Release form and composition
Pilobact is produced in the form of a combined set of tablets and capsules (2 capsules of omeprazole, 2 tablets of clarithromycin and 2 tablets of tinidazole (6 pcs. in total) in blisters, 7 blisters in a cardboard box).
1 capsule of omeprazole contains the active substance: omeprazole – 20 mg.
The composition of 1 film-coated tablet of clarithromycin includes the active substance: clarithromycin - 250 mg.
The composition of 1 film-coated tablet of tinidazole includes the active substance: tinidazole - 500 mg.
Pilobact AM
Pilobact AM (omeprazole + clarithromycin + amoxicillin) is a combination drug from the Indian pharmaceutical used for the treatment of helicobacteriosis against the background of duodenal ulcer. The inclusion of three independent drugs in Pilobact AM provides a high percentage of Helicobacter eradication (85-94%). Omeprazole suppresses the secretion of hydrochloric acid in the stomach by inhibiting the so-called proton pump - the enzyme H+ K+-ATPase. Reduces stimulated and unstimulated (basal) secretion, and in the first case - regardless of the nature of the irritating agent. After oral administration of a single dose of omeprazole, the effect is noted already in the first hour and continues throughout the day. The peak effect of omeprazole occurs 2 hours after its administration to the body. When the drug is discontinued, secretory function is completely restored after 3-5 days. Clarithromycin is an antibiotic belonging to the group of macrolides and is a semi-synthetic derivative of erythromycin. Its antibacterial effect is based on the ability to suppress protein synthesis through interaction with the 50S ribosomal subunit of the bacterial cell. Active against a wide range of gram-positive and gram-negative microorganisms, aerobes and anaerobes, including Helicobacter. It is metabolized to form 14-hydroxyclarithromycin, which is also endowed with pronounced antibacterial activity. Amoxicillin is a synthetically produced penicillin. Has a bactericidal effect against a wide range of microorganisms. The antimicrobial activity of the drug is due to the suppression of the synthesis of peptidoglycan (a structure-forming component of the cell wall) in the most important period of a cell’s life - when it divides and grows. At the same time, amoxicillin is especially hostile to Helicobacter. Resistance of the latter to the drug is extremely rare. If we talk about the combination of clarithromycin with amoxicillin, then it is truly destructive for Helicobacter, i.e.
because each of its components potentiates the action of the other. All three drugs included in Pilobact AM are well absorbed when taken orally. Omeprazole is rapidly absorbed after oral administration. Food intake does not affect the bioavailability of the drug, which averages 30-40%. The peak concentration of omeprazole in the blood is reached after 0.5-1 hour. It is excreted mainly by the kidneys. Clarithromycin is ahead of omeprazole in terms of bioavailability, which is 50%. The maximum concentration of the active substance in the blood is achieved after 2 hours. The half-life of clarithromycin ranges from 3 to 4 hours. Excreted in urine and feces. The uncontested leader in bioavailability among all three drugs is amoxicillin - 75-90%. Its half-life is 1-1.5 hours. It is excreted mainly by the kidneys.
Pilobact AM is available in the form of kits containing tablets and capsules and placed in strips. Each strip is designed for one day of treatment and consists of two multi-colored parts: red (morning) and blue (evening). One kit contains two amoxicillin capsules, one clarithromycin tablet and one omeprazole capsule. All ingredients of the kit are taken before meals. Tablets and capsules should be swallowed whole without chewing. The duration of the medication course is 1 week. Before starting pharmacotherapy, it is necessary to make sure that there is no cancer: otherwise, treatment may mask malignant symptoms and delay the diagnosis of a much more serious disease. Pilobact AM is used with caution in combination with drugs metabolized by the liver. The combination of Pilobact AM with indirect anticoagulants (for example, warfarin) requires monitoring of the prothrombin time (blood clotting time). Amoxicillin is poorly compatible with oral contraceptives (when taken together, the effect of the latter weakens).
Side effects
- Digestive system: dry mouth, flatulence, dysbiosis, constipation or diarrhea, vomiting, metallic taste in the mouth, stomatitis, nausea, abdominal pain, taste disturbance, decreased appetite, transient increase in the activity of liver enzymes in plasma, functional liver disorders, hepatitis ( including with jaundice), encephalopathy with a history of liver disease; rarely – pseudomembranous enterocolitis;
- Central nervous system: tinnitus, ataxia, headache, agitation, dizziness, fatigue, drowsiness, weakness, insomnia, depression, paresthesia, confusion, epileptic reactions, hallucinations, disorientation, peripheral neuropathy, depersonalization, fear, convulsions, nightmares dreams, psychosis;
- Musculoskeletal system: myalgia, muscle weakness, arthralgia;
- Hematopoietic system: thrombocytopenic purpura, leukopenia, thrombocytopenia, neutropenia, anemia;
- Skin: itching; rarely - skin rash; very rarely – exudative erythema multiforme, photosensitivity, alopecia;
- Allergic reactions: anaphylactic shock, angioedema, urticaria, bronchospasm;
- Others: fever, increased sweating, tachycardia, blurred vision, interstitial nephritis, peripheral edema, gynecomastia.
special instructions
Before starting a treatment course, it is necessary to exclude a malignant process (masking symptoms can make it difficult to make a correct diagnosis).
Caution must be observed when used together with drugs metabolized by the liver. When combined with warfarin or other indirect anticoagulants, prothrombin time must be monitored.
If there is a history of heart disease, simultaneous use with cisapride, terfenadine, or astemizole is not recommended.
Tinidazole may cause urine to become dark in color.
During therapy, care must be taken when driving vehicles and performing other potentially dangerous types of work that require high concentration and rapid psychomotor reactions.
Drug interactions
When used in combination with certain drugs/substances included in the set of medicines, the following effects may be observed:
- Theophylline (with clarithromycin): increasing its concentration;
- Zidovudine (with clarithromycin): decreased absorption (a break of at least 4 hours is required between doses);
- Lincomycin, clindamycin (with clarithromycin): development of cross-resistance;
- Terfenadine (with clarithromycin): an increase in its concentration and, as a consequence, prolongation of the QT interval;
- Indirect anticoagulants (with clarithromycin): potentiation of their action;
- Carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin (with clarithromycin): their levels may increase;
- Phenytoin, diazepam, warfarin (with omeprazole): their elimination is likely to slow down;
- Ketoconazole, ampicillin and iron salts (with omeprazole): affects their absorption;
- Indirect anticoagulants, ethanol (with tinidazole): their effect is enhanced (disulfiram-like reactions may be observed);
- Phenobarbital (with tinidazole): the metabolism of tinidazole is accelerated.
Omeprazole enhances the inhibitory effect of other drugs on the hematopoietic system.
Concomitant use of tinidazole with ethionamide is not recommended.
Instructions for use
Pilobact is a drug with a pronounced antiulcer and antimicrobial effect. The combined effect of the following drugs included in its composition guarantees high eradication of Helicobacter pylori:
- Omeprazole - reduces the production of gastric acid, regardless of the nature of the irritant. After taking it, the substance begins to act within an hour.
- Clarithromycin is an antibiotic belonging to the macrolide group, active against Helicobacter pylori. Suppresses protein synthesis in microorganisms.
- Tinidazole is capable of damaging the DNA of a pathogenic microorganism and inhibiting its synthesis. It is characterized by high activity against anaerobes, amoebas, Trichomonas, Giardia, and Helicobacter pylori.
Indications for use
Pilobact is used to eradicate Helicobacter pylori for ulcerative manifestations in the stomach and duodenum. The drug also brings good results in the treatment of active chronic gastritis.
Mode of application
Each Pilobact blister contains a set of drugs intended for one day of treatment. Tablets and capsules are swallowed whole without breaking or chewing. All three components are taken twice a day before meals, 1 pc.
After a week's course of treatment, doctors often prescribe taking Omeprazole (20 mg) for another 3 weeks.
Before starting a course of treatment, be sure to take into account the following features of the drug:
- Before using the medicine, malignant processes are completely excluded;
- The drug is limited in use for people with organic lesions of the nervous system;
- While taking the drug, drinking alcohol is unacceptable to avoid the occurrence of a disulfiram-like reaction;
- When used in parallel with substances that are utilized in the liver, the drug is used especially carefully;
- When taken together with indirect anticoagulants, prothrombin time is monitored;
- Thiadazole can turn urine dark.
While following the course of treatment, you need to be especially careful when driving a car or doing potentially dangerous work that requires quick reaction and concentration.
Release form, composition
Pilobact is available in the form of capsules and tablets, packaged in strips containing the daily dose for administration. The package includes 7 blisters. Each strip, calculated for the day of treatment, contains:
- Omeprazole (20 mg) – 2 capsules;
- Clarithromycin (250 mg) – 2 tablets;
- Tinidazole (500 mg) – 2 tablets.
Interaction with other drugs
When taking Pilobact together with other drugs, the following interactions occur:
- Simultaneous administration of Pilobact with Theophylline increases the concentration of the latter;
- Reduces the absorption of Zidovudine (joint use is not allowed);
- Use with Clindamycin and Lincomycin leads to cross-resistance;
- Combination with Terfenadine increases its concentration and prolongs the QT interval;
- With indirect coagulants, it potentiates their action;
- Co-administration with the following drugs increases their level: Cyclosporine, Lovastidine, Pomoside, Digoxin, Carbamazepine, Disopyramide, Cisapride, Phenytoin, Valproate, Astemizole;
- When taken simultaneously with Warfarin, Phenytoin and Diazepam, their elimination may slow down;
- Affects the absorption of drugs with iron salts, Ketoconazole and Ampicillin;
- Strengthens the effect of indirect coagulants with the possible occurrence of disulfiram-like reactions;
