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Alfa Normix® (Rifaximin) 200 mg, 12 coated tablets

$47.50

5a14ebc51577

Description

Compound

  • One film-coated tablet contains the active ingredients – Rifaximin (α polymorphic form) 200 mg,
  • Excipients: sodium starch glycolate, glycerol tristearate, colloidal silicon dioxide, talc, microcrystalline cellulose
  • Shell: Opadry OY-S-34907 (hydroxypropyl methylcellulose, titanium dioxide E 171, sodium edetate, propylene glycol, iron oxide red E 172).

 

Pharmacological properties

Pharmacokinetics

Rifaximin is poorly absorbed when taken orally (less than 1%) and has an intra-intestinal effect. A very high concentration of the drug is created in the intestinal lumen (the concentration of the antibiotic in feces reaches 4000-8000 mcg/kg 3 days after the administration of the drug at a dose of 800 mg/day), which significantly exceeds the minimum inhibitory concentration for known enteropathogenic microorganisms.

The drug is not detected in plasma after taking therapeutic doses (detection limit less than 0.5-2 ng / ml) or is found in extremely low concentrations (less than 10 ng / ml) both in healthy volunteers and in patients with ulcerative lesions of the mucous membranes intestines (ulcerative colitis, Crohn’s disease).

No more than 0.4% of the oral dose of rifaximin is found in the urine.

Pharmacodynamics

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

Alpha Normix’s spectrum of activity includes most gram-negative and gram-positive, aerobic and anaerobic bacteria that cause gastrointestinal infections, including traveler’s diarrhea.

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.

Anaerobes: Bacteroides spp., including Bacteroides fragilis; Fusobacterium nucleatum.
Gram-positive
Aerobes: Streptococcus spp.; Enterococcus spp., including Enterococcus fecalis; Staphylococcus spp.

Anaerobes: Clostridium spp., including Clostridium difficile and Clostridium perfrigens; Peptostreptococcus spp.

The drug does not disturb the balance of the normal saprophytic intestinal microflora.

The wide antibacterial spectrum of rifaximin helps to reduce the pathogenic intestinal bacterial load, which causes some pathological conditions. The drug reduces:

– the formation 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;
increased proliferation of bacteria in the syndrome of excessive growth of microorganisms in the intestine;

– the presence in the diverticula of the colon 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;

– antigenic stimulation, which, in the presence of genetically determined defects in mucosal immunoregulation and/or in protective function, can initiate or permanently maintain chronic inflammation of the intestine;

– the risk of infectious complications in colorectal surgery.

 

Indications for use

  • Gastrointestinal infections caused by bacteria sensitive to rifaximin, incl. acute gastrointestinal infections, traveler’s diarrhea, gut microbial overgrowth syndrome, hepatic encephalopathy, uncomplicated diverticular disease of the colon, and chronic inflammatory bowel disease;
  • Prevention of infectious complications in colorectal surgery.

 

Dosage and administration

Treatment of diarrhea

Adults and children over 12 years of age: from 200 mg tablets every 8 hours – up to 400 mg every 8-12 hours (corresponding to 600-1200 mg of rifaximin per day).

Children 6-12 years: 200 mg every 8-12 hours to 400 mg every 12 hours (equivalent to 400-800 mg of rifaximin per day).

Prevention of infectious complications in the pre- and postoperative period:

Adults and children over 12 years: 400 mg every 12 hours.

Children 6-12 years old: 200-400 mg every 12 hours.

In the complex treatment of hyperammonemia

Adults and children over 12 years: 400 mg every 8 hours.

Children 6-12 years old: 200-300 mg every 8 hours.

Doses and frequency of administration can be changed according to the doctor’s prescription. The duration of treatment should not exceed 7-10 days, unless otherwise prescribed by the doctor.

 

Possible side effects

– dizziness, headache

– nausea, vomiting, abdominal pain, diarrhea, flatulence, loss of appetite

– allergic reactions like urticaria skin rash, allergic dermatitis

 

Contraindications

– increased individual sensitivity to any of the components of the drug, as well as to other antibiotics of the rifamycin group

– intestinal obstruction

– ulcerative colitis

 

Drug Interactions

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

 

Special instructions

The period of pregnancy and lactation

There are currently insufficient clinical data on the use of rifaximin in pregnant and lactating women.

If absolutely necessary, the drug can be prescribed during pregnancy and lactation under the strict supervision of a physician.

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

Does not affect the ability to drive a car and to control machines and mechanisms.

 

Overdose

At the moment, no cases of drug overdose have been reported.

In case of accidental overdose – symptomatic treatment.

 

Storage conditions

At a temperature not exceeding 30 ° C in a tightly closed package.
Keep out of the reach of children!

Shelf life – 3 years.
Do not use after the expiration date!

Additional information

Ingredient

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