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Osarcid (Suppositories) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

G01AB01 (Acetarsol)

Active Substances

Acetarsol (Rec.INN registered by WHO)

Sulfanilamide (Rec.INN registered by WHO)

Dosage Form

Bottle Rx Icon Osarcid Vaginal suppositories 300 mg+300 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories 1 supp.
Acetarsol 300 mg
Sulfanilamide 300 mg

5 pcs. – contour cell packs (1) – cardboard packs.
5 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

A drug with antiprotozoal and antibacterial action for topical use in gynecology

Pharmacotherapeutic Group

Antiprotozoal agent

Pharmacological Action

Antiprotozoal agent. By blocking sulfhydryl enzyme systems, it disrupts the metabolic processes in protozoa (including trichomonads, amoebas), as well as some spirochetes. To reduce resorption (and the risk of possible intoxication), it is necessary to maintain an acidic environment in the vagina.

Sulfanilamide is a bacteriostatic agent; its mechanism of action is due to competitive antagonism with PABA and inhibition of dihydropteroate synthase activity, which leads to disruption of dihydrofolic acid synthesis, and subsequently tetrahydrofolic acid, and as a result, to disruption of microbial nucleic acid synthesis.

Indications

  • Trichomonal colpitis.

ICD codes

ICD-10 code Indication
A59 Trichomoniasis
N77.1 Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
ICD-11 code Indication
1A92 Trichomoniasis
1F23.10 Candidiasis of vulva and vagina
1F65 Enterobiasis
1H0Z Unspecified infection
1A94.0 Genital or urogenital tract infection caused by Herpes simplex virus
GA41 Ulcerative or erosive diseases of vulva

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer one suppository intravaginally once daily for a total treatment duration of ten consecutive days.

Perform the administration while in a lying position to ensure proper placement and retention of the suppository. Complete the full prescribed course of therapy even if symptoms improve earlier.

Adverse Reactions

Monitor for systemic reactions including hepatobiliary disorders such as jaundice and hepatitis.

Report any neurological symptoms indicative of polyneuritis or manifestations of allergic reactions immediately. Discontinue use upon the appearance of any severe adverse effects.

Contraindications

  • Hypersensitivity to acetarsol, sulfanilamide, or any component of the formulation.
  • Patients with renal impairment of any severity.
  • Diagnosis of diabetes mellitus.
  • Presence of hemorrhagic diathesis.
  • Active or latent tuberculosis.
  • Pregnancy at any trimester.

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy.

Use in Renal Impairment

Contraindicated in renal impairment.

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

Rx Only

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.

Medical Disclaimer

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