Composition, form of production and packaging
? The tablets covered with an enteric coating of white or almost white color are round.
1 tab.
natamycin 100 mg
Auxiliary substances: potato starch - 79.2 mg, povidone K30 - 5 mg, magnesium stearate - 2.5 mg, lactose monohydrate - 66 mg.
The composition of the coating: 18 mg, triacetin 2.7 mg, sucrose 122 mg, methyl parahydroxybenzoate 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 - 3.3 mg, beeswax white - 0.13 mg.
20 pcs. - bottles of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Antifungal polyene (tetraene) antibiotic from the group of macrolides. It has a predominantly fungicidal effect. Natamycin irreversibly binds to the ergosterol of the cell membrane of the fungal cell, which leads to a violation of its integrity, loss of cytoplasm and cell death.
Most pathogenic yeast and mold fungi are sensitive to natamycin, including the genera Candida, Aspergillus, Cephalosporium, Fusarium and Penicillium. Less sensitive to natamycin are dermatophytes and Pseudoallescheria boydii. No cases of resistance to natamycin were observed in clinical practice.
Natamycin in the dosage form of the tablet, covered with an enteric coating, acts only in the lumen of the intestine.
PHARMACOKINETICS
When administered orally, natamycin is not practically absorbed from the digestive tract and does not have a systemic effect.
INDICATIONS
- Candidiasis of the intestine;
- Acute pseudomembranous and acute atrophic candidiasis in patients with cachexia, immune deficiency, and also after therapy with antibiotics, corticosteroids, cytostatics;
- sanitation of the intestinal reservoir of fungi of the genus Candida with candidiasis of the skin and mucous membranes, incl. with candidal vaginitis, vulvitis and vulvovaginitis.
DOSING MODE
The drug is taken orally. Eating does not affect the effectiveness of the drug.
When candidiasis of the intestine, adults are recommended to take 100 mg (1 tab.) 4 times / day, children - 100 mg (1 tab.) 2 times / day. The average duration of the course of treatment is 1 week.
With persistent flow of vaginitis caused by fungi of the genus Candida , together with local antifungal drugs (for example, suppositories of Pimafucin В® ) for the sanation of the focus of candidiasis infection in the intestine use Pimafucin В® tablets (inside 100 mg (1 tab.) 4 times / day for 10-20 days).
The duration of the course of treatment is set individually. After the disappearance of the symptoms of the disease is recommended to continue treatment a few more days.
SIDE EFFECT
On the part of the digestive system: nausea, diarrhea (arising during the first days of taking the drug and going on independently during the treatment) are possible.
The patient should be warned that if any of the side effects listed in the manual are aggravated or he has noticed any other side effects not listed in the instructions, you should inform the doctor about it.
CONTRAINDICATIONS
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Possible use of Pimafucin during pregnancy and lactation.
APPLICATION FOR CHILDREN
Pimafucin В® in this dosage form is not recommended for use in infants due to possible difficulty in swallowing tablets.
Children are prescribed 100 mg (1 tab.) 2 times / day.
SPECIAL INSTRUCTIONS
Patients with a rare congenital intolerance to galactose, fructose, lactase deficiency lapp, glucose-galactose malabsorption, or sucrose-isomaltase deficiency must take into account that the preparation contains lactose monohydrate (66 mg) and sucrose (122 mg). If the patient suffers from one of the listed diseases, before taking pimafucin В® tablets, it is absolutely necessary to consult a doctor.
Pimafucin В® in this dosage form is not recommended for use in infants due to possible difficulty in swallowing tablets.
Impact on the ability to drive vehicles and manage mechanisms
Pimafucin В® does not affect the ability to drive vehicles and mechanisms.
OVERDOSE
At present, no cases of an overdose of PimafucinВ® have been reported.
DRUG INTERACTION
Drug interaction of the drug Pimafucin В® with other medicinal products was not detected.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of no higher than 25 В° C. Shelf life - 4 years.
