Alpha Normix tablets coated. 200 mg 36 pcs. (Ryfaksymyn)

Release form

film-coated tablets

Packing

36 pcs.

Pharmacological action

Rifaximin is a broad-spectrum antibiotic from the rifamycin group. Like other representatives of this group, it irreversibly binds the beta subunit of the bacterial enzyme to 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 susceptible bacteria. The drug has a wide spectrum of antimicrobial activity, including most gram-negative and gram-positive, aerobic and anaerobic bacteria.

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

The drug reduces:

- the formation by bacteria of ammonia and other toxic compounds, which in case of severe liver disease, accompanied by a violation of the detoxification process, play a role in the pathogenesis and clinical manifestations of hepatic encephalopathy

- increased proliferation of bacteria in the syndrome of excessive

growth of microorganisms in the intestine

- the presence in the diverticulum of the colon of bacteria that can cause inflammation in and around the diverticular sac and, possibly, play a key role in the development and complications of diverticular disease

- an antigenic stimulus that, in the presence of genetically determined defects in the immunoregulation of the mucosa and / or in the protective function, can ie to initiate or continuously maintain a chronic inflammation of the intestine

- the risk of infectious complications in colorectal surgery.

Resistance mechanism

The development of rifaximin resistance is due to reversible damage to the rpoB gene, which encodes bacterial RNA polymerase. The incidence of resistant subpopulations among bacteria isolated from patients with traveler's diarrhea was low.

According to clinical studies, a three-day course of rifaximin therapy in patients with traveler's diarrhea was not accompanied by the appearance of resistant gram-positive (enterococci) and gram-negative (E. coli) bacteria. When re-using rifaximin in high doses in healthy volunteers and in patients with inflammatory bowel disease, rifaximin-resistant strains appeared, however, they did not colonize the gastrointestinal tract (GIT) and did not displace rifaximin-sensitive strains.

When therapy was discontinued, resistant strains quickly disappeared. Experimental and clinical data suggest that the use of rifaximin in patients with traveler's diarrhea and latent infection of Mycobacterium tuberculosis and Neisseria meningitidis will not be accompanied by the selection of rifampicin-resistant strains.

Sensitivity

In vitro susceptibility testing cannot be used to determine the sensitivity or resistance of bacteria to rifaximin. Currently, there is insufficient clinical data to establish limits for evaluating sensitivity tests. Rifaximin was evaluated in vitro against pathogens of traveler's diarrhea from four regions of the world: enterotoxigenic and enteroaggregate strains of E. coli, Salmonella spp., Shigella spp., Non-cholera vibrios, Plesiomonas spp., Aeromonas spp. and Campylobacter spp. MPC90 (minimum inhibitory concentration) for the isolated strains was 32 μg / ml, and this level is easily achievable in the intestinal lumen as a result of the high concentration of rifaximin in the feces. Since rifaximin in polymorphic alpha has low absorption from the digestive tract and acts locally in the intestinal lumen, it may be clinically ineffective against invasive bacteria, even if these bacteria are sensitive to it in vitro.

Pharmacokinetics

Absorption

Rifaximin in polymorphic form alpha is practically not absorbed when taken orally (less than 1%). With repeated use in healthy volunteers and in patients with damaged intestinal mucosa, with inflammatory bowel diseases, the plasma concentration is very low (less than 10 ng / ml). When using the drug 30 minutes after ingestion of fatty foods, an increase in the systemic absorption of rifaximin, not having clinical significance, was noted.

Distribution of

Rifaximin binds moderately to plasma proteins. Communication with proteins in healthy volunteers is 67.5%, and in patients with liver failure 62%.

Excretion

It is excreted unchanged by the intestines (96.9% of the dose taken), as it does not undergo degradation and metabolism when passing through the gastrointestinal tract. Detected by labeled isotopes in urine, rifaximin is not more than 0.025% of the oral dose. Less than 0.01% of the dose is excreted by the kidneys as 25-deacetylrifaximin, the only metabolite of rifaximin identified in humans. Kidney excretion of 14C rifaximin does not exceed 0.4%. Non-linear system exposure dose-dependent, which is comparable to the absorption of rifaximin, possibly a limited dissolution rate.

Special patient groups

With renal failure

There are no clinical data on the use of rifaximin in renal failure.

With liver failure

Systemic exposure in patients with liver failure is greater than that in healthy volunteers. An increase in systemic exposure in these patients should be considered in light of the local effect of rifaximin in the intestine and its low systemic bioavailability, as well as the available data on the safety of rifaximin in patients with cirrhosis.

Children

The pharmacokinetics of rifaximin in children has not been studied.

Indications

Treatment of gastrointestinal infections caused by bacteria that are susceptible to rifaximin, for example, with acute gastrointestinal tract syndromes and acute gastrointestinal infections microorganisms in the intestine, hepatic encephalopathy, symptomatic uncomplicated diverticular disease of the colon and chronic intestinal inflammation.

Prevention of infectious complications in colorectal surgery.

Contraindications

- Hypersensitivity to rifaximin or other rifamycins or to any of the components that make up the drug.

- Diarrhea accompanied by fever and loose stools with blood.

- Intestinal obstruction (including partial).

- Severe intestinal ulceration.

- Children under 12 years of age (efficacy and safety not established).

- Hereditary fructose intolerance, malabsorption of glucose-galactose, insufficiency of sucrose-isomaltase (for the dosage form of a granule for the preparation of a suspension for oral administration).

Precautions

Renal failure, concomitant use with oral contraceptives, concomitant use with a P-glycoprotein inhibitor such as cyclosporine.

Composition

Each film-coated tablet contains:

Active ingredient:

rifaximin with a polymorphic structure of alpha 200 mg.

Excipients: sodium carboxymethyl starch 15 mg, glyceryl palmitostearate 18 mg, colloidal silicon dioxide 1 mg, talc 1 mg, microcrystalline cellulose 115 mg. Film sheath: hypromellose 5.15 mg, titanium dioxide (E171) 1.5 mg, disodium edetate 0.02 mg, propylene glycol 0.5 mg, red oxide red (E172) 0.15 mg.

Dosage and administration

Take orally with a glass of water, regardless of food intake.

Treatment of diarrhea

Adults and children over 12 years of age: 1 tablet of 200 mg or 10 ml of suspension (equivalent to 200 mg of rifaximin) every 6 hours. Treatment of traveler's diarrhea should not exceed 3 days.

Hepatic encephalopathy:

Adults and children over 12 years of age: 2 tablets of 200 mg or 20 ml

suspension (equivalent to 400 mg of rifaximin) every 8 hours. Prevention of postoperative complications in colorectal surgery:

Adults and children over 12 years of age: 2 tablets of 200 mg or 20 ml of suspension (equivalent to 400 mg of rifaximin) every 12 hours.

Prevention is carried out 3 days before surgery.

Overgrowth syndrome:

Adults and children over 12 years of age: 2 tablets of 200 mg every 8-12 hours.

Symptomatic uncomplicated diverticulosis:

Adults and children over 12 years of age: 1-2 tablets of 200 mg or 10 to 20 ml of suspension (equivalent to 200 to 400 mg of rifaximin) every 8-12 hours.

Chronic inflammatory bowel disease:

Adults and children 12 years of age and older: 1-2 tablets of 200 mg or 10 to 20 ml of suspension (which is equivalent to 200 to 400 mg of rifaximin) every 8-12 hours.

The duration of treatment with Alpha Normix should not exceed 7 days. A second course of treatment should be carried out no earlier than 20 to 40 days later. The total duration of treatment is determined by the clinical condition of the patients. On the recommendation of a doctor, the dose and frequency of their administration can be changed.

Dose adjustment in elderly patients and in patients with hepatic and renal failure is not required.

Preparation of suspension

Granules for preparation of suspension for oral administration are in a hermetically sealed vial. To prepare the suspension,

needs to open the bottle, add water to the mark and shake the bottle well. Add water repeatedly until until the suspension reaches the indicated level of 60 ml.

The concentration of rifaximin in the prepared suspension is 100 mg in 5 ml. Shake the suspension well before use. Measure the finished suspension with the measuring cup available in the package.

Side effects

Side effects are classified by frequency of occurrence as follows: very often (? 1/10), often (? 1/100 -? 1/10), infrequently (? 1/1000 -? 1/100), rarely (? 1/10000 -? 1/1000), very rarely (? 1/10000), unknown (frequency cannot be set based on available data).

From the cardiovascular system:

Infrequently: palpitations, flushing of the face, increased blood pressure.

Blood side:

Infrequently: lymphocytosis, monocytosis, neutropenia.

Unknown: thrombocytopenia.

On the part of the immune system:

Unknown: anaphylactic reactions, hypersensitivity, anaphylactic shock, laryngeal edema.

Metabolic disorders:

Infrequently: loss of appetite, dehydration.

Mental disorders:

Infrequently: pathological dreams, depressed mood, insomnia, nervousness.

From the central nervous system:

Often: dizziness, headache.

Infrequently: hypesthesia, migraine, paresthesia, drowsiness, headache in the sinus area.

Unknown: fainting state, arousal.

On the part of the organ of vision:

Infrequently: diplopia.

From the inner ear:

Infrequently: earache, systemic dizziness.

Respiratory:

Infrequently: shortness of breath, dry throat, nasal congestion, pain in the oropharynx, cough, rhinorrhea.

From the gastrointestinal tract and liver:

Often: bloating, abdominal pain, constipation, diarrhea, flatulence, nausea, tenesmus, vomiting, urge to defecate.

Infrequently: pain in the upper abdomen, ascites, dyspepsia, impaired gastrointestinal motility, mucus and blood secretion with stools, dry lips, “hard” stools, increased activity of aspartate aminotransferase, agevezia.

Unknown: impaired liver function tests, heartburn.

From the urinary system:

Infrequently: glucosuria, polyuria, pollakiuria, hematuria, proteinuria.

From the skin and subcutaneous fat:

Infrequently: rash, sunburn.

Unknown: angioedema, allergic dermatitis, exfoliative dermatitis, eczema, erythema, pruritus, purpura, urticaria, erythematous rash, erythema of the palms, genital itching.

From the musculoskeletal system:

Infrequently: back pain, muscle spasm, muscle weakness, myalgia, neck pain.

Infections:

Infrequently: candidiasis, herpes simplex, nasopharyngitis, pharyngitis, upper respiratory tract

infections.

Unknown: clostridial infection.

Reproductive system disorders:

Infrequently: polymenorrhea.

Common symptoms:

Often: fever.

Infrequently: asthenia, pain and unpleasant sensations of uncertain localization, chills, cold sweat, flu-like symptoms, peripheral edema, hyperhidrosis, facial edema, fatigue.

Laboratory Research: Changing the International Normalized Relationship.

Drug interaction

In vitro studies show that rifaximin does not inhibit isoenzymes of the cytochrome P-450 system (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4) and does not induce CYP1B6, but not induces CYP1A2 and CYP3A4. Clinical studies of drug interactions suggest that in healthy volunteers, rifaximin does not have a significant effect on the pharmacokinetics of drugs metabolized with CYP3A4. In patients with impaired liver function, it cannot be ruled out that rifaximin can reduce the exposure of drugs to CYP3A4 substrates (for example, warfarin, antiarrhythmic, anticonvulsants, etc.) when used simultaneously, since it has a higher systemic exposure compared to liver failure with healthy volunteers.

In patients who continued to take warfarin and rifaximin, a decrease and increase in the international normalized ratio (in some cases with bleeding episodes) were recorded. If co-administration is necessary, careful monitoring of the international normalized relationship at the beginning and at the end of treatment should be carried out. To maintain the desired level of anticoagulation, it may be necessary to select a dose of oral anticoagulants.

In vitro studies suggest that rifaximin is a moderate substrate of P-glycoprotein and is metabolized by the CYP3A4 isoenzyme.

It is not known whether systemic exposure to rifaximin is increased by drugs that inhibit CYP3A4 while used with it.

In healthy volunteers, co-administration of a single dose of cyclosporin (600 mg), a potent inhibitor of P-glycoprotein, and a single dose of rifaximin (550 mg) resulted in an 83-fold and 124-fold increase in the mean values ​​of Cmax and AUC? rifaximin. The clinical relevance of this increase to systemic exposure is not known.

Potential interactions of rifaximin with other drugs that are excreted from the cell using P-glycoprotein or other transport proteins (MRP2, MRP4, BCRP, BSEP) are unlikely.

Overdose of

According to clinical studies, doses of rifaximin up to 1800 mg / day were well tolerated in patients with traveler's diarrhea.

Even in patients with normal bacterial intestinal flora, rifaximin at a dose of up to 2400 mg / day for 7 days did not cause adverse symptoms. In case of accidental overdose, symptomatic and supportive therapy is indicated.

Storage conditions

Keep out of the reach and sight of children, at temperatures not exceeding 30 ° C.

Deystvuyuschee substances

Ryfaksymyn

Form of Treatment

tablets

Appointment by

Children by doctor's appointment, Adults by doctor's appointment, Corms over 11 years

Indications

Diarrhea, Colitis, Salmonella, Intestinal infections, Poisoning

Possible product names

ALPHA NORMIX 0.2 N36 TABLE P / O

Alpha Normix 200mg Tab. p / pl / rev X36

Alpha Normix 200mg No. 36 tab

ALFA NORMIX 200MG. No. 36 TAB. P / O

ALFA NORMIX TAB. P.P.O. 200MG No. 36

Alfasigma S.p.A., Italy



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