Ersefuril - instructions for use, dose, side effects, contraindications

body: gelatin - up to 100%, titanium dioxide (E171) - 2.0%, iron oxide dye Yellow (E172) - 0.6286%; lid: gelatin - up to 100%, titanium dioxide (E171) - 2.0%, dye iron oxide yellow (El72)-0,6286 %.

Description:

Hard gelatin capsules No. 1, consisting of a yellow body and

The lids are yellow. The contents of the capsules are a yellow powder.

Pharmacotherapeutic group:Antimicrobial agent, nitrofuran.

ATX: & nbsp

A.07.A.X.03 Nifuroxazide

Pharmacodynamics:

Like other nitrofurans, nifuroxazide blocks some oxidation-reduction enzyme reactions in cells of microorganisms. When used in tTherapeutic doses have a bacteriostatic effect in high doses - bactericidal. Highly active in relation to Campylobacter jejuni, Escherichia coli, Salmonella spp, Shigella spp; Clostridium perfringens, Vibrio cholerae, pathogenic Vibrions and Vibrio parahaemolytique, Staphylococcus spp.

Weakly sensitive to nifuroxazide: Citrobacter spp, Enterobacter cloacae and Proteus indologenes.

Resistant to nifuroxazide: Klebsiella spp, Proteus mirabilis, Providencia spp., Pseudomonas spp.

He influences on saprophyte flora (does not cause dysbiosis). Resistance of microorganisms to the drug does not develop.

Pharmacokinetics:Nifuroxazide is practically not absorbed from the gastrointestinal tract, 99% of the dose taken remains in the intestine and exerts its antimicrobial effect there. Nifuroxazide is excreted by the intestine: 20% unchanged, and the rest of the nifuroxazide is chemically altered.

Indications:Acute bacterial diarrhea that occurs without deterioration in the general condition, fever, intoxication (in addition to adequate severity of rehydration diarrhea by taking fluid and electrolytes inside or, if necessary, their intravenous administration).

Contraindications:

- Hypersensitivity to nitrofuran derivatives or any excipients of the drug.

- Children under 6 years.

- Pregnancy.

- Fructose intolerance, glucose-galactose malabsorption syndrome or

insufficiency of sugar and isomaltase (due to the presence of sucrose in the formulation).

Pregnancy and lactation:Pregnancy

In animal studies, nifuroxazide had no teratogenic effect. However, as a precautionary measure, nifuroxazide during pregnancy, is not recommended (insufficient clinical experience in pregnancy).

Lactation period

During the lactation period, it is possible to continue breastfeeding in the case of a short course of treatment with the drug.

Dosing and Administration:The drug is intended only for oral administration by adults or children over the age of 6 years.

Adults: 4 capsules (800 mg) per day, divided into 2-4 admission.

Children older than 6 years: 3-4 capsules (600-800 mg) per day, divided into 2-4 admission.

Duration of treatment: not more than 7 days.

Side effects:

Allergic reactions, such as skin rashes, hives, Quincke's edema, anaphylactic shock.

Overdose:

No data.

Interaction:No data.

Special instructions:

In the case of bacterial diarrhea with signs of systemic damage (worsening of the general conditions, fever, symptoms of intoxication, or infection) should use antibacterial drugs with good systemic diffusion.

In the case of pronounced prolonged diarrhea, severe vomiting or refusal to eat should consider the introduction of intravenous fluid and electrolytes for rehydration.

If the diarrhea persists over the course of treatment for more than 2 days, treatment should be reviewed and consider the need to take liquids and electrolytes inwards or their intravenous administration. The volume of injected liquid and the method of its introduction (inside, in / in)should correspond to the severity of diarrhea, age and clinical status patient.

Effect on the ability to drive transp. cf. and fur:

A drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities.

Form release / dosage:

Capsules 200 mg.

Packaging:

For 14 capsules in PVC / aluminum foil blisters.

For 1 or 2 blisters together with instructions for use in a cardboard box.

Storage conditions:Store in a dry place at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life:5 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N012447 / 01

Date of registration:12.08.2011

The owner of the registration certificate:Sanofi-Aventis FranceSanofi-Aventis France France

Manufacturer: & nbsp

SANOFI WINTHROP INDUSTRIE France

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp30.07.2015

Illustrated instructions

Instructions

Ersefuril® (Ercefuryl®)