the International non-proprietary name Nifuroksazid Lekarstvennaya a form
of the Capsule of 200 mg
One capsule contains
active agent – nifuroksazid 200.00 mg,
excipients: corn starch, sucrose, magnesium stearate,
structure of a gelatin capsule: titan dioxide (E 171), gland (III) oxide yellow (E 172), gelatin.
of the Capsule of yellow color of oblong shape of No. in size 1. Contents of capsules – powder of yellow color.
Antidiarrheal drugs. Other intestinal antimicrobial drugs. Nifuroksazid.
The ATX A07AX03 code
Pharmacokinetics At properties to the uninjured mucous membrane of intestines absorption of drug is extremely low.
Ersefuril belongs to the nitrofuran derivatives containing nitrogroup (NO2) which possesses antiseptic action. The radical of NO2 can be restored to nitrozo-derivatives which change the bases of bacterial DNA. All these derivatives possess bacteriostatic and bactericidal action.
Ersefuril has the braking impact on activity of dehydrogenases and protein synthesis in bacterial cells mostly in an intestines gleam. Ersefuril does not cause resistance of bacterial strains, does not oppress saprophytic flora of intestines which represents the first protective barrier of digestive tract against pathogenic microorganisms.
By clinical trials it was established what nifuroksazid does not raise population of resistant bacteria in intestines and barmy mushrooms in comparison with an antibiotic (for example, reception of Neomycinum of 7 days).
Other clinical trials showed what nifuroksazid does not influence fecal flora at healthy subjects, as after use of a high dose (1200 mg), and at usual therapeutic doses (800 mg/days within 6 days).
Activity of a nifuroksazid concerning some strains:
very sensitive group the minimum inhibiting concentration (MIC & lt, 8 mg/l): Campylobacter, Vibrio cholerae, Shigella Clostridium perfrigers, srednechuvstvitelny group (MIC & lt, from 8 to 32 mg/l): Escherichia coli, Salmonella, Haffnia, Yersinia, Staphylococcus, Enterococcus, resistant group (MIC & gt, 32 mg/l): Klebsiella, Enterobacter, Serratia, Proteus mirabillis, Providentia, Pseudomonas, Acinetobacter.
– acute bacterial diarrhea if there is no suspicion on spread of an infection to other bodies and systems (i.e. deteriorations in the general state, temperature increase, symptoms of intoxication)
This therapy does not replace a diet and rehydration at their need.
The route of administration and doses
is recommended to Adults the daily dose of 800 mg divided into 2-4 receptions regardless of meal, for example, on 1 capsule (200 mg) 4 times a day or on 2 capsules (400 mg) 2 times a day
to Teenagers are more senior than 15 years up to 18 years the daily dose of 600 – 800 mg divided into 2-4 receptions regardless of meal, for example, on 1 capsule (200 mg) 3-4 times for about a day on 2 capsules (400 mg) 2 times a day is recommended.
The maximum daily dose for adults and teenagers of 800 mg. Duration of a course of treatment – 3 days. If within 2 days of treatment the diarrhea does not stop, it is necessary to reconsider therapeutic approach.
– allergic reactions: skin rashes, urticaria, a Quincke’s edema, an acute anaphylaxis
of the Contraindication
– hypersensitivity to nitrofuran derivatives, or to any of drug components
– children’s and teenage age up to 15 years (in connection with risk of hit in airways)
– intolerance of fructose, a glucose galactose sprue, deficiency of invertase-isomaltase
– pregnancy and the period of a lactation
Ersefuril is not recommended to apply Medicinal interactions in a combination with the drugs leading to disulfiramopodobny reactions or with depressants of the central nervous system.
If against the background of treatment the diarrhea remains more than 3 days, it is necessary to reconsider treatment.
Need and volume of oral or infusional rehydration therapy is defined according to weight of diarrhea, age and a condition of the patient (including associated diseases).
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
does not influence.
Data on overdose of a nifuroksazid are absent.
In case of overdose it is necessary to control a condition of the patient and to carry out symptomatic therapy.
A form of release and packing
On 14 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 1 or 2 blister strip packaging together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
At a temperature not higher than 30C.
To store out of children’s reach!
Not to apply a period of storage of 5 years after the expiration date specified on packing.
the Producer Sanofi Vintrop the Industry, France for Sanofi-Aventis France, France