Pylobact® (Pilobact®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsptablets and capsules set
Composition:

Omeprazole, capsules, 20 mg

One capsule contains:

active substance: omeprazole 20 mg;

Excipients: Non Pareil seeds 61.5 mg, lactose 80 mg, corn starch 5 mg, mannitol 30 mg, povidone 15 mg, talc purified 14.5 mg, sodium lauryl sulfate 1.1 mg, sodium cyanide, sodium hydrophosphate (anhydrous) 4.5 mg;

enteric coating material: hypromellose phthalate 32 mg, dichloromethane q.s., isopropanol q.s., diethyl phthalate 5 mg, titanium dioxide 1.4 mg, shell of empty hard gelatin capsule size 2 with a blue lid and a transparent pink body 3.25 mg;

Lid (blue): dye carmozine (azorubin) - 0.0107 mg, dye brilliant blue 0.1072 mg, methylparahydroxybenzoate 0.1372 mg, propyl parahydroxybenzoate 0.0343 mg, gelatin - 21,4327 mg.

body (transparent pink): dye carmozine (azorubin) 0.0098 mg, methyl parahydroxybenzoate 0.2096 mg, propyl parahydroxybenzoate 0.0523 mg, gelatin 32.7456 mg.

Clarithromycin, film-coated tablets, 250 mg

One tablet contains:

active substance: clarithromycin 250 mg;

Excipients: cellulose microcrystalline 101.5 mg, povidone 17.5 mg, croscarmellose sodium 30.5 mg, magnesium stearate 6.5 mg, stearic acid 11 mg, talc purified 7 mg, silicon dioxide colloid 6 mg;

film sheath: hypromellose 8.45 mg, giprolose 1.65 mg, propylene glycol 3.18 mg, sorbitan oleate 1.37 mg, titanium dioxide 1.95 mg, lacquer yellow 0,087 mg, vanillin 1,95 mg, talc purified 1.37 mg;

ink composition for the inscription Opacode S-1-17823: glazed shellac 45% (20% esterified) in ethanol 44.467% mass / mass, iron dye oxide black 23,409% w / w, isopropanol 26.882% w / w, n-butyl alcohol 2.242% mass / mass, propylene glycol 2,000%, mass / weight, ammonium hydroxide 28% - 1,000% mass / mass.

* evaporates and is not present in the final product

Tinidazole, film-coated tablets, 500 mg

One tablet contains:

active substance: tinidazole 500 mg;

Excipients: cellulose microcrystalline 45 mg, starch corn 63 mg, croscarmellose sodium 12 mg, silicon dioxide colloid 6 mg, magnesium stearate 7 mg;

film sheath: fall off OY-L-58900 (white): hypromellose 3.36 mg, titanium dioxide 3.12 mg, macrogol 4000 1.2 mg, lactose 4.32 mg.

Description:

Omeprazole. Hard caps with a "lock" size "2" with a blue lid and a transparent pink body, containing white or almost white spherical pellets / granules, coated with an enteric coating.

Clarithromycin. Tablets of light yellow color, oval, biconcave, covered with a film membrane, with a black ink printed on it "CLT" on one side.

Tinidazole. White to almost white, biconvex oval-shaped tablets, covered with a film shell with an engraving "TZT"on one side.

Pharmacotherapeutic group:peptic ulcer treatment
ATX: & nbsp
  • Combinations of drugs for eradication of Helicobacter pylori
    • Pharmacodynamics:

    Omeprazole oppresses the secretion of gastric acid due to specific inhibition of H+TO+-ATPase - an enzyme located in the membranes of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion irrespective of the nature of the stimulus. After a single intake of the drug, omeprazole acts within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.

    Clarithromycin - semisynthetic antibiotic from the group of macrolides of a wide spectrum of action. Has antimicrobial effect, which is associated with the suppression of protein synthesis by interacting with 50S ribosomal subunit of the microbial cell.Effective against a large number of Gram-positive, Gram-negative aerobic and anaerobic microorganisms, including H.Pylori. The metabolite 14-hydroxyclarithromycin formed in the body also has a pronounced antimicrobial activity.

    Tinidazole inhibits synthesis and damages the structure of bacterial DNA. Has activity against anaerobic bacteria, protozoa and H.Pylori.

    Pharmacokinetics:

    All three preparations included in the composition of Pylobact® have good absorption by oral administration.

    Omeprazole quickly absorbed after ingestion, and its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. The maximum concentration of the drug in plasma (FROMmax) is achieved after 0.5-1 hour. The connection with plasma proteins is 90%. It is almost completely metabolized in the liver. The main way of excretion is with urine (80%).

    Clarithromycin quickly absorbed from the gastrointestinal tract. The absolute bioavailability of 250 mg of clarithromycin is approximately 50%. Food intake slightly slows the onset of absorption of clarithromycin and the formation of 14-hydroxyclarithromycin, but does not affect bioavailability.When taken on an empty stomach, peak serum concentrations are reached within 2 hours after oral administration and are 0.6 and 0.7 μg / ml for clarithromycin and its main metabolite. The half-life of clarithromycin is 3-4 hours. Clarithromycin widely distributed in the body. The concentration of clarithromycin in tissues exceeds that in serum. The connection with proteins ranges from 42% to 70%. It is excreted by the kidneys and with fecal masses (20-30% in unchanged form, the rest in the form of metabolites).

    The simultaneous administration of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the mean FROMmax increases by 10%, the minimum concentration - by 15% compared with the same parameters for monotherapy with clarithromycin. The concentration of clarithromycin in the gastric mucosa while concomitantly administered with omeprazole is also increased.

    Bioavailability Tinidazole - about 100%. Connection with plasma proteins - 12%. The time to reach the maximum concentration is 2 hours. Penetrates through the blood-brain barrier, the placenta. Excreted in breast milk. Metabolised in the liver with the formation of pharmacologically active hydroxylated derivatives, which can enhance the action of tinidazole. The half-life is 12-14 hours.It is excreted with bile - 50%, kidneys - 25% unchanged and 12% in the form of metabolites. It is reversed in the renal tubules.

    Indications:

    Eradication therapy N. Pylori with duodenal ulcer.

    Contraindications:

    - Hypersensitivity to omeprazole, clarithromycin or tinidazole, as well as antibiotics of the macrolide group;

    - Combined use with cisapride, pimozide, astemizole, terfenadine, ethanol is prohibited (see section "Interaction with other drugs");

    - pregnancy;

    - lactation period;

    - organic diseases of the central nervous system;

    - porphyria;

    - oppression of bone marrow hematopoiesis;

    - childhood;

    - renal and / or liver failure.

    Dosing and Administration:

    Each strip containing tablets and capsules of the Pylobacter® kit is designed for one day of treatment and consists of two parts: yellow with the inscription "morning" and blue with the inscription "evening".

    In the morning reception during or after a meal, you should take the contents of the "morning" part completely (one capsule of omeprazole, one tablet of tinidazole and one tablet of clarithromycin).

    In the evening reception during or after a meal should take the contents of the "evening" in full (one capsule of omeprazole, one tablet of tinidazole and one tablet clarithromycin).

    Tablets and capsules can not be broken and chewed, they should be swallowed whole. Duration of treatment is 7 days

    Side effects:

    On the part of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, "metallic" aftertaste in the mouth, reduced appetite, stomatitis, transient increase in "liver" enzymes in plasma, the liver, hepatitis (including jaundice), in patients with previous liver disease - encephalopathy; rarely - pseudomembranous enterocolitis.

    From the nervous system: headache, dizziness, agitation, fatigue, weakness, drowsiness, insomnia, ataxia, paresthesias, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy, convulsions, anxiety, "nightmarish" dream, disorientation, psychosis, depersonalization, noise ears.

    From the side of the musculoskeletal system: muscle weakness, myalgia, arthralgia.

    On the part of the hematopoiesis system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.

    From the skin: itching; rarely - skin rash; in some cases - photosensitivity, multiforme exudative erythema, alopecia.

    Allergic reactions: urticaria, skin itching, angioedema, bronchospasm and anaphylactic shock.

    Other: tachycardia, interstitial nephritis, visual impairment, peripheral edema, increased sweating, fever, gynecomastia.

    Overdose:

    Clarithromycin

    Symptoms: from the gastro-intestinal tract (nausea, vomiting, diarrhea); headache, confusion.

    Treatment: immediate lavage stomach and symptomatic treatment. Hemodialysis and peritoneal dialysis do not lead to a significant change in the level of clarithromycin in the blood serum.

    Omeprazole

    Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

    Treatment: a specific antidote is not exist. Treatment is symptomatic. Hemodialysis is not effective enough.

    Tinidazole

    When an overdose of tinidazole is prescribed symptomatic treatment. Hemodialysis is effective.

    Interaction:

    Simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in the concentration of theophylline.

    Clarithromycin decreases the absorption of zidovudine (between the use of drugs should be an interval of at least 4 hours).

    It is possible to develop cross-resistance between clarithromycin, lincomycin and clindamycin.

    Simultaneous administration of clarithromycin with terfinadine increases the concentration of the latter and may lead to lengthening of the interval QT.

    Simultaneous administration of clarithromycin with indirect anticoagulants can potentiate the effect of the latter.

    At simultaneous appointment with clarithromycin levels of carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin can be increased.

    Omeprazole can slow the elimination of phenytoin, diazepam, warfarin, and also affect the absorption of ketoconazole, ampicillin and iron salts by inhibiting the secretion of acid in the stomach. Increases the inhibitory effect on the hemopoietic system of other drugs.

    Tinidazole strengthens the effect of indirect anticoagulants and the action of ethanol - disulfiram-like reactions are possible. It is not recommended to prescribe together with ethionamide. Phenobarbital accelerates the metabolism of tinidazole.

    Special instructions:

    Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with gastric ulcer), because treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

    Caution is prescribed against the background of taking medicines metabolized by the liver.

    In the case of co-administration with warfarin or other indirect anticoagulants, prothrombin time should be monitored.

    With heart disease in the anamnesis, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

    Tinidazole causes dark staining of urine.

    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Tablets and capsules set.
    Packaging:

    Tablets and capsules set: 2 capsules of omeprazole, 2 tablets of clarithromycin and 2 tablets Tinidazole in a strip of aluminum foil.

    7 strips with instructions for medical use in a cardboard bundle.

    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012233 / 01
    Date of registration:30.12.2011 / 30.01.2012
    The owner of the registration certificate:Ranbaxy Irland Ltd.Ranbaxy Irland Ltd. Ireland
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp12.02.2016
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