Alpha нормикс

Alpha нормикс – the antibiotic of a broad spectrum of activity belonging to group of Rifamycinum.

Form of release and structure

• Tablets, film coated: round, biconvex, pink color (on 12 pieces in the blister, 1 blister in a cardboard pack);
• Granules for preparation of suspension for intake: orange color, with a smell and taste of cherry (wild sweet cherry) (in the bottles from dark glass closed by the aluminum screwing-up cap, 1 bottle complete with a measured cup in a cardboard pack).

Active agent – рифаксимин with polymorphic structure an alpha:

• 1 tablet – 200 mg;
• 1 bottle of granules (60 ml) – 1200 mg, i.e. in 1 ml of suspension – 20 mg.

Additional components of tablets:

• Excipients: glyceryl пальмитостеарат, sodium carboxymethylstarch, cellulose microcrystallic, talc, silicon dioxide colloid;
• Structure of a cover: titanium dioxide (E171), propylene glycol, dinatrium эдетат, gipromelloza, iron oxide red (Е 172).

Auxiliary components of granules: karmelloza of sodium, sucrose, kaolin, pectin, cellulose microcrystallic, Natrium benzoicum, sodium saccharinate, fragrance cherry (wild sweet cherry).

Indications to use

Alpha нормикс – drug for treatment of the gastrointestinal infections caused by microorganisms, sensitive to a rifaksimin, including:

• Diarrhea of travelers;
• Chronic inflammation of intestines;
• Syndrome of excess growth of microorganisms in intestines;
• Symptomatic uncomplicated divertikulezny disease of a colon;
• Acute gastrointestinal infections;
• Hepatic encephalopathy.

Also the Alpha нормикс is applied to prevention of infectious complications when carrying out colorectal surgical interventions.

Contraindications

• Children's age up to 12 years;
• Period of pregnancy and lactation;
• Intestinal impassability, including partial;
• The diarrhea which is followed by fever and a liquid chair with blood;
• Heavy canker of intestines;
• Glucose galactose absorption disturbance, hereditary intolerance of fructose, insufficiency of invertase-isomaltase (for granules);
• Hypersensitivity to drug components.

With care:

• Renal failure;
• Use of oral contraceptives.

Route of administration and dosage

Alpha нормикс it is necessary to accept inside, washing down with a large amount of water (200 ml). Meal does not influence efficiency of drug.

From granules prepare suspension. For this purpose to a mark add water to a bottle and well stir up. If necessary add a little more water until the level of suspension reaches a point of 60 mg. Before reception drug should be shaken up well. For convenience of dosing the measured cup is provided in a set.

The recommended dosages depending on indications:

• Diarrhea: on 1 tablet or 10 ml of suspension each 6 hours;
• Syndrome of excess bacterial growth: on 2 таб. each 8-12 hours;
• Hepatic encephalopathy: on 2 таб. or 20 ml сусп. each 8 hours;
• Chronic inflammatory diseases of intestines, symptomatic uncomplicated divertuculosis: on 1-2 таб. or 10-20 ml сусп. each 8-12 hours.

In some cases the doctor can change a dose and/or frequency of reception.

At diarrhea of travelers duration of treatment should not exceed 3 days, in other cases – 7 days. If necessary with an interval of 20-40 days carry out a repeated course of treatment.

For prevention of post-operational complications at colorectal surgical interventions appoint 2 tablets or 20 ml of suspension each 12 hours in 3 days prior to operation.

Side effects

• From the central nervous system: often (> 1/100 - <1/10) – a headache, dizziness; infrequently (> 1/1000 - <1/100) – a headache in nose bosoms, migraine, drowsiness, paresthesia, a hypesthesia; frequency is unknown – excitement, a preunconscious state;
• Mental disturbances: infrequently – sleeplessness, depressive mood, nervousness, pathological dreams;
• From digestive tract and a liver: often – desires on defecation, diarrhea, a lock, tenesmus, an abdominal pain, a meteorism, abdominal distention, nausea, vomiting; infrequently – dryness of lips, ascites, pain in an upper half of a stomach, an ageusia, mucifying and blood with a chair, disturbance of motility of digestive tract, dyspepsia, a "firm" chair, increase in activity of aspartate aminotransferase; frequency is unknown – heartburn, disturbance of hepatic functional tests;
• From skin and a hypodermic fatty tissue: infrequently – a sunblister, rash; frequency is unknown – exfoliative dermatitis, allergic dermatitis, eczema, erythematic rash, a purpura, an erythema of palms, urticaria, an itch, an erythema, a Quincke's disease, an itch of generative organs;
• Metabolic disturbances: infrequently – dehydration, a loss of appetite;
• From immune system: it is unknown – hypersensitivity, throat hypostasis, anaphylactic reactions, an acute anaphylaxis;
• From cardiovascular system: infrequently – increase in arterial pressure, rushes of blood to face skin, a heart consciousness;
• From a musculoskeletal system: infrequently – a mialgiya, muscular weakness, a dorsodynia, neck pain, a muscular spasm;
• From an urinary system: infrequently – a polyuria, a glucosuria, a pollakiuria, a proteinuria, a hamaturia;
• From an organ of sight: infrequently – a diplopia;
• From blood: infrequently – a neutropenia, a monocytosis, a lymphocytosis; it is unknown – thrombocytopenia;
• From reproductive system: infrequently – a polymenorrhea;
• From a respiratory organs: infrequently – dryness in a throat, cough, pain in a stomatopharynx, a rhinorrhea, a nose congestion, an asthma;
• From an inner ear: infrequently – a rotatory vertigo, ear pain;
• Infections: infrequently – pharyngitis, a nasopharyngitis, candidiasis, upper respiratory tract infections, a herpes simplex; it is unknown – a klostridialny infection;
• Laboratory researches: change INR (the international normalized relation);
• General symptoms: often – fever; infrequently – a fever, grippopodobny symptoms, cold sweat, fatigue, an adynamy, a face edema, peripheral hypostases, a hyperhidrosis, pain and unpleasant feelings of uncertain localization.

Special instructions

According to clinical data, the Alpha нормикс it is inefficient at the intestinal infections caused by Shigella spp, Salmonella spp., Campylobacter jejuni which cause fever, diarrhea and release of blood with a chair.

If within 48 hours symptoms of diarrhea amplify or remain, it is necessary to cancel the Alpha нормикс and to appoint other antibacterial therapy. The same concerns cases of development of the superinfection caused by microorganisms, insensitive to a rifaksimin.

As well as at use practically of all other antibacterial agents, during treatment the Alpha normiksy development of the diarrhea associated with Clostridium difficile is possible. It is impossible to exclude potential probability of development of pseudomembranous colitis.

Rifaksimin can paint urine in red color.

Owing to influence on an indestinal flora рифаксимин can reduce efficiency of the oral contraceptives containing estrogen (especially in concentration less than 50 mkg) therefore during treatment it is recommended to use additional measures of contraception.

At the combined use with absorbent carbon the Alpha нормикс it is necessary to accept not earlier than in 2 hours after it.

Drug in certain cases can cause drowsiness and dizziness. Such patients should refrain from driving and performance of potentially dangerous types of works.

Medicinal interaction

At patients with abnormal liver functions рифаксимин, presumably, can reduce exposure of medicines of CYP3A4 substrates, for example, of anticonvulsant and antiarrhythmic drugs, warfarin.

Terms and storage conditions

To store at a temperature up to 30 ºС in the place, unavailable to children.

Period of validity – 3 years.

The suspension prepared from granules can be stored within 7 days at the room temperature (to 30 ºС).