Iodoxyd (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

Contact Information

NIZHPHARM group of companies (Russia)

ATC Code

G01AX11 (Povidone-iodine)

Active Substance

Povidone-iodine

Dosage Form

Iodoxyd

Vaginal suppositories 200 mg: 10 or 15 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories brown with a brownish tint, torpedo-shaped, marbling of the surface is allowed.

Excipients: polyethylene oxide 1500, polyethylene oxide 400.

5 pcs. – contour cell packs (2) – cardboard packs.
5 pcs. – contour cell packs (3) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in gynecology

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic for topical use in gynecology. It blocks the amino groups of cellular proteins. It has a broad spectrum of antimicrobial action.

Active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa.

The active substance of the drug – iodine – is in the form of a complex with polyvinylpyrrolidone (povidone), which belongs to iodophors that bind iodine. The concentration of active iodine is 0.1-1%. Upon contact with the skin and mucous membranes, iodine is gradually and evenly released, exerting a bactericidal effect on microorganisms. A thin colored layer remains at the application site, which persists until all the iodine is released.

Pharmacokinetics

Data on the pharmacokinetics of Iodoxyd are not provided.

Indications

• Treatment of acute and chronic infectious and inflammatory diseases of the vagina (trichomonal, fungal, viral, nonspecific, mixed infections), bacterial vaginitis;
• Prevention of infectious and inflammatory complications before gynecological interventions (artificial termination of pregnancy, insertion and removal of an intrauterine device, diathermocoagulation of the cervix, hysterosalpingography).

ICD codes

Dosage Regimen

For acute vaginitis, administer 1 suppository twice daily for 7 days.

For subacute and chronic vaginitis, administer 1 suppository once daily at bedtime for 14 days.

Apply the regimen regardless of the menstrual cycle phase.

For prevention of infectious complications before gynecological procedures, follow the specific regimen and duration prescribed by a physician.

Insert the suppository deep into the vagina while in a supine position.

Thoroughly wash hands before and after the administration procedure.

Use a panty liner during treatment, as the suppository may cause staining.

Complete the full course of treatment as directed, even if symptoms improve earlier.

Consult a physician if no improvement is observed within the specified treatment period.

Adverse Reactions

Allergic reactions: itching, hyperemia.

Contraindications

• Concurrent therapy with radioactive iodine;
• Duhring’s dermatitis herpetiformis;
• Thyroid adenoma;
• Thyrotoxicosis;
• Newborns;
• Hypersensitivity to the components of the drug.

Use with caution in chronic renal failure.

Use in Pregnancy and Lactation

Use of the drug in the II and III trimesters of pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

The drug should be used with caution during lactation.

Use in Renal Impairment

Use with caution in chronic renal failure.

Special Precautions

In the presence of blood, the bactericidal effect of the drug may decrease.

In case of non-manifest hyperthyroidism and other thyroid diseases (especially in elderly patients), the drug should be used only under strict indications and with constant medical supervision.

Avoid contact with eyes.

Overdose

Data on overdose of Iodoxyd are not provided.

Drug Interactions

Iodoxyd is incompatible with disinfectants, mercury-containing preparations, oxidizing agents, alkalis, and substances with an acidic reaction.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 20°C (68°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.