Polyoxidonium^® (Tablets, Solution, Lyophilisate, Suppositories) Instructions for Use

ATC Code

L03 (Immunostimulants)

Active Substance

Azoximer bromide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Immunomodulator

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Azoximer bromide has a complex action: immunomodulatory, detoxifying, antioxidant, anti-inflammatory.

Azoximer bromide increases the body’s resistance to local and generalized infections of bacterial, fungal, and viral etiology. It restores immunity in secondary immunodeficiency states caused by various infections, traumas, postoperative complications, burns, autoimmune diseases, malignant neoplasms, and the use of chemotherapeutic agents, cytostatics, and steroid hormones.

A characteristic feature of azoximer bromide during local (intranasal, sublingual) application is its ability to activate the factors of the body’s early defense against infection: the drug stimulates the bactericidal properties of neutrophils and macrophages, enhances their ability to phagocytose bacteria, and increases the bactericidal properties of saliva and the secretion of the upper respiratory tract mucosa. The detoxifying and antioxidant properties of azoximer bromide are determined by its structure and high-molecular nature. Azoximer bromide blocks soluble toxic substances and microparticles, has the ability to remove toxins and heavy metal salts from the body, and inhibits lipid peroxidation. Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.

Azoximer bromide is well tolerated, does not possess mitogenic or polyclonal activity, lacks antigenic properties, and does not have allergenic, mutagenic, embryotoxic, teratogenic, or carcinogenic effects.

Azoximer bromide is odorless and tasteless and does not cause local irritation when applied to the nasal and oropharyngeal mucosa.

Pharmacokinetics

Absorption and Distribution

Azoximer bromide is characterized by rapid absorption and a high distribution rate in the body. C_max of the drug in the blood after intramuscular administration is reached within 40 minutes. The bioavailability of the drug is high: more than 90% for parenteral administration.

Azoximer bromide is rapidly distributed to all organs and tissues of the body, penetrates the blood-brain barrier and the blood-ophthalmic barrier. There is no cumulative effect.

Metabolism and Excretion

In the body, Azoximer bromide undergoes biodegradation to low-molecular oligomers, is excreted mainly by the kidneys, and no more than 3% is excreted in feces.

T_1/2 for different ages ranges from 36 hours to 65 hours.

Indications

As part of complex therapy in adults

• In chronic recurrent infectious and inflammatory diseases of various locations of bacterial, viral, and fungal etiology in the acute phase;
• In acute viral and bacterial infections of the ENT organs, upper and lower respiratory tract, and in gynecological and urological diseases;
• In acute and chronic allergic diseases (including hay fever, bronchial asthma, atopic dermatitis) complicated by bacterial, viral, and fungal infections;
• In malignant tumors during and after chemotherapy and radiation therapy to reduce the immunosuppressive, nephro- and hepatotoxic effects of drugs;
• In generalized forms of surgical infections;
• For the prevention of postoperative infectious complications;
• For the activation of regenerative processes (fractures, burns, trophic ulcers);
• In rheumatoid arthritis complicated by bacterial, viral, and fungal infections, against the background of long-term use of immunosuppressants;
• In pulmonary tuberculosis.

As part of complex therapy in children over 6 months

• In acute and chronic inflammatory diseases of any location (including ENT organs, sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, ARVI) caused by pathogens of bacterial, viral, fungal infections;
• In acute allergic and toxic-allergic conditions complicated by bacterial, viral, and fungal infections;
• In bronchial asthma complicated by chronic respiratory tract infections;
• In atopic dermatitis complicated by purulent infection;
• In intestinal dysbiosis (in combination with specific therapy).

As monotherapy in adults and children from 6 months

• For the prevention of influenza and ARVI;
• For the prevention of postoperative infectious complications.

ICD codes

Dosage Regimen

Solution

For oral, parenteral, intranasal, rectal use. The doses, route of administration, and regimen are determined by the physician depending on the diagnosis, severity of the disease, and the patient’s age.

Suppositories

For rectal and intravaginal administration, 1 suppository once a day. The method and dosage regimen are determined by the physician depending on the diagnosis, acuity, and severity of the process. The drug can be used daily, every other day, or twice a week.

Suppositories 12 mg are used in adults rectally and intravaginally.

Suppositories 6 mg are used in children over 6 years only rectally; in adults – rectally and intravaginally.

Standard application scheme

1 suppository of 6 mg or 12 mg once a day daily for 3 days, then every other day for a course of 10 suppositories.

If necessary, the treatment course can be repeated after 3-4 months. The necessity and frequency of subsequent therapy courses are determined by the physician; the effectiveness does not decrease upon repeated prescription.

Patients with chronic immune deficiency (including those receiving long-term immunosuppressive therapy, with oncological diseases, HIV, or those who have undergone radiation) are indicated for long-term maintenance therapy with this agent from 2-3 months to 1 year ( adults 12 mg, children over 6 years – 6 mg 1-2 times a week).

Recommended application schemes as part of complex therapy

For treatment

Adults

For chronic infectious and inflammatory diseases in the acute stage – suppositories 12 mg once a day daily for 3 days, then every other day. Treatment course – 10 suppositories.

For acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) – suppositories 12 mg once a day daily. Treatment course – 10 suppositories.

For gynecological diseases – suppositories 12 mg once a day daily for 3 days, then every other day. Treatment course 10 suppositories.

For exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) – suppositories 12 mg once a day daily. Treatment course – 10 suppositories.

For pulmonary form of tuberculosis – suppositories 12 mg once a day daily for 3 days, then every other day. Treatment course – 20 suppositories. Subsequently, maintenance therapy with suppositories 6 mg twice a week for up to 2-3 months is possible.

In complex therapy of oncological diseases during chemotherapy and radiation therapy – suppositories 12 mg daily 2-3 days before the start of the course of chemotherapy or radiation therapy. Then 12 mg twice a week for a course of up to 20 suppositories.

For allergic diseases complicated by infectious syndrome – suppositories 12 mg once a day daily. Treatment course – 10 suppositories.

For rheumatoid arthritis – suppositories 12 mg every other day. Treatment course – 10 suppositories.

Children and adolescents from 6 to 18 years

For children and adolescents aged 6 to 18 years, suppositories are administered only rectally, 1 suppository of 6 mg once a day after bowel cleansing.

For chronic infectious and inflammatory diseases in the acute stage – suppositories 6 mg once a day daily for 3 days, then every other day. Treatment course – 10 suppositories.

For acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers) – suppositories 6 mg once a day daily. Treatment course – 10 suppositories.

For exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis) – suppositories 6 mg once a day daily. Treatment course – 10 suppositories.

For pulmonary form of tuberculosis – suppositories 6 mg once a day daily for 3 days, then every other day. Treatment course 20 suppositories. Subsequently, maintenance therapy with suppositories 6 mg twice a week for up to 2-3 months is possible.

In complex therapy of oncological diseases during chemotherapy and radiation therapy – suppositories 6 mg daily 2-3 days before the start of the course of chemotherapy or radiation therapy. Then 6 mg twice a week for a course of up to 20 suppositories.

For allergic diseases complicated by infectious syndrome – suppositories 6 mg once a day daily. Treatment course – 10 suppositories.

For rheumatoid arthritis – suppositories 6 mg every other day. Treatment course – 10 suppositories.

For prophylaxis (monotherapy)

Exacerbations of chronic foci of infections, recurrent herpetic infection of the urogenital tract – suppositories 6 mg every other day. Course – 10 suppositories.

Influenza and ARVI – suppositories 6 mg once a day. Course – 10 suppositories.

Lyophilisate

Methods of application of the drug Polyoxidonium^®: parenteral, intranasal, sublingual.

The dosage regimen, route of administration, necessity and frequency of subsequent therapy courses are determined by the physician depending on the diagnosis, severity of the disease, and the patient’s age.

Adults

IM or IV drip

Administered at a dose of 6-12 mg once a day daily, every other day, or 1-2 times a week depending on the diagnosis and severity of the disease.

For acute viral and bacterial infections of the ENT organs, upper and lower respiratory tract, gynecological and urological diseases 6 mg daily for 3 days, then every other day for a course of 10 injections.

For chronic recurrent infectious and inflammatory diseases of various locations, bacterial, viral, and fungal etiology in the acute phase 6 mg every other day, 5 injections are given, then 2 times a week for a course of 10 injections.

For acute and chronic allergic diseases (including hay fever, bronchial asthma, atopic dermatitis) complicated by bacterial, viral, and fungal infections: 6-12 mg, course – 5 injections.

For rheumatoid arthritis complicated by bacterial, viral, and fungal infections, against the background of long-term use of immunosuppressants: 6 mg every other day 5 injections, then 2 times a week for a course of 10 injections.

For generalized forms of surgical infections 6 mg daily for 3 days, then every other day for a course of 10 injections.

To activate regenerative processes (fractures, burns, trophic ulcers) 6 mg for 3 days, then every other day for a course of 10 injections.

For the prevention of postoperative infectious complications 6 mg every other day – 5 injections.

For pulmonary tuberculosis: 6 mg 2 times a week for a course of 20 injections.

In patients with oncological diseases

• before and during chemotherapy to reduce the immunosuppressive, hepatotoxic and nephrotoxic effects of chemotherapeutic agents prescribed 6 mg every other day for a course of 10 injections; then the frequency of administration is determined by the physician depending on tolerance and duration of chemo- and radiation therapy;
• for the prevention of the immunosuppressive effect of the tumor, for the correction of immunodeficiency after chemo- and radiation therapy, after surgical removal of the tumor long-term use of the drug Polyoxidonium^® (from 2-3 months to 1 year) at 6 mg 1-2 times a week is indicated. When prescribing a long course, no cumulative effect, manifestations of toxicity or habituation are observed.

Intranasally – at a dose of 6 mg/day – 3 drops into each nasal passage 3 times/day for 10 days.

Recommended treatment regimens for children

Administered parenterally, intranasally, sublingually. Doses and route of administration are determined by the physician depending on the diagnosis, severity of the disease, and the patient’s age.

IM or IV drip

For children aged from 6 months at a dose of 100-150 mcg/kg daily, every other day or 2 times a week for a course of 5-10 injections.

For acute and exacerbations of chronic inflammatory diseases of any location (including ENT organs – sinusitis, rhinitis, adenoiditis, hypertrophy of the pharyngeal tonsil, ARVI) caused by pathogens of bacterial, viral, fungal infections the drug is prescribed at 100 mcg/kg for 3 consecutive days, then for a course of 10 injections.

For acute allergic and toxic-allergic conditions (including bronchial asthma, atopic dermatitis) complicated by bacterial, viral, and fungal infections the drug is administered IV drip at a dose of 100 mcg/kg for 3 days daily, then every other day for a course of 10 injections in combination with basic therapy.

Intranasally and sublingually

Used daily at a daily dose of 150 mcg/kg for a course of up to 10 days. Administer 1-3 drops into one nasal passage or under the tongue at intervals of at least 1-2 hours, in 2-3 doses per day.

1 drop (0.05 ml) of the prepared solution contains 150 mcg of the drug.

For intranasal and sublingual administration, the calculation of the daily dose for children is presented in the table

If the child’s body weight is more than 20 kg, the daily dose is calculated at 1 drop per 1 kg of body weight, but not more than 40 drops (6 mg of active substance).

Intranasally used daily, 1-2 drops into each nasal passage 3 times/day for a course of up to 10 days.

Sublinguallyfor young, preschool, and primary school children daily at a daily dose of 150 mcg/kg in 2 doses for 10 days.

Tablets

Used sublingually and orally, daily 2 times/day.

Adults and children over 10 years – 12 mg, children aged 3 to 10 years – 1/2 tab. (6 mg).

If necessary, repeated therapy courses can be conducted after 3-4 months. Upon repeated prescription, the effectiveness of the drug does not decrease.

Sublingually

For treatment of influenza and acute respiratory infectionsadults and children over 10 years – 12 mg 2 times/day for 7 days; children aged 3 to 10 years – 6 mg 2 times/day for 7 days.

For inflammatory diseases of the oral cavity and pharynxadults – 12 mg 2 times/day for 10 days; children over 10 years – 12 mg 2 times/day for 7 days; children aged 3 to 10 years – 6 mg 2 times/day for 7 days.

For exacerbation of chronic diseases of the upper respiratory tract, paranasal sinuses, chronic otitisadults – 12 mg 2 times/day for 10 days; children over 10 years – 12 mg 2 times/day for 7 days.

For treatment of allergic diseases (including hay fever, bronchial asthma), complicated by recurrent bacterial, fungal and viral infectionadults – 12 mg 2 times/day for 10 days; children over 10 years – 12 mg 2 times/day for 7 days; children aged 3 to 10 years – 6 mg 2 times/day for 7 days.

For prevention of influenza and acute respiratory infections in the pre-epidemic periodadults – 12 mg/day for 10 days; children over 10 years – 12 mg/day for 7 days; children aged 3 to 10 years – 6 mg/day for 7 days.

For prevention of recurrent herpetic infection of the nasal and labial areaadults – 12 mg 2 times/day for 10 days; children over 10 years – 12 mg 2 times/day for 7 days; children aged 3 to 10 years – 6 mg 2 times/day for 7 days.

For prevention of exacerbations of chronic foci of infection of the oropharynx, paranasal sinuses, upper respiratory tract, inner and middle earadults and children over 10 years – 12 mg 1 time/day for 10 days; children aged 3 to 10 years – 6 mg 1 time/day for 10 days.

For prevention of secondary immunodeficiencies arising from aging or exposure to adverse factorsadults – 12 mg 1 time/day for 10 days.

Orally

For diseases of the upper and lower respiratory tractadults and children over 10 years – 12 mg 2 times/day for 10 days.

Adverse Reactions

With parenteral administration infrequently (≥1/1000 to <1/100) at the injection site – pain, redness and induration of the skin.

With parenteral administration and with topical application very rarely (≥1/10,000) – increased body temperature, mild anxiety, chills, hypersensitivity to the components of the drug (allergic reactions).

Contraindications

• Hypersensitivity to the drug used;
• Acute renal failure;
• Pregnancy;
• Breastfeeding period;
• Children under 6 months of age.

With caution

Chronic renal failure (use no more than 2 times a week).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding. There is no clinical experience of use.

Use in Renal Impairment

Contraindicated for use in acute renal failure.

Patients with chronic renal failure should use it no more than 2 times a week.

Pediatric Use

Contraindicated in children under 6 months of age.

Special Precautions

If an allergic reaction develops in case of hypersensitivity to the components of the drug, the patient should stop using this remedy and consult a doctor.

If it is necessary to stop use, withdrawal can be done immediately, without gradual dose reduction.

When administered intravenously (drip), it should not be dissolved in infusion solutions containing protein.

Drug Interactions

Azoximer bromide does not inhibit the CYP1A2, CYP2C9, CYP2C19, CYP2D6 isoenzymes of cytochrome P450, therefore the drug is compatible with many drugs, including antibiotics, antiviral, antifungal and antihistamine drugs, corticosteroids and cytostatics.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.