Dafnegin (Cream, Suppositories) Instructions for Use
ATC Code
G01AX12 (Ciclopirox)
Active Substance
Ciclopirox (Rec.INN registered by WHO)
Clinical-Pharmacological Group
A drug with antifungal action for topical use in gynecology
Pharmacotherapeutic Group
Antifungal agent
Pharmacological Action
Broad-spectrum antifungal agent. It has a bacteriostatic effect.
It is active against dermatophytes, yeast-like, mold and other types of fungi, as well as against some strains of gram-negative and gram-positive bacteria.
Indications
- Treatment of diseases of the nails, skin, and vagina caused by pathogens sensitive to ciclopirox.
- Prevention of fungal infections.
Apply externally and topically for these conditions.
ICD codes
| ICD-10 code | Indication |
| B35.2 | Mycosis of hands |
| B35.3 | Tinea pedis |
| B35.4 | Tinea corporis |
| B37.2 | Candidiasis of skin and nails |
| B37.3 | Candidiasis of vulva and vagina |
| N77.1 | Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere |
| Z29.8 | Other specified prophylactic measures |
| ICD-11 code | Indication |
| 1F23.10 | Candidiasis of vulva and vagina |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| 1F28.2 | Dermatophytosis of foot |
| 1F28.Y | Other specified dermatophytosis |
| 1F65 | Enterobiasis |
| 1H0Z | Unspecified infection |
| QC05.Z | Prophylactic measures, unspecified |
| 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. |
Apply externally and topically. Set the regimen individually based on the indication, patient age, and specific dosage form (cream or suppository).
Follow the specific application frequency and duration as directed for the treated condition, such as vulvovaginal candidiasis or cutaneous mycosis.
Cream, Suppositories
It is used externally and topically. The dosage regimen is set individually, depending on the indications, the age of the patient and the dosage form used.
Adverse Reactions
The following local reactions are possible: allergic reactions, hyperemia, swelling, and itching at the application site.
When used for onychomycosis, observe for discoloration of the nail and redness or peeling of the periungual skin.
Contraindications
- Hypersensitivity to ciclopirox or any component of the formulation.
- Pregnancy and the period of breastfeeding.
- Childhood – contraindication depends on the specific dosage form; verify age restrictions for the product.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and during breastfeeding.
Pediatric Use
It can be used in children of the appropriate age categories strictly according to the indications, in the recommended doses and dosage forms.
It is necessary to strictly follow the instructions in the instructions for ciclopirox drugs on contraindications for the use of specific dosage forms of ciclopirox in children of different ages.
Special Precautions
In case of fungal infections of the vagina, simultaneous treatment of sexual partners is recommended.
During the treatment of onychomycosis, it is not recommended to use cosmetic nail polishes.
Avoid contact of the product with the eyes.
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Vaginal cream 1%: tube 78 g in a set with applicators
Marketing Authorization Holder
Polichem S.r.L. (Italy)
Manufactured By
Doppel Farmaceutici, S.r.l. (Italy)
Dosage Form
 |
Dafnegin | Vaginal cream 1%: tube 78 g in a set with applicators |
Dosage Form, Packaging, and Composition
Vaginal cream 1%, homogeneous, from white to cream color (ivory).
| 100 g | |
| Ciclopirox olamine | 1 g |
Excipients: 2-octyldodecanol, petrolatum oil, cetyl alcohol, stearyl alcohol, myristyl alcohol, coconut fatty acid diethanolamide, polysorbate 60, sorbitan monostearate, benzyl alcohol, lactic acid, purified water.
78 g – aluminum tubes (1) in a set with applicators (14 pcs.) – cardboard packs.
Vaginal suppositories 100 mg: 6 pcs. with finger cots
Marketing Authorization Holder
Polichem S.r.L. (Italy)
Manufactured By
Doppel Farmaceutici, S.r.l. (Italy)
Dosage Form
|
Dafnegin | Vaginal suppositories 100 mg: 6 pcs. with finger cots |
Dosage Form, Packaging, and Composition
Vaginal suppositories of oval shape, cream color (ivory).
| 1 supp. | |
| Ciclopirox olamine | 100 mg |
Excipients: benzoic acid, glyceryl monoricinoleate, Novata A mass, Novata C mass.
6 pcs. – blisters (1) in a set with finger cots (6 pcs.) – cardboard packs.
![Dafnegin [Cream, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Dafnegin [Cream, Suppositories] 2")