Description
Latin name
Tantum Rosa
Release form
Powder for preparation 3rd solution srdld powder4 .
Packaging
In a sachet of paper and polypropylene 9.44 g of powder. The package contains 10 sachets.
Pharmacological action
Pharmacotherapeutic group: non-steroidal drug . ATX code: GO2SSOZ
Pharmacological action:
Benzidamine is a non-steroidal anti-inflammatory drug that belongs to the group of indazoles. It has anti-inflammatory and local anesthetic effects, has antibacterial, antifungal and antiseptic effects. The mechanism of action of the drug is associated with stabilization of cell membranes and inhibition of prostaglandin synthesis.
Benzidamine has an antibacterial and specific antimicrobial effect due to the rapid penetration of microorganisms through the membranes, followed by damage to cellular structures, metabolic processes and cell lysosomes.
Has antifungal activity against Candida alYcans. It causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzidamine in inflammatory processes, including infectious etiology.
Pharmacokinetics:
When applied topically, the drug is well absorbed through the mucous membranes and penetrates into the inflamed tissue.
Excretion of the drug occurs mainly by the kidneys and through the intestines 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 (in complex therapy)
non-specific vulvovaginitis and cervicovaginitis of any etiology, including secondary to chemotherapy and radiotherapy
bacterial vaginosis
prevention of postoperative infectious complications in surgical gynecology.
Contraindications
Hypersensitivity to any of the components of the drug.
Use during pregnancy and lactation
There are no contraindications to the local use of the drug Tantum ® Rosa during pregnancy and lactation (breast-feeding).
Composition
For one sachet of powder for the preparation of a vaginal solution 500 mg:
The active ingredient is benzidamine hydrochloride – 0.500 g.
Auxiliary components:
trimethylacetyl ammonium para-toluenesulfonate,
povidone,
sodium chloride.
Dosage and Administration
Intravaginally.
Powder for the preparation of a solution of vaginal 500 mg – the contents of 1 sachet are dissolved in 500 ml of boiled water. For single douching use 140 ml of the resulting solution. The prepared solution can be stored up to 5 days at room temperature. With repeated use, the solution must be heated to body temperature.
The douching procedure should be carried out lying down, the fluid should remain in the vagina for several minutes.
– in the postpartum period as a therapeutic and prophylactic agent to accelerate the process of rehabilitation and prevention of postpartum infectious complications: vaginal irrigation 1 time per day for 3 to 5 days,
– for bacterial vaginosis: vaginal irrigation 1 to 2 times per day 7-lOne.
– for non-specific vulvovaginitis and cervicovaginitis of any etiology, including secondary ones developed during chemotherapy and radiotherapy: 2 times a day for at least 1 day
– for specific vulvovaginitis, as part of complex therapy: 2 times a day 3-5 days
– prevention of pre- and postoperative complications in operative gynecology: 1 time per day for 3-5 days.
Side effects
In rare cases, allergic reactions, dry mucous membranes are possible the shell of the oral cavity.
Drug Interaction
No clinically relevant interaction of Tantum ® Rose with other medicinal products has been established.
Overdose
There have been no reports of overdoses with Tantum ® Rose.
Storage conditions
Store at a temperature not exceeding 25 ° C, in a dark place.
Expiration
5 years.
Prescribing
Prescribing
, For women, Nursing as prescribed by the doctor Adults
Asiende Kimike Riunite Angelini Francesco A.K.P.A., Italy