Pylobact Tablets N7 Strip Kit
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Active ingredients
Omeprazole + Clarithromycin + Tinidazole
Release form
Pills
Composition
Active ingredient: 1 capsule omeprazole 20 mg; 1 tablet clarithromycin 250 mg; 1 tablet of tinidazole 500 mg. Concentration of active ingredient (mg): 500 mg + 250 mg + 20 mg
Pharmacological 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 parenteral 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 achieved after 2 hours. After cessation of the drug, secretory activity is fully restored after 3-5 days. Clarithromycin is a semi-synthetic antibiotic from the group of macrolides with a wide spectrum of action. 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, including Helicobacter pylori. The metabolite 14-hydroxylarithromycin formed in the body also has a pronounced antimicrobial activity. Tinidazole inhibits synthesis and damages the structure of the DNA of bacteria. It is active against anaerobic bacteria, protozoa and Helicobacter pylori.
Pharmacokinetics
All three drugs that make up Pylobact have good oral absorption. Omeprazole is rapidly absorbed after oral administration, its bioavailability is 30–40%. Eating does not affect the bioavailability of omeprazole. Сmax 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 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, peak serum concentrations 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. Communication with proteins 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 value of 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 the appointment with omeprazole is also increased. Bioavailability of tinidazole is about 100%. Communication with plasma proteins 12%. The time to reach Cmax is 2 h. It penetrates the BBB, the placenta. It is excreted in breast milk. It is metabolized in the liver to form pharmacologically active hydroxylated derivatives, which can enhance the action of tinidazole. T1 / 2 is 12-14 hours. It is excreted in bile by 50%, by the kidneys - 25% unchanged and 12% in the form of metabolites. It is reabsorbed in the renal tubules.
Indications
Eradication therapy of N. Pylori in duodenal ulcer.
Contraindications
Hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as to macrolide antibiotics; Combined use with cisapride, pimozide, astemizole and terfenadine (see Interaction with other medicines); Pregnancy; Lactation; Porphyria; Childhood; / or liver failure.
Precautionary measures
Do not exceed recommended doses.
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Dosage and administration
Each set of Pylobact AM contains two capsules of omeprazole (20 mg), two pills 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 clarithromin and two capsules of amoxicillin twice a day before meals in the morning and evening. Tablets and capsules can not be broken and chewed, they should be swallowed whole. 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 disorders, stomatitis, transient increase in liver enzyme activity in the liver, abnormal liver function, rarely pseudomembranous enterocolitis.Nervous system disorders: headache, dizziness, agitation, drowsiness, insomnia, ataxia, paresthesias, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy. On the part of the musculoskeletal system: muscular weakness, myalgia, arthralgia. On the part of the hemopoietic system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia. On the part of the skin: itching; rarely, skin rash, in some cases photosensitization, exudative erythema multiforme, alopecia. Allergic reactions: urticaria, angioedema, bronchospasm and anaphylactic shock. Other: tachycardia, interstitial nephritis, blurred vision, 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 serum level of clarithromycin. Amoxicillin Symptoms: nausea, vomiting, diarrhea, impaired water and electrolyte balance (as a result of vomiting and diarrhea). Treatment: gastric lavage, activated charcoal, saline laxative, drugs correction of water and electrolyte balance, hemodialysis. Tinidazole For overdose of tinidazole, symptomatic treatment is prescribed. Hemodialysis is effective.
Interaction with other drugs
The simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in theophylline concentration. Clarithromycin reduces zidovudine absorption (between the use of drugs should be an interval of at least 4 hours). The development of cross-resistance between clarithromycin, lincomycin and clindamycin is possible. Simultaneous administration of clarithromycin with terphinadine increases the concentration of the latter and may lead to prolongation of the interval. Disopyramide, Lovastatin, Valproate, Cisapride, Pimozide, Astemizole, Digoxin may be elevated. meprazol may slow elimination phenytoin, diazepam, warfarin and also affect the absorption of ketoconazole, ampicillin, iron salts and by inhibition of gastric acid secretion.It enhances the inhibitory effect on the hematopoietic system and other drugs. Tinidazole enhances the effect of indirect anticoagulants and the action of ethanol - disulfiram-like reactions are possible. Not recommended with ethionamide. Phenobarbital accelerates the metabolism of tinidazole.
special instructions
Before starting therapy, it is necessary to exclude the presence of a malignant process, since treatment, masking the symptoms, may delay the correct diagnosis. With caution prescribed against 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 the prothrombin time. In case of heart diseases in the history, simultaneous use with terfenadine, cisapride, astemizole is not recommended. Tinidazole causes dark urine staining. Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration. of attention and attitudes of psychomotor reactions.