Pylobact® AM (Pylobact® AM)

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

Active substance: clarithromycin 500 mg;

Excipients: microcrystalline cellulose 203 mg, povidone 35 mg, purified water * q.s., magnesium stearate 13 mg, steric acid 22 mg, talc purified 14 mg, silicon dioxide colloid 12 mg croscarmellose sodium 61 mg;

film sheath material: hypromellose 30 mg, giprolose 3 mg, propylene glycol 6 mg, sorbitan monooleate 2.5 mg, titanium dioxide 3.54 mg, dye quinoline yellow 0.142 mg, vanillin 3.54 mg, water purified * qs, talc purified 2.5 mg ;

ink for writing: black ink Opacode S-1 -17823 (glazed shellac 45% (20% esterified) in ethanol 44.467% w / w, iron dye oxide black 23.409% w / w, isopropanol 26.882% w / w, n-butyl alcohol 2.242% mass / mass, propylene glycol 2% mass / mass, ammonium hydroxide 28% - 1% mass / mass).

* is lost in the production process

Active substance: amoxicillin trihydrate 592.856 mg, equivalent to amoxicillin 500 mg;

Excipients: sodium lauryl sulfate 3.12 mg, silicon dioxide colloid 3.12 mg, croscarmellose 1.88 mg, cellulose microcrystalline 17.774 mg, magnesium stearate 6.25 mg;

capsule shell: cap: blue diamond 0.004 mg, azorubin dye 0,0592 mg, quinoline yellow dye 0,0752 mg, titanium dioxide 0,7878 mg, methyl parahydroxybenzoate 0,3006 mg, propyl parahydroxybenzoate 0,0752 mg, sodium lauryl sulfate 0.0301 mg, gelatin 37, 5806 mg; body: dye sunset yellow 0.0027 mg, quinoline yellow dye 0.2322 mg, titanium dioxide 0.8444 mg, methyl parahydroxybenzoate 0.4826 mg, propyl parahydroxybenzoate 0.1206 mg, sodium lauryl sulfate 0.0483 mg, gelatin 60.3196 mg;

ink for writing: dehydrated alcohol * q.s.,, butyl alcohol q.s., shellac q.s., iron dye oxide black q, s.,

Concentrated ammonia solution q.s., propylene glycol q.s.

* is lost in the production process

Active substance: omeprazole 20 mg;

Excipients: Non Pared Seeds (granules of sucrose and corn starch, coated with enteric coating) 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 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; a shell of an empty hard gelatin capsule of size 2 with a dark blue lid and a transparent pink body of 3.25 mg.

* is lost in the production process

capsule shell: cap: brilliant blue 0.1072 mg, carmosein (azorubin) 0.0107 mg, gelatin 21.4327 mg, methyl parahydroxybenzoate 0.1372 mg, propylpyridroxybenzoate 0.0343 mg; body: carmoizine (azorubin) 0.0098 mg, gelatin 32.7456 mg, methyl parahydroxybenzoate 0.2096 mg, propylpyridroxybenzoate 0.0523 mg.

Description:

Clarithromycin, film-coated tablets: pills of light yellow color, oval in shape, biconcave, covered with a film shell with printed black ink inscription "СХТ 500" on one side.

Amoxicillin, capsules: hard gelatin capsules, size "0 e1" (capsule cover diameter 7.57-7.71 mm capsule shell diameter 7.27-7.41 mm, cap capsule length 11.22-12.30 mm, capsule body length 19, 70-20,70 mm), the case is yellow, the lid of brown color with the printed black ink inscription "500" on the lid and the case. Capsule contents: white to almost white granular powder / pellets.

Omeprazole, capsules: hard gelatin capsules with a "lock" size No.2 with a lid of a dark blue color and a transparent pink body containing white or almost white spherical granules covered with an enteric coating.

Pharmacotherapeutic group:peptic ulcer treatment
ATX: & nbsp
  • Omeprazole, amoxicillin and clarithromycin
    • Pharmacodynamics:

    Triple therapy, which includes omeprazole, clarithromycin and amoxicillin allows you to achieve a high percentage of eradication Helicobacter pylori (85-94%).

    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 - antibiotic from the macrolide group, polysynthetic derivative of erythromycin A. It has an antimicrobial effect, which is associated with the suppression of protein synthesis by interaction with the 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.

    Amoxicillin - semi-synthetic penicillin, has a bactericidal action, has a wide range of action.The antimicrobial effect is associated with the inhibition of the synthesis of peptidoglycan (the supporting polymer of the cell wall) during the period of division and growth. Has a pronounced activity in relation to H. Pylori. Resistance H. Pylori to amoxicillin is rare.

    The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect in relation to N. Pylori.

    Pharmacokinetics:

    All three preparations that are part of Pylobact® AM 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 (CmOh) 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 in the 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 CmOh increases by 10%, a minimum concentration of 5% compared with the same parameters with monotherapy with clarithromycin. The concentration of clarithromycin in the gastric mucosa while concomitantly administered with omeprazole is also increased.

    Amoxicillin quickly absorbed from the gastrointestinal tract. The intake of food does not affect the absorption of amoxicillin. Bioavailability of amoxicillin is 75-90%. The drug is quickly distributed in the tissues of the body. The half-life is 1-1.5 hours.

    Connection with proteins 20%.About 60% of the dose is excreted in the urine unchanged, a small amount is excreted with feces.

    Indications:Eradication therapy N. Pylori with peptic ulcer disease.
    Contraindications:

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

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

    - Pregnancy;

    - lactation period;

    - porphyria;

    - childhood;

    renal and / or hepatic insufficiency.

    Dosing and Administration:

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

    In the morning reception before eating, you should take the contents of the "morning" part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).

    In the evening reception before eating, you should take the contents of the "evening" part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).

    Tablets and capsules can not be broken and chewed, they should be swallowed whole.

    The 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 disorders, stomatitis, transient increase in the activity of "liver" enzymes in the plasma, a violation of liver function; rarely - pseudomembranous enterocolitis.

    From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, ataxia, paresthesia, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy.

    From 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, angioedema, bronchospasm, and anaphylactic shock.

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

    Interaction:

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

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

    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, acid secretion in the stomach.

    With the simultaneous administration of amoxicillin with oral contraceptives, it is possible to reduce the effect of the latter

    Special instructions:

    Before the beginning of therapy it is necessary to exclude the presence of malignant process (especially in case of gastric ulcer), t.treatment, masking the symptoms, can delay the setting 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.

    Form release / dosage:

    Tablets and capsules set (clarithromycin - film coated tablets, 500 mg, amoxicillin capsules, 500 mg, omeprazole - enteric 20 mg capsules).

    Packaging:

    Tablets and capsules set: 2 tablets of clarithromycin, 4 capsules of amoxicillin, 2 capsules of omeprazole in one contour non-jawed package of aluminum foil (strip).

    Seven strips in a cardboard box with instructions for use.

    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:

    2 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002173
    Date of registration:01.12.2011
    The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India
    Manufacturer: & nbsp
    Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED
    Information update date: & nbsp12.02.2016
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