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. Pylobact - an effective remedy for peptic ulcer

Pylobact AM (omeprazole + clarithromycin + amoxicillin) is a combined drug from the Indian pharmaceutical company Ranbaxi, used to treat helicobacteriosis against the background of duodenal ulcer. The inclusion of three independent drugs in the composition of Pilobact AM at once provides a high percentage of Helicobacter eradication (85-94%). Omeprazole inhibits 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 of action of omeprazole occurs 2 hours after its introduction into the body. When the drug is discontinued, the secretory function is fully restored after 3-5 days. Clarithromycin is a macrolide antibiotic that is a semi-synthetic derivative of erythromycin. Its antibacterial action is based on the ability to inhibit protein synthesis through interaction with the 50S subunit of the bacterial cell ribosome. Active against a wide range of gram-positive and gram-negative microorganisms, aerobes and anaerobes, including Helicobacter. It undergoes metabolism with the formation of 14-hydroxyclarithromycin, which is also endowed with a pronounced antibacterial activity. Amoxicillin is a synthetic penicillin. It 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 (the structure-forming component of the cell wall) in the most important period of the cell's life - when it divides and grows. At the same time, amoxicillin is especially hostile to Helicobacter. The resistance of the latter to the drug is extremely rare. If we talk about the combination of clarithromycin with amoxicillin, then it is truly detrimental to Helicobacter, because.

to. each of its components potentiates the action of another. All three drugs included in Pylobact AM are well absorbed when taken orally. Omeprazole is rapidly absorbed after oral administration. Eating 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 reached after 2 hours. The half-life of clarithromycin varies from 3 to 4 hours. Excreted with urine and feces. The uncontested leader in terms of bioavailability among all three drugs is amoxicillin - 75-90%. Its half-life is 1-1.5 hours. It is excreted mainly by the kidneys.

Pylobact AM is available as kits containing tablets and capsules and placed in strips. Each such strip is designed for one day of treatment and consists of two multi-colored parts: red (morning) and blue (evening). One set 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 drug course is 1 week. Before starting pharmacotherapy, it is necessary to make sure that there are no oncological diseases: otherwise, the treatment may mask malignant symptoms and delay the diagnosis of a much more serious disease. Pylobact AM is used with caution in conjunction with drugs metabolized by the liver. The combination of Pylobact AM with indirect anticoagulants (for example, with warfarin) requires monitoring of the prothrombin time (blood clotting time). Amoxicillin is poorly compatible with oral contraceptives (when they are taken together, the effect of the latter weakens).

Pharmacology

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, which 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 clarithromycin absorption 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.

Release form

Combination set (daily dose)
The strip contains:

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

Dosage

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.

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.

Side effects

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.

Indications

Helicobacter pylori eradication therapy for duodenal ulcer.

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.

Application features

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation.

Application for violations of liver function

Contraindicated in liver failure.

Application for violations of kidney function

Contraindicated in renal failure.

Use in children

Contraindicated in childhood.

special instructions

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.

Antiulcer drug that has a bactericidal effect on Helicobacter pylori

Active ingredients

Release form, composition and packaging

combo set (daily dose)
The strip contains:

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

pharmachologic effect

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

Clarithromycin is an antibiotic from the group of macrolides, a semi-synthetic derivative of A. It has an antimicrobial effect, which 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 metabolite 14-hydroxyclarithromycin formed in the body also has a pronounced 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 make up 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 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.

Indications

- Helicobacter pylori eradication therapy for duodenal ulcer.

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.

Dosage

Side effects

From the side 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, abnormal 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 hematopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.

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

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

Others: tachycardia, interstitial nephritis, visual impairment, 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,

Antiulcer drug that has a bactericidal effect on Helicobacter pylori

Active ingredients

Release form, composition and packaging

combo set (daily dose)
Blister contains:

6 pcs. (included - tablets of two types and capsules) - blisters (7) - packs of cardboard.

pharmachologic effect

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- a semi-synthetic antibiotic from the group of macrolides with a wide spectrum of action. It has an 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.

inhibits synthesis and damages the structure of bacterial DNA. It has activity against anaerobic bacteria, protozoa and Helicobacter pylori.

Pharmacokinetics

All three drugs that are part of Pylobact have good absorption when taken orally.

Omeprazole rapidly absorbed after oral administration, its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. C max is reached in 0.5–1 h. The protein binding is 90%. Almost completely metabolized in the liver. The main route of excretion is with urine (80%).

Clarithromycin 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. T 1/2 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 simultaneous administration with omeprazole is also increased.

Bioavailability tinidazole about 100%. Communication with plasma proteins 12%. Time to reach Cmax 2 hours. Penetrates through the BBB, the placenta. It is allocated with breast milk. It is metabolized in the liver with the formation of pharmacologically active hydroxylated derivatives, which can enhance the effect of tinidazole. T1 / 2 is 12-14 hours. Excreted with bile 50%, kidneys - 25% unchanged and 12% as metabolites. It is reabsorbed in the renal tubules.

Indications

- Helicobacter pylori eradication therapy for duodenal ulcer.

Contraindications

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

- combined use with cisapride, pimozide, astemizole, terfenadine, ethanol is prohibited;

- pregnancy;

- lactation period;

- organic diseases of the central nervous system;

- porphyria;

- inhibition of bone marrow hematopoiesis;

- childhood;

- renal and / or liver failure.

Dosage

Each strip of Pilobact contains two capsules of omeprazole (20 mg), two tablets of clarithromycin (250 mg) and two tablets of tinidazole (500 mg), and is designed for 1 day of treatment.

Take orally one capsule of omeprazole, one tablet of clarithromycin and one tablet of tinidazole 2 times a day during or after meals in the morning and evening. Tablets and capsules should not be broken or chewed and should be swallowed whole.

The duration of treatment is 7 days.

Side effects

From the side of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbance, metallic taste in the mouth, loss of appetite, stomatitis, transient increase in plasma liver enzymes, abnormal liver function, hepatitis (and so on). hours with jaundice), in patients with previous liver disease - encephalopathy; rarely pseudomembranous enterocolitis.

From the side of the central nervous system: headache, dizziness, agitation, fatigue, weakness, drowsiness, insomnia, ataxia, paresthesia, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy, convulsions, fear, nightmares, disorientation, psychosis, depersonalization, tinnitus.

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

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

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

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

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

Overdose

Clarithromycin

Symptoms: from the gastrointestinal tract (nausea, vomiting, diarrhea); headache, confusion.

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

Amoxicillin

Symptoms: nausea, vomiting, diarrhea, violation of water and electrolyte balance (as a result of vomiting and diarrhea).

Treatment: gastric lavage, saline laxatives, drugs for the correction of water and electrolyte balance, hemodialysis.

Tinidazole

In case of an overdose of tinidazole, symptomatic treatment is prescribed. Hemodialysis is effective.

drug interaction

The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentration. Clarithromycin reduces the absorption of zidovudine (there should be an interval of at least 4 hours between the use of drugs). Cross-resistance between clarithromycin, lincomycin and clindamycin is possible.

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.

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. Enhances the inhibitory effect on the hematopoietic system and other drugs.

Tinidazole enhances the effect of indirect anticoagulants and the effect 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 starting therapy, it is necessary to exclude the presence of a malignant process, because. treatment, by masking symptoms, may delay the correct diagnosis.

Tinidazole causes dark staining of urine.

For impaired liver function

The drug is contraindicated in liver failure.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

Store in a dry place at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf life 3 years. Do not use after the expiry date stated on the packaging.

Pylobact AM
Buy Pylobact AM in pharmacies
Pylobact AM in the medicine guide

DOSAGE FORMS
pills and capsules set

MANUFACTURERS
Ranbaxi Laboratories Limited (India)

GROUP
Antiulcer drugs

COMPOSITION
A set of tablets and capsules (clarithromycin - film-coated tablets, amoxicillin - capsules, omeprazole - enteric capsules).

INTERNATIONAL NON-PROPRIETARY NAME
Amoxicillin + Clarithromycin + Omeprazole

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. 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 clarithromycin absorption 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.

INDICATIONS FOR USE
Eradication therapy of H. Pylori in duodenal ulcer.

CONTRAINDICATIONS
. Hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as macrolide antibiotics; . Combined use with cisapride, pimozide, astemizole and terfinadine is prohibited; . Pregnancy; . lactation period; . Porfiria; . Childhood; . Renal and / or liver failure.

SIDE EFFECT
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.

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.

METHOD OF APPLICATION AND DOSAGE
Each Pylobact AM kit contains two capsules of omeprazole (20 mg), two tablets of clarithromycin (500 mg) and four capsules of amoxicillin (500 mg) and is designed for one day of treatment. Take orally one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin twice a day before meals in the morning and evening. Tablets and capsules should not be broken or chewed and should be swallowed whole. The duration of treatment is 7 days.

OVERDOSE
No data.

SPECIAL INSTRUCTIONS
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.

STORAGE CONDITIONS
Store in a dry place at a temperature not exceeding 25°C. Keep out of the reach of children.

Release form

Tablets

Composition

The kit contains: clarithromycin 2 tablets, amoxicillin 4 capsules, omeprazole 2 capsules 1 film-coated tablet contains the active ingredient: clarithromycin 500 mg. Excipients: MCC; povidone; magnesium stearate; steric acid; talc purified; silicon dioxide colloidal; croscarmellose sodium. Film coating: hypromellose; hyprolosis; propylene glycol; sorbitan monooleate; titanium dioxide; quinoline yellow dye; vanillin; purified talc. The composition of the ink for the inscription: black ink Opacode S-1-27794 (methylated alcohol IMS 74 OP, 47.5% shellac solution in methylated alcohol IMS 74 OP, iron dye black oxide, n-butyl alcohol, propylene glycol, purified water). 1 capsule contains: active substance amoxicillin trihydrate 592.856 mg (equivalent to 500 mg amoxicillin). Excipients: sodium lauryl sulfate; silicon dioxide colloidal; croscarmellose; MCC; magnesium stearate. Capsule composition: cap - brilliant blue dye; azorubin dye; quinoline yellow dye; titanium dioxide; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium lauryl sulfate; gelatin. Hull - dye sunset yellow; quinoline yellow dye; titanium dioxide; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium lauryl sulfate; gelatin. Lettering ink: dehydrated alcohol; butyl alcohol; shellac; iron dye black oxide; concentrated ammonia solution; propylene glycol. 1 enteric-coated capsule contains the active ingredient Omeprazole 20 mg. Excipients: Non Pareil Seeds (granules of sucrose and corn starch, enteric-coated); lactose; corn starch; mannitol; povidone; talc purified; sodium lauryl sulfate; sodium hydrogen phosphate (anhydrous). The composition of the enteric shell: hypromellose phthalate, dichloromethane, isopropanol, diethyl phthalate, titanium dioxide, the shell of an empty hard gelatin capsule size No2 with a dark blue cap and a transparent pink body. Capsule shell: cap - brilliant blue; carmoisin (azorubine); gelatin; methyl parahydroxybenzoate; propyl parahydroxybenzoate. Body - carmoisine (azorubine); gelatin; methyl parahydroxybenzoate; propyl parahydroxybenzoate

Pharmacological effect

Triple therapy, including omeprazole, clarithromycin and amoxicillin, allows achieving 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, which 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. Resistance of Helicobacter pylori 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 have good oral absorption. Omeprazole is rapidly absorbed after oral administration, and its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. Cmax 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 clarithromycin absorption 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 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, while prescribing it 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

Indications

Helicobacter pylori eradication therapy for duodenal ulcer

Contraindications

Combined use with cisapride, pimozide, astemizole is prohibited; - pregnancy; - lactation; - porphyria; - children's age; - renal and / or liver failure; - hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as macrolide antibiotics

Precautionary measures

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), because. treatment, masking the symptoms, can delay the correct diagnosis. With caution, it is prescribed 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 PV. In case of a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended

Use during pregnancy and lactation

Contraindicated during pregnancy and lactation

Dosage and administration

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. 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 the activity of "liver" enzymes in plasma, impaired liver function, rarely - pseudomembranous enterocolitis. side of the nervous system: headache, dizziness, agitation, drowsiness, insomnia, ataxia, paresthesia, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy. On the part of the musculoskeletal system: muscle weakness, myalgia, arthralgia. On the part of the hematopoietic 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. Others: tachycardia, interstitial nephritis, blurred vision, peripheral edema, increased sweating, fever, gynecomastia

Overdose

Symptoms: possible increase in side effects. Treatment: carry out symptomatic therapy.

Interaction with other drugs

Simultaneous administration of theophylline and clarithromycin is accompanied by an increase in theophylline concentration. Simultaneous administration of clarithromycin with terfinadine increases the concentration of the latter and can lead to a prolongation of the QT interval. Simultaneous administration of clarithromycin with indirect anticoagulants can potentiate the effect of the latter. , lovastatin, valproate, cisapride, pimozide, astemizole, digoxin can 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. oral contraceptives may reduce the effect of the latter

special instructions

Before starting therapy, it is necessary to exclude the presence of a malignant process (especially with a stomach ulcer), since treatment, masking the symptoms, can delay the correct diagnosis. With caution, it is prescribed against the background of taking drugs that are 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