Alpha normix® (Alfa normix® )

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceRifaximinRifaximin
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  • Alpha normix®
    pills inwards 
    Alfa Wassermann SpA     Italy
  • Alpha normix®
    granules inwards 
    Alfa Wassermann SpA     Italy
    • Dosage form: & nbsp
    Granules for preparation of suspension for oral administration
    Composition:

    Granules for the preparation of a suspension for oral administration in 1 bottle (60 ml) contain:

    Active substance: rifaximin with a polymorphic structure of alpha 1.2 g.

    Excipients: cellulose microcrystalline 70 mg, carmellose sodium 710 mg, pectin 780 mg, kaolin 4.002 g, sodium saccharinate 60 mg, sodium benzoate 36 mg, sucrose 17,280 g, cherry flavor 240 mg.

    Description:
    Granules of orange color with a smell and taste of cherry (wild cherry).
    Pharmacotherapeutic group:Antibiotic, rifaximin
    ATX: & nbsp

    A.07.A.A   Antibiotics

    A.07.A.A.11   Rifaximin

    Pharmacodynamics:

    Rifaximin is a broad-spectrum antibiotic from the rifamycin group. Like other representatives of this group, irreversibly binds the beta subunit of the enzyme bacteria of DNA-dependent PEC polymerase and, consequently, 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 drug has a broad spectrum of antimicrobial activity, including the majority of gram-negative and gram-positive, aerobic and anaerobic bacteria.

    The broad 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 that, in the case of severe liver disease accompanied by a detoxification process, play a role in the pathogenesis and clinical manifestations of hepatic encephalopathy;

    - increased bacterial proliferation in the syndrome of excessive growth of microorganisms in the intestine;

    - the presence of bacteria in the diverticulum of the colon that can cause inflammation inside and around the diverticulum sac and may play a key role in the development of the symptoms and complications of diverticular disease;

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

    - the risk of infectious complications in colorectal surgical interventions.

    The mechanism of resistance

    The development of resistance to rifaximin is due to the reversible damage of the gene, which encodes the bacterial RNA polymerase. The occurrence of resistant subpopulations among bacteria isolated from patients with traveler's diarrhea was low. According to clinical studies, a three-day course therapy with rifaximin in patients with traveler's diarrhea was not accompanied by the appearance of resistant Gram-positive (enterococci) and Gram-negative (E. coli) bacteria. With the repeated use of rifaximin in high doses in healthy volunteers and in patients with inflammatory intestinal diseases resistant Rifaximin strains appeared, however, they did not colonize the gastrointestinal tract (GIT) and did not displace rifaximin-sensitive strains.

    When termination of resistant therapies the 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 sensitivity testing can not be used to determine the sensitivity or resistance of bacteria to rifaximin. Currently, clinical data is not sufficient to establish limits for the evaluation of sensitivity tests. Rifaximin were evaluated in vitro against pathogens of traveler from four regions of the world: enterotoxigenic and enteroaggregative strains of E. coli, Salmonella spp., Shigella spp., noncholerous vibrios, Plesiomonas spp., Aeromonas spp. and Campylobacter spp. IPC90 (minimum inhibitory concentration) for isolated strains was 32 μg / ml, and this level is easily attainable in the lumen of the intestine as a result of high concentrations of rifaximin in the feces. Because the rifaximin in polymorphic form, alpha has a low absorption from the gastrointestinal tract and acts locally in the lumen of the intestine, it can be is clinically ineffective against invasive bacteria, even if these bacteria are sensitive to it in vitro.

    Pharmacokinetics:

    Suction

    Rifaximin in polymorphic form of alpha is practically not absorbed when taken orally (less than 1%). With repeated use in healthy volunteers and patients with a 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 the intake of fatty foods, a clinically significant increase in systemic absorption of rifaximin was noted.

    Distribution

    Rifaximin moderately binds to plasma proteins. The connection with proteins in healthy volunteers is 67.5%, and in patients with hepatic New edition insufficiency of 62%.

    Excretion

    It is excreted from the body in unchanged intestine (96.9% of the adopted dose), since not degraded and metabolism during passage through the digestive tract. Detectable with using labeled isotopes in urine, rifaximin is not more than 0.025% of the dose taken internally. Less than 0.01% of the dose is excreted kidney in the form of a 25- deacetyltrifaximin, the onlymetabolite of rifaximin, identified in humans. Kidney excretion 14C rifaximin does not exceed 0.4%. Systemic exposure nonlinear, dose-dependent, which is comparable to absorption of rifaximin, possibly limited dissolution rate.

    Special patient groups

    With renal insufficiency

    There are no clinical data on rifaximin renal failure.

    With hepatic insufficiency

    Systemic exposure in patients with hepatic insufficiency exceeds that of healthy volunteers. Increase system exposure of these patients should be considered in light of local action rifaximin in the intestine and its low systemic bioavailability, as well as available data on rifaximin patients with cirrhosis of the liver.

    Children

    Pharmacokinetics of rifaximin y children have not been studied.

    Indications:Treatment of gastrointestinal infections caused by bacteria sensitive to rifaximin, for example, in acute gastrointestinal infections, traveler's diarrhea, the syndrome of excessive growth of microorganisms in the intestine, hepatic encephalopathy, symptomatic uncomplicated diverticulosis of the colon and chronic inflammation of the intestine.

    Prevention of infectious complications in colorectal surgery.

    Contraindications:

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

    - Diarrhea accompanied by fever and stools with blood.

    - Intestinal obstruction (including partial obstruction).

    - Severe ulcerative bowel disease.

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

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

    Carefully:
    Renal failure, concomitant use with oral contraceptives.
    Pregnancy and lactation:Data on the use of Alpha Normix during pregnancy are very limited. Animal studies have shown the transient effect of rifaximin on ossification and skeletal structure in the fetus. The clinical significance of these results is unknown.

    The use of Alpha Normix during pregnancy is not recommended. It is not known whether the rifaximin in breast milk. It is impossible to exclude the risk for a child who is breastfed. To decide whether to continue taking rifaximin during breastfeeding, it is necessary to assess the risk-to-child ratio and benefit for the mother.

    Dosing and Administration:Take ingestion with a glass of water, regardless of food intake.

    Treatment of diarrhea

    Adults and children over 12 years of age: 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: 20 ml suspension (equivalent to 400 mg rifaximin) every 8 hours.

    Prevention postoperative complications in colorectal surgical interventions

    Adults and children over 12 years of age: 20 ml suspension (which is equivalent to 400 mg of rifaximin) every 12 hours. Prevention is carried out 3 days before operation.

    Symptomatic uncomplicated diverticulosis:

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

    Chronic inflammatory bowel diseases:

    Adults and children over 12 years of age: 10 to 20 ml of suspension (equivalent to 200400 mg of rifaximin) every 8-12 hours.

    Duration of treatment Alpha Normix should not exceed 7 days. A repeat course of treatment should be carry out no earlier than 20 to 40 days. Total duration treatment is determined by clinical patients. By doctor's recommendations may be the dose and frequency of the reception were changed.

    Correction of dose in elderly patients age and in patients with hepatic and renal failure is not it takes.

    Preparation of the suspension

    Granules for the preparation of suspension for ingestion are in hermetically sealed vial. For preparation of the suspension is necessary open the vial, add water before label and shake well. Add water repeatedly, until the suspension level is will reach the specified level of 60 ml. The concentration of rifaximin in the prepared suspension is 100 mg in 5 ml. Shake well before use. Measure the finished suspension with a measuring cup in the package.

    Side effects:

    Side effects are classified according to 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), is unknown (the frequency can not be set based on the available data).

    From the cardiovascular system:

    Infrequently: heart palpitations, "hot flashes" of blood to the skin of the face, increased blood pressure.

    From the side of the blood:

    Infrequently: lymphocytosis, monocytosis, neutropenia.

    Unknown: thrombocytopenia.

    From the immune system:

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

    Metabolic disorders:

    Infrequently: decreased appetite, dehydration.

    Mental disorders:

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

    From the central nervous system:

    Often: dizziness, headache pain.

    Infrequently: hypoesthesia, migraine. paresthesia, drowsiness, headache in the area of ​​the sinuses of the nose.

    Unknown: pre-occult condition, agitation.

    From the side of the organ of vision:

    Infrequently: diplopia.

    From the inner ear:

    Infrequently: pain in the ear, systemic dizziness.

    On the part of the respiratory system:

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

    From the gastrointestinal side tract and liver:

    Often: bloating, pain in the stomach, constipation, diarrhea, flatulence, nausea, tenesmus, vomiting, urge for defecation.

    Infrequently: pain in the upper half abdomen, ascites, dyspepsia, violation of motility of the gastro-

    intestinal tract, mucus and blood with a stool, dry lips, "hard" stool, enhancement activity aspartate aminotransferase, agvezia.

    Unknown: hepatic impairment functional tests, heartburn.

    From the urinary system:

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

    From the side of the skin and subcutaneous-fatty tissue:

    Infrequently: rash, sunburn.

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

    From the side of the locomotor system apparatus:

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

    Infections:

    Infrequently: Candidiasis, herpes simplex, nasopharyngitis, pharyngitis, infections upper respiratory tract.

    Unknown: clostridial infection.

    On the part of reproductive system:

    Infrequently: polymenorrhea.

    Common symptoms:

    Often: fever.

    Infrequently: asthenia, pain and unpleasant feelings of uncertainty localization, chills, cold sweat, influenza-like symptoms, peripheral edema, hyperhidrosis, swelling of the face, fatigue.

    Laboratory research:

    change in international normalized relationship.

    Overdose:
    According to clinical studies,in patients with traveler's diarrhea rifaximin doses up to 1800 mg / day were well tolerated. Even in patients with normal bacterial intestinal flora rifaximin in a dose up to 2400 mg / day for 7 days did not cause adverse symptoms. In case of an accidental overdose, symptomatic and supportive therapy is indicated.
    Interaction:
    In vitro studies show that rifaximin does not inhibit isozymes of cytochrome P450 (CYP1A2, 2A6, 2B6, 2S8, 2S9, 2C19, and 3A4 2D6,2E1) and does not induce CYP 1A2 and CYP2B6, but a weak inducer of CYP3A4. Clinical studies of drug interactions indicate that in healthy volunteers rifaximin no significant effect on the pharmacokinetics of drugs metabolized involving CYP3A4. In patients with impaired liver function, it can not be ruled out that rifaximin can reduce the exposure of drugs to substrates CYP3A4 (for example, warfarin, Antiarrhythmics, anticonvulsants etc.), while the use of them, as in hepatic failure has a higher systemic exposure when compared to healthy volunteers.In vitro studies suggest that rifaximin is a moderate substrate of the P-glycoprotein and is metabolized by the CYP3 A4 isoenzyme. It is not known whether rifaximin systemic exposure enhances drugs that inhibit P-glycoprotein and / or CYP3A4 when used concomitantly with it. Potential interactions of rifaximin with other drugs that are cleared from the cell by P-glycoprotein or other transport proteins (MDR1, MRP2 MRP4, BCRP, BSEP) are unlikely.
    Special instructions:

    Clinical evidence suggests that Alfa Normix® is ineffective in treating intestinal infections caused by Campylobacter jejuni, Salmonella spp., Shigella spp, which cause frequent diarrhea, fever, and blood and stool production. The drug Alpha Normix® is not recommended if patients have fever and a loose stool with blood. The drug Alpha Normix® should be discontinued if symptoms of diarrhea are worse or persist for more than 48 hours. Other antibacterial therapy should be prescribed. Treatment of traveler's diarrhea should not exceed 3 days.

    It is known that Clostridium difficile-associated diarrhea, can develop with the use of almost all antibacterial agents, including the drug Alpha Normix®. The potential relationship of the Alpha Normix® preparation to the development of Clostridium difficile-associated diarrhea and pseudomembranous colitis can not be ruled out. The experience of rifaximin with other rifamycins is absent. Patients should be warned that, despite the slight absorption of rifaximin (less than 1%), it can cause urine staining to reddish: this is due to the active substance rifaximin, which, like most antibiotics of this series (rifamycin), has a reddish-orange color. With the development of superinfection with microorganisms insensitive to rifaximin, the use of Alpha Normix® should be discontinued and appropriate therapy prescribed. Due to the influence of Alpha Normix® on intestinal flora, the effectiveness of oral contraceptives containing estrogens may decrease after its administration. It is recommended to use additional measures of contraception when taking the drug Alpha Normix®, especially if the content of estrogens in oral contraceptives is less than 50 μg. The preparation of Alpha Normix® is possible not earlier than 2 hours after the reception of activated carbon.Granules for the preparation of the suspension for oral administration contain sucrose, therefore the preparation of Alpha Normix® in this dosage form can not be used with hereditary fructose intolerance, impaired absorption of glucose-galactose, insufficiency of sucrose-isomaltase.

    Effect on the ability to drive transp. cf. and fur:Although dizziness and drowsiness are observed with Alfa Normix®, however, it has no significant effect on the ability to drive vehicles and engage in activities requiring increased attention and speed of psychomotor reactions. In case of occurrence of dizziness and drowsiness at application of a preparation, it is necessary to refrain from performance of the specified kinds of activity.
    Form release / dosage:

    Granules for the preparation of a suspension for oral administration 100 mg / 5ml.

    Packaging:

    A bottle of dark glass covered with an aluminum screw cap, together with a measuring cup and instructions for use in a cardboard bundle.

    Storage conditions:
    At a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    Shelf life of the prepared suspension: 7 days at room temperature not higher than 30 ° С.

    Do not use after the time specified on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001994
    Date of registration:31.08.2010 / 24.07.2014
    Expiration Date:Unlimited
    The owner of the registration certificate:Alfa Wassermann SpAAlfa Wassermann SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspALPHA VASSERMANN LLC ALPHA VASSERMANN LLC Italy
    Information update date: & nbsp16.07.2017
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