Composition, form of production and packaging
Combination kit (daily dose)
Blister contains:
capsules (2 pcs in pack) 1 caps.
omeprazole 20 mg
coated tablets (2 pcs in pack) 1 tab.
clarithromycin 250 mg
coated tablets (2 pcs in pack) 1 tab.
tinidazole 500 mg
6 pcs. (in the complete set - tablets of two kinds and a capsule) - blisters (7) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Omeprazole oppresses the secretion of gastric acid due to specific inhibition of H + K + -ATPase - an enzyme found in membranes of parental mucous membranes of the stomach. Reduces basal and stimulated secretion irrespective of the nature of the stimulus. After a single dose of the drug, omeprazole acts within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After discontinuation of the drug secretory activity is completely restored after 3-5 days.
Clarithromycin is a semisynthetic antibiotic from the group of macrolides of a wide spectrum of action. Has 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 antimicrobial activity.
Tinidazole inhibits synthesis and damages the structure of bacterial DNA. Has an activity against anaerobic bacteria, protozoa and Helicobacter pylori.
PHARMACOKINETICS
All three preparations included in Pylobact В® have good absorption by oral administration.
Omeprazole is rapidly absorbed after ingestion, its bioavailability is 30-40%. Eating does not affect the bioavailability of omeprazole. C max is reached after 0.5-1 h. The connection with plasma proteins is 90%. It is almost completely metabolized in the liver. The main way 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%. Food intake slightly slows 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 Ојg / ml for clarithromycin and its main metabolite. T 1/2 ofclarithromycin is 3-4 hours. Clarithromycin is widely distributed in the body. The concentration of clarithromycin in tissues exceeds that in serum. The connection with proteins is from 42 to 70%. It is excreted by the kidneys and with fecal masses (20-30% in unchanged form, the rest in the form of metabolites). Simultaneous administration of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the mean C max is increased by 10%, the minimum concentration by 15% compared to the same parameters with monotherapy with clarithromycin. The concentration of clarithromycin in the gastric mucosa with concomitant administration with omeprazole is also increased.
Bioavailability of tinidazole is about 100%. Relationship with plasma proteins 12%. Time to reach C max 2 h. Penetrates through GEB, placenta. Excreted in breast milk. Metabolised in the liver with the formation of pharmacologically active hydroxylated derivatives, which can enhance the action of tinidazole. T 1/2 is 12-14 hours. It is excreted with bile 50%, kidneys - 25% unchanged and 12% in the form of metabolites. It is reversed in the renal tubules.
INDICATIONS
- eradication therapy of Helicobacter pylori in duodenal ulcer.
DOSING MODE
Each Pylobact В® В® strip contains two capsules of omeprazole (20 mg each), two clarithromycin (250 mg) and two 500 mg tablets of tinidazole, and are calculated for 1 day of treatment.
Take 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 in the evening.Tablets and capsules can not be broken and chewed, they should be swallowed whole.
Duration of treatment is 7 days.
SIDE EFFECT
On the part of the digestive system: dysbacteriosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorder, metallic taste in the mouth, decreased appetite, stomatitis, transient increase in hepatic enzymes in the plasma, hepatitis (including jaundice), in patients with a previous liver disease - encephalopathy; rarely pseudomembranous enterocolitis.
From the central nervous system: headache, dizziness, agitation, fatigue, weakness, drowsiness, insomnia, ataxia, paresthesia, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy, convulsions, fear, nightmares, disorientation, psycho, depersonalization, noise in ears.
From the musculoskeletal system: muscle weakness, myalgia, arthralgia.
On the part of the hematopoiesis system: leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.
From the skin: itching; rarely - skin rash; in some cases - photosensitivity, multiforme exudative erythema, 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 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;
- oppression of bone marrow hematopoiesis;
- childhood;
renal and / or hepatic insufficiency.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is contraindicated in renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in case of liver failure.
APPLICATION FOR CHILDREN
The drug is contraindicated in childhood.
SPECIAL INSTRUCTIONS
Before the beginning of therapy it is necessary to exclude the presence of malignant process, t. treatment, masking the symptoms, can delay the setting of the correct diagnosis.
Caution is prescribed against the background of taking medicines metabolized by the liver. In the case of co-administration with warfarin or other indirect anticoagulants, prothrombin time should be monitored.
With heart disease in the anamnesis, simultaneous administration with terfenadine, cisapride, astemizole is not recommended.
Tinidazole causes dark staining of urine.
Impact on the ability to drive vehicles and manage mechanisms.
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration of attention and the ramifications of psychomotor reactions.
OVERDOSE
Clarithromycin
Symptoms: on the part of the digestive 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, disturbance of water-electrolyte balance (as a consequence of vomiting and diarrhea).
Treatment: gastric lavage, activated charcoal, salt laxatives, medicines for correction of water-electrolyte balance, hemodialysis.
Tinidazole
When an overdose of tinidazole is prescribed symptomatic treatment. Hemodialysis is effective.
DRUG INTERACTION
Simultaneous appointment of theophylline and clarithromycin is accompanied by an increase in the concentration of theophylline. Clarithromycin decreases the absorption of zidovudine (between the use of drugs should be an interval of at least 4 hours). It is possible to develop cross-resistance between clarithromycin, lincomycin and clindamycin.
Simultaneous administration of clarithromycin with terfinadine increases the concentration of the latter and may lead to an elongation of the QT interval.
Simultaneous administration of clarithromycin with indirect anticoagulants can potentiate the effect of the latter.
At simultaneous appointment with clarithromycin levels of carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin can be increased.
Omeprazole can slow the elimination of phenytoin, diazepam, warfarin, and also affect the absorption of ketoconazole, ampicillin and iron salts by inhibiting the secretion of acid in the stomach. Increases the inhibitory effect on the hemopoietic system and other medicines.
Tinidazole enhances the effect of indirect anticoagulants and the action of ethanol - disulfiram-like reactions are possible. It is not recommended to administer with ethionamide. Phenobarbital accelerates the metabolism of tinidazole.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place at a temperature of no higher than 25 В° C.
Keep out of the reach of children.
Shelf life 3 years. Do not use after the expiry date printed on the package.
