Active ingredients: Cyclopyroxolamine
DAFNEGIN® 0.2% Vaginal Solution
Dafnegin package inserts are available for pack sizes:- DAFNEGIN® 0.2% Vaginal Solution
- DAFNEGIN® 1% Vaginal Cream, DAFNEGIN® 100 mg Vaginal Ovules
Why is Dafnegin used? What is it for?
Pharmacotherapeutic group
Antifungal and antibacterial
Therapeutic indications
Adjuvant in the therapy of vulvo-vaginal infections caused by Candida; it can also be used after other vaginal therapy, in order to reduce the risk of relapse.
Contraindications When Dafnegin should not be used
Known individual hypersensitivity to the drug.
Precautions for use What you need to know before taking Dafnegin
It is advisable for the patient to practice irrigation in a lying or semi-sitting position trying to keep the solution in the vagina for a few minutes. In intravaginal applications there is practically no systemic absorption of the preparation. However, as with most drugs, the use of the drug in pregnancy should only take place following a rigorous choice of indications, under direct medical supervision. The use, especially if prolonged, of drugs for vaginal use can give rise to sensitization phenomena. In this case it is necessary to suspend the treatment and adopt suitable therapeutic measures.
Warnings It is important to know that:
To prevent reinfection, your partner should also undergo medical supervision.
During pregnancy, the drug should be administered in cases of real need and under the direct supervision of the doctor.
Dose, Method and Time of Administration How to use Dafnegin: Posology
Apply the vaginal solution daily, preferably in the morning, for a period of five days, using the entire bottle with the following methods of use:
- Hold the bottle by the ring and fold the cap until the safety seal breaks
- Extract the cannula until it stops in order to hear the click of the correct position
- Introduce the cannula into the vagina and press the walls of the bottle in order to allow it to be completely emptied.
It is suggested to perform the irrigation operation in a relaxed position and slowly.
Side Effects What are the side effects of Dafnegin
Dafnegin vaginal solution is generally well tolerated, however rare cases of itching, burning or local irritation have been reported.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
It is important to inform the doctor or pharmacist of the appearance of undesirable effects, even those not described in the package leaflet.
Expiry and Retention
Do not use the medicine after the expiry date indicated on the package. This date refers to the intact product correctly stored.
Other information
Composition
100 ml of vaginal solution contain: ciclopiroxolamine 200 mg.
Excipients: polyethylene glycol 300; polyglycollum; undebenzophene; polysorbate 20; lactic acid; rose perfume; purified water.
Pharmaceutical form and content
vaginal solution - 5 bottles with 150 ml cannula
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
DAFNEGIN 0.2% VAGINAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of vaginal solution contains 200 mg ciclopiroxolamine.
03.0 PHARMACEUTICAL FORM
Vaginal solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adjuvant in the therapy of vulvo-vaginal infections from Candida; it can also be used after other topical therapy, in order to reduce the risk of relapses.
04.2 Posology and method of administration
Apply the vaginal solution daily, preferably in the morning, for a period of 5 days, using the entire bottle with the following methods of use:
A) Hold the bottle by the ring and fold the cap until the safety seal breaks.
B) Extract the cannula until it stops in order to hear the click of the correct positioning.
C) Introduce the cannula into the vagina and press the walls of the bottle in order to allow it to be completely emptied.
It is suggested to perform the irrigation operation in a relaxed position and slowly.
04.3 Contraindications
Known individual hypersensitivity to the drug.
04.4 Special warnings and appropriate precautions for use
To prevent reinfection, it would be advisable for the partner to also undergo medical supervision.
It is advisable for the patient to practice irrigation in a lying or semi-sitting position trying to keep the solution in the vagina for a few minutes. The use, especially if prolonged, of topical drugs can give rise to sensitization phenomena. In this case it is necessary to suspend the treatment and adopt suitable therapeutic measures.
04.5 Interactions with other medicinal products and other forms of interaction
They are not known
04.6 Pregnancy and breastfeeding
In intravaginal applications there is practically no systemic absorption of the preparation. However, as with most drugs, use during pregnancy should only take place following a rigorous choice of indications, under direct medical supervision.
04.7 Effects on ability to drive and use machines
No adverse effects are reported.
04.8 Undesirable effects
Rarely itching, burning or local irritation.
04.9 Overdose
Given the pharmacological characteristics, there is no risk of overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Dafnegin contains ciclopiroxolamine, the progenitor of a new class of antifungal drugs: oxopyridines.
It also possesses a peculiar mechanism of action and a broad antibacterial spectrum. Dafnegin therefore determines a certain negativization of the microbiological picture and a rapid resolution of symptoms.
Dafnegin single-use vaginal solution is formulated appropriately in order to allow medicated cleansing of the vulvo-vaginal mucosa, in particular as an adjunct to the therapy practiced with cream preparations and vaginal ovules or when it is deemed appropriate to prolong the effects in order to reduce the risk of relapse. .
Finally, Dafnegin proved to be endowed with a high degree of tolerability.
Microbiological properties
Dafnegin, a synthetic antifungal with a broad spectrum of antimicrobial activity, inhibits the growth of most pathogenic fungi, including dermatophytes and Candida albicans and of Gram-positive and Gram-negative bacteria. The minimum inhibitory concentration (MIC) for dermatophytes and Candida species ranges from 0.5 to 4 mcg / ml. MICs are little affected by protein addition, inoculum size and incubation period. On the basis of studies on the mechanism of action of the product, mainly in Candida albicans, the activity of cyclopyroxolamine is to be attributed to an inhibition of the absorption of precursors of macromolecule synthesis from the culture medium. In experimental infections cyclopyroxolamine has shown a high level of therapeutic efficacy.
05.2 Pharmacokinetic properties
After oral administration, absorption is about 75% of the ingested dose. The absorbed portion is eliminated mainly via the kidney in the form of derivatives of glucuroconjugation.
For topical administration, cyclopyroxolamine has an extremely reduced systemic absorption with the achievement of practically negligible plasma levels.
05.3 Preclinical safety data
The LD50 in rats and mice is greater than 2000 mg / kg orally. Oral administration to rats for 4 weeks was well tolerated at doses up to 30 mg / kg. There were no manifestations of toxicity in vaginal treatment at doses of 12.5 mg / kg for approximately 3 months. Administration to rats and rabbits did not show teratogenic effects, nor did it affect fertility and reproductive capacity. There are no mutagenic effects. IV administration did not affect cardiovascular and respiratory function in the various species treated.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polyethylene glycol 300, polyglycol, undebenzophene, polysorbate 20, lactic acid, rose perfume, purified water.
06.2 Incompatibility
Not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
No particular precautions: normal storage conditions at room temperature.
06.5 Nature of the immediate packaging and contents of the package
Polyethylene bottles with incorporated applicator cannula - Box of 5 bottles of 150 ml
06.6 Instructions for use and handling
See Paragr. 4.2
07.0 MARKETING AUTHORIZATION HOLDER
Costanzafarma S.r.l. Via Taranto, 4 - 20142 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC 025217136
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
1 September 1989/31 May 2005
10.0 DATE OF REVISION OF THE TEXT
August 2012
