Amoxicillin, clarithromycin , Omeprazole | Pilobact AM set, combined, 7 pcs.

release form

Set of tablets and capsules

Packaging

7 sets of

Pharmacological action

Pilobact AM - anti-helicobacter, antiulcer.

Pharmacodynamics

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 by specifically inhibiting H + K + -ATPase, an enzyme located in the membranes of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion regardless of the nature of the stimulus. After a single oral administration, the action of omeprazole occurs within the first hour and lasts for 24 hours, maximum effect is achieved after 2 hours. After discontinuation of the drug, secretory activity is fully 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 H.pulori. The metabolite formed in the body - 14-hydroxyclarithromycin - also has a pronounced antimicrobial activity.

Amoxicillin is a semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with the inhibition of the synthesis of peptidoglycan (a supporting polymer of the cell wall) during the period of division and growth. It has a pronounced activity against H.pulori. Amoxicillin resistance of H.pullori is rare.

The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against H. pulori.

Pharmacokinetics

All three drugs that make up Pilobact® 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 of the drug in plasma is reached after 0.5–1 hours. Binding to 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 digestive tract. The absolute bioavailability of 250 mg of clarithromycin is approximately 50%. Eating slightly slows the onset of clarithromycin absorption and the formation of 14-hydroxyclarithromycin, but does not affect bioavailability. When taken on an empty stomach, serum Cmax 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 feces (20-30% - in unchanged form, the rest - in the form of metabolites). The simultaneous administration of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the average Cmax value increases by 10%, the minimum concentration - by 15% compared with the same parameters with clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa while prescribing it with omeprazole is also increased.

Amoxicillin is rapidly absorbed from the digestive 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 unchanged in the urine, a small amount with feces.

Indications

Helicobacter pylori eradication therapy for duodenal ulcer.

Contraindications

hypersensitivity to omeprazole, clarithromycin or tinidazole, as well as antibiotics of the

macrolide group, combined use with cisapride, pimozide, astemizole, terfenadine is prohibited, ethanol

pregnancy

lactation period

organic diseases of the central nervous system

porphyria

inhibition of bone marrow hematopoiesis

childhood

renal and / or liver failure.

Special instructions

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

Use 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 PV.

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

Use 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 PV.

With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.

Composition

1 set:

Tablets

1 tablet contains:

Active ingredient: clarithromycin 500 mg

Excipients: MCC povidone magnesium stearate steric acid talc purified silicon dioxide colloidal sodium crosc.

Capsules

1 capsule contains:

Active ingredient: amoxicillin trihydrate

Excipients: sodium lauryl sulfate silica colloidal croscarmellose dioxide MCC magnesium stearate.

Enteric-soluble capsules

1 capsule contains:

Active ingredient: omeprazole 20 mg

Excipients: Non Pareil Seeds (enteric-coated sucrose and corn starch granules) lactose starch corn mannate sulfate sodium hydrofluoride hydrofluoride sulfate.

Side effects of

From the digestive system: dysbiosis, 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.

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

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

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

Drug interaction

The simultaneous administration of theophylline and clarithromycin is accompanied by an increase in theophylline concentrations (monitoring of theophylline levels in blood plasma is necessary). With the simultaneous use of clarithromycin with carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate (sodium valproate), cisapride, pimozide, astemizole, digoxin, an increase in the concentration of the latter in plasma is possible. The simultaneous administration of clarithromycin with terfenadine increases the concentration of the latter and can lead to an extension of the QT interval. With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended. The simultaneous administration of clarithromycin with oral anticoagulants can potentiate the effect of the latter. In the case of joint administration with indirect anticoagulants, it is necessary to control prothrombin time.

Omeprazole may slow the elimination of phenytoin, diazepam, warfarin. By inhibiting the secretion of acid in the stomach, omeprazole can affect the absorption of ketoconazole, ampicillin and iron salts.

With the simultaneous administration of amoxicillin with oral contraceptives (femoden, regulon, triquilar, silest, belara, zhanin, yarin, etc.), the effect of the latter may be reduced.

Storage conditions

In a dry place at a temperature not exceeding 25 РC.

Term hodnosty

2 years

Conditions of release from drugstores

Prescription

Ranbaxy Laboratories Limited, India