Polyoxidonium, vaginal and rectal suppositories 6 mg 10 pcs

Pharmacodynamics

Longidase® has hyaluronidase (enzymatic) activity with prolonged action, chelating, antioxidant, immunomodulatory and moderately pronounced anti-inflammatory properties.

The prolonged action of the enzyme is achieved by covalent binding of the enzyme with a physiologically active polymeric carrier (azoximer). Longidase® shows antifibrotic properties, weakens acute phase of inflammation, regulates (increases or decreases depending on the initial level) synthesis of inflammatory mediators (interleukin-1 and tumor necrosis factor-alpha), increases humoral immune response and resistance of the body to infection.

The pronounced antifibrotic properties of Longidase are provided by conjugation of hyaluronidase with the carrier, which significantly increases resistance of the enzyme to denaturing influences and to the action of inhibitors: the enzymatic activity of Longidase is maintained when heated to 37 °С for 20 days, while the native hyaluronidase in the same conditions loses its activity within a day.

The specific substrate of testicular hyaluronidase is glycosaminoglycans (hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate), which form the basis of the connective tissue matrix.

Glycosaminoglycans change their basic properties as a result of depolymerization (breaking the bond between C1 acetylglucosamine and C4 glucuronic or induronic acids): viscosity is reduced, the ability to bind water, metal ions is reduced, the permeability of tissue barriers is temporarily increased, fluid movement in the intercellular space is facilitated, the elasticity of connective tissue is increased, which is manifested in a reduction of tissue swelling, flattening of scars, increased joint movement, reduction of contractures and prevention of their formation, reduction of adhesions.

Biochemical, immunological, histological and electron-microscopic investigations demonstrate that Longidase® does not damage the normal connective tissue, but causes destruction of connective tissue altered in its composition and structure in the area of fibrosis.

Longidaza® has no mutagenic, embryotoxic, teratogenic and carcinogenic effect.

The drug is well tolerated by patients, no local and general allergic reactions were noted.

The use of Longidase in therapeutic doses during or after surgical treatment does not cause deterioration of the course of postoperative period or progression of the infection; it does not slow down the recovery of bone tissue.

Pharmacokinetics

The experimental study of pharmacokinetics established that with rectal administration Longidase® is characterized by high rate of distribution in the body, is well absorbed into the systemic bloodstream and reaches maximum concentration in the blood after 1 hour. Period of half-distribution is about 0.5 hours; period of half-elimination is from 42 to 84 hours. It is excreted mainly by the kidneys.

The drug penetrates into all organs and tissues, including those through the blood-brain and blood-ophthalmic barriers. It was found that there is no tissue cumulation.

The bioavailability of Longidase® by rectal administration is high: about 90 %.

Indications

Bronchial asthma, Fungus, Immunodeficiency conditions, Pollinosis, Tuberculosis, Trophic ulcers, Otitis, Pharyngitis, Herpes, Cytomegalovirus infection, Urethritis, Chronic infections, Cancer, Bone fractures, Rheumatoid arthritis, Guillotine, Burns, Female genital inflammation, Prostatitis, Flu, Colds, Dermatitis, Flu and cold prevention

In adults and children over 6 years of age.

In complex therapy for the correction of immune deficiencies:

• chronic recurrent infectious and inflammatory diseases that do not respond to standard therapy both in the acute and in remission;
• acute viral, bacterial and fungal infections;
• inflammatory diseases of the urogenital tract, including.ч. urethritis, cystitis, pyelonephritis, prostatitis, salpingo-oophoritis, endometritis, colpitis, cervicitis, cervicosis, bacterial vaginosis (including those of viral etiology)
• various forms of tuberculosis;
• allergic illnesses complicated by recurrent bacterial, fungal and viral infections
• allergic diseases, complicated by recurrent bacterial, fungal and viral infections (including pollinosis, bronchial asthma and bronchitis).
• Allergic diseases complicated by recurrent bacterial and fungal and viral infections (including pollinosis, bronchial asthma, atopic dermatitis).
• Rheumatoid arthritis, long-term immunosuppressant therapy; with a complicated course of the disease
• for activation of regenerative processes (fractures, burns, trophic ulcers);
• to rehabilitate people who are sick often and for a long time (over 4-5 times a year).
• in the process and after chemotherapy and radiation therapy in tumors
• to reduce nephro-and hepatotoxic effects of drugs.

In the form of monotherapy:

• for the prevention of recurrent herpetic infection;
• for seasonal prevention of exacerbations of chronic foci of infection, for the prevention of influenza and acute respiratory infections in the preepidemic period;
• for correction of secondary immune deficiencies resulting from aging or adverse factors.

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Active ingredient

Azoximera bromide

Composition

Composition per suppository:

Active substance:

Azoximer bromide – 6 mg;

Excipients:

mannitol – 1.8 mg,

povidone K 17 – 1.2 mg,

cocoa butter – 1291.0 mg (for 6 mg dosage).

How to take, the dosage

Longidaza® suppositories 3000 IU are recommended for rectal or vaginal use once daily at bedtime for a course of 10 to 20 injections.

In adolescents 12 to 18 years of age, the suppositories are administered rectally only.

Adults and adolescents over 12 years of age rectally: 1 suppository once daily after bowel cleansing.

Adults vaginally: 1 suppository once a day (at night), the suppository is inserted into the vagina in a supine position.

The regimen of administration is adjusted depending on the severity, stage and duration of the disease: Longidaza® is administered every other day or at 2-3 day intervals.

Recommended regimens and doses:

• in urology: 1 suppository every other day and 10 instillations every 2-3 days, for a total course of 20 suppositories.

• In gynecology: rectally or vaginally, 1 suppository every 2 days and 10 instillations, then if necessary prescribes maintenance therapy.

• in dermatovenerology: 1 suppository every 1-2 days 10-15 injections.
• in surgery: 1 suppository every 2-3 days and 10 instillations.
• in pulmonology and phthisiology: 1 suppository every 2-4 days and 10-20 instillations.

If necessary, it is recommended to repeat the course of the preparation Longidase® not earlier than in three months or long-term maintenance therapy with 1 suppository once in 5-7 days during 3-4 months.

Interaction

Longidase® can be combined with antibiotics, antiviral, antifungal drugs, bronchodilators.

When prescribing in combination with other drugs (antibiotics, local anesthetics, diuretics) the possibility of increasing bioavailability and enhancing their action should be taken into account.

In co-administration with high doses of salicylates, cortisone, adrenocorticotropic hormone (ACTH), estrogens or antihistamines the enzymatic activity of Longidase® may be reduced.

Longidase® should not be used concomitantly with drugs containing furosemide, benzodiazepines, phenytoin.

Special Instructions

Follow the directions in the package insert carefully when taking this medicine.

If you have any questions, ask your doctor or pharmacist for clarification.

If an allergic reaction develops, discontinue use of Longidase®.

When used against a background of worsening foci of infection, antimicrobial agents must be administered under cover to prevent the spread of infection.

If any adverse reactions occur, or if an adverse reaction occurs that is not mentioned in the instructions for medical use, the physician should be consulted.

Do not use the drug if there are visual signs of its unsuitability (defective packaging, change in color of the suppository).

If the next dose of the drug is missed, then use as usual (do not administer a doubled dose).

If it is necessary to discontinue Longidase®, discontinuation can be done immediately, without gradually reducing the dose.

Impact on the ability to operate vehicles, machines

The use of Longidase® does not affect the ability to drive vehicles, operate machinery and other types of work requiring high concentration and quick psychomotor reaction.

Contraindications

• hypersensitivity to hyaluronidase-based products;
• pulmonary bleeding and hemoptysis;
• fresh vitreous hemorrhage;
• malignant neoplasms;
• acute renal failure;
• children under 12 years of age (no clinical findings);
• pregnancy and breastfeeding period.

WARNING

With caution, use no more than once a week in patients with chronic renal failure, history of pulmonary bleeding.

Side effects

The frequency of adverse reactions is presented according to the following classification: very frequent ≥10%; frequent ≥1% and < 10%; infrequent ≥0.1% and < 1%; rare ≥0.01% and < 0.1%; very rare < 0.001%.

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

Overdose

Symptoms of overdose may manifest as chills, fever, dizziness, hypotension.

Pregnancy use

Polioxidonium is contraindicated in pregnancy, lactation and children under 6 months of age (no clinical experience of use).

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