Pilobact AM
Pilobact AM: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Pylobact AM
ATX code: A02BD05
Active ingredient: Amoxicillin (Amoxicillin), Omeprazole (Omeprazole), Clarithromycin (Clarithromycin)
Manufacturer: Ranbaxi (India)
Description and photo update: 2018-18-05
Prices in pharmacies: from 900 rubles.
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Pilobact AM is a drug for the treatment of peptic ulcers.
Release form and composition
Dosage form of release of Pilobact AM - tablets and capsules set:
- clarithromycin tablets, film-coated: biconvex, oval, light yellow, with the inscription in black ink "CXT 500" on one side;
- amoxicillin capsules: gelatinous, hard, size No. 0el, with a yellow body, brown cap and inscription in black ink "500"; inside filled with almost white or white granular pellets / powder;
- omeprazole capsules: gelatinous, hard, size No. 2, with a lock, a dark blue lid and a pink transparent body, inside filled with spherical almost white or white enteric coated granules.
In strips of 2 omeprazole capsules, 4 amoxicillin capsules and 2 clarithromycin tablets; 7 strips in a cardboard box.
Composition of 1 clarithromycin tablet:
- active substance: clarithromycin - 0.5 g;
- auxiliary components: croscarmellose sodium - 0.061 g; colloidal silicon dioxide - 0.012 g; purified talc - 0.014 g; stearic acid - 0.022 g; magnesium stearate - 0.013 g; purified water; povidone - 0.035 g; microcrystalline cellulose - 0.203 g; purified water;
- film shell: purified talc - 0.002 5 g; vanillin - 0.003 54 g; quinoline yellow dye - 0.000 142 g; titanium dioxide - 0.003 54 g; sorbitan monooleate - 0.002 5 g; propylene glycol - 0.006 g; hyprolosis - 0.003 g; hypromellose - 0.03 g; purified water;
- ink: black Opacode S-1-17823 ink [ammonium hydroxide 28% - 1% w / w, propylene glycol - 2% w / w, n-butyl alcohol - 2.242% w / w, isopropanol - 26.882% w / w, iron dye black oxide - 23.409% w / w, glazed shellac - 45% (20% esterified) in ethanol - 44.467% w / w].
Composition of 1 capsule of amoxicillin:
- active substance: amoxicillin trihydrate - 0.592 856 g (corresponds to the content of amoxicillin - 0.5 g);
- auxiliary components: magnesium stearate - 0.006 25 g; microcrystalline cellulose - 0.017 774 g; croscarmellose - 0.001 88 g; colloidal silicon dioxide - 0.003 12 g; sodium lauryl sulfate - 0.003 12 g;
- cap: gelatin - 0.037 580 6 g; sodium lauryl sulfate - 0.000 030 1 g; propyl parahydroxybenzoate - 0.000 075 2 g; methyl parahydroxybenzoate - 0.000 300 6 g; titanium dioxide - 0.000 787 8 g; quinoline yellow dye - 0.000 075 2 g; dye azorubin - 0.000 059 2 g; brilliant blue dye - 0.000 004 g;
- body: gelatin - 0.060 319 6 g; sodium lauryl sulfate - 0.000 048 3 g; propyl parahydroxybenzoate - 0.000 120 6 g; methyl parahydroxybenzoate - 0.000 482 6 g; titanium dioxide 0.000 844 4 g; quinoline yellow dye - 0.000 232 2 g; dye sunset sunset yellow - 0.000 002 7 g;
- ink: iron dye black oxide, shellac, butyl alcohol, dehydrated alcohol.
Composition of 1 capsule of omeprazole:
- active substance: omeprazole - 0.02 g;
- auxiliary components: sodium hydrogen phosphate (anhydrous) - 0.004 5 g; sodium lauryl sulfate - 0.001 1 g; purified talc - 0.014 5 g; povidone - 0.015 g; mannitol - 0.03 g; corn starch - 0.005 g; lactose - 0.08 g; Non Pared Seeds - 0.061 5 g;
- enteric coating: titanium dioxide - 0.001 4 g; diethyl phthalate - 0.005 g; isopropanol; dichloromethane; hypromellose phthalate - 0.032 g;
- cap: propyl parahydroxybenzoate - 0.000 034 3 g; methyl parahydroxybenzoate - 0.000 137 2 g; gelatin - 0.021 432 7 g; carmoisine (azorubin) - 0.000 010 7 g; brilliant blue - 0.000 107 2 g;
- body: propyl parahydroxybenzoate - 0.000 052 3 g; methyl parahydroxybenzoate - 0.000 209 6 g; gelatin - 0.032 745 6 g; carmoisine (azorubin) - 0.000 009 8 g.
Pharmacological properties
Pharmacodynamics
A high percentage of Helicobacter pylori (H. pylori) eradication - up to 85–94% - is achieved thanks to triple therapy, including amoxicillin, clarithromycin and omeprazole.
Actions of Pilobact AM, due to its constituent active substances
- omeprazole: through specific inhibition of H + / K + -ATPase (hydrogen-potassium adenosine triphosphatase) - an enzyme of the hydrolase class, inhibits the secretion of gastric acid; reduces stimulated and basal secretion, regardless of the nature of the stimulus; its effect after a single oral administration occurs within the first hour and lasts for 24 hours, the maximum effect is observed after 2 hours; after its cancellation, secretory activity is fully restored after 3-5 days;
- clarithromycin: has antimicrobial properties associated with the suppression of protein synthesis through interaction with the 50S-ribosomal subunit of the microbial cell; is active against a large number of anaerobic, aerobic, gram-positive and gram-negative microorganisms, including H. pylori. Its metabolite (14-hydroxyclarithromycin), which is formed in the body, also has a pronounced antimicrobial effect;
- amoxicillin: has bactericidal properties, has a wide spectrum of action; by inhibiting the synthesis of peptidoglycan during the period of growth and division, it has an antimicrobial effect; shows pronounced activity against H. Pylori; in rare cases, H. pylori resistance to amoxicillin is observed.
The combined administration of clarithromycin and amoxicillin has a potentiated antimicrobial effect against H. pylori.
Pharmacokinetics
The active substances of the drug are well absorbed when taken orally.
Pharmacokinetic characteristics of the active ingredients of Pilobact AM:
- omeprazole: rapidly absorbed after oral administration; its metabolism is almost completely carried out in the liver; 80% excreted in the urine. Bioavailability varies from 30 to 40%, it is not influenced by food intake; the time to reach the maximum plasma concentration (Cmax) is achieved after ½ – 1 hour; the connection with plasma proteins is 90%;
- clarithromycin: rapidly absorbed from the gastrointestinal tract; widely distributed in the body; excreted by the kidneys and feces (20-30% unchanged, the rest in the form of metabolites). The absolute bioavailability of 0.25 g of the drug is approximately 50%. Food slightly slows down the onset of its absorption and the formation of 14-hydroxyclarithromycin, but does not affect bioavailability. If clarithromycin is taken on an empty stomach, peak serum concentrations of both the drug and its main metabolite are reached within 2 hours after oral administration and are 0.000 6 and 0.000 7 mg per ml, respectively. The half-life is 3-4 hours. Its concentration in tissues exceeds that in serum. Protein binding varies from 42 to 70%;
- amoxicillin: absorption is not affected by food, it is rapidly absorbed from the gastrointestinal tract. Its bioavailability ranges from 75 to 90%. It is distributed quickly in body tissues. Its half-life is 1-1.5 hours. The connection with proteins is 20%. 60% (approximately) unchanged is excreted in the urine, with feces it is excreted in a small amount.
The combined use of omeprazole and clarithromycin improves the pharmacokinetic properties of the latter: its average Cmax value increases by 10%, and the minimum concentration by 5%, compared with the same indicators with its monotherapy. Also, when taking this combination, the concentration of clarithromycin in the gastric mucosa increases.
Indications for use
Pilobact AM is used for the eradication treatment of H. pylori against the background of duodenal ulcer.
Contraindications
Absolute:
- renal and / or hepatic impairment;
- porphyria;
- concomitant use of terfenadine, astemizole, pimozide, cisapride;
- childhood;
- pregnancy;
- lactation period;
- individual intolerance of the components of Pilobact AM or macrolide antibiotics.
A relative contraindication to taking the drug is simultaneous therapy with drugs metabolized by the liver.
Instructions for the use of Pilobact AM: method and dosage
Pilobact AM tablets and capsules are taken orally, whole, without breaking or chewing, before meals.
One strip with tablets and capsules is intended for one day of therapy and consists of 2 parts: red - "morning", blue - "evening".
In the morning, at one time, take the entire contents of the "morning" part (1 clarithromycin tablet, 1 omeprazole capsule and 2 amoxicillin capsules).
In the evening, at one time, take the entire contents of the “evening” part (1 clarithromycin tablet, 1 omeprazole capsule and 2 amoxicillin capsules).
The duration of therapy is 7 days.
Side effects
- digestive organs: abdominal pain, dry mouth, taste disturbances, diarrhea or constipation, flatulence, nausea, vomiting, stomatitis, dysbiosis, liver dysfunction, transient increase in the activity of liver enzymes in plasma; rarely - pseudomembranous enterocolitis;
- nervous system: peripheral neuropathy, epileptic reactions, hallucinations, confusion, depression, paresthesia, ataxia, insomnia, drowsiness, agitation, dizziness, headache;
- musculoskeletal system: arthralgia, myalgia, muscle weakness;
- hematopoietic system: anemia, thrombocytopenic purpura, thrombocytopenia, neutropenia, leukopenia;
- skin: itching; rarely - skin rash; in some cases - alopecia, exudative erythema multiforme, photosensitization;
- allergic reactions: anaphylactic shock, bronchospasm, angioedema, urticaria;
- others: gynecomastia, fever, increased sweating, peripheral edema, visual impairment, interstitial nephritis / tachycardia.
Overdose
There are no data on an overdose of Pilobact AM.
special instructions
Before starting to take the drug, it is important to exclude the presence of a malignant process (especially against the background of a stomach ulcer), since Pilobact AM, masking the symptoms, can delay the correct diagnosis.
When prescribing a drug with warfarin or other indirect anticoagulants, prothrombin time is controlled.
In cases of a history of heart disease, combination therapy with astemizole, cisapride or terfenadine is not recommended.
Application during pregnancy and lactation
According to the instructions, Pilobact AM is contraindicated during pregnancy and during breastfeeding.
Pediatric use
Pilobact AM is contraindicated for use in pediatric practice.
With impaired renal function
Pilobact AM is contraindicated in renal failure.
For violations of liver function
Pilobact AM is contraindicated in liver failure.
Drug interactions
Effect of active substances of Pilobact AM on drugs / substances in combined use:
- theophylline: clarithromycin increases its concentration;
- terfenadine: clarithromycin increases its concentration, prolongation of the QT interval is possible;
- indirect anticoagulants: clarithromycin can potentiate their action;
- digoxin, astemizole, pimozide, cisapride, valproate, lovastatin, disopyramide, phenytoin, cyclosporin, carbamazepine: clarithromycin may increase their levels;
- warfarin, diazepam, phenytoin: omeprazole may slow down their elimination;
- iron salts, ampicillin, ketoconazole: omeprazole can affect their absorption by inhibiting acid secretion in the stomach;
- oral contraceptives: amoxicillin may reduce their effect.
Analogs
There is no information about analogs of Pilobact AM.
Terms and conditions of storage
Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Pilobact AM
According to reviews, Pilobact AM is a fast-acting drug that is effective in treating ulcers and rarely causes side effects.
Price for Pilobact AM in pharmacies
The approximate price of Pilobact AM tablets and capsules of the set (56 pieces in a package - 7 strips, designed for 1 course) - 1135 rubles.
Pilobact AM: prices in online pharmacies
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Drug name Price Pharmacy |
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Pilobact AM tablets and capsules set 56 pcs. RUB 900 Buy |
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Pilobact AM tablets and capsules combination set. 56 pcs. 1082 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
