Tantum^® Rosa (Powder, Solvent) Instructions for Use

Instructions
Dosage forms

ATC Code

G02CC03 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical NSAID for use in gynecology

Pharmacotherapeutic Group

Other drugs used in gynecology; anti-inflammatory drugs for vaginal administration

Pharmacological Action

NSAID for vaginal administration, belongs to the indazole group. It has anti-inflammatory and local analgesic action, and possesses antibacterial, antifungal, and antiseptic action.

The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzydamine exerts an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cell structures, disruption of metabolic processes, and cell lysis.

It has an antifungal effect against Candida albicans. It causes structural modifications of the fungal cell wall and metabolic chains of mycetes and thus prevents their reproduction.

Pharmacokinetics

When applied topically, it is well absorbed through the mucous membranes and penetrates into inflamed tissues.

Benzydamine is excreted mainly by the kidneys and through the intestine in the form of metabolites or conjugation products.

Indications

In the postpartum period as a therapeutic and prophylactic agent for the prevention of postpartum infectious complications; specific vulvovaginitis (as part of complex therapy); nonspecific vulvovaginitis and cervicovaginitis of any etiology, including those secondarily developed against the background of chemotherapy and radiotherapy; bacterial vaginosis; prevention of postoperative infectious complications in operative gynecology.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
N72	Inflammatory disease of cervix uteri (including cervicitis, endocervicitis, exocervicitis)
N76	Other inflammatory diseases of vagina and vulva
N77.1	Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
N89.8	Other noninflammatory disorders of vagina
O86	Other postpartum infections
T88.8	Other specified complications of surgical and medical care, not elsewhere classified
Z29.8	Other specified prophylactic measures

ICD-11 code	Indication
1F23.10	Candidiasis of vulva and vagina
1F65	Enterobiasis
1H0Z	Unspecified infection
GA00	Vulvitis
GA02.Z	Unspecified vaginitis
GA0Z	Inflammatory diseases of female genital tract, unspecified
GC42.1	Painful intercourse
JB40.Z	Infections in the puerperium, unspecified
MF3A	Vaginal discharge
NE8Z	Injury or harm caused as a result of surgical or therapeutic interventions, not elsewhere classified, unspecified
QC05.Z	Prophylactic measures, unspecified
1A94.0	Genital or urogenital tract infection caused by Herpes simplex virus
GA41	Ulcerative or erosive diseases of vulva
GA0Z	Inflammatory diseases of female genital tract, unspecified
XA5WW1	Cervix uteri
GA1Z	Unspecified noninflammatory disorders of female genital tract
XA1LK7	Vagina

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.

Prepare the solution immediately before use. Dissolve the entire contents of one sachet in one liter of warm, previously boiled water.

Use the prepared solution for vaginal irrigation (douching) or sitz baths. Perform the procedure once or twice daily, typically in the morning and evening.

For therapeutic purposes, the standard course of treatment is 7 to 10 days. For prophylactic use in the postpartum period or postoperatively, the duration is typically 3 to 5 days.

Adjust the frequency and duration of application based on the clinical response and the specific indication being treated. Discontinue use if signs of local hypersensitivity appear.

Adverse Reactions

Rarely, allergic reactions, dryness of the oral mucosa are possible.

Contraindications

Hypersensitivity to benzydamine.

Use in Pregnancy and Lactation

There are no contraindications to the topical use of benzydamine during pregnancy and lactation (breastfeeding).

Special Precautions

Long-term use may cause hypersensitivity reactions.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer