2010/09/20

Alfa Normix

Composition, structure and packing

Coated tablets pink, round, biconvex.

1 tab. rifaksimin 200 mg.

Excipients: sodium starch glycolate, glycerol stearate palmityl-ether, precipitated silica, talc, microcrystalline cellulose, hydroxypropylmethylcellulose, titanium dioxide, disodium edetate, propylene glycol, iron oxide red (E172).

Granules for suspension for oral orange, the smell and taste of cherry (wild cherry).

5 ml of a suspension prepared. rifaksimin 100 mg.

Excipients: microcrystalline cellulose, sodium carboxymethylcellulose, pectin, kaolin, sodium saccharin, sodium benzoate, sucrose, flavoring, cherry (wild cherry).

Clinico-pharmacological group: Antibiotic rifamycin group.

Pharmacological action

Broad-spectrum antibiotic, is a semisynthetic derivative of rifamycin SV. Irreversibly binds beta-subunit of the enzyme bacterial DNA-dependent RNA polymerase and thus inhibits the synthesis of RNA and proteins of bacteria.

As a result of irreversible binding to the enzyme rifaksimin exhibits bactericidal against susceptible bacteria. The drug has a broad spectrum of antibacterial activity that includes most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections, including travelers' diarrhea.

It is active against gram-negative aerobic bacteria: Salmonella spp., Shigella spp., Enterotoxogenic 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.

Use of the drug alpha Normiks reduces pathogenic intestinal bacterial load, which causes some pathological conditions.

The drug reduces:
formation of ammonia by bacteria and other toxic compounds, which in the case of severe liver disease, accompanied by violation of detoxification, are involved in the pathogenesis of hepatic encephalopathy;
increased proliferation of bacteria in the syndrome of excessive growth of microorganisms in the intestine;
presence in the diverticulum of the colon bacteria, which may participate in 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 antigenic stimulus, which in the presence of genetically determined defects in mucosal immune regulation and / or protective function, can initiate or permanently maintain a chronic inflammation of the intestine;
risk of infectious complications in colorectal surgery. The drug acts in the lumen of the intestine.

Pharmacokinetics

Absorption

Rifaksimin poorly absorbed when administered (less than 1%). In the digestive tract are very high concentrations of antibiotic, which is significantly higher MIC tested enteropathogenic microorganisms. The drug is not detected in plasma after ingestion of therapeutic doses (detection limit <0.5 - 2 ng / ml) or detected at very low concentrations (less than 10 ng / ml in almost all cases) in both healthy volunteers and patients with lesions intestine (as a result of ulcerative colitis or Crohn's disease).

Distribution

In fact, virtually 100% rifaksimina, received by mouth, is located in the gastrointestinal tract, where it reaches very high concentrations of the drug (the concentration in the feces 4-8 mg / g is achieved after 3 days taking the drug at a daily dose of 800 mg).

Withdrawal

The drug is excreted in the feces. Found in urine rifaksimin is no more than 0.5% of the accepted oral dose.

Statement

Treatment of gastrointestinal infections caused by bacteria sensitive to rifaksiminu, including at:
acute gastro-intestinal 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.

Dosage regimen

Adults and children over 12 years, drug prescribed 200 mg (1 tab. Or 10 ml suspension) every 8 h or 400 mg (2 tab. Or 20 ml suspension) every 8-12 hours

If necessary, the dose and frequency of reception may be changed under the supervision of a physician.

Duration of treatment should not exceed 7 days and determined the clinical status of patients. A second course of treatment should be carried out not earlier than 20 - 40 days.

Terms preparation of the suspension

It should open the bottle, add water to the mark and shake well. Then re-add water until the level of the suspension until it reaches the specified levels of 60 ml. Before each receiving a suspension should be well shaken. For the dosing of the suspension is attached dimensional cup.

Side effect

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

On the part of the digestive system: in some cases - nausea, indigestion, vomiting, abdominal pain / colic, which usually take place independently without the need to change the dose or stopping therapy.

Allergic reactions: seldom - urticaria.

Contraindications

Hypersensitivity to rifaksiminu, another rifamycin or to any of the components that make up the drug.

Pregnancy and lactation

In pregnancy use of drugs is possible only if absolutely necessary, subject to safeguards and under the direct supervision of a physician.

Use of the drug during breast feeding is allowed during the appropriate medical supervision.

Cautions

With long-term treatment of the drug in high doses or in case of damages the intestinal mucosa, small amounts of the drug can be absorbed into the systemic circulation and cause staining of urine a reddish color, due to the reddish-orange color of rifamycin antibiotics.

Overdose

Cases of overdose Alpha Normiks not marked.

Drug Interactions

So far, no established medicinal drug interaction Alfa Normiks. Because of the poor systemic absorption (less than 1%) drug interactions at the system level are unlikely.

Terms and Conditions of storage

The drug should be stored out of reach of children at or above 30 ° C. Shelf life - 3 years. Preparation of suspensions should be stored for 7 days at room temperature not exceeding 30 ° C.