Polyoxidonium suppositories vaginal and rectal 6mg, 10pcs

Composition

Composition per suppository:  Active substance:  Azoximer bromide – 6 mg;

Auxiliary substances:  mannitol-1.8 mg, povidone K17-1.2 mg, cocoa butter-1291.0 mg (for a dosage of 6 mg).

Pharmacological action

Pharmacodynamics

Longidase® has a hyaluronidase (enzymatic)activity. long-acting activity, chelating, antioxidant, immunomodulatory and moderately pronounced anti-inflammatory properties.

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

Pronounced antifibrotic properties of Longidase are provided by conjugation of hyaluronidase with the carrier, which significantly increases the resistance of the enzyme to denaturing effects and the action of inhibitors: the enzymatic activity of Longidase is preserved when heated to 37 °C for 20 days, while native hyaluronidase under the same conditions loses its activity during the day.

Longidase® provides simultaneous local presence of the enzyme hyaluronidase and a carrier capable of binding enzyme inhibitors and stimulators of collagen synthesis released during hydrolysis of matrix components (iron, copper, heparin, etc. ). Due to these properties, Longidase® has not only the ability to depolymerize the connective tissue matrix in fibrogranulomatous formations, but also to suppress the reverse regulatory reaction aimed at the synthesis of connective tissue components.

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.

As a result of depolymerization (breaking the bond between C1 of acetylglucosamine and C4 of glucuronic or induronic acids), glycosaminoglycans change their basic properties: the viscosity decreases, the ability to bind water and metal ions decreases, the permeability of tissue barriers temporarily increases, the movement of fluid in the intercellular space is facilitated, the elasticity of connective tissue increases, which is manifested in a decrease in tissue edema, flattening of scars, an increase in the volume of joint movement, a decrease in contractures and prevention of their formation, a decrease in the adhesive process.

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

Longidase® has no mutagenic, embryotoxic, teratogenic or carcinogenic effects.

The drug is well tolerated by patients, there are no local and general allergic reactions.

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

Pharmacokinetics

An experimental study of pharmacokinetics allowed us to establish that when rectally administered, the drug Longidaza® is characterized by a high rate of distribution in the body, is well absorbed into the systemic circulation and reaches its maximum concentration in the blood after 1 hour. The half-life is about 0.5 hours, the half-elimination period is from 42 to 84 hours. It is mainly excreted by the kidneys.

The drug penetrates all organs and tissues, including passing through the blood-brain and blood-ophthalmic barriers. The absence of tissue accumulation was found.

The bioavailability of Longidase® with rectal use is high: about 90%.

Indications

For adults and children over 6 years of age.

In complex therapy for the correction of immune insufficiency:

• chronic recurrent infectious and inflammatory diseases that are not amenable to standard therapy in the acute stage, and in remission;
• acute viral, bacterial and fungal infections;
• inflammatory diseases of the urogenital tract, including urethritis, cystitis, pyelonephritis, prostatitis, salpingoophoritis, endomyometritis, colpitis, cervicitis, Servicos, bacterial vaginosis (including viral etiology);
• various forms of tuberculosis;
• allergic disease complicated by recurrent bacterial, fungal and viral infection (including hay fever, asthma, atopic dermatitis);
• rheumatoid arthritis treated with long-term immunosuppressant drugs; in complicated ARI Jiarui the course of the disease;
• to activate regenerative processes (fractures, burns, trophic ulcers);
• for rehabilitation and often long-term (more than 4-5 times a year) ill people;
• during and after chemo – and radiotherapy of tumors;
• to reduce the nephrotoxicity and hepatotoxicity of drugs.

As monotherapy:

• for the prevention of recurrent herpetic infection;
• for seasonal prevention of exacerbations of chronic foci of infections, for the prevention of influenza and acute respiratory infections in the pre-epidemic period;
• for the correction of secondary immunodeficiency that occurs due to aging or exposure to adverse factors.

Use during pregnancy and lactation

Polyoxidonium is contraindicated in pregnancy, breast-feeding and children under 6 months of age (there is no clinical experience with its use).

Contraindications

• hypersensitivity to drugs based on hyaluronidase;
• pulmonary hemorrhage and hemoptysis;
• fresh vitreous hemorrhage;
• malignant neoplasms;
• acute renal failure;
• children under 12 years of age (no results of clinical studies);
• pregnancy and lactation.

WITH CAUTION

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

Side effects

The frequency of adverse reactions is classified as follows: 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, itching of the perianal zone, vaginal itching due to individual sensitivity to the components of the drug.

Interaction

The drug Longidaza® can be combined with antibiotics, antivirals, antifungal drugs, bronchodilators.

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

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

Do not use Longidase® concomitantly with drugs containing furosemide, benzodiazepines, or phenytoin.

How to take, course of use and dosage

Longidase ® suppositories 3000 IU is recommended for rectal or vaginal use once a day at night with a course of 10 to 20 injections.

For adolescents from 12 to 18 years of age, suppositories are administered only rectally.

Adults and adolescents over 12 years of age rectally: 1 suppository 1 time a day after bowel cleansing.

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

The schedule of use is adjusted depending on the severity, stage and duration of the disease: Longidaza® is prescribed every other day or with interruptions of 2-3 days.

Recommended regimens and doses:

• in urology: 1 suppository every other day for 10 injections, then after 2-3 days for 10 injections, with a total course of 20 suppositories.

• in gynecology: rectally or vaginally,1 suppository after 2 days of 10 injections, then, if necessary, maintenance therapy is prescribed.

• in dermatovenereology: 1 suppository in 1-2 days 10-15 injections.
• in surgery: 1 suppository in 2-3 days 10 injections.
• in pulmonology and phthisiology: 1 suppository after 2-4 days,10-20 injections.

If necessary, it is recommended to repeat the course of Longidase® no earlier than after three months or long-term maintenance therapy of 1 suppository 1 time in 5-7 days for 3-4 months.

Overdose

Symptoms of overdose may include chills, fever, dizziness, and hypotension. use of the drug is stopped and symptomatic therapy is prescribed.

Special instructions

When taking the drug, strictly follow the instructions given in the instructions.

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

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

When used against the background of acute foci of infection, to prevent the spread of infection, it is necessary to prescribe under the cover of antimicrobial agents.

If side effects occur, or if an adverse reaction occurs that is not mentioned in the instructions for medical use, you should consult your doctor.

Do not use the product if there are visual signs of its unsuitability (defective packaging, discoloration of the suppository).

In case of missing the next dose of the drug, continue to use as usual (do not enter the doubled dose).

If it is necessary to stop taking Longidase®, withdrawal can be carried out immediately, without gradually reducing the dose.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS

The use of the drug Longidaza® does not affect the ability to drive vehicles, maintain mechanisms and other types of work that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Suppositories for vaginal or rectal use

Storage conditions

Store in a dry place protected from light at a temperature of 2 to 15 ° C. Keep away from children.

Shelf

life is 2 years. Do not use the drug after the expiration date indicated on the package.

Active ingredient

Azoximer bromide

Dosage form

rectal suppositories

Purpose

For the elderly, Children over 6 years old, For adults

Indications

Dermatitis, Rheumatoid arthritis, Colds, sores, Burns, Immunodeficiency, Cytomegalovirus infection, Fungus, Prostatitis, Flu, hay fever, Inflammation of the female genital organs, Urethra, Cancer, Herpes, Sinusitis, broken bones, Bronchial asthma, Prevention of colds and flu, Strep throat, Tuberculosis, Otitis media, Chronic infection