Fungostatin 100,000 U / ml 50 ml 7,5g

The instruction for medical use of FUNGOSTATIN® medicine Trade name ФУНГОСТАТИН® the International unlicensed name Nystatin Dosage Form of the Granule for preparation of suspension for topical administration of 100,000 PIECES/ml 7.5 g / 50 ml Structure One bottle contains active agent – nystatin of 1000 mg (it is calculated taking into account activity of 100,000 PIECES/ml), excipients: avitset CL 611, methylparahydroxybenzoate, propilparagidroksibenzoat, anhydrous citric acid, citrate sodium a dihydrate, Natrium benzoicum, cellulose microcrystalline PH 105, sodium of a kroskarmelloz, sodium saccharin, sucrose, povidone (PVP K30), aerosil 200, banana fragrance, alcohol of 96.6%. The description of the Granule of yellow color with a banana smell. After cultivation, water forms suspension of yellow color with a banana smell. Pharmacotherapeutic group Dental drugs. Antimicrobial drugs for topical treatment of diseases of an oral cavity. The ATX A01AB code the Pharmacological Pharmacokinetics Drug properties is practically not soaked up in an oral cavity and therefore resorptive action is not significant. Nystatin has no cumulative properties. The pharmacodynamics Nistatin is an antifungal antibiotic from group of polyenes. Nystatin renders fungistatic, and in high doses - fungicide action on a pathogenic fungi and, especially, on yeast-like mushrooms of the sort Candida and also on aspergilla. Changes permeability of cellular membranes of mushrooms and slows down their growth. Has a large number of the double bonds causing a high tropnost of substance to styrene formation of a cytoplasmic membrane of mushrooms in structure. Thereof the molecule is built in a cell membrane with formation of a set of the channels promoting uncontrollable transport of water, electrolytes and nonelectrolytes. The cell loses resistance to influence of external osmotic forces and lyses. The tolerance to nystatin of sensitive mushrooms develops very slowly. Concerning bacteria it is inactive. Indications - candidiasis of a mucous membrane of an oral cavity the Route of administration and doses to Newborns and children till 1 year: appoint 2.0 ml (200000 PIECES of nystatin) 4 times a day after feeding. 1 ml of drug is applied on one side of an oral cavity, the remained 1 ml is applied on other party by means of the measured pipette. To the premature or weakened children appoint 1 ml (100000 PIECES of nystatin) 4 times a day after feeding. On 0.5 ml on each side of an oral cavity. To children from 1 year to 6 years – on 4 ml (400000 PIECES of nystatin) 4 times a day after feeding. On 2 ml on each side of an oral cavity. To children 6 years and the adult are more senior: – on 6 ml (600000 PIECES of nystatin) 4 times a day between meals. On 3 ml on each side of an oral cavity. Suspension it is necessary to hold some time in a mouth, without swallowing. The course of therapy makes 7 days. For prevention of a recurrence of a fungal infection, treatment of FUNGOSTATINOM should be continued during 48 h after disappearance of symptoms of a disease and obtaining negative takes of a cultural research. Suspension preparation. To add a small amount of boiled water of room temperature to the bottle containing FUNGOSTATINA granules, it is good to shake up, then to bring suspension volume water to a mark in a bottle. To close a bottle a cover, to shake up within several minutes, to let stand about 20 seconds. The received suspension is ready to the use. Before each use suspension should be shaken up. To apply strictly on doctor's orders. Side effects Seldom - nausea, vomiting, gastrointestinal discomfort, an abdominal pain, diarrhea - irritation and increase in sensitivity of a mucous membrane of an oral cavity - allergic reactions, including skin rash, Stephens-Johnson's syndrome - superinfection mushrooms, resistant to nystatin, Very seldom - tachycardia, a bronchospasm, a hyperthermia, a fever, a face edema, Contraindication muscle pain - hypersensitivity to nystatin or any auxiliary component of drug - an acute liver failure - acute pancreatitis - a peptic ulcer of a stomach and duodenum in an aggravation stage - pregnancy Medicinal interactions At simultaneous use with Clotrimazolum and other antifungal means from group of azoles reduces their efficiency. Strengthening of antifungal effect at FUNGOSTATINA combination with the following drugs is observed: tetracyclines, rifampitsina, polymyxins and levomycetinum. Methylparahydroxybenzoate, propilparagidroksibenzoat which can cause allergic reactions contains the special instructions Drug (including delayed-type hypersensitivity reactions). Considering sucrose content in drug, it is necessary to be careful at use by the patients having diabetes. The lactation period Though nystatin is soaked up in insignificant quantities, it is unknown whether it is allocated with breast milk therefore in need of use in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination. The feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms does not influence. Overdose Symptoms: nausea, vomiting. Treatment: drug withdrawal, symptomatic therapy. The form of release and packing On 7.5 g of a granule place in bottles from dark glass with a tag and corked by the screwing-up polypropylene cover with control of the first opening. 1 bottle together with the measured pipette and the instruction for medical use in the state and Russian languages is placed in a cardboard pack. Storage conditions In the dry place protected from light, at a temperature not over 25 ºС. To store out of children's reach! Storage after preparation of suspension In the fridge at a temperature from 2 ° up to 8 °C. A period of storage 4 years the Period of use of the prepared suspension no more than 10 days. Prescription status According to the prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Phone number: (+7 727) 399-50-50 Fax number: (+7 727) 399-60-60 E-mail address of nobel@nobel.kz