Ovidika^® (Suppositories) Instructions for Use

Marketing Authorization Holder

Pharmaprim, LLC (Republic of Moldova)

ATC Code

G01AX11 (Povidone-iodine)

Active Substance

Povidone-iodine (BAN)

Dosage Form

Ovidika®

Vaginal suppositories 200 mg: 14 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories of a torpedo-like shape, brown in color, with a specific odor of iodine; a longitudinal section may show the presence of an air core or a funnel-shaped depression.

Excipients: macrogol 1000 – 1800 mg.

7 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics, except combinations with corticosteroids; other antimicrobial agents and antiseptics

Pharmacological Action

It has antiseptic, disinfectant, antifungal, and antiprotozoal action. It blocks the amino groups of cellular proteins. It has a broad spectrum of antimicrobial action. Active against bacteria (including E. coli, Staphylococcus aureus), fungi, viruses, protozoa.

When released from the complex with polyvinylpyrrolidone upon contact with the skin and mucous membranes, iodine forms iodamines with bacterial cell proteins, coagulates them, and causes the death of microorganisms.

It has a rapid bactericidal effect on gram-positive and gram-negative bacteria (except for Mycobacterium tuberculosis).

Pharmacokinetics

With topical application, almost no absorption of iodine from the mucous membrane occurs.

Indications

Acute or chronic vaginitis (mixed, nonspecific infection); bacterial vaginosis (caused by Gardnerella vaginalis); candidiasis; Trichomonas vaginalis infection; vaginal infections after therapy with antibiotics or steroid drugs; prophylaxis before surgical or diagnostic interventions in the vagina.

ICD codes

Dosage Regimen

Administer one suppository intravaginally, once or twice daily.

Determine the duration of treatment individually based on clinical indication and response.

Continue treatment during menstruation without interruption.

For preoperative or diagnostic prophylaxis, follow the specific regimen prescribed by the physician.

Wash hands thoroughly before and after handling the suppository.

Insert the suppository deeply into the vagina while lying on your back with knees bent.

Use a sanitary pad to protect clothing from potential staining, as the suppository melts at body temperature.

Adverse Reactions

Local reactions rarely – itching, hyperemia, hypersensitivity reactions.

In rare cases, the development of a hypersensitivity reaction is possible, for example, contact dermatitis with the formation of psoriasiform red small bullous elements. If such phenomena occur, the use of the drug should be discontinued.

Long-term use of povidone-iodine can lead to the absorption of significant amounts of iodine. In some cases, the development of iodine-induced hyperthyroidism has been described, mainly in patients with pre-existing thyroid disease.

Contraindications

Hypersensitivity to iodine; thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto’s thyroiditis, hyperthyroidism); acute thyroid diseases; thyroid adenoma; Duhring’s dermatitis herpetiformis; before and during the use of radioactive iodine for the treatment of thyroid carcinoma or scintigraphy; pregnancy, breastfeeding period; girls who have not reached adolescence.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Use in Renal Impairment

Caution should be exercised with regular use of the drug in patients with previously diagnosed renal failure.

Pediatric Use

The use of povidone-iodine is allowed from the neonatal period, but considering the dosage form – vaginal suppositories – it is not recommended for use in girls under 8 years of age and caution should be exercised when administering to virgins.

Geriatric Use

Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.

Special Precautions

Due to the oxidative properties of povidone-iodine, its traces can lead to false-positive results of some types of tests for the detection of occult blood in the stool, as well as blood or glucose in the urine.

During the use of povidone-iodine, the uptake of iodine by the thyroid gland may decrease, which may affect the results of some diagnostic tests (e.g., thyroid scintigraphy, protein-bound iodine determination, measurements using radioactive iodine), and may also interact with iodine preparations used to treat thyroid diseases. To obtain undistorted results of thyroid scintigraphy after long-term therapy with povidone-iodine, it is recommended to allow a sufficiently long period of time without this drug.

In case of thyroid dysfunction, the drug can be used only as directed by a doctor. If symptoms of hyperthyroidism occur during the course of treatment, thyroid function should be checked.

Caution should be exercised with regular use of the drug in patients with previously diagnosed renal failure.

Regular use of preparations containing Povidone-iodine should be avoided in patients receiving lithium preparations.

Drug Interactions

Incompatible with other disinfectant and antiseptic agents, especially those containing alkalis, enzymes, and mercury.

Concomitant use of povidone-iodine and hydrogen peroxide, as well as enzyme preparations containing silver and taurolidine for wound treatment, as well as antiseptic preparations, leads to a mutual decrease in effectiveness.

In the presence of blood, the bactericidal effect may decrease; however, with an increase in the concentration of the active substance, bactericidal activity may be increased.

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

Over-the-Counter

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.