Pimafucin® (Tablets, Cream, Suppositories) Instructions for Use
ATC Code
D01AA02 (Natamycin)
Active Substance
Natamycin (Rec.INN registered by WHO)
Clinical-Pharmacological Group
External antifungal drug
Pharmacotherapeutic Group
Antifungal agent
Pharmacological Action
Antifungal polyene antibiotic of the macrolide group, has a broad spectrum of antifungal action. It has a fungicidal effect.
Natamycin binds to sterols in cell membranes, disrupting their integrity and functions, which leads to the death of microorganisms.
Most pathogenic yeasts, especially Candida albicans, are sensitive to natamycin.
Dermatophytes are less sensitive to natamycin.
Resistance to natamycin has not been observed in clinical practice.
Pharmacokinetics
When taken orally, Natamycin is practically not absorbed from the gastrointestinal tract.
When applied to intact skin and mucous membranes, it undergoes practically no systemic absorption.
Indications
Infections of the skin and mucous membranes caused by Candida or other sensitive yeasts, yeast-like fungi, or dermatophytes (including vulvitis, vulvovaginitis, balanoposthitis, otomycoses, dermatomycoses).
ICD codes
| ICD-10 code | Indication |
| B37.2 | Candidiasis of skin and nails |
| B37.3 | Candidiasis of vulva and vagina |
| B37.4 | Candidiasis of other urogenital sites |
| H62.2 | Otitis externa in mycotic diseases |
| N51.2 | Balanitis in diseases classified elsewhere |
| N77.1 | Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere |
| ICD-11 code | Indication |
| 1F23.10 | Candidiasis of vulva and vagina |
| 1F23.11 | Candidal balanoposthitis |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| 1F65 | Enterobiasis |
| 1H0Z | Unspecified infection |
| AA3Y | Other specified otitis externa |
| GB06.0Z | Unspecified balanoposthitis |
| 1A94.0 | Genital or urogenital tract infection caused by Herpes simplex virus |
| GA41 | Ulcerative or erosive diseases of vulva |
| 1F23.1Z | Candidiasis of skin or mucous membranes, unspecified |
| XA5FG3 | Genital region |
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. |
Tablets
The single oral dose is 100 mg.
The frequency of administration for adults is 4 times/day, for children – 2 times/day.
The duration of the treatment course is determined individually.
After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days.
Cream
For external and topical use, apply once or several times a day.
The duration of the treatment course is determined individually.
After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days.
Suppositories
Intravaginally – once/day at night for 3-6 days.
The duration of the treatment course is determined individually.
After the symptoms of the disease disappear, it is recommended to continue treatment for a few more days.
Adverse Reactions
Local reactions mild irritation, burning sensation are possible.
Contraindications
Hypersensitivity to natamycin.
Use in Pregnancy and Lactation
Can be used during pregnancy and lactation according to indications in recommended doses.
Pediatric Use
Natamycin can be prescribed to newborns.
Special Precautions
In case of chronic or recurrent infection, local treatment may be supplemented with systemic administration.
Natamycin can be prescribed to newborns.
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
Enteric-coated tablets, 100 mg: 20 pcs.
Marketing Authorization Holder
Cheplapharm Arzneimittel, GmbH (Germany)
Manufactured By
Haupt Pharma Wulfing, GmbH (Germany)
Dosage Form
 |
Pimafucin® | Enteric-coated tablets, 100 mg: 20 pcs. |
Dosage Form, Packaging, and Composition
Enteric-coated tablets white, round, biconvex.
| 1 tab. | |
| Natamycin | 100 mg |
Excipients : potato starch – 85 mg, povidone K30 – 5 mg, magnesium stearate – 2.5 mg, lactose monohydrate – 66 mg.
Shell composition cellacephate – 18 mg, triacetin – 2.7 mg, sucrose – 122 mg, methylparahydroxybenzoate – 0.07 mg, calcium carbonate – 30 mg, kaolin – 14.2 mg, talc – 21.7 mg, titanium dioxide – 3 mg, acacia gum – 7.3 mg, gelatin – 3.4 mg, Opaglos 6000 – 0.9 mg (yellow carnauba wax – 5%, white beeswax – 5%, shellac – 9.1%, anhydrous ethanol (not present in the finished product) – 80.9%).
20 pcs. – dark glass bottles (1) – cardboard packs with first-opening control (stickers).
Cream for external use 2%: 30 g tube
Marketing Authorization Holder
Cheplapharm Arzneimittel, GmbH (Germany)
Manufactured By
Temmler Italia, S.r.L. (Italy)
Dosage Form
|
Pimafucin® | Cream for external use 2%: 30 g tube |
Dosage Form, Packaging, and Composition
Cream for external use homogeneous, from white to light yellow in color.
| 1 g | |
| Natamycin | 20 mg |
Excipients : cetearyl alcohol – 135 mg, sodium lauryl sulfate – 15 mg, propylene glycol – 150 mg, cetyl ester wax – 50 mg, decyl oleate – 100 mg, methylparahydroxybenzoate – 2 mg, propylparahydroxybenzoate – 1 mg, purified water – up to 1000 mg.
30 g – aluminum tubes (1) – cardboard packs.
Vaginal suppositories 100 mg: 3 or 6 pcs.
Marketing Authorization Holder
Leo Pharma, A/S (Denmark)
Manufactured By
Temmler Italia, S.r.L. (Italy)
Dosage Form
|
Pimafucin® | Vaginal suppositories 100 mg: 3 or 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories torpedo-shaped, from white with a yellowish tint to light yellow with a brownish tint.
| 1 supp. | |
| Natamycin | 100 mg |
Excipients : cetyl alcohol – 690 mg, hard fat – 700 mg, sorbitan trioleate – 460 mg, polysorbate 80 – 460 mg, sodium bicarbonate – 69 mg, adipic acid – 64 mg.
3 pcs. – strips of aluminum foil (1) – cardboard packs.
3 pcs. – strips of aluminum foil (2) – cardboard packs.
![Pimafucin® [Tablets, Cream, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Pimafucin® [Tablets, Cream, Suppositories] 2")