Rifaximin prescription in Latin. Rifaximin

Rifaximin INN

International name: Rifaximin

Dosage form: granules for suspension for oral administration, coated tablets

Pharmachologic effect:

Broad-spectrum antibiotic, semi-synthetic derivative of rifamycin SV. Irreversibly binds the beta subunit of the bacterial enzyme, DNA-dependent RNA polymerase, and therefore inhibits the synthesis of RNA and bacterial proteins. As a result of irreversible binding to the enzyme, rifaximin exhibits bactericidal properties against sensitive bacteria. The spectrum of antimicrobial activity includes most gram-negative and gram-positive, aerobic and anaerobic bacteria. Gram-negative aerobic: Salmonella spp., Shigella spp., Escherichia coli, enteropathogenic strains, Proteus spp., Campylobacter app., Pseudomonas spp., Yersinia spp., Enterobacter spp., Klebsiella spp., Helicobacter pylori. Gram-negative anaerobic: Bacteroides spp., including Bacteroides fragilis; Fusobacterium nucleatum. Gram-positive aerobic: Streptococcus spp., Enterococcus spp., including Enterococcus fecalis; Staphylococcus spp. Gram-positive anaerobic: Clostridium spp., including Clostridium difficile and Clostridium perfrigens; Peptostreptococcus spp. In the gastrointestinal tract, very high concentrations of the antibiotic are created, which are significantly higher than the MIC for the investigated enteropathogenic microorganisms.

Pharmacokinetics:

Poorly absorbed when taken orally (less than 1%). The drug is not detected in plasma after taking therapeutic doses (detection limit less than 0.5-2 ng / ml) or is found at very low concentrations (less than 10 ng / ml). In the urine, no more than 0.5% of the dose taken orally is found. Almost 100% of ingested rifaximin is found in the gastrointestinal tract, where very high concentrations of the drug are achieved (concentration in feces of 4000-8000 μg / g is achieved after 3 days of treatment with a dose of 800 mg / day).

Indications:

Gastrointestinal infections caused by bacteria sensitive to rifaximin: acute gastrointestinal infections, travelers' diarrhea, intestinal overgrowth syndrome, hepatic encephalopathy, symptomatic uncomplicated colonic diverticulosis, chronic colitis. Prevention of infectious complications in colorectal surgery.

Contraindications:

Hypersensitivity (including to other rifamycins). With caution. Pregnancy, lactation.

Dosing regimen:

Adults and children over 12 years old: 600 mg every 8 hours or 1200 mg every 8-12 hours. The course of treatment is 7 days; if it is necessary to conduct a second course, it should be carried out no earlier than in 20-40 days. The total duration of treatment is determined by the clinical condition of the patients.

Side effects:

Nausea, dyspepsia, vomiting, abdominal pain / colic, allergic reactions (including urticaria).

Special instructions:

During long-term treatment with high doses or if the gastrointestinal mucosa is affected, small amounts of the drug (less than 1%) may be absorbed, which can cause reddish urine staining (due to the active substance, which has a reddish-orange color). During pregnancy and lactation, the drug should be taken only if absolutely necessary and under the direct supervision of a physician.

Interaction:

Due to the negligible absorption in the gastrointestinal tract of rifaximin when taken orally (less than 1%), drug interactions are unlikely.

Structural formula

Russian name

Latin name of the substance Rifaximin

chemical name

25-(Acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadekatrienimino)benzofuropyridobenzimidazole-1,15 (2H)-dione

Gross formula

Pharmacological group of the substance Rifaximin

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Rifaximin

A broad-spectrum antibiotic, is a semi-synthetic derivative of rifamycin SV.

Pharmacology

Inhibits DNA-dependent RNA polymerase of bacterial cells and causes their death. A wide antibacterial spectrum of rifaximin contributes to the suppression of pathogenic intestinal bacterial flora, which causes a number of pathological conditions. Rifaximin reduces the production of ammonia and other toxic compounds by bacteria, which, in the case of severe liver disease, accompanied by a violation of the detoxification process, are involved in the pathogenesis and symptoms of hepatic encephalopathy. Reduces the increased proliferation of bacteria in the syndrome of excessive growth of microorganisms in the intestine. In colonic diverticula, it reduces the number of bacteria that may be involved in inflammation around the diverticular sac and may play a key role in the development of symptoms and complications of diverticular disease.

Poorly absorbed when taken orally (less than 1%). Almost 100% of ingested rifaximin is in the intestinal tract, where high concentrations of the drug are achieved. It is excreted unchanged in the faeces, no more than 0.5% of the dose taken is found in the urine.

Application of the substance Rifaximin

Gastrointestinal infections caused by bacteria sensitive to rifaximin: acute gastrointestinal infections, travelers' diarrhea, intestinal overgrowth syndrome, hepatic encephalopathy, symptomatic uncomplicated colonic diverticulosis, chronic colitis. Prevention of infectious complications in colorectal surgery.

Contraindications

Hypersensitivity, incl. to rifamycins.

Use during pregnancy and lactation

During pregnancy, it should be taken only if absolutely necessary and under the direct supervision of a physician.

At the time of treatment, it is necessary to stop breastfeeding (it is not known whether rifaximin passes into breast milk).

Side effects of the substance Rifaximin

Nausea, vomiting, dyspepsia, abdominal pain/colic, allergic skin reactions (urticaria).

Interaction

Research in vitro indicate that rifaximin induces the CYP3A4 isoenzyme of cytochrome P450. A clinical study in healthy volunteers showed that rifaximin 200 mg orally every 8 hours for 3 days or every 8 hours for 7 days had no effect on the pharmacokinetics of a single dose of the CYP3A4 substrate midazolam (2 mg IV or 6 mg orally) . Thus, rifaximin had no significant effect on intestinal or hepatic CYP3A4 activity.

Recipe (international)

Rep.: Tab. Rifaximin 0.04 №12
D.S. Inside 1 tab. 2 times a day.

pharmachologic effect

A broad-spectrum antibiotic, is a semi-synthetic derivative of rifamycin SV. It irreversibly binds the beta subunits of the bacterial enzyme, DNA-dependent RNA polymerase, and therefore inhibits the synthesis of bacterial RNA and proteins. As a result of irreversible binding to the enzyme, rifaximin exhibits bactericidal properties against sensitive bacteria.

It has a wide spectrum of antibacterial activity, including most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections, including traveler's diarrhea.

Active against gram-negative aerobic bacteria: Salmonella spp., Shigella spp., enteropathogenic strains of Escherichia coli, Proteus spp., Campylobacter spp., Pseudomonas spp., Yersinia spp., Enterobacter spp., Klebsiella spp., Helicobacter pylori; gram-negative anaerobes: Bacteroides spp., including Bacteroides fragilis, Fusobacterium nucleatum; gram-positive aerobes: Streptococcus spp., Enterococcus spp., including Enterococcus fecalis, Staphylococcus spp.; gram-positive anaerobes: Clostridium spp., including Clostridium difficile and Clostridium perfrigens, Peptostreptococcus spp.

Rifaximin reduces the production of ammonia and other toxic compounds by bacteria, which, in the case of severe liver disease, accompanied by a violation of the detoxification process, are involved in the pathogenesis of hepatic encephalopathy; increased proliferation of bacteria in the syndrome of excessive growth of microorganisms in the intestine; the presence of bacteria in the colonic diverticulum that can cause inflammation in and around the diverticular sac and may play a key role in the development of symptoms and complications of diverticular disease; the intensity of the antigenic stimulus, which, in the presence of genetically determined defects in mucosal immunoregulation and/or in protective function, can initiate or permanently maintain chronic intestinal inflammation; the risk of infectious complications in colorectal surgery.

Acts in the intestinal lumen.

Mode of application

For adults: Adults and children over 12 years old are prescribed 200 mg every 8 hours or 400 mg every 8-12 hours.

If necessary, the dose and frequency of administration can be changed under the supervision of a physician.
The duration of treatment should not exceed 7 days and is determined by the clinical condition of the patients.

A second course of treatment should be carried out no earlier than 20-40 days later.

Indications

For oral administration: acute and chronic intestinal infections caused by gram-positive and gram-negative microorganisms, diarrheal syndrome, diarrhea caused by imbalance of the intestinal microflora (summer diarrhea, travelers' diarrhea, enterocolitis), pre- and postoperative prevention of infectious complications during surgical intervention on organs PS.

For external use: infectious-inflammatory and purulent skin diseases caused by microorganisms sensitive to the drug, including contagious impetigo, diaper rash, ecthyma, folliculitis, furunculosis, angular cheilitis, hydradenitis, erythrasma.

Contraindications

Hypersensitivity to rifaximin and other antibiotics of the rifamycin group.

Side effects

When taken orally: at the first application, vomiting is possible, which subsequently stops without discontinuing the drug; rarely - with high doses of therapy for a long time, skin AR (urticaria) is possible. For external use: rarely - local irritation, hyperemia.

With the growth of microorganisms insensitive to this antibiotic, treatment should be suspended and appropriate therapy should be started.

If signs of sensitization appear during treatment, the drug should be discontinued.

Release form

Coated tablets. One tablet contains 200 mg of the active ingredient (12 tablets per pack).
Vials with granulate for suspension preparation. In one vial - 100 ml of granulate (100 mg in 5 ml of the finished suspension).
Ointment (1 g of ointment contains 50 mg of rifaximin).

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RIFAXIMIN

RIFAXIMIN: instructions for use and reviews

The active substance of the drug RIFAXIMIN

Drug ATC code RIFAXIMIN

A07AA11 (Rifaximin)

Clinical and pharmacological group of the drug RIFAXIMIN

06.023 (An antibiotic of the rifamycin group)

Indications

Treatment of gastrointestinal infections caused by bacteria sensitive to rifaximin, incl. with acute gastrointestinal infections - travelers' diarrhea - syndrome of excessive growth of microorganisms in the intestine - hepatic encephalopathy - symptomatic uncomplicated diverticulosis of the colon - chronic inflammation of the intestine.

Prevention of infectious complications in colorectal surgery.

pharmachologic effect

An enzyme-wide antibiotic, rifaximin exhibits bactericidal properties against sensitive bacteria.

It has a wide spectrum of antibacterial activity, including most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections, including traveler's diarrhea.

Active towards Gram-negative aerobic bacteria: Salmonella spp., Shigella spp., enteropathogenic strains of Escherichia coli, Proteus spp., Campylobacter spp., Pseudomonas spp., Yersinia spp., Enterobacter spp., Klebsiella spp., Helicobacter pylori- Gram-negative anaerobes: Bacteroides spp., including Bacteroides fragilis, Fusobacterium nucleatum- Gram-positive aerobes: Streptococcus spp., Enterococcus spp., including Enterococcus fecalis, Staphylococcus spp.- Gram-positive anaerobes: Clostridium spp., including Clostridium difficile and Clostridium perfrigens, Peptostreptococcus spp.

Rifaximin reduces the production of ammonia and other toxic compounds by bacteria, which, in the case of severe liver disease, accompanied by a violation of the detoxification process, are involved in the pathogenesis of hepatic encephalopathy; increased proliferation of bacteria in the syndrome of overgrowth of microorganisms in the intestine; presence of bacteria in the diverticulum of the colon that can cause inflammation in and around the diverticular sac and possibly play a key role in the development of symptoms and complications of diverticular disease - the intensity of the antigenic stimulus, which, in the presence of genetically determined defects in mucosal immunoregulation and / or protective function, can initiate or permanently maintain chronic intestinal inflammation - the risk of infectious complications when colorectal surgery.

Acts in the intestinal lumen.

Pharmacokinetics

Rifaximin is poorly absorbed when taken orally (less than 1%). Very high concentrations of the antibiotic are created in the gastrointestinal tract, which are significantly higher than the MIC for the tested enteropathogenic microorganisms.

Not detectable in plasma after administration at therapeutic doses (detection limit< 0.5 - 2 нг/мл) или обнаруживается в очень низких концентрациях (менее 10 нг/мл почти во всех случаях).

Almost 100% of rifaximin taken orally is in the gastrointestinal tract, where very high concentrations are achieved (concentrations in the feces of 4-8 mg / g are achieved after 3 days of administration at a daily dose of 800 mg).

Rifaximin is excreted in the feces. The rifaximin found in the urine is no more than 0.5%.

Dosage

Adults and children over 12 years old appoint 200 mg every 8 hours or 400 mg every 8-12 hours. If necessary, the dose and frequency of administration can be changed under the supervision of a physician. The duration of treatment should not exceed 7 days and is determined by the clinical condition of the patients. A second course of treatment should be carried out no earlier than 20-40 days later.

Pregnancy and lactation

During pregnancy, the use is possible only in case of emergency, with the observance of precautionary measures and under the direct supervision of a physician.

The use of the drug during breastfeeding is allowed under medical supervision.

Side effects of the drug

The drug is poorly absorbed from the gastrointestinal tract, which eliminates the risk of systemic adverse effects.

From the digestive system: in some cases - nausea, dyspepsia, vomiting, abdominal pain / colic, which usually disappear on their own without the need to change the dose or stop therapy.

Allergic reactions: rarely - urticaria.

Contraindications

Hypersensitivity to rifaximin and other antibiotics of the rifamycin group.

special instructions

With prolonged use of rifaximin in high doses or with damage to the intestinal mucosa, small amounts of the active substance can be absorbed into the systemic circulation and cause urine to become reddish, which is due to the reddish-orange color of the antibiotics of the rifamycin group.

Alpha Normix

International non-proprietary name

Rifaximin

Dosage form

Film-coated tablets, 200 mg

Compound

One tablet contains

active substance - rifaximin 200 mg,

Excipients: sodium starch glycolate, glycerol distearate, colloidal silicon dioxide, talc, microcrystalline cellulose,

shell compositionOpadry OY- S-34907 : hypromellose, titanium dioxide (E171), disodium edetate, propylene glycol, iron oxide red (E172).

Description

Pink, round, biconvex, film-coated tablets.

Pharmacotherapeutic group

Antidiarrheals. Intestinal antimicrobial and anti-inflammatory drugs. Antibacterial drugs. Rifaximin

ATX code A07AA11

Pharmacological properties

Pharmacokinetics

Rifaximin is poorly absorbed when taken orally (less than 1%). In the gastrointestinal tract (GIT), a high concentration of antibiotic is created, which significantly exceeds the minimum inhibitory concentration (MIC) for known enteropathogenic microorganisms.

Rifaximin is not detected in plasma after administration at therapeutic doses (detection limit< 0.5 - 2 нг/мл) или обнаруживается в очень низких концентрациях (менее 10 нг/мл почти во всех случаях). Практически 100% рифаксимина, принятого внутрь, находится в ЖКТ, где достигаются очень высокие концентрации (концентрации в кале 4-8 мг/г достигаются через 3 сут приема в суточной дозе 800 мг). Рифаксимин выводится с калом. Обнаруживаемый в моче рифаксимин составляет не более 0.5%.

Pharmacodynamics

Alfa Normix contains rifaximin in the α polymorphic form.

Rifaximin is a broad-spectrum antibiotic, a semi-synthetic derivative of rifamycin SV. Differs in very low absorption in the gastrointestinal tract after oral administration, due to which it creates high concentrations of the drug in the intestinal lumen, the drug is clinically inactive against pathogens that have penetrated the intestinal walls, even if these bacteria are sensitive to the drug in vitro. Like other antibiotics of the rifamycin group, rifaximin irreversibly binds the beta subunits of bacterial DNA-dependent RNA polymerase, thus inhibiting the synthesis of RNA and proteins in bacterial cells. The result of irreversible binding to the enzyme is the bactericidal properties of rifaximin against sensitive bacteria. The drug has a wide spectrum of antimicrobial activity, including most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections and includes:

Gram-positive aerobic bacteria: Streptococcus spp., Enterococcus spp. (including Enterococcus fecalis), Staphylococcus spp.;

anaerobic: Clostridium spp. , including Clostridium difficile and Clostridium perfrigens, Peptostreptococcus spp.

Gram-negative aerobic bacteria: enteropathogenic strains Escherichia coli, Shigella spp., Salmonella spp.., Campylobacterspp.; Pseudomonas spp.; Enterobacter spp.; Klebsiella spp.; Helicobacter pylori Yersinia spp., Proteus spp.,

Gram-negative anaerobic bacteria Bacteroides spp.(includingBacteroides fragilis, Fusobacterium nucleatum

The MIC50 and MIC90 (minimum inhibitory concentrations capable of stopping the growth of 90% or 50% of strains in vitro) of rifaximin are 1.25 and 50 mg/ml, respectively, against enteropathogenic strains of E. coli, Salmonella and Shigella. Whereas the MIC for Salmonella and enterotoxigenic Escherichia coli ranges from 0.098 to 200 and from 1.25 to 200 mg/ml for Shigella.

The feasibility of using non-absorbable antibiotics in the treatment hepatic encephalopathy due to the role played by the increased formation of ammonia and other toxic substances (fatty acids, phenols) by the intestinal microflora in the pathogenesis of this complication. Currently, 16 clinical studies have been published on the use of rifaximin in the treatment of hepatic encephalopathy in more than 800 patients. It was shown that the use of rifaximin at different daily doses (600, 1200, 2400 mg) for 7 days led to an improvement in the portosystemic encephalopathy index and EEG parameters, as well as a decrease in the concentration of ammonia in the blood.

Rifaximin reduces bacterial overgrowth in intestinal microbial overgrowth syndrome. In colonic diverticula, it reduces the number of bacteria that may be involved in inflammation around the diverticular sac and may play a key role in the development of symptoms and complications of diverticular disease.

Indications for use

Treatment of gastrointestinal infections caused by bacteria sensitive to rifaximin: acute gastrointestinal infections, traveler's diarrhea caused by non-invasive strains Escherichia coli, intestinal overgrowth syndrome, symptomatic uncomplicated colonic diverticulosis, chronic colitis

Prevention of infectious complications in colorectal surgery

Hepatic encephalopathy

Dosage and administration

inside.

For traveler's diarrhea, 200 mg (1 tablet) every 8 hours; the daily dose is 600 mg.

With hepatic encephalopathy, the dose of the administered drug is 1200 mg / day, divided into 2-3 doses, with diverticulosis of the colon, chronic colitis - 800 mg / day, divided into 2-3 doses, with excessive bacterial growth, prevention of infectious complications in colorectal surgical interventions - from 800 to 1200 mg / day, divided into 2-3 doses. The duration of treatment should not exceed 3 days for traveler's diarrhea, for other indications for use - 7 days and is determined by the patient's clinical condition and laboratory data.

If necessary, the course of treatment should be repeated no earlier than after 20-40 days. The total duration of treatment is determined by the attending physician, depending on the patient's condition and the laboratory data obtained.

Rifaximin should be discontinued and alternative therapy considered if diarrhea symptoms worsen or persist for more than 24-48 hours.

Side effects

Adverse events at least possibly related to rifaximin are classified by frequency and organ/organ system as follows: very common (>10%), frequent >1%<10%, нечастые >0,1% <1%, редкие >0,01%<0,1%, очень редкие <0,01%.

Listed below are side effects that have been observed in double-blind, placebo-controlled clinical trials. Most side effects, especially those of the gastrointestinal tract, may be symptoms of a disease for which treatment was prescribed during clinical trials and which are reported with the same frequency in patients receiving placebo.

Often

- dizziness, headache

Bloating, abdominal pain, constipation, diarrhea, flatulence, nausea,

tenesmus, vomiting, urge to defecate.

- fever

Infrequently

Palpitations, "flushing" of blood to the skin of the face, increased arterial

pressure

Shortness of breath, dry throat, nasal congestion, runny nose, cough, sore throat

laryngopharyngeal region

- asthenic conditions, chills, pain and discomfort, flu-like

symptoms, peripheral edema

Lymphocytosis, monocytosis, neutropenia

Loss of taste, hypoesthesia, paresthesia, headache, drowsiness,

Migraine, insomnia, abnormal dreams, dizziness,

depressed mood, nervousness, earache

Diplopia

Anorexia, dehydration, ascites, abdominal pain, dry lips, dyspepsia,

gastrointestinal motility disorder, secretion of mucus and blood

with stool, "hard" stool, increased activity

aspartate aminotransferase

Glucosuria, polyuria, pollakiuria, hematuria, proteinuria

Rash, skin eruptions, cold sweat, sweating

- back pain, muscle spasm, muscle weakness, myalgia, neck pain

Candidiasis, herpes simplex virus, nasopharyngitis, pharyngitis, infections

upper respiratory tract

Polymenorrhea

In the post-marketing period of the use of rifaximin, the following side effects were observed very rarely: pseudomembranous colitis, thrombocytopenia, anaphylactic reactions, angioedema, hypersensitivity, syncope, changes in liver function tests, dermatitis, eczema, erythema, pruritus, purpura, urticaria.

Contraindications

Hypersensitivity to rifaximin and other antibiotics

rifamycin groups

Children under 18 years of age (no data on safety and

efficiency)

Intestinal obstruction

Ulcerative colitis

Drug Interactions

Due to poor absorption from the gastrointestinal tract, the drug does not interact with other drugs at the systemic level.

special instructions

During long-term treatment with high doses or with damage to the intestinal mucosa, absorption of the drug in small amounts (less than 1%) is possible, which can cause the urine to become reddish. This is due to the active substance, which, like most antibiotics of the rifamycin series, has a reddish-orange color.

Before prescribing rifaximin, pseudomembranous colitis should be excluded.

Pregnancy and lactation

As a precautionary measure, the use of rifaximin during pregnancy is not recommended unless absolutely necessary and under the direct supervision of a physician based on a benefit/risk assessment.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Has no effect.

Overdose

There were no cases of overdose of the drug.

Release form and packaging

Film-coated tablets, 200 mg. 12 tablets in a blister pack made of PVC / PE / PVDC film and aluminum foil.

1 blister pack, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 30o C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date

Terms of dispensing from pharmacies

On prescription

Name and country of the organization - manufacturer

Alpha Wassermann S.p.A.

Name and country of the marketing authorization holder

Alpha Wassermann S.p.A.

Via Enrico Fermi, 1 - 65020 Alano (Pescara), Italy

Name and country of organization - packer

Alpha Wassermann S.p.A.

Via Enrico Fermi, 1 - 65020 Alano (Pescara), Italy

Address of the organization accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Republic of Kazakhstan, 050011, Almaty, st. Paris Commune, 27A-8.

E-mail address: translate- gm[email protected] mail. en

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