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Polyoxidonium suppositories 12 mg N10

Registration Certificate Holder

NPO PETROVAX PHARM (Russia)

Dosage form

Medicine – Polyoxidonium® (Polyoxidonium®)

Description

Vaginal and rectal suppositories

torpedo-shaped, light yellow in color, with a faint specific odor of cocoa butter; suppositories must be homogeneous; an air rod or a funnel-shaped depression is allowed on the cut.

1 sup.

azoximer bromide 12 mg

Excipients

: mannitol - 3.6 mg, povidone K17 - 2.4 mg, cocoa butter - 1282 mg.

5 pieces. — contour cell packaging (2) — cardboard packs.

Indications

For treatment as part of complex therapy of infectious and inflammatory diseases (viral, bacterial and fungal etiology) in the acute stage and remission in adults and children over 6 years of age

acute and exacerbation of chronic recurrent infectious and inflammatory diseases of various localization, bacterial, viral and fungal etiology;
inflammatory diseases of the urogenital tract (urethritis, cystitis, pyelonephritis, prostatitis, salpingo-oophoritis, endomyometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis);
various forms of tuberculosis;
allergic diseases (including hay fever, bronchial asthma, atopic dermatitis), complicated by recurrent bacterial, fungal and viral infections;
rheumatoid arthritis, complicated by recurrent bacterial, fungal and viral infections, against the background of long-term use of immunosuppressants;
to activate regenerative processes (fractures, burns, trophic ulcers);
in complex therapy of oncological diseases during chemotherapy and radiation therapy, to reduce the nephro- and hepatotoxic effects of drugs.

As monotherapy:

for the prevention of recurrent herpetic infections;
for seasonal prevention of exacerbations of chronic foci of infections;
for the prevention of influenza and acute respiratory infections in the pre-epidemic period in immunocompromised individuals;
for the correction of secondary immunodeficiencies resulting from aging or exposure to adverse factors.

Contraindications for use

increased individual sensitivity;
acute renal failure;
pregnancy;
breastfeeding period;
children under 6 years of age.

Carefully:

chronic renal failure (prescribed no more than 2 times a week).

pharmachologic effect

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

Azoximer bromide increases the body's resistance to local and generalized infections. Restores immune responses in secondary immunodeficiency conditions caused by various infections, injuries, burns, malignant neoplasms, complications after surgery, the use of chemotherapeutic agents, incl. cytostatics, steroid hormones.

The basis of the mechanism of the immunomodulatory effect of azoximer bromide is a direct effect on phagocytic cells and natural killer cells, as well as stimulation of antibody formation. Azoximer bromide reduces the inflammatory response by normalizing the synthesis of pro- and anti-inflammatory cytokines.

The detoxification and antioxidant properties of azoximer bromide are determined by the structure and high-molecular nature of the drug. 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 is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergenic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

Drug interactions

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

Dosage regimen

The drug is intended for rectal and intravaginal administration, 1 suppository 1 time/day. The method and dosage regimen is determined by the doctor depending on the diagnosis, severity and severity of the process. The drug can be used daily, every other day or 2 times a week.

Suppositories 12 mg

used in
adults
rectally and intravaginally.

Suppositories 6 mg

used in
children over 6 years of age
only rectally;
in adults
- rectally and intravaginally.

Rectally, suppositories are administered into the rectum after cleansing the intestines 1 time per day. Intravaginally, suppositories are inserted into the vagina in a lying position, 1 time/day at night.

Standard application scheme

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

If necessary, the course of treatment is repeated after 3-4 months. The need and frequency of subsequent courses of therapy are determined by the doctor; if the drug is re-prescribed, the effectiveness does not decrease.

Patients with chronic immune deficiency

(including those receiving immunosuppressive therapy for a long time, those with cancer, HIV, those exposed to radiation) long-term maintenance therapy with Polyoxidonium® is indicated for 2-3 months to 1 year (
adults
12 mg,
children over 6 years old
- 6 mg 1 -2 times per week).

Variants of recommended regimens for use as part of complex therapy

For treatment:

For adults

rectally, 1 suppository 1 time/day after bowel cleansing;
vaginally for gynecological diseases, 1 suppository 1 time per day (at night) is inserted into the vagina in a lying position.

For chronic infectious and inflammatory diseases in the acute stage

— suppositories 12 mg 1 time/day daily for 3 days, then every other day. The course of treatment is 10 suppositories.

For acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers)

– suppositories 12 mg 1 time/day daily. The course of treatment is 10 suppositories.

For gynecological diseases

– suppositories 12 mg 1 time/day daily for 3 days, then every other day. The course of treatment is 10 suppositories.

In case of exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis)

— suppositories 12 mg 1 time/day daily. The course of treatment is 10 suppositories.

For pulmonary tuberculosis

– suppositories 12 mg 1 time/day daily for 3 days, then every other day. The course of treatment is 20 suppositories. Further, it is possible to use maintenance therapy with suppositories 6 mg 2 times a week, for a course of up to 2-3 months.

In complex therapy of oncological diseases during chemotherapy and radiation therapy

– suppositories 12 mg daily 2-3 days before the start of chemotherapy or radiation therapy. Then 12 mg 2 times a week, for a course of up to 20 suppositories.

For allergic diseases complicated by infectious syndrome

– suppositories 12 mg 1 time/day daily. The course of treatment is 10 suppositories.

For rheumatoid arthritis

– suppositories 12 mg every other day. The course of treatment is 10 suppositories.

Children and teenagers from 6 to 18 years old

For children and adolescents aged 6 to 18 years, suppositories are administered only rectally, 1 suppository 6 mg 1 time / day after cleansing the intestines.

For chronic infectious and inflammatory diseases in the acute stage

– suppositories 6 mg 1 time/day daily for 3 days, then every other day. The course of treatment is 10 suppositories.

For acute infectious processes and to activate regenerative processes (fractures, burns, trophic ulcers)

– suppositories 6 mg 1 time/day daily. The course of treatment is 10 suppositories.

In case of exacerbation of urological diseases (urethritis, pyelonephritis, cystitis, prostatitis)

– suppositories 6 mg 1 time/day daily. The course of treatment is 10 suppositories.

For pulmonary tuberculosis

– suppositories 6 mg 1 time/day daily for 3 days, then every other day. The course of treatment is 20 suppositories. Further, it is possible to use maintenance therapy, suppositories 6 mg 2 times a week, for a course of up to 2-3 months.

In complex therapy of oncological diseases during chemotherapy and radiation therapy

– suppositories 6 mg daily 2-3 days before the start of chemotherapy or radiation therapy. Then 6 mg 2 times a week, for a course of up to 20 suppositories.

For allergic diseases complicated by infectious syndrome

— suppositories 6 mg 1 time/day daily. The course of treatment is 10 suppositories.

For rheumatoid arthritis

– suppositories 6 mg every other day. The course of treatment is 10 suppositories.

For prevention (monotherapy):
Exacerbations of chronic foci of infections, recurrent herpetic infections of the urogenital tract
- suppositories 6 mg every other day. Course – 10 suppositories.

Flu and ARVI

– suppositories 6 mg 1 time/day. Course - 10 suppositories.

Overdose

Currently, no cases of overdose of the drug Polyoxidonium® have been reported.

Side effect

Very rarely:

local reactions in the form of redness, swelling, itching of the perianal area, vaginal itching due to individual sensitivity to the components of the drug.

special instructions

If it is necessary to discontinue drug therapy, discontinuation can be carried out immediately.

If you miss a single dose of the drug, you should take it as soon as possible, but if it is time to take the next dose, the dose should not be increased.

The drug should not be used if there are visual signs of its unsuitability (defective packaging, discoloration of suppositories).

If an allergic reaction develops, the patient should stop using the drug and consult a doctor.

Use in pediatrics

For children and adolescents aged 6 to 18 years, suppositories are administered only rectally.
Effect on the ability to drive vehicles and machinery
The use of the drug Polyoxidonium® does not affect the ability to drive vehicles, maintain machinery and other types of work that require increased concentration and speed of psychomotor reactions.

Storage conditions

The drug should be stored in a dry place, out of reach of children, at a temperature of 2° to 15°C.

Best before date

Shelf life: 2 years.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated.

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

Experimental
studies
of the drug Polyoxidonium® in animals did not reveal embryotoxic or teratogenic effects or effects on fetal development.

Use for renal impairment

Restrictions for impaired renal function - With caution.

Carefully _

the drug should be prescribed to patients with impaired renal function (clinical studies have not been conducted).
The use of the drug is contraindicated in acute renal failure.
Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

Carefully _

the drug should be prescribed to patients with impaired liver function (clinical studies have not been conducted).

Use in children

Restrictions for children - With caution.

The use of the drug in children under 6 years of age is contraindicated (there is no clinical experience with its use).

The drug in the form of 12 mg suppositories is contraindicated in people under 18 years of age.

Terms of sale

Over the counter.

Hotline number

Contacts for inquiries

NPO Petrovax Pharm LLC (Russia)

142143 Moscow region, Podolsk village. Pokrov, Sosnovaya st. 1 Tel./fax, 730-75-60