletes.

Impact on the ability to drive vehicles and operate machinery

There is no data on the negative effect of the drug on the ability to drive a car or other vehicles.

special instructions

It is highly not recommended to use the drug in any form for more than 10 days and in the presence of damage to the eardrum.

After opening the bottle, it must be hermetically sealed and the treatment procedure must be carried out only with clean hands, since the likelihood of contamination of the drug with pathogenic organisms increases.

Polydexa does not have any negative effect on concentration, therefore, during the course of therapy it is not prohibited to personally drive a car.

How to replace the drug

The drug has no complete structural analogues. It is distinguished from many other local antibiotics by the presence of a vasoconstrictor component, as well as the presence of two antibacterial ingredients, supplemented by an anti-inflammatory one. In many cases, doctors select alternative drugs that are approved or conditionally approved during pregnancy in order to minimize the risk of negative consequences for the fetus.

Table: drugs with similar effects

Photo gallery: Polydex analogues during pregnancy