Polyoxidonium tablets 12 mg - official instructions

What is Polyoxidonium used for?

This medicine corrects the body's immune defense against various infectious and systemic lesions. It alleviates physical condition, prevents intoxication by metabolic products, and shortens the acute period of illness. The active substance of Polyoxidonium is azoximer bromide.

The drug is produced in several forms:

• uncoated tablets containing 12 mg of active ingredient: yellow or orange, chamfered;
• suppositories: in a dosage of 6 or 12 mg, yellowish-waxy in color, torpedo-shaped;
• lyophilized powder for the preparation of nasal and parenteral solutions.

Release form

Polyoxidonium has three dosage forms:

• pills;
• rectal-vaginal suppositories;
• lyophilized powder.

The suppositories are torpedo-shaped, light yellow in color and have a specific smell of cocoa butter.

The tablets are flat-cylindrical, each of them has a chamfer. Their color can vary from yellowish-white to orange-yellow. The presence of slightly noticeable particles of more intense color is allowed in tablets.

How does Polyoxidonium work?

Azoximer bromide stimulates the body's resistance to the aggression of pathogens: fungi, viruses and bacteria. It promotes accelerated synthesis of antibodies, restores defenses after diseases, chemotherapy, complex surgical operations, radiation exposure, long-term treatment with steroid hormones and cytostatics.

Polyoxidonium increases the resistance of cell walls to damage by biological and chemical toxins, accelerates regeneration, and helps reduce the duration of treatment. The drug is non-toxic, has high bioavailability, is completely metabolized by the kidneys, and does not accumulate in the blood and tissues.

Pharmacodynamics and pharmacokinetics

Polyoxidonium (or azoximer bromide ) helps increase the body's resistance to infections caused by viruses, bacteria or fungi.

The mechanism of its action is associated with the substance’s ability to influence phagocytic cells and NK cells (natural or natural killer cells), as well as stimulate the process of antibody formation.

The drug helps restore the immune status in secondary immunodeficiency conditions, caused by various types of infections, injuries, burns, malignant tumors , complications after surgical interventions, treatment with chemotherapy drugs, including cytostatic agents and steroid hormones .

Along with the immunocorrective effect of azoximer, bromide also has a pronounced detoxifying effect, which is due to the structure and high-molecular nature of this substance.

The result of its effect on the body is an increase in the resistance of cell membranes to the cytotoxic (causing damage to cells up to their death) action of drugs and chemicals, as well as a decrease in the toxicity of the latter.

Prescribing Polyoxidonium in combination with other drugs significantly increases the effectiveness of therapy, shortens its duration, allows you to reduce doses or completely avoid the use of antibiotics , bronchodilators and glucocorticosteroids , and helps to increase the period of remission (that is, the period of weakening or complete disappearance of the symptoms of the disease).

Polyoxidonium is well tolerated by patients, does not exhibit mitogenic or polyclonal activity, does not have antigenic properties, does not provoke the development of allergies , mutations and other defects in fetal development , does not have a teratogenic effect on the developing fetus, and has no carcinogenic or embryotoxic properties.

Azoximer bromide is characterized by a high bioavailability, which is about 89 percent. When administered intramuscularly, Cmax in blood plasma is observed 40 minutes after injection.

The substance is distributed fairly quickly in tissues. In the body , azoximer bromide is biotransformed. Its elimination is carried out mainly by the kidneys.

What is Polyoxidonium used for?

The drug is prescribed in complex therapy and independently:

• for respiratory infections, including recurrent ones;
• acute or chronic infectious lesions of internal organs;
• to reduce the side effects of immunosuppressants in rheumatoid arthritis;
• for recovery after a course of potent drugs or operations;
• for fractures, burns, trophic ulcers;
• for the prevention of ARVI during epidemics.

The treatment regimen and dosage form are selected individually depending on the disease and physical condition of each patient.

How to prepare drops from Polyoxidonium powder

The lyophilized substrate must be diluted in distilled water or isotonic saline solution: 6 mg of powder per 20 drops (1 ml). It is important to ensure that the liquid is at room temperature.

The resulting drug is instilled into the nasal passages up to 4 times a day for 5–7 days:

• for respiratory infections;
• for the prevention of ARVI;
• for complicated rhinitis and sinusitis.

The drops can be stored for no more than 24 hours in a tightly closed bottle. After this period, it is necessary to prepare a new portion of the drug.

How to use Polyoxidonium suppositories

Medicinal suppositories are intended for rectal or intravaginal use. The total number of suppositories per course of treatment is 10 pieces. Repeated local therapy is allowed after 3–4 months.

The medicine is administered into the intestines once a day, in the evening, placing a 6 or 12 mg suppository 5–6 cm deep. Before the procedure, it is advisable to visit the toilet or do an enema. To relieve acute symptoms, the drug must be used daily. For maintenance therapy, it is enough to use it once every 2-3 days.

In the treatment of gynecological pathologies, 12 mg suppositories are used. They are administered before bedtime, placing them as deeply as possible into the vagina. For acute diseases, repeat the procedure for 3–4 days in a row, then proceed to maintenance treatment: 1 suppository every 2–3 days. For indolent chronic diseases, it is recommended to use suppositories 1-2 times a week.

Instructions for use POLYOXIDONIUM lyophilisate 6 mg

Methods of using the drug Polyoxidonium®:

• parenterally, intranasally. Methods of application are selected by the doctor depending on the severity of the disease and the age of the patient.

IM or IV (drip):

the drug is prescribed in doses of 6-12 mg 1 time/day daily, every other day, or 1-2 times a week, depending on the diagnosis and severity of the disease.

For intramuscular administration

add 1-2 ml of 0.9% sodium chloride solution or water for injection to the contents of the bottle and leave for 2-3 minutes to swell, then mix the contents with rotational movements.

For IV drip administration

2 ml of 0.9% sodium chloride solution is added to the contents of the bottle and left for 2-3 minutes to swell, then mixed with rotational movements and sterilely transferred into a bottle/bag with a 0.9% sodium chloride solution with a volume of 50-400 ml.

The prepared solution for parenteral administration cannot be stored.

Intranasally:

a dose of 6 mg is dissolved in 1 ml (20 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature.

The prepared solution can be stored at room temperature in the manufacturer’s original packaging for up to 48 hours.

Recommended treatment regimens for adults

Parenteral (IM and IV drip)

For acute inflammatory diseases:

6 mg daily for 3 days, then every other day with a total course of 5-10 injections.

For chronic inflammatory diseases:

6 mg every other day for 5 injections, then 2 times a week for a course of at least 10 injections.

For tuberculosis:

6-12 mg 2 times a week for a course of 10-20 injections.

In patients with acute and chronic urogenital diseases:

6 mg every other day for a course of 10 injections as part of complex therapy.

For chronic recurrent herpes:

6 mg every other day for a course of 10 injections in combination with antiviral drugs, interferons and/or inducers of interferon synthesis.

For the treatment of complicated forms of allergic diseases:

6 mg each, course of 5 injections - the first two injections daily, then every other day.

For acute allergic and toxic-allergic conditions:

6-12 mg intravenously in combination with antiallergic drugs.

For rheumatoid arthritis:

6 mg intramuscularly every other day for 5 injections, then 2 times a week for a course of at least 10 injections.

In cancer patients:

• before and during chemotherapy to reduce the immunosuppressive, hepato- and nephrotoxic effects of chemotherapeutic agents, 6-12 mg every other day for a course of at least 10 injections; further, the frequency of administration is determined by the doctor depending on the tolerability and duration of chemotherapy and radiation therapy;
• for the prevention of the immunosuppressive effect of the tumor, for the correction of immunodeficiency after chemotherapy and radiation therapy, after surgical removal of the tumor, long-term use of the drug Polyoxidonium® is indicated (from 2-3 months to 1 year) at a dose of 6-12 mg 1-2 times a week.

Intranasally

For treatment and prevention:

• acute and chronic infections of the ENT organs (rhinitis, sinusitis, otitis media);
• to enhance the regenerative processes of mucous membranes;
• for the prevention of complications and relapses of diseases;
• for the prevention of influenza and acute respiratory infections.

Prescribe 3 drops in each nasal passage every 1-2 hours (at least 3 times a day) for 5-10 days.

Before using the drug, it is necessary to clean the nasal cavity

.

Directions for use and doses for children

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Methods of using the drug Polyoxidonium®:

• parenterally, intranasally, sublingually. Methods of application are selected by the doctor depending on the diagnosis, severity of the disease, age and body weight of the patient.

IM or IV (drip):

prescribed to children from 6 months at a dose of 0.1-0.15 mg/kg daily, every other day or 2 times a week with a course of 5-10 injections (dose calculation is indicated in Table 1).

For intramuscular administration

the drug Polyoxidonium® 6 mg is dissolved in 2 ml of water for injection or 0.9% sodium chloride solution. After adding the solvent, the drug is left for 2-3 minutes to swell, then mixed with rotational movements.

For IV drip

administration, the drug Polyoxidonium® is dissolved in 1.5-2 ml of sterile 0.9% sodium chloride solution. After adding the solvent, the drug is left for 3-5 minutes to swell, then mixed with rotational movements. The dose calculated for the patient is sterilely transferred into a bottle/bag with 0.9% sodium chloride solution with a volume of 25-50-100-200 ml.

The prepared solution for parenteral administration cannot be stored.

Table 1. Calculation of the dose of Polyoxidonium® for intramuscular or intravenous administration for children

Intranasal and sublingual:

daily at a daily dose of 0.15 mg/kg for 5-10 days. The drug is administered 1-3 drops into one nasal passage or under the tongue with an interval of 1-2 hours, in 2-3 doses per day.

To prepare the solution

for intranasal and sublingual use, a dose of 6 mg is dissolved in 2.0 ml (40 drops) of distilled water, 0.9% sodium chloride solution or boiled water at room temperature. One drop (0.05 ml) of the prepared solution contains 0.15 mg of the drug. The indicated dose is 0.15 mg, contained in 1 drop, prescribed per 1 kg of child’s body weight. Calculation of the daily dose for intranasal and sublingual use is presented in Table 2.

Table 2. Calculation of the dose of Polyoxidonium® for intranasal or sublingual use for children

The prepared solution for intranasal and sublingual use can be stored at room temperature in the manufacturer’s original packaging for up to 48 hours.

Recommended treatment regimens for children

Parenterally

For acute inflammatory diseases:

0.1 mg/kg every other day for a course of 5-7 injections.

For chronic inflammatory diseases:

0.15 mg/kg 2 times a week for a course of up to 10 injections.

For acute allergic and toxic-allergic conditions:

IV drip at a dose of 0.15 mg/kg in combination with antiallergic drugs.

For the treatment of complicated forms of allergic diseases

in combination with basic therapy:

• IM 0.1 mg/kg in a course of 5 injections with an interval of 1-2 days.

Intranasally:

daily 1-2 drops in one nasal passage every 1-2 hours (2-3 times/day) for a course of 5-10 days.

For acute and chronic rhinitis

(treatment and prevention of exacerbations).

For rehabilitation

frequently and long-term ill children.

For preoperative preparation

patients for surgical interventions for ENT pathology, as well as in the postoperative period in order to prevent infectious complications or relapses of the disease.

Treatment and prevention of influenza and other acute respiratory viral infections

(at any time after the onset of the disease and during the period of convalescence).

Sublingual for infants and young children:

daily at a daily dose of 0.15 mg/kg in 1-2 doses for 10 days.

For adenoiditis, hypertrophy of the tonsils:

as a component of conservative treatment.

For preoperative preparation

and postoperative rehabilitation for ENT pathology.

For seasonal prevention of exacerbations

chronic foci of infections of the oropharynx, upper respiratory tract, inner and middle ear.

For the treatment of intestinal dysbiosis

(in combination with basic therapy) for 10-20 days.

Special categories of patients

Patients with impaired renal function

:

• in the presence of chronic renal failure, the drug is prescribed no more than 2 times a week.

Patients with impaired liver function:

no dose adjustment is required.

Elderly patients:

6 mg every other day - 5 injections, then 2 times a week for a course of at least 10 injections