Why is Pylobact prescribed - instructions, price, analogues, reviews. Pylobact (Pylobact AM, Pylobact NEO). What is this drug and what is it used for? Indications, contraindications and instructions for use. Adverse reactions when taking the drug. Prices and reviews

Ranbaxy Laboratories Limited Ranbaxy Laboratories Limited (Dewas)

Country of origin

India

Product group

Digestive tract and metabolism

peptic ulcer treatment remedy

Release form

• 8 - strips (7) - packs of cardboard.

Description of the dosage form

• tablets and capsules set (clarithromycin - film-coated tablets, amoxicillin - capsules, omeprazole - enteric capsules).

pharmachologic effect

Triple therapy, including omeprazole, clarithromycin and amoxicillin, allows a high percentage of Helicobacter pylori eradication to be achieved. Omeprazole inhibits the secretion of gastric acid due to the specific inhibition of H + K + -ATPase, an enzyme located in the membranes of the parietal cells of the gastric mucosa. Reduces basal and stimulated secretion, regardless of the nature of the stimulus. After a single dose of the drug inside, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. Clarithromycin is an antibiotic from the macrolide group, a semi-synthetic derivative of erythromycin A. It has an antimicrobial effect that is associated with the suppression of protein synthesis by interacting 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. Rylori. The 14-hydroxyclarithromycin metabolite formed in the body also has a pronounced antimicrobial activity. Amoxicillin - semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with inhibition of the synthesis of peptidoglycan (the supporting polymer of the cell wall) during the period of division and growth. Possesses the expressed activity in relation to Н.Ру1ои. The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against H. Pylori.

Pharmacokinetics

All three drugs that are part of Pylobact AM have good absorption when taken orally. Omeprazole is rapidly absorbed after oral administration, and its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. The maximum concentration of the drug in plasma is reached after 0.5 - 1 hour. Communication with plasma proteins is high. Almost completely metabolized in the liver. The main route of excretion is with urine. Clarithromycin is rapidly absorbed from the gastrointestinal tract. Eating slightly slows down 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. The half-life of clarithromycin is 3-4 hours. Clarithromycin is widely distributed in the body. The concentration of clarithromycin in tissues exceeds that in serum. It is excreted by the kidneys and with feces in unchanged form, the rest is in the form of metabolites. Co-administration of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin. The concentration of clarithromycin in the gastric mucosa with its simultaneous appointment with omeprazole is also increased. Amoxicillin is rapidly absorbed from the gastrointestinal tract. Eating does not affect the absorption of amoxicillin. The bioavailability of amoxicillin is high. The drug is rapidly distributed in the tissues of the body. The half-life is 1-1.5 hours. Most of the dose taken is excreted in the urine unchanged, a small amount is excreted in the feces.

Special conditions

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because. treatment, by masking symptoms, may delay the correct diagnosis. It is prescribed with caution against the background of taking drugs metabolized by the liver. In the case of a joint appointment with warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time. With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

Compound

• Active substance: clarithromycin - 500 mg Excipients", sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose, microcrystalline cellulose, magnesium stearate. Active substance: omeprazole 20 mg Excipients: Non Pared Seeds (granules of sucrose and corn starch, enteric-coated), lactose, corn starch, mannitol, povidone, purified talc, sodium lauryl sulfate, sodium hydrogen phosphate (anhydrous).

Pylobact AM indications for use

• Helicobacter pylori eradication therapy for duodenal ulcer.

Pylobact AM contraindications

• - combined use with cisapride, pimozide, astemizole and terfenadine is prohibited (see section "Interaction with other drugs"); - pregnancy; - lactation period; - porphyria; - childhood; - renal and / or liver failure; - hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as antibiotics of the macrolide group.

Pylobact AM side effects

• On the part of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in the activity of "liver" enzymes in plasma, impaired 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. From the hemopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia. On the part of the skin: itching; rarely - skin rash, in some cases - photosensitivity, erythema multiforme exudative, alopecia. Allergic reactions: urticaria, angioedema, bronchospasm and anaphylactic shock. Other: tachycardia, interstitial nephritis, blurred vision, peripheral edema, increased sweating, fever, gynecomastia.

drug interaction

The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentration. Co-administration of clarithromycin with terfinadine increases the concentration of the latter and may lead to prolongation of the QT interval. Co-administration of clarithromycin with indirect anticoagulants may potentiate the action of the latter. With simultaneous appointment with clarithromycin, the levels of carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin may be increased. Omeprazole can slow down the elimination of phenytoin, diazepam, warfarin, and also affect the absorption of ketoconazole, ampicillin and iron salts by inhibiting gastric acid secretion. With the simultaneous appointment of amoxicillin with oral contraceptives, the effect of the latter may be reduced.

Storage conditions

• keep away from children

Information provided by the State Register of Medicines.

Synonyms

• 7 strips per pack, each strip contains: 2 capsules of omeprazole; 4th amoxicillin caps; 2nd tablet of clarithromycin

A drug Pylobact AM (Pylobact AM)- antiulcer, antihelicobacter drug.
Triple therapy, including omeprazole, clarithromycin and amoxicillin, allows to achieve a high percentage of Helicobacter pylori eradication (85-94%).
Omeprazole inhibits the secretion of gastric acid due to the specific inhibition of H + K + -ATPase, an enzyme located in the membranes of the parietal cells of the gastric mucosa. Reduces basal and stimulated secretion, regardless of the nature of the stimulus. After a single dose of the drug inside, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is completely restored after 3-5 days.
Clarithromycin is an antibiotic from the macrolide group, a semi-synthetic derivative of erythromycin A. It has an antimicrobial effect that is associated with the suppression of protein synthesis by interacting 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 formed in the body - 14-hydroxyclarithromycin - also has a pronounced antimicrobial activity.
Amoxicillin - semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with inhibition of the synthesis of peptidoglycan (the supporting polymer of the cell wall) during the period of division and growth. Possesses the expressed activity in relation to Н.pуlori. H.pylori resistance to amoxicillin is rare.
The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against H.pylori.

Pharmacokinetics

All three drugs that are part of Pylobact® AM are well absorbed when taken orally.
Omeprazole is rapidly absorbed after oral administration, and its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. Cmax of the drug in plasma is reached after 0.5-1 h. Plasma protein binding is 90%. Almost completely metabolized in the liver. The main route of excretion is with urine (80%).
Clarithromycin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of 250 mg clarithromycin is approximately 50%. Eating slightly slows down the onset of absorption of clarithromycin and the formation of 14-hydroxyclarithromycin, but does not affect bioavailability. When taken on an empty stomach, Cmax in serum is reached within 2 hours after oral administration and is 0.6 and 0.7 μg / ml for clarithromycin and its main metabolite. T1 / 2 of clarithromycin is 3-4 hours. Clarithromycin is widely distributed in the body. The concentration of clarithromycin in tissues exceeds that in serum. Protein binding ranges from 42 to 70%. It is excreted by the kidneys and with feces (20-30% - in unchanged form, the rest - in the form of metabolites). The simultaneous appointment of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the average Cmax increases by 10%, the minimum concentration by 15% compared with the same indicators for clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa with its simultaneous appointment with omeprazole is also increased.
Amoxicillin is rapidly absorbed from the gastrointestinal tract. Eating does not affect the absorption of amoxicillin. The bioavailability of amoxicillin is 75-90%. The drug is rapidly distributed in the tissues of the body. T1 / 2 is 1-1.5 hours. Protein binding is 20%. About 60% of the dose taken is excreted in the urine unchanged, a small amount - in the feces.

Indications for use

A drug Pylobact AM used in the eradication therapy of H. pylori with duodenal ulcer.

Mode of application

Each strip containing tablets and capsules of the set Pylobact AM, 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 before meals, you should take the contents of the “morning” part in full (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin). In the evening before meals, you should take the contents of the "evening" part in full (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).
Tablets and capsules should not be broken or chewed and 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 disturbances, stomatitis, transient increase in plasma liver enzymes, impaired 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.
From the hemopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.
On the part of the skin: itching; rarely - skin rash, in some cases - photosensitivity, erythema multiforme exudative, alopecia.
Allergic reactions: urticaria, angioedema, bronchospasm and anaphylactic shock.
Other: tachycardia, interstitial nephritis, blurred vision, peripheral edema, increased sweating, fever, gynecomastia.

Contraindications

Contraindications to the use of the drug Pylobact AM are: hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as to antibiotics of the macrolide group; combined use with cisapride, pimozide, astemizole and terfenadine; pregnancy; breast-feeding; porphyria; childhood; kidney or liver failure.

Pregnancy

The use of the drug is contraindicated Pylobact AM during pregnancy.

Interaction with other drugs

The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentration.
Co-administration of clarithromycin with terfenadine increases the concentration of the latter and may lead to prolongation of the QT interval.
Co-administration of clarithromycin with indirect anticoagulants may potentiate the action of the latter.
With simultaneous appointment with clarithromycin, the levels of carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin may be increased.
Omeprazole can slow down the elimination of phenytoin, diazepam, warfarin, and also affect the absorption of ketoconazole, ampicillin and iron salts by inhibiting gastric acid secretion.
With the simultaneous appointment of amoxicillin with oral contraceptives, the effect of the latter may be reduced.

Storage conditions

Pylobact AM should be stored in a dry place, at a temperature not exceeding 25 °C.
Keep out of the reach of children.

Release form

Pylobakt AM - combined set - 8 pcs. - strips (7) - packs of cardboard
Film-coated tablets (2 pieces in a strip).
Capsules (4 pieces in a strip).
Enteric capsules (2 pcs in a strip).

Compound

Strip Pylobact AM contains:
1 tablet contains: clarithromycin 500 mg.
1 capsule contains: amoxicillin 500 mg.
1 capsule contains: omeprazole 20 mg.

Additionally

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because. treatment, by masking symptoms, may delay the correct diagnosis.
It is prescribed with caution against the background of taking drugs metabolized by the liver. In the case of co-administration with warfarin or other indirect anticoagulants, it is necessary to control the PT.
With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

Main settings

Name:	PILOBACT AM
ATX code:	A02BD05 -

Pylobact AM is almost the only drug on the domestic pharmaceutical market that contains all the components for an effective fight against the bacterium Helicobacter pylori.

This microorganism is the cause of peptic ulcers of the digestive system, in particular, duodenal ulcers.

1. Instructions for use

Pylobact AM is a combination drug used to treat duodenal ulcers caused by Helicobacter pylori.

Advantages of the medicinal complex:

• high level of eradication (destruction) of the pathogen - up to 97%;
• short course - only 7 days;
• one package is designed for the entire course of treatment;
• few side effects;
• convenient packaging that excludes overdose, even if the patient is forgetful.

Indications for use

The main pathologies in the treatment of which the drug Pilobact is effective:

Relative indications for which the drug is prescribed:

• functional dyspepsia;
• gastropathy resulting from the use of non-steroidal anti-inflammatory drugs;
• GERD, or gastroesophageal reflux disease.

Release form, composition

Pylobact AM is available in the form of capsules. The composition of the medicinal complex includes drugs:

The active substances produce the following effects:

• omeprazole- inhibits the production of gastric juice, reduces basal and stimulated secretion, acts within an hour after ingestion, the maximum concentration is observed after 2 hours, the maximum period of action is 24 hours;
• clarithromycin- a macrolide antibiotic of semi-synthetic origin, a derivative of erythromycin A, acts on bacteria and inhibits protein synthesis, is characterized by a wide spectrum of action;
• amoxicillin- also a semi-synthetic antibiotic from penicillins, effective against many pathogenic microorganisms.

Clarithromycin and amoxicillin in this bundle enhance each other's action.

Mode of application

Each strip contains a daily dose of drugs, which is convenient for the patient, and is divided into two colored zones - morning and evening.

Take in the morning and evening:

• omeprazole and clarithromycin - 1 tablet each;
• amoxicillin - 2 tablets.

Capsules are not opened, tablets are not crushed, because then the effectiveness of the drug decreases.

Interaction with other drugs

The active substances of the complex react with certain drugs. The following combinations are undesirable:

• with theophylline - clarithromycin increases the concentration;
• with terfenadine - clarithromycin increases the concentration, while prolonging the QT interval is possible;
• with indirect coagulants - the action is potentiated by clarithromycin;
• with carbamazepine, cyclosporine, phenytoin, lovastatin, valproate, digoxin, astemizole, disopyramide, cisapride - clarithromycin increases the concentration;
• with phenytoin, warfarin, diazepam - the concentration increases omeprazole;
• with ketoconazole, ketoconazole, iron salts, ampicillin - affects the absorption of omeprazole;
• with oral contraceptives - reduces the effectiveness of amoxicillin.

Pylobact AM can cause adverse events, which the doctor warns the patient about before starting treatment. There are also some contraindications.

2. Side effects

The following side effects should be expected from Pilobact AM:

• from the gastrointestinal tract: stomatitis, dry mouth, taste disturbance, vomiting, nausea, dysbacteriosis, stool disorders, liver dysfunction and increased activity of the enzymes of this organ;
• from the musculoskeletal system: muscle weakness and pain, arthralgia (joint pain);
• circulatory system: shifts in the blood formula - leukopenia, neutropenia, thrombocytopenia (decrease in the level of leukocytes, neutrophilic leukocytes, platelets, respectively), thrombocytopenic purpura (Wergolf's disease) - primary hemorrhagic diathesis caused by platelet deficiency;
• nervous system: headache, confusion, epileptic seizures, drowsiness, hallucinations, depression, ataxia (impaired coordination of movements), agitation, paresthesia (impaired skin sensitivity);
• possible allergic reactions- angioedema, bronchospasm, urticaria, anaphylactic shock;
• other side effects- disorders of visual function, tachycardia (heart rhythm disturbance), abnormal sweating, in men - gynecomastia (enlargement of the mammary glands), fever, interstitial nephritis, peripheral edema.

Contraindications

Pylobact AM is not used for the treatment of persons with such diseases:

• intolerance to any component of the drug;
• porphyria - a hereditary disease associated with a violation of pigment metabolism and a high concentration of porphyrins in the blood;
• insufficient liver or kidney function.

The complex is contraindicated in childhood.

During pregnancy and breastfeeding

Pylobact AM it is forbidden to prescribe to women during pregnancy and lactation. If there is a need to use the drug during lactation, then breastfeeding is interrupted.

3. Terms and conditions of storage

Pylobact AM store at room temperature up to 25 °C, in a dark, dry place no longer than 2 years from the date of production. The first-aid kit is placed in such a way as to exclude unauthorized access by children and their accidental use of capsules and tablets. In pharmacies, Pilobact AM is dispensed by prescription.

Video on the topic: Dyspepsia. Symptoms, signs and treatments

4. Price Pylobakt AM

• average price in Russia- 1250 rubles;
• average cost in Ukraine- 1130 UAH

5. Analogues

The analogue is Pylobakt of the same company Ranbaxi. The difference is that instead of amoxicillin, the synthetic antibiotic tinidazole was used at a dosage of 0.5 g. There are also differences in the quantitative composition: instead of 4 tablets of amoxicillin, 2 tablets of tinidazole are used.

Some facts about the product:

Instructions for use

Price in the online pharmacy site: from 1 220

Some facts

Pylobact AM is an antiulcer and antimicrobial drug that acts in the gastric mucosa, eliminating the bacteria of the Helicobacter pylori group. Thus, the patient's condition is facilitated, and ulcers heal. In addition, it is effective against amoebic microorganisms, Trichomonas and other types of bacteria.

Eradication therapy is a special group of therapeutic measures aimed at the destruction of microorganisms that harm the gastrointestinal tract. The use of Pylobact AM is part of such a specific approach to treatment, the effectiveness of which has been proven in practice.

Dosage form and pharmacological properties

The composition of the drug is a combination of various active ingredients in capsules and tablets, packed in aluminum strips. Each package contains seven such strips with a unique complex of therapeutic components, including:

• omeprazole capsules to reduce stomach acid production;
• amoxicillin capsules for antibacterial effect, is a broad-spectrum penicillin;
• clarithromycin tablets to inhibit protein synthesis, an antibiotic with an active antimicrobial effect.

In one blister there are substances in the following volumes: omeprazole - two capsules of 20 mg, amoxicillin - 4 capsules of 500 mg and two clarithromycin tablets of 500 mg each. In addition, instructions for use are attached to each package with Pilobact AM.

Indications for use

The drug is effective in the fight against bacteria of the Helicobacter group and in the treatment of diseases of the gastrointestinal tract as part of eradication therapy.

Method of application and dosage

The content of one aluminum strip, which includes eight substances in the form of tablets and capsules, is one daily dose, divided into morning and evening intake. Preparations in a blue blister are taken in the morning, orally, that is, directly swallowed during a meal without chewing. The morning dose includes one omeprazole capsule, two amoxicillin capsules and a clarithromycin tablet. The composition of the evening dosage includes an identical set, packed in a red blister. Thus, in the package we have seven such sets, designed for a course of admission in one week.

Overdose and side effects

The instruction indicates the possible occurrence of unpleasant symptoms if the dosing regimen is violated. These can be headache, drowsiness, nausea.

There may be manifestations of allergic reactions in the form of rashes, itching, redness of the skin. There is also some possibility of manifestation of conditions such as depression and nervous disorders, weakness, anemia, leukopenia, abnormal heart rhythms, hyperhidrosis, visual disturbances and fever.

In case of manifestation of one of these symptoms, you should immediately consult a doctor to receive qualified assistance and prevent possible complications.

Contraindications for use

There may be hypersensitivity to the components in the composition of Pylobact AM. Conditions in which it is also contraindicated to take Pylobact AM are pregnancy, the period of breastfeeding, the presence of kidney or liver diseases, the detection of malignant tumors in the stomach. Negative indications for taking the drug among children.

Interaction with alcohol and drugs

Pilobact AM should not be taken in combination with terfenadine, pimozide and cisapride. Amoxicillin may reduce the effectiveness of oral contraceptives.

Use with caution in combination with drugs metabolized by the liver.

Omeprazole has the ability to slow down the metabolism of diazepam and phenytoin, reduces the effectiveness of ampicillin and ketoconazole. Simultaneous use together with terfenadine leads to an increase in its concentration, which enhances its effect.

You should also be aware of contraindications for driving and other vehicles while taking the drug, as it reduces the reaction rate and causes drowsiness.

Analogues

There are several analogues of Pylobact AM on the pharmaceutical market that have a similar therapeutic effect. Among these are Beta-clatinol, Ornistat, Peptika Kombipek, Ezoksium Combi, Arvicin, Gastrozol, Clarithromycin, Gynomax, Zimbaktar, Klabaks and others.

You should carefully consult with your doctor before taking any drug from this group so that its components do not cause unpleasant symptoms, but bring only the most beneficial therapeutic effect.

The preparation contains a simultaneous combination of three medicinal substances: omeprazole, tinizadol and clarithromycin, the effectiveness of which has been proven in practice.

Terms of sale and storage

It is released only if the patient has a prescription. It is necessary to store the pharmaceutical product in a place with limited access for children, the temperature in which does not exceed 25 degrees Celsius. The shelf life of the drug is 2 years. It is not recommended to use after the expiration date indicated on the package.

Combination set:

• Tablets (2 pieces in a strip) - 1 tab.: Clarithromycin 500 mg.
• Capsules (4 pcs in a strip) - 1 capsule: amoxicillin 500 mg.
• Enteric capsules (2 pieces in a strip) - 1 capsule: omeprazole 20 mg.

8 pcs. - strips (7) - packs of cardboard.

Description of the dosage form

Combined set (daily dose).

Characteristic

Combined agent for the treatment of peptic ulcer associated with Helicobacter pylori, consisting of clarithromycin, omeprazole and amoxicillin.

pharmachologic effect

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

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

Clarithromycin is an antibiotic from the macrolide group, a semi-synthetic derivative of erythromycin A. It has an antimicrobial effect that is associated with the suppression of protein synthesis by interacting with the 50S ribosomal subunit of the microbial cell. Effective against a large number of gram-positive, gram-negative aerobic and anaerobic microorganisms, including Helicobacter pylori. The 14-hydroxyclarithromycin metabolite formed in the body also has a pronounced antimicrobial activity. Amoxicillin - semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with inhibition of the synthesis of peptidoglycan (the supporting polymer of the cell wall) during the period of division and growth. Possesses the expressed activity in relation to Helicobacter pylori. Helicobacter pylori resistance to amoxicillin is rare.

The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against Helicobacter pylori.

Pharmacokinetics

All three drugs that are part of Pylobact AM are well absorbed when taken orally.

Omeprazole is rapidly absorbed after oral administration, and its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. C max is reached in 0.5 -1 h. Communication with plasma proteins is 90%. Almost completely metabolized in the liver. The main route of excretion is with urine (80%). Clarithromycin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of 250 mg clarithromycin is approximately 50%. Eating slightly slows down 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 is widely distributed in the body. The concentration of clarithromycin in tissues exceeds that in serum. Communication with proteins is from 42% to 70%. It is excreted by the kidneys and with feces (20-30% in unchanged form, the rest in the form of metabolites). The simultaneous appointment of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the average value of C max increases by 10%, the minimum concentration by 15% compared with the same indicators for clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa with its simultaneous appointment with omeprazole is also increased.

Amoxicillin is rapidly absorbed from the gastrointestinal tract. Eating does not affect the absorption of amoxicillin. The bioavailability of amoxicillin is 75-90%. The drug is rapidly distributed in the tissues of the body. The half-life is 1-1.5 hours. Communication with proteins is 20%. About 60% of the dose taken is excreted in the urine unchanged, a small amount is excreted in the feces.

Pharmacodynamics

Combination therapy, including omeprazole, clarithromycin and amoxicillin, allows you to achieve a high percentage of eradication of Helicobacter pylori (85-94%). Omeprazole inhibits the secretion of gastric acid due to the specific inhibition of H + -K + -ATPase, an enzyme located in the membranes of the parietal cells of the gastric mucosa. Reduces basal and stimulated secretion, regardless of the nature of the stimulus. After a single dose of the drug inside, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After stopping the drug, secretory activity is completely restored after 3-5 days. Clarithromycin is an antibiotic from the macrolide group, a semi-synthetic derivative of erythromycin A. It has an antimicrobial effect that is associated with the suppression of protein synthesis by interacting 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 14-hydroxyclarithromycin metabolite formed in the body also has a pronounced antimicrobial activity. Amoxicillin - semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with inhibition of the synthesis of peptidoglycan (the supporting polymer of the cell wall) during the period of division and growth. Possesses the expressed activity in relation to N. Pylori. H. Pylori resistance to amoxicillin is rare. The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against H. Pylori.

Clinical pharmacology

An antiulcer drug that has a bactericidal effect on Helicobacter pylori.

Indications for use Pylobact am

Eradication therapy of Helicobacter pylori in duodenal ulcer.

Contraindications to the use of Pilobact am

• Combined use with cisapride, pimozide, astemizole and terfenadine is prohibited (see section "Interaction with other drugs");
• pregnancy;
• lactation period;
• porphyria;
• childhood;
• renal and / or liver failure;
• hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as antibiotics of the macrolide group.

Pylobact am Use in pregnancy and children

Contraindicated during pregnancy and lactation.

Use in children

Contraindicated in childhood.

Pylobact am side effects

On the part of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in the activity of "liver" enzymes in plasma, impaired 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.

From the hemopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.

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

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

Other: tachycardia, interstitial nephritis, blurred vision, peripheral edema, increased sweating, fever, gynecomastia.

drug interaction

The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentration.

Co-administration of clarithromycin with terfinadine increases the concentration of the latter and may lead to prolongation of the QT interval.

Co-administration of clarithromycin with indirect anticoagulants may potentiate the action of the latter,

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

Omeprazole can slow down the elimination of phenytoin, diazepam, warfarin, and also affect the absorption of ketoconazole, ampicillin and iron salts by inhibiting gastric acid secretion.

With the simultaneous appointment of amoxicillin with oral contraceptives, the effect of the latter may be reduced.

Dosage of Pylobact am

Each strip containing tablets and capsules of the Pylobact AM set 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 before meals, you should take the contents of the "morning" part in full (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin). In the evening, before meals, you should take the contents of the "evening" part in full (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin). Tablets and capsules should not be broken or chewed and should be swallowed whole. The duration of treatment is 7 days.

Precautionary measures

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis.

It is prescribed with caution against the background of taking drugs metabolized by the liver. In the case of a joint appointment with warfarin or other indirect anticoagulants, it is necessary to control the prothrombin time.