Alpha нормикс

General characteristics. Structure:

Active ingredient: рифаксимин 200 mg;
excipients: starch sodium glycollate; ether of a glitserol palmitostearinovy; the silicon besieged; talc; MKTs; gidroksipropilmetiltsellyuloza; titanium dioxide; dinatrium эдетат; propylene glycol; iron oxide red E172;

Pharmacological properties:

Pharmacodynamics. It is irreversible communicates with a beta in subunit of enzyme of bacteria, RNA DNA-dependent a polymerase and, therefore, inhibits synthesis of RNA and proteins of bacteria. As a result of irreversible linkng with enzyme рифаксимин shows bactericidal properties concerning sensitive bacteria.
Drug possesses the wide range of antimicrobic activity including the majority of the gram-negative and gram-positive, aerobic and anaerobic bacteria causing gastrointestinal infections including diarrhea of travelers.

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.
Anaerobe bacterias: Bacteroides spp., including Bacteroides fragilis; Fusobacterium nucleatum.

Gram-positive
Aerobes: Streptococcus spp.; Enterococcus spp., including Enterococcus faecalis; Staphylococcus spp.
Anaerobe bacterias: Clostridium spp., including Clostridium difficile and Clostridium perfringens; Peptostreptococcus spp.
The wide antibacterial range of a rifaksimin promotes decrease in pathogenic intestinal bacterial loading which causes some morbid conditions. Drug reduces:
- education by bacteria of ammonia and other toxic connections which in case of the serious illness of a liver which is followed by disturbance of process of a detoxification participate in a pathogeny and symptomatology of hepatic encephalopathy;
- the increased proliferation of bacteria at a syndrome of excess growth of microorganisms in intestines;
- presence at diverticulums of a colon of bacteria which can participate in an inflammation around a diverticular bag and, perhaps play a key role in development of symptoms and complications of a diverticular disease;
- an antigenic incentive which with genetically caused defects in immunoregulation mucous and/or in protective function, can initiate or constantly support a chronic inflammation of intestines;
- risk of infectious complications at colorectal surgical interventions.

Pharmacokinetics. Rifaksimin is badly soaked up at intake (less than 1%) and possesses intra intestinal action. In a GIT very high concentration of an antibiotic which are much higher than MPK for the checked enteropathogenic microorganisms are created.
Drug is not found in plasma after reception of therapeutic doses (the detection limit <0,5–2 ng/ml) or is found in very low concentration (<honor 10 ng/ml in all cases) both at healthy volunteers, and at patients with damaged mucous intestines (as a result of ulcer colitis or a disease Krone).
Nearly 100% of the rifaksimin which arrived inside are in an intestinal path where very high concentration of drug are reached (concentration in Calais of 4000-8000 mkg/g are reached in 3 days of treatment by a daily dose of 800 mg).
Found in urine рифаксимин makes no more than 0,5% of the dose accepted inside.

Indications to use:

- treatment of the gastrointestinal infections caused by the bacteria sensitive to a rifaksimin including acute gastrointestinal infections, diarrhea of travelers, a syndrome of excess growth of microorganisms in intestines, hepatic encephalopathy, an uncomplicated divertikulezny disease of a colon and a chronic inflammation of intestines;

- prevention of infectious complications at colorectal surgical interventions.

Route of administration and doses:

Inside. To adults and children 12 years — from 1 tab. each 8 h to 2 tab. each 8–12 h are more senior (there correspond 600–1200 mg of a rifaksimin).
Duration of treatment should not exceed 7 days and is defined by a clinical condition of patients.
If necessary the repeated course of treatment should be carried out not earlier than in 20–40 days. The general duration of treatment is defined by a clinical condition of patients.
According to the recommendation of the doctor doses and frequency of their reception can be changed.

Features of use:

During long treatment by high doses or at injuries of a mucous membrane of intestines small amounts of drug (less than 1%) can be soaked up that can cause coloring of urine in reddish color — it is caused by active agent which as well as the majority of antibiotics of this row (Rifamycinums) has reddish-orange coloring.

Side effects:

Drug is badly soaked up from a GIT that excludes risk of development of system undesirable effects.

Pains in stomachs/gripes which usually spontaneously disappeared without the need for change of a dose or suspension of therapy were in certain cases observed weak to moderated undesirable gastrointestinal effects, for example nausea, dyspepsia, vomiting.

In rare instances the skin reactions like an urtikariya which are possibly connected with unpredictable individual intolerance of treatment can develop.

In case of development of heavier or other undesirable effects it is necessary to see the attending physician immediately.

Interaction with other medicines:

Interactions it is not established so far.

Because of it is insignificant small absorption in a GIT of a rifaksimin at intake (less than 1%), medicinal interactions at the system level are improbable.

Contraindications:

Hypersensitivity to a rifaksimin or other Rifamycinums or to any of the components which are a part of drug the Alpha нормикс.

Use at pregnancy and feeding by a breast
In case of pregnancy drug should be accepted only in urgent cases and under direct observation of the doctor.
Use of a rifaksimin by the nursing women is allowed when carrying out the corresponding medical observation.

Overdose:

There are no data.

Storage conditions:

At a temperature not above 30 °C.
To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Alpha нормикс, tablets, film coated 200 mg; blister 12, pack cardboard.