Nifuroxazide official instruction. Instructions for use of nifuroxazide for intestinal infections


Pharmachologic effect:

To nifuroxazide most pathogens that cause intestinal diseases are sensitive: salmonella, staphylococcus, enterobacter, coli, Klebsiella, Shigella, Yersinia, Vibrio cholerae. It is inactive only against Pseudomonas and some strains of Proteus.

The drug can act both bacteriostatically and bactericidal, this effect is dose-dependent. Mechanism of action Nifuroxazide based on the inhibition of the activity of the enzyme dehydrogenase and the violation of protein synthesis by bacterial cells. In medium doses, the drug does not suppress the growth of normal intestinal microflora, does not cause the appearance of bacterial strains that are resistant to the action of antimicrobial agents. If the intestinal infection is caused by viruses, Nifuroxazide prevents the addition of a secondary infection.

Nifuroxazide not absorbed in the stomach, thus creating a high concentration active substance in the intestine. Due to the peculiarities of the pharmacokinetics of the drug, it does not have a systemic effect (it enters the blood in small quantities), it is excreted in the feces.

Indications for use

Treatment of diarrhea caused by a drug-sensitive infection;

Complex therapy of chronic colitis and enterocolitis;

Prevention of infections during abdominal operations;

Treatment of intestinal dysbiosis.

Mode of application

Tablets are prescribed for adults and children over 6 years of age. For children under 6 years of age, the use of a suspension is recommended.

The suspension must be thoroughly shaken before use, until a homogeneous mass is obtained. Dosage Nifuroxazide for children depends on age: from 2 to 6 months. - 0.5 -1 tsp (110-220 mg) twice a day, from 6 months. up to 6 years - 1 tsp (220 mg) three times a day, children over 6 years old and adults 1 tsp (220 mg) 4 times a day.

Side effects

The drug usually does not cause side effects, only in rare cases, dyspepsia and even a short-term increase in diarrhea are possible. Side effects do not require treatment or discontinuation of the drug.

In cases of allergic reactions (rash, shortness of breath), the drug should be discontinued.

Contraindications

Hypersensitivity to nitrofuran derivatives or any auxiliary components of the drug Nifuroxazide.

Pregnancy

During pregnancy, the drug can be used only under strict indications and under medical supervision.

Interaction with other drugs

The drug has high adsorption properties, which should be taken into account when taken simultaneously with other drugs.

Interaction systemic drugs impossible, due to the fact that the drug is found in the blood only in trace concentrations.

Overdose

Cases of overdose are unknown. If there has been a significant excess of the therapeutic dose Nifuroxazide, gastric lavage is necessary.

Release form

100 mg film-coated tablets, pack of 24 tablets.

Suspension for oral administration, in a bottle of 90 ml (with an active substance content of 220 mg per 5 ml).

Storage conditions

Store in a dry place, protected from sunlight, at room temperature (17-25 degrees Celsius).

Synonyms

Enterofuril, Lecor.

Compound

Tablets:

Active substance: nifuroxazide 100 mg.

Additional substances: Si dioxide, potato starch, gelatin, talc, Mg stearate, hypromellose, polyethylene glycol, quinoline yellow, Ti dioxide.

Suspension:

Active substance: nifuroxazide 44 mg per 1 ml.

Additional substances: carbomer, sucrose, Na hydroxide, citric acid monohydrate, simethicone, methyl paraben, banana essence, treated water.

Additionally

In the presence of symptoms of septicemia, the drug is not prescribed as monotherapy. If there are symptoms of dehydration, along with antimicrobial therapy, sufficient rehydration therapy is required.

During treatment Nifuroxazide, it is necessary to completely exclude the intake of alcohol, because of the possibility of developing a hypersensitivity reaction with tachycardia, a feeling of fear, redness of the skin, a feeling of heat, dyspepsia, difficulty breathing.

Nifuroxazide does not affect the speed of psychomotor reactions, its use is not a contraindication to working with complex mechanisms or driving vehicles.

Due to the lack of systemic action of the drug, the possibility of it getting into breast milk minimal, which means that it can be used in women during lactation.

main parameters

Name: NIFUROXAZIDE
ATX code: A07AX03 -

The nature of the stool is an important indicator child health. With diarrhea, it is liquid, and from frequent trips to the toilet, the child loses a lot of fluid. At the same time, the digestibility of nutrients in the intestines is disturbed: food does not stay in it for a long time. It interferes with the absorption of vitamins and the harmful microflora that caused it. Antidiarrheals will help in the treatment. For example, Nifuroxazide, which we will talk about now.

Nifuroxazide is mainly used as an intestinal antiseptic.

When is Nifuroxazide prescribed?

Shown Nifuroxazide for children from 2 months with diarrhea, due to various reasons:

  • The predominance of Gram-positive bacteria and some types of Gram-negative bacteria in the intestine (Vibrio cholera, Salmonella, Klebsiella, Shigella, Escherichia coli and Enterobacter).
  • Diseases, a symptom of which is diarrhea:, appendicitis, autoimmune chronic gastritis.
  • Reception.
  • Food poisoning.

Attention! Do not panic if you notice loose stools in a child once, and this has not happened again. Treatment is necessary only in cases where repeated diarrhea occurs during the day.

Additional alarming symptoms may be: nausea and vomiting, fever and bad feeling, weakness.

For prolonged abdominal pain, see a doctor.

Composition and action of the drug

The active component of the intestinal antiseptic is called nifuroxazide (Nifuroxazide). 5 ml of suspension contains 220 mg of this substance. Additionally, the composition includes:

  • sucrose;
  • sodium hydroxide;
  • carboxypolymethylene;
  • distilled water;
  • methyl parahydroxybenzoate;
  • citric acid monohydrate;
  • banana essence (aromatic);
  • emulsion that inhibits foaming (Antifoam F).

A drug not absorbed into the blood and is concentrated only in the gastrointestinal tract. In small and medium doses, Nifuroxazide acts as antibacterial medicine(stops reproduction only harmful bacteria sensitive to the active substance). In high - as a bactericidal agent (completely kills intestinal microflora, including useful).

The medicine is excreted with feces.

The time of action is the first few hours after ingestion. It depends on the dose taken and the condition of the intestine. On average, it is 6-12 hours. The drug is excreted within a few days along with feces.

Christina left a comment:

Nifuroxazide - effective remedy from diarrhea. It quickly eliminates diarrhea, keeping the body's water balance normal. At the end of the course of treatment, the intestines are completely freed from pathogens. But, despite the fact that the drug is practically devoid of side effects before using it, consult your pediatrician.

Alisa Nikitina

Compound medicinal product Nifuroxazide

tab. po 100 mg, № 24 UAH 6.16

Nifuroxazide 100 mg

Other Ingredients: Hydrophilic Aerosil 200, Potato Starch, Gelatin, Talc, Magnesium Stearate, Hydroxypropyl Methylcellulose, Polyethylene Glycol 20,000, Quinoline Yellow Color, Titanium Dioxide.

No. UA/2807/01/01 from 14.03.2005 to 14.03.2010

susp. d/peroral. approx. 220 mg/5 ml vial 90 ml, No. 1 UAH 11.54

Nifuroxazide 4 g/100 g

Other ingredients: carbomer 934, sucrose, sodium hydroxide, citric acid monohydrate, simethicone emulsion 30%, methyl p-hydroxybenzoate, banana essence, purified water.

Dosage form

tablets

Pharmacological properties

Nifuroxazide is an intestinal antiseptic, a derivative of 5-nitrofuran; active against most pathogens of intestinal infections (including mutant strains resistant to other antimicrobial agents): gram-positive (Staphylococcus family) and gram-negative (Enterobacteriaceae family: Escherichia, Citrobacter, Enterobacter, Klebsiella, Salmonella, Shigella, Proteus, Yersinia), and also Vibrio cholerae. It is not active against bacteria of the genus Pseudomonas and the genus Proteus (Proteus inconstans species), as well as strains of subgroup A of the Providentia alcalifaciens species.

It is assumed that the drug inhibits the activity of dehydrogenases and disrupts the synthesis of proteins in pathogenic bacteria. In average therapeutic doses it has bacteriostatic activity, and in higher doses it acts bactericidal. The effect is shown from the first hours of reception. In therapeutic doses, it practically does not disturb the balance of the saprophytic flora of the large intestine; does not cause the development of resistant strains of pathogenic microorganisms and cross-resistance of bacteria to other antimicrobial agents, which allows, if necessary, in case of generalized infections, to prescribe it in complex therapy with systemic drugs. In intestinal infections of viral origin, it prevents the development of bacterial superinfection.

After oral administration, it is practically not absorbed from the gastrointestinal tract, creating a high concentration of the active substance in the intestine. In plasma, trace concentrations of the drug are determined; a small amount is found in the urine unchanged. Due to such pharmacokinetic features, the drug has an exclusively enteral antiseptic effect, does not have systemic antibacterial activity, and does not cause general toxic effects; excreted from the body with feces.

Nifuroxazide - indications for use

acute diarrhea of ​​infectious origin; chronic colitis and enterocolitis of infectious etiology; complex treatment intestinal dysbiosis syndrome; prevention of infectious complications from the gastrointestinal tract with surgical operations.

Contraindications

hypersensitivity to the components and derivatives of 5-nitrofuran; age up to 2 months

Usage Precautions

the drug is not prescribed as monotherapy for the treatment of intestinal infections complicated by septicemia. If there are symptoms of dehydration, in combination with treatment, it is necessary to carry out rehydration therapy (for adults - about 2 liters of fluid per day).

Alcohol increases the body's sensitivity to the drug and can provoke a disulfiram-like reaction, expressed by diarrhea, vomiting, abdominal pain, skin flushing, a feeling of heat on the face and upper body, noise in the head, shortness of breath, tachycardia, a feeling of fear. The use of alcoholic beverages while taking Nifuroxazide is contraindicated.

Nifuroxazide does not affect the psychomotor reactions of the body. Under the supervision of a physician, the drug can be prescribed during pregnancy and lactation. During treatment, you should follow a certain diet: do not eat raw fruits and vegetables, juices, spicy and indigestible foods.

Interaction with drugs

due to the strong adsorption properties of Nifuroxazide, its simultaneous administration with other oral preparations should be avoided.

Since nifuroxazide does not enter the circulatory system, interaction with systemic drugs is unlikely.

Nifuroxazide - method of administration and dosage

Tablets

The drug is taken orally. Adults and children over 6 years of age are prescribed 2 tablets 4 times a day at regular intervals (every 6 hours). The drug is taken regardless of the meal. The course of treatment is 5–7 days. Children under 6 years of age are recommended to prescribe the drug in the form of a suspension.

Suspension

The drug is taken orally. Before use, the vial must be shaken thoroughly until a homogeneous suspension is obtained. 5 ml (1 teaspoon) contains 220 mg of nifuroxazide.

Children aged 2-6 months are prescribed 2.5-5 ml (1/2 - 1 teaspoon) 2 times a day; from 6 months to 6 years, 5 ml (1 teaspoon) 3 times a day; older than 6 years, 5 ml (1 teaspoon) 4 times a day; adults: 5 ml (1 teaspoon) 4 times a day.

Side effects

Nifuroxazide is well tolerated, practically does not show side effects, only occasionally there may be temporary pain in the abdomen, nausea, increased diarrhea. These symptoms do not require discontinuation of the drug.

In isolated cases, individual hypersensitivity to the drug is possible (shortness of breath, skin rashes, itching), which requires discontinuation of the drug.

Overdose

there are no data on overdose symptoms. In case of overdose, gastric lavage and symptomatic treatment are recommended.

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

The drug Nifuroxazide

Nifuroxazideantibacterial drug, intended for the treatment of intestinal infections occurring with diarrhea (diarrhea). Produced in Poland (firm "Polfa"), Germany ("Gedeon Richter") and in Russia.

Many patients ask: Is nifuroxazide an antibiotic or not?

No, Nifuroxazide is not an antibiotic, although it has an antibacterial effect. This is a drug from the group of nitrofurans, sometimes erroneously called " intestinal antibiotic". Nifuroxazide differs from antibiotics in that it does not destructive influence on the normal microflora intestines; is not absorbed from the digestive tract into the blood and is not carried with the bloodstream throughout the body. He purposefully fights pathogenic bacteria, one way or another that has entered the intestines.

Release forms

Nifuroxazide - tablets
Each tablet contains 100 mg of the drug; tablets are covered with a shell of bright yellow color.

Nifuroxazide - suspension 4% for oral administration
Produced in bottles of 125 ml; for ease of dosage, the kit includes a measuring spoon of 2.5 ml or 5 ml. One scoop of suspension per 2.5 ml contains 110 mg of the drug; in a measuring spoon for 5 ml - 220 mg.

Suspension has light yellow color, sweet taste and smell of banana. It is intended mainly for the treatment of children under 6 years of age, but if desired, the suspension can be used by patients of any age.

Before use, the suspension must be shaken so that there is no sediment at the bottom of the vial.

Sometimes a suspension of Nifuroxazide is called a syrup or solution, but this is not correct. The release form of Nifuroxazide syrup does not exist.

Analogues

The drug Nifuroxazide has a number of analogues, i.e. medicines containing the same active substance. Analogues of Nifuroxazide include:
  • Nifuroxazide-Richter (100 mg tablets);
  • Nifuroxazide-Richter (oral suspension);
  • Ecofuril (100 mg capsules and 200 mg capsules);
  • Enterofuril (100 mg capsules, 200 mg capsules and suspension);
  • Ersefuril (200 mg capsules);
  • Lecor (200 mg capsules and suspension);
  • Stopdiar (100 mg tablets).

Nifuroxazide - instructions for use

Indications for use

  • Acute intestinal infections with diarrhea;
  • chronic intestinal infections - colitis and enterocolitis;
  • dysbacteriosis (violation of microflora) of the intestine - as part of complex treatment;
  • prevention of infectious complications during operations on the gastrointestinal tract.

Contraindications

1. Individual hypersensitivity to the drug (allergy).
2. The child is under two months of age.

Dosage and administration

Nifuroxazide is taken orally, without chewing the tablet, but swallowing it whole. Drink clean water. The suspension also needs to be washed down. You can take the medicine both before meals and after - it does not matter. However, between doses you need to observe equal intervals of time.

Nifuroxazide tablets are usually prescribed in the following dosage:
Adults - 2 tablets. 4 times a day (i.e. every 6 hours).


The dosage of the drug for children over 6 years old is the same as for adults.

Suspension of Nifuroxazide is prescribed for adults, one scoop (5 ml) 4 times a day.
Children over 6 years of age receive the same dosage.

The course of treatment is 5-7 days.

special instructions

During the period of treatment with Nifuroxazide, the patient must follow a diet that excludes raw vegetables and fruits, juices, as well as spicy, fatty and indigestible foods. You need to drink plenty of fluids (mineral water, weak unsweetened tea, saline solutions).

It is impossible to drink alcohol during treatment, because. Nifuroxazide in combination with alcohol can cause increased diarrhea, vomiting, abdominal pain, difficulty breathing, increased heart rate, rush of blood to the upper half of the body, a feeling of fear.

Nifuroxazide does not affect the speed of the patient's reactions and the ability to concentrate.

Nifuroxazide - instructions for use for children

Features of the use of the drug in pediatrics

AT pediatric practice Nifuroxazide is widely used and is considered one of the best medicines for the treatment of intestinal infections. A big plus is the fact that Nifuroxazide does not destroy the normal intestinal microflora and, therefore, does not cause the development of dysbacteriosis. The second plus is the rapid action of the drug: healing effect manifests itself in the first few hours after taking the medicine. And of course, it is important to have a child-friendly dosage form- Suspensions with a pleasant taste.

Indications for the use of Nifuroxazide in children

  • Diarrhea (diarrhea) caused by acute intestinal infections;
  • intestinal dysbacteriosis;
  • Prevention of infections during surgical operations on the intestines.
Chronic colitis and enterocolitis in children are rare, but if there is such a pathology, then Nifuroxazide can be used to treat it.

Contraindications

1. Prematurity.
2. Age less than two months.
3. Allergy to the drug.

Dosage

The dosage of Nifuroxazide suspension for children aged 2-6 months is 2.5 ml or 5 ml twice a day (i.e. every 12 hours). The dose is chosen by the doctor individually, depending on the severity of the disease.

For children from 6 months to 6 years, the dosage increases: 5 ml of Nifuroxazide suspension three times a day (every 8 hours).

For children over 6 years of age, the dosage of the drug is the same as for adults: 5 ml of Nifuroxazide suspension four times a day (every 6 hours).

special instructions

In children early age(2 months - 1 year) before starting treatment with Nifuroxazide, it is necessary to exclude congenital disease associated with a lack of enzymes that break down sucrose.

Nifuroxazide during pregnancy

Studies on the use of Nifuroxazide during pregnancy and lactation have not been conducted. AT clinical practice there were no cases of a negative effect of the drug on the development of the fetus. Therefore, treatment with Nifuroxazide in pregnant women is allowed, but only as prescribed by a doctor who evaluates the ratio of the possible benefits of using the drug, with the possible risk of the drug affecting the fetus.

Capsules 100 mg:

Hard gelatin capsules No. 1 cylindrical shape with yellow hemispherical ends.

Capsules 200 mg:

Hard gelatin capsules No. 0 cylindrical shape with yellow hemispherical ends.

Compound

Each capsule contains:

active substance: nifuroxazide - 100 mg or 200 mg;

Excipients: sucrose, magnesium stearate, modified corn starch (Starch 1500).

The composition of the gelatin capsule shell:

Gelatin, titanium dioxide E171, quinoline yellow E104, azorubine E122, crimson
4R E124, purified water.

Release form

Capsules 100 mg, 200 mg.

Pharmacotherapeutic group

Antidiarrheal, anti-inflammatory, antimicrobial agents for the treatment of intestinal infections.

ATX code

Indications for use

Treatment of acute diarrhea of ​​bacterial origin caused by susceptible strains of Staphylococcus spp., Salmonella spp., Escherichia coli in the absence of signs of invasion (for example, worsening general condition, fever, toxic infection, etc.) in addition to rehydration therapy.

The dose and method of rehydration (oral or intravenous) is determined depending on the severity of diarrhea, age, condition of the patient, the presence of concomitant diseases.

Method of application and dosage

Nifuroxazide-LF is taken orally, regardless of food intake, at regular intervals.

Adults - 800 mg (4 capsules of 200 mg or 8 capsules of 100 mg) per day, divided into 4 doses.

Children over 6 years old - 600-800 mg (3-4 capsules of 200 mg or 6-8 capsules of 100 mg) per day, divided into 3-4 doses.

For the treatment of acute diarrhea, the drug must be taken within 3 days. If after this the symptoms of the disease do not disappear, you should consult a doctor.

The duration of taking nifuroxazide should not exceed 7 days.

Side effect

From the hematopoietic and lymphatic system:

One case of granulocytopenia has been described.

From the gastrointestinal tract:

In cases of individual hypersensitivity to nifuroxazide, abdominal pain, nausea and exacerbation of diarrhea may occur. In the event of the appearance of such symptoms of low intensity, there is no need for special therapy or discontinuation of the use of nifuroxazide. With the development of the above symptoms of significant intensity, you should stop taking the medication. In the future, the patient should not take nitrofuran derivatives.

From the skin and subcutaneous tissue:

Perhaps the development of allergic reactions (skin rash, urticaria, Quincke's edema, anaphylactic reactions).

In case of hypersensitivity reactions, such as shortness of breath, swelling of the face, tongue, lips, skin rash, itching, you should immediately stop using the drug.

In case of occurrence adverse reactions, including those not listed in this leaflet, you should stop using the drug and consult a doctor.

Contraindications

  • allergic reactions to derivatives of 5-nitrofuran;
  • hypersensitivity to any of the components of the drug;
  • fructose intolerance, glucose-galactose malabsorption syndrome or sucrase and isomaltase deficiency (due to the presence of sucrose in the preparation).
  • childhood up to 6 years old.

Overdose

Overdose symptoms are not known. In case of exceeding the dose, gastric lavage and symptomatic treatment are recommended.

Use during pregnancy and lactation

The use of nifuroxazide during pregnancy:

There are no clinical data regarding the use of nifuroxazide during pregnancy. Animal studies do not show any direct or indirect effect on the course of pregnancy, the development of the embryo or fetus, the course of childbirth, or the development of the child after childbirth.

Nifuroxazide is preferably not used in pregnant women. Before prescribing the drug, the attending physician should carefully weigh the expected benefits and risks of its use.

The use of nifuroxazide during breastfeeding:

Due to the lack of sufficient clinical data, caution should be exercised when prescribing nifuroxazide to women who are breastfeeding.

Precautionary measures

During treatment with nifuroxazide, the use of alcoholic beverages is contraindicated, because. alcohol increases the body's sensitivity to the drug and can provoke a disulfiram-like reaction, which is expressed by exacerbation of diarrhea, vomiting, abdominal pain, skin flushing, a feeling of heat in the face and upper body, noise in the head, shortness of breath, tachycardia, a feeling of fear.

The drug is not prescribed as monotherapy for the treatment of intestinal infections accompanied by septicemia.

If symptoms of dehydration appear during treatment with the drug, it is necessary, depending on clinical condition patient, conduct rehydration therapy (adults - about 2 liters of fluid per day).

In the event of hypersensitivity reactions, such as shortness of breath, skin rash, itching, the use of the drug should be discontinued.

Nifuroxazide should be used with a strict diet, excluding juices, raw vegetables and fruits, spicy and indigestible foods.

In the case of persistent diarrhea after 3 days of treatment, an in-depth diagnosis should be carried out, the purpose of which is to determine the cause of the symptoms, and consideration should be given to starting antibiotic therapy.

In the case of severe invasive diarrhea, antibiotic therapy is necessary, since nifuroxazide is not absorbed from the gastrointestinal tract.

The ability to influence the reaction rate when driving vehicles or while working with other mechanisms

The drug does not affect the ability to drive a car and work with other mechanisms.

Interaction with other drugs

Drinking alcohol during treatment with nifuroxazide may cause disulfiram-like reactions. While taking nifuroxazide, the simultaneous administration of other oral agents should be avoided due to the strong adsorption properties of the drug.

Storage conditions and shelf life

Store in a place protected from moisture and light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life - 2 years.

Do not use after the expiry date stated on the package.

Package

10 capsules in a blister pack made of PVC film and aluminum foil.

Three blister packs, together with instructions for use, are placed in a pack of cardboard.