Nifuroxazide lf 200 instructions for use. Nifuroxazide tablets and suspensions - instructions for use, analogues. Special instructions for treatment with Nifuroxazide

Nifuroxazide is a drug with antibacterial and bactericidal action. The drug is prescribed to patients with intestinal infections complicated by the presence of diarrhea (diarrhea). The drug is produced in three countries: Poland, Russia and Germany.

According to doctors, Nifuroxazide is not an antibiotic, despite its antibacterial effect. The drug is a nitrofuran and has a targeted effect on pathogenic bacteria that have entered the intestines in one way or another.

Unlike antibiotics, the drug does not affect the normal microflora, does not spread throughout the body through the bloodstream, and is not absorbed into the blood from the digestive tract.

1. Instructions for use

pharmachologic effect

Most microorganisms that cause intestinal diseases (staphylococcus, E. coli, Shigella, Vibrio cholerae, Salmonella, Enterobacter, Klebsiella, Yersinia) are sensitive to nifuroxazide. But it is worth noting that this substance is inactive against some strains of Proteus and pseudomonads.

The drug can act both bactericidal and bacteriostatic (the effect is dose-dependent). When using Nifuroxazide, the synthesis of proteins by pathogen cells is disrupted, and the activity of the dehydrogenase enzyme is inhibited.

When the drug was prescribed in medium doses, neither the emergence of strains resistant to antimicrobial drugs nor the suppression of the growth of normal intestinal microflora was observed. For intestinal infections caused by viruses, Nifuroxazide prevents the addition of a secondary infection.

The drug is not absorbed in the stomach and creates a high concentration of the active component in the intestines. The pharmacokinetics of Nifuroxazide are such that it does not have a systemic effect (it enters the blood in small quantities) and is excreted in the feces.

Indications for use

Nifuroxazide is prescribed to people suffering from:

The drug is also used to prevent infections during abdominal operations.

Mode of application

All dosage forms of Nifuroxazide are intended for oral use.

Pills

Children over six and adults are prescribed 2 tablets of the drug (200 mg) four times a day (no matter before or after meals). The interval between two “adjacent” doses should be about 6 hours.

Duration of therapy is 5-7 days. If the child is not yet six years old, the medicine in the form of a suspension is used for his treatment.

Suspension

The dosage is determined by the patient's age:

• babies from 2 to 6 months: 2.5 or 5 ml twice a day;
• children from 6 months to 6 years: 5 ml three times a day every 8 hours;
• adults, children over 6: 5 ml (one scoop) four times a day every 6 hours.

Note: Before use, shake the suspension thoroughly until a homogeneous mass is obtained.

Pharmachologic effect:

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

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

Nifuroxazide is not absorbed in the stomach, thereby creating a high concentration of the active substance in the intestine. Due to the pharmacokinetics of the drug, it does not have a systemic effect (it enters the blood in small quantities) and 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 to adults and children over 6 years of age. For children under 6 years of age, the use of a suspension is recommended.

Before use, the suspension must be thoroughly shaken 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 old - 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

Usually the drug 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 according to strict indications and under the supervision of a doctor.

Interaction with other drugs

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

Interaction with systemic drugs is 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 is a significant excess of the therapeutic dose Nifuroxazide, gastric lavage is necessary.

Release form

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

Suspension for oral use, in a 90 ml bottle (containing active substance 220 mg per 5 ml).

Storage conditions

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

Synonyms

Enterofuril, Lekor.

Compound

Pills:

Active substance: nifuroxazide 100 mg.

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

Suspension:

Active substance: nifuroxazide 44 mg per 1 ml.

Additional substances: carbomer, sucrose, Na hydroxide, citric acid monohydrate, simethicone, methylparaben, banana essence, prepared water.

Additionally

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

During treatment Nifuroxazide, it is necessary to completely eliminate alcohol intake, due to the possibility of developing a hypersensitivity reaction with tachycardia, a feeling of fear, redness of the skin, a feeling of heat, dyspepsia, and 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 passing into breast milk is minimal, which means it can be used in women during lactation.

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NIFUROXAZIDUM RICHTER

NIFUROXAZIDUM A07A X03 Gedeon Richter

COMPOSITION AND FORM OF RELEASE NIFUROXAZIDE RICHTER:

table p/o 100 mg, no. 24
Nifuroxazide 100 mg

Other ingredients: anhydrous colloidal silicon dioxide, potato starch, gelatin, talc, magnesium stearate, hypromellose, polyethylene glycol, yellow quinoline E 104, titanium dioxide (E171).

No. UA/9060/01/01 from 12/30/2009 to 12/30/2014

susp. d/oral. approx. 220 mg/5 ml vial. 90 ml, with measuring spoon, no. 1
Nifuroxazide 220 mg/5 ml

Other ingredients: carbomer 934, sucrose, sodium hydroxide, citric acid monohydrate, simethicone, methylparaben, banana essence, purified water.

No. UA/9060/02/01 from 08.11.2010 to 08.11.2015

PHARMACOLOGICAL PROPERTIES OF NIFUROXAZIDE RICHTER:

pharmacodynamics. 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). Shows a local antibacterial effect in the intestinal lumen against some types of gram-positive bacteria from the Staphylococcus family and some types of gram-negative bacteria from the Enterobacteriaceae family: Yersinia spp., Escherichia spp., Citrobacter spp., Enterobacter spp., Klebsiella spp., Salmonella spp.
Nifuroxazide does not have an antibacterial effect on bacteria of the species Proteus vulgaris, Proteus mirabilis and Pseudomonas aeruginosa.
It is assumed that the drug Nifuroxazide Richter inhibits the activity of dehydrogenases and disrupts protein synthesis in pathogenic bacteria. At moderate therapeutic doses it has bacteriostatic activity, and at higher doses it has a bactericidal effect. The effect appears from the first hours of administration. In therapeutic doses, it practically does not disturb the balance of the saprophytic bacterial 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 the case of generalized infections, to prescribe it in complex therapy with systemic antibacterial drugs. In case of intestinal infections of viral origin, it prevents the development of bacterial superinfection. The effectiveness of the drug does not depend on the pH in the intestinal lumen.
Pharmacokinetics. After oral administration, it is practically not absorbed into the gastrointestinal tract, creating a high concentration of the active substance in the intestine. Due to its pharmacokinetic properties, the drug has an exclusively enteral antiseptic effect, does not have systemic antibacterial activity, and does not cause general toxic effects; excreted unchanged from the body in feces.

INDICATIONS FOR NIFUROXAZIDE RICHTER:

acute and chronic diarrhea of ​​infectious origin.

APPLICATION OF NIFUROXAZIDE RICHTER:

pills NIFUROXAZIDE RICHTER
Adults and children over 7 years of age are prescribed 2 tablets of Nifuroxazide Richter 4 times a day (every 6 hours). The drug is taken orally with a small amount of water, regardless of meals. The duration of treatment is no more than 7 days.
During the treatment of acute diarrhea, constant oral or intravenous replenishment of fluid deficiency in the body is mandatory, depending on the general condition of the patient.
Suspension NIFUROXAZIDE RICHTER
The drug Nifuroxazide Richter is taken orally. Before use, the bottle of suspension must be shaken thoroughly. For dosing, I use a double measuring spoon (included in the package) of 2.5 ml (smaller measuring spoon) or 5 ml (large measuring spoon). 1 smaller 2.5 ml scoop contains 110 mg of nifuroxazide; 1 large 5 ml scoop contains 220 mg of nifuroxazide.
Doses for children under 7 years of age: at the age of 1-6 months - 2.5 ml (1 smaller measuring spoon) 2-3 times a day; from 6 months to 2 years - 2.5 ml (1 smaller measuring spoon) 4 times a day; 2-7 years - 5 ml (1 large measuring spoon) 3 times a day.
Doses for children over 7 years of age and adults: children over 7 years of age and adults - 5 ml (1 large measuring spoon) 4 times a day; Children over 7 years old can use Nifuroxazide Richter film-coated tablets, 100 mg.
The drug Nifuroxazide Richter is recommended to be taken at regular intervals, regardless of meals. The course of treatment is 5-7 days. During the treatment of acute diarrhea, constant oral or intravenous replenishment of fluid deficiency in the body is necessary, depending on the general condition of the patient.

CONTRAINDICATIONS TO THE USE OF NIFUROXAZIDE RICHTER:

hypersensitivity to nifuroxazide and other nitrofuran derivatives or to any of the excipients; Nifuroxazide Richter, tablets 100 mg, is used in children over 7 years of age, in children under 7 years of age the drug is used in the form of a suspension; for the suspension also - hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; children's age up to 1 month.

SIDE EFFECTS OF NIFUROXAZIDE RICHTER:

Occasionally, organ and system disorders may occur.
From the blood and lymphatic system: in isolated cases - granulocytopenia.
From the gastrointestinal tract: individual cases of hypersensitivity to nifuroxazide are manifested by transient abdominal pain, nausea, vomiting and exacerbation of diarrhea. If such mild symptoms occur, there is no need to use special therapy or discontinue the use of nifuroxazide, as the symptoms quickly disappear. If the exacerbation is severe, you should stop taking nifuroxazide. In the future, the patient should not take nifuroxazide and other nitrofuran derivatives.
On the part of the skin and subcutaneous tissue: reactions in the form of skin rash and itching rarely occur. In isolated cases - pustulosis (in an elderly patient), persistent papular urticaria (in the presence of a contact allergy to nifuroxazide).
Hypersensitivity reactions: in isolated cases, urticaria and shortness of breath were noted - conditions requiring discontinuation of the drug.

SPECIAL INSTRUCTIONS:

Before prescribing Nifuroxazide Richter in the form of an oral suspension in infants, it is necessary to exclude congenital deficiency of enzymes that break down sucrose.
Nifuroxazide is not recommended to be taken for more than 7 days. In case of ongoing diarrhea for more than 3 days from the start of treatment, in-depth diagnosis is necessary to determine the cause of the development of symptoms. Antibiotic therapy may be necessary.
The drug is not prescribed as monotherapy for the treatment of intestinal infections complicated by septicemia. In case of severe invasive diarrhea, an antibiotic should be prescribed, since nifuroxazide is not absorbed from the gastrointestinal tract.
If a hypersensitivity reaction occurs (shortness of breath, skin rash, itching), you should stop taking the drug.
During treatment, you should adhere to a certain diet: exclude juices, raw vegetables and fruits, spicy and difficult to digest foods.
The preservative methylparaben (E218) may cause a delayed allergic reaction.
The drug contains sucrose, which must be taken into account when using it in patients with diabetes.
During treatment with nifuroxazide, you should not drink alcoholic beverages due to the possibility of developing disulfiram-like reactions, which are manifested by exacerbation of diarrhea, vomiting, abdominal pain, skin flushing, a feeling of heat, tinnitus, difficulty breathing, tachycardia, and a feeling of fear.
Use of the drug Nifuroxazide Richter during pregnancy and lactation
Pregnancy period. There are no clinical data regarding the use of nifuroxazide during pregnancy. Animal studies show neither direct nor indirect effects on the course of pregnancy, the development of the embryo or fetus, or the course of childbirth. The physician should carefully assess the benefit/risk ratio when prescribing nifuroxazide during pregnancy.
Breastfeeding period. It is known that nifuroxazide is not absorbed from the gastrointestinal tract. However, due to the lack of sufficient clinical data, caution should be exercised when prescribing nifuroxazide to women who are breastfeeding.
Children. Nifuroxazide Richter, 100 mg tablets, is used in children over 7 years of age. In children under 7 years of age, the drug is used in the form of a suspension. In the form of a suspension, the drug is not prescribed to children under 1 month of age.
The ability to influence reaction speed when driving vehicles and working with other mechanisms. Nifuroxazide does not affect the reaction rate when driving vehicles or operating other mechanisms.

INTERACTIONS:

simultaneous (at the same time) administration of other oral medications (including sorbents) should be avoided due to the strong adsorption properties of nifuroxazide.
During treatment with nifuroxazide, you should not drink alcoholic beverages due to the possibility of developing a disulfiram-like reaction, which is manifested by exacerbation of diarrhea, vomiting, and abdominal pain.

OVERDOSE:

Symptoms of an overdose with Nifuroxazide Richter are unknown. In case of overdose, gastric lavage and symptomatic treatment are recommended.

STORAGE CONDITIONS:

at a temperature not exceeding 25 °C.

Manufacturer: JLLC "Lekpharm" Republic of Belarus

ATS code: A07AX03

Farm group:

Release form: Solid dosage forms. Capsules.

General characteristics. Compound:

Indications for use:

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Storage conditions:

In a place protected from moisture and light at a temperature not exceeding 25 ° C. Store in places protected from children. Shelf life 2 years.

Vacation conditions:

Over the counter

Package:

10 capsules in blister packs. 3 blister packs in a cardboard box along with instructions for use.

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Trade name of the drug: Nifuroxazide lf (Nifuroxasidum)

Active ingredients: Nifuroxazide

Pharmacotherapeutic group: Antibacterial synthetic agent (gr. nitrofuran)., Antibacterial synthetic agent (gr. nitrofuran).

Release form:

10 capsules per blister pack made of polyvinyl chloride film and aluminum foil. Three blister packs along with instructions for use are placed in a cardboard pack.

Capsules N30 (3x10) (blister packs)

Each capsule contains: active substance: nifuroxazide – 100 mg or 200 mg; excipients: sucrose, magnesium stearate, modified corn starch. Composition of the gelatin capsule shell: Gelatin, titanium dioxide E171, quinoline yellow E104, azorubine E122, crimson 4R E124, purified water.

Treatment of acute diarrhea of ​​bacterial origin in the absence of signs of invasion (for example, deterioration in general condition, fever, toxic infection, etc.) in addition to rehydration therapy. The dose and method of rehydration (orally or intravenously) is determined depending on the severity of diarrhea, age, condition of the patient, and the presence of concomitant diseases.

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 2-4 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 2-4 doses. To treat acute diarrhea, the drug must be taken for 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.

Nifuroxazide is usually well tolerated and exhibits virtually no side effects. 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. If such symptoms of minor intensity occur, there is no need to use special therapy or discontinue the use of nifuroxazide. If the above symptoms develop to significant intensity, you should stop taking the medication. In the future, the patient should not take nitrofuran derivatives. From the skin and subcutaneous tissue: Allergic reactions may develop (skin rash, urticaria, Quincke's edema, anaphylactic reactions).

 allergic reactions to 5-nitrofuran derivatives;  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 drug).  pregnancy;  children under 6 years of age.

When treating with nifuroxazide, simultaneous use of oral medications should be avoided due to the strong adsorption properties of the drug. Since nifuroxazide does not enter the circulatory system, interactions with systemic drugs are unlikely and are not yet known. Ethanol intake may cause hypersensitivity symptoms. It is not recommended to take the drug in combination with drugs leading to reactions such as withdrawal syndrome or antidepressants.

The drug does not affect the ability to drive a car or operate other mechanisms. During treatment with nifuroxazide, the consumption of alcoholic beverages is contraindicated, because alcohol increases the body's sensitivity to the drug and can provoke a disulfiram-like reaction, expressed by exacerbation of diarrhea, vomiting, abdominal pain, skin flushing, a feeling of heat in the face and upper body, noise in the head, difficulty breathing, tachycardia, and 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 the clinical condition of the patient, to carry out rehydration therapy (for adults - about 2 liters of fluid per day). If hypersensitivity reactions occur, such as shortness of breath, skin rash, itching, you should stop using the drug. Nifuroxazide should be used with a strict diet, excluding juices, raw vegetables and fruits, spicy and indigestible foods. There are no clinical data regarding the use of nifuroxazide during pregnancy. Animal studies show no direct or indirect effect on pregnancy, embryonic or fetal development, labor or child development after birth. During pregnancy, nifuroxazide is contraindicated. 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. During the lactation period, it is possible to continue breastfeeding in case of a short course of treatment with the drug.