Pylobact AM
Ranbaxy Laboratories Ltd
1656 Items
2019-09-19
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Clinical Pharmacology
Pylobact AM - anti-helicobacter, anti-ulcer.
Pharmacodynamics
Triple therapy, including omeprazole, clarithromycin and amoxicillin allows you to achieve a high percentage of eradicationHelicobacter pylori(85–94%).
Omeprazole inhibits gastric acid secretion by specifically inhibiting H+ TO+-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 omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is reached after 2 hours. After stopping the drug, secretory activity is fully restored in 3-5 days.
Clarithromycin - macrolide antibiotic, a semi-synthetic derivative of erythromycin A. It has an antimicrobial effect, which is associated with the suppression of protein synthesis through interaction with the 50S ribosomal subunit of the microbial cell. Effective against a large number of gram-positive, gram-negative aerobic and anaerobic microorganisms, includingH.plori. The metabolite formed in the body - 14-hydroxyclaritromycin - 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 peptidoglycan synthesis (the supporting polymer of the cell wall) during the period of division and growth. It has a pronounced activity in relation toH.plori. ResistanceH.plori Amoxicillin is rare.
The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect againstH.plori.
Pharmacokinetics
All three drugs that are part of Pylobact® AM, have good oral absorption.
Omeprazole quickly absorbed after ingestion, and its bioavailability is 30–40%. Eating does not affect the bioavailability of omeprazole. Cmax drug in plasma is achieved in 0.5–1 hours. Plasma 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 of clarithromycin is approximately 50%. Food intake slightly slows the beginning of the absorption of clarithromycin and the formation of 14-hydroxylarithromycin, but does not affect bioavailability. When taken on an empty stomach Cmax serum levels are reached within 2 hours after oral administration and are 0.6 and 0.7 mcg / ml for clarithromycin and its main metabolite. T1/2 clarithromycin is 3-4 hours. Clarithromycin is widely distributed in the body. The concentration of clarithromycin in the 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: average Cmax increased by 10%, the minimum concentration - by 15% compared with the same indicators for clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa while its appointment with omeprazole is also increased.
Amoxicillin rapidly absorbed from the gastrointestinal tract. Food intake does not affect the absorption of amoxicillin. 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 - 20%. About 60% of the dose taken is excreted in the urine unchanged, a small amount is excreted.
Indications
Eradication therapy of Helicobacter pylori in duodenal ulcer.
Composition
1 set:
Pills
1 tablet contains:
Active substance: clarithromycin 500 mg;
Excipients: MCC; Povidone; magnesium stearate; steric acid; purified talc; colloidal silicon dioxide; croscarmellose sodium.
Capsules
1 capsule contains:
Active substance: Amoxicillin trihydrate;
Excipients: sodium lauryl sulfate; colloidal silicon dioxide; croscarmellose; MCC; magnesium stearate.
Enteric Capsules
1 capsule contains:
Active substance: Omeprazol20 mg;
Excipients: Non Pareil Seeds (sucrose and corn starch granules coated with an enteric coating); lactose; corn starch; mannitol; Povidone; purified talc; sodium lauryl sulfate; sodium phosphate (anhydrous).
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Dosage and Administration
For oral use.
Each strip containing pills and capsules of the Pylobact AM kit is designed for one day of treatment and consists of two parts: red with the words “morning” and blue with the words “evening”.
In the morning before the meal, take the contents of the “morning” part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin). In the evening before the meal, you should take the contents of the “evening” part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).
pills and capsules can not be broken and chewed, they should be swallowed whole. The duration of treatment is 7 days.
Adverse reactions
On the part of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in liver enzyme activity 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 hemopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.
On the part of the skin: itching; seldom - skin rash, in some cases - photosensitization, exudative erythema multiforme, alopecia.
Allergic reactions: urticaria, angioedema, bronchospasm and anaphylactic shock.
Other: tachycardia, interstitial nephritis, visual impairment, peripheral edema, increased sweating, fever, gynecomastia.
Contraindications
- hypersensitivity to omeprazole, clarithromycin or tinidazole, as well as to macrolide antibiotics;
- combined use with cisapride, pimozide, astemizole, terfenadine, ethanol is prohibited;
- pregnancy;
- lactation period;
- organic diseases of the central nervous system;
- porphyria;
- oppression of bone marrow hematopoiesis;
- childhood;
- renal and / or liver failure.
Drug interactions
The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentrations (control of theophylline level in the blood plasma is necessary). With simultaneous use of clarithromycin with carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate (sodium valproate), cisapride, pimozide, astemizole, digoxin, it is possible to increase the concentration of the latter in plasma. The simultaneous appointment of clarithromycin with terfenadine increases the concentration of the latter and may lead to a prolongation of the QT interval. With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended. The simultaneous appointment of clarithromycin with oral anticoagulants can potentiate the effect of the latter. In the case of co-administration with indirect anticoagulants, it is necessary to control the prothrombin time.
Omeprazole can 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 appointment of amoxicillin with oral contraceptives (femoden, regulon, trikvilar, silest, Belara, Jeanine, Yarin, etc.) may decrease the effect of the latter.
Special instructions
Before starting treatment, it is necessary to exclude the presence of a malignant process (especially in case of a stomach ulcer), since treatment, masking the symptoms, may delay the correct diagnosis.
Be wary appointed on the background of medication, metabolized by the liver.In the case of co-administration with warfarin or other indirect anticoagulants, it is necessary to control PT.
With a history of heart disease, simultaneous use with terfenadine, cisapride, astemizole is not recommended. treatment, masking the symptoms, may delay the correct diagnosis.
Be wary appointed on the background of medication, metabolized by the liver. In the case of co-administration with warfarin or other indirect anticoagulants, it is necessary to control PT.
With a history of heart disease, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.
- Brand name: Pylobact AM
- Active ingredient: Amoxicillin, Clarithromycin, Omeprazole
- Dosage form: A set of pills and capsules
- Manufacturer: Ranbaxy Laboratories Ltd
- Country of Origin: India
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