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Pilobact®

Clarithromycin

When used simultaneously with astemizole, cisapride, pimozide, terfenadine, an increase in the concentration of the latter in the blood was reported, which can lead to cardiac arrhythmias (prolongation of the QT interval on the electrocardiogram, ventricular tachycardia, ventricular fibrillation, torsade de pointes). Concomitant use of clarithromycin with astemizole. cisapride, pimozide, terfenadine are contraindicated.

The simultaneous use of clarithromycin and ergotamine or dihydroergotamine (ergot alkaloids) can lead to acute ergotamine intoxication, accompanied by severe peripheral vasospasm (impaired sensitivity, paresthesia, pain and a marked decrease in pulsation in the extremities, disorders of the central nervous system - dizziness, convulsions, coma). Concomitant use of clarithromycin with ergot alkaloids is contraindicated. Caution should be exercised when using clarithromycin concomitantly with ototoxic drugs, primarily aminoglycosides, due to increased ototoxicity. During and after treatment, the function of the hearing organ and vestibular apparatus should be monitored. Concomitant use of zidovudine in HIV-infected adult patients may result in decreased steady-state zidovudine concentrations. Since clarithromycin affects the absorption of concomitantly administered oral zidovudine, it is recommended that these drugs be taken at least 4 hours apart.

Concomitant use of clarithromycin and digoxin

Digoxin is suspected to be a Pgp substrate. Clarithromycin is known to inhibit Pgp. When clarithromycin and digoxin are used together, inhibition of Pgp by clarithromycin may result in increased effects of digoxin. Post-marketing studies have shown that coadministration of digoxin and clarithromycin may also result in increased serum concentrations of digoxin. Some patients have experienced clinical symptoms of digoxin toxicity, including potentially fatal arrhythmias. Serum digoxin concentrations should be carefully monitored when clarithromycin and digoxin are coadministered.

Interactions caused by
CYP3A CYP3A4
isoenzyme (for example, rifampicin, phenytoin, carbamazepine, phenobarbital, St. John's wort) can induce the metabolism of clarithromycin . This may result in subtherapeutic concentrations of clarithromycin, resulting in reduced effectiveness. In addition, it is necessary to monitor the concentration of the CYP3A isoenzyme inducer in the blood plasma, which may increase due to the inhibition of the CYP3A isoenzyme by clarithromycin. The following drugs have a proven or suspected effect on clarithromycin plasma concentrations; if they are used together, dosage adjustments or switching to alternative treatment may be necessary.

Efavirenz, nevirapine, rifampicin, rifabutin, rifapentine increase the metabolism of clarithromycin, reducing its concentration in the blood plasma and increasing the concentration of its biologically active metabolite 14-hydroxyclarithromycin. In patients receiving inducers of CYP3A isoenzymes, alternative antibiotic therapy options should be considered. The simultaneous use of clarithromycin and rifabutin leads to an increase in the concentration of rifabutin and a decrease in the concentration of clarithromycin in the blood plasma with the risk of developing uveitis.

The concentration of clarithromycin decreases with the use of etravirine, but the concentration of the active metabolite 14-hydroxyclarithromycin increases. Because 14-hydroxyclarithromycin has little activity against Mycobacterium avium complex (MAC) infections, overall activity against Mycobacterium avium complex (MAC) infections may vary and alternative treatments should be considered for the treatment of MAC.

The simultaneous use of fluconazole leads to an increase in the steady-state concentration and area under the curve of “conconcurrent” ventricular tachycardia. Monitoring of ECG (increased QT interval) and serum concentrations of these drugs is necessary. Cases of hypoglycemia have been reported with the combined use of clarithromycin and disopyramide. It is necessary to monitor the concentration of glucose in the blood plasma when using these drugs simultaneously.

Concomitant use with HMG-CoA reductase inhibitors (simvastatin, lovastatin) leads to an increased risk of developing myopathy and rhabdomyolysis. Concomitant use of clarithromycin with simvastatin and lovastatin is contraindicated. Clarithromycin should be used with caution in combination therapy with other statins. If co-administration with statins is necessary, it is necessary to use statins that do not depend on CYP3A metabolism (for example, fluvastatin). It is recommended to take the lowest dose of statin. The development of signs and symptoms of myopathy should be monitored.

When using clarithromycin simultaneously with blockers of “slow” calcium channels that are metabolized by the CYP3A4 isoenzyme (for example, verapamil, amlodipine, diltiazem), caution should be exercised, as there is a risk of arterial hypotension and bradyarrhythmia. Plasma concentrations of clarithromycin, as well as slow calcium channel blockers, may increase with simultaneous use. Arterial hypotension, bradyarrhythmia and lactic acidosis are possible when taking clarithromycin and verapamil simultaneously.

Colchicine is a substrate for both CYP3A and P-glycoprotein, which are inhibited by clarithromycin. A single dose of 0.6 mg colchicine combined with clarithromycin 250 mg twice daily for a week resulted in a 197% increase in the maximum concentration of colchicine and the area under the conconconcontraindications curve. Omeprazole has been shown to interact with some antiretroviral drugs. The mechanisms and clinical significance of these interactions are not always known. An increase in pH during omeprazole therapy may affect the absorption of antiretroviral drugs. Interaction at the level of the CYP2C19 isoenzyme is also possible. When omeprazole is co-administered with certain antiretroviral drugs, such as atazanavir and nelfinavir, a decrease in their serum concentrations is observed during omeprazole therapy. In this regard, the combined use of omeprazole with antiretroviral drugs such as atazanavir and nelfinavir is not recommended.

With the simultaneous use of omeprazole and saquinavir, an increase in the concentration of saquinavir in the serum was noted; when used with some other antiretroviral drugs, their concentration did not change.

Omeprazole inhibits CYP2C19, the main isoenzyme involved in its metabolism. Concomitant use of omeprazole with other drugs metabolized by the CYP2C19 isoenzyme, such as diazepam, warfarin (R-warfarin) or other vitamin K antagonists phenytoin and cilostazol, may lead to a slower metabolism of these drugs. Monitoring of patients taking phenytoin and omeprazole is recommended; a dose reduction of phenytoin may be required. However, concomitant treatment with omeprazole at a daily dose of 20 mg does not affect the concentration of phenytoin in the blood plasma in patients taking the drug for a long time. When using omeprazole in patients receiving warfarin or other vitamin K antagonists, monitoring of the international normalized ratio is necessary; in some cases, it may be necessary to reduce the dose of warfarin or another vitamin K antagonist. At the same time, concomitant treatment with omeprazole at a daily dose of 20 mg does not lead to a change in coagulation time in patients taking warfarin for a long time.

The use of omeprazole at a dose of 40 mg once daily resulted in an increase in Cmax and AUC of cilostazol by 18% and 26%, respectively; for one of the active metabolites of cilostazol, the increase was 29% and 69%, respectively.

According to the study results, a pharmacokinetic/pharmacodynamic interaction was noted between clopidogrel (loading dose of 300 mg and maintenance dose of 75 mg/day) and omeprazole (80 mg/day orally), which leads to a decrease in exposure to the active metabolite of clopidogrel by an average of 46 % and reducing the maximum inhibition of ADP-induced platelet aggregation by an average of 16%.

The clinical significance of this interaction is unclear. An increased risk of cardiovascular events with concomitant use of clopidogrel and proton pump inhibitors, including omeprazole, was not shown in a prospective, randomized, open-label study of more than 3,760 patients receiving placebo or omeprazole 20 mg/day. concomitantly with clopidogrel and acetylsalicylic acid (ASA) therapy, and was not confirmed by additional non-randomized analysis of clinical outcomes from large prospective randomized trials involving more than 47,000 patients.

The results of a number of observational studies are contradictory and do not provide a clear answer about the presence or absence of an increased risk of thromboembolic cardiovascular complications during the combined use of clopidogrel and proton pump inhibitors.

When clopidogrel was used together with a fixed combination of 20 mg esomeprazole and 81 mg ASA, exposure to the active metabolite of clopidogrel decreased by almost 40% compared with clopidogrel monotherapy, while the maximum levels of inhibition of ADP-induced platelet aggregation were the same, which is likely due to simultaneous taking ASA in a low dose.

Omeprazole does not affect the metabolism of drugs metabolized by the CYP3A4 isoenzyme. such as cyclosporine, lidocaine, quinidine, estradiol, erythromycin and budesonide.

No interaction of omeprazole with the following drugs has been identified: antacids, caffeine, theophylline, S-warfarin, piroxicam, diclofenac, naproxen, metoprolol, propranolol and ethanol.

With the simultaneous use of omeprazole and tacrolimus, an increase in the concentration of tacrolimus in the blood serum was noted.

Some patients experienced a slight increase in methotrexate concentrations when combined with proton pump inhibitors. If high doses of methotrexate are prescribed, temporary discontinuation of omeprazole should be considered.

Effect of drugs on the pharmacokinetics of omeprazole

The isoenzymes CYP2C19 and CYP3A4 are involved in the metabolism of omeprazole. Concomitant use of omeprazole and inhibitors of CYP2C19 and CYP3A4 isoenzymes. such as clarithromycin and voriconazole, may lead to increased plasma concentrations of omeprazole by slowing the metabolism of omeprazole. Concomitant use of voriconazole and omeprazole results in a more than twofold increase in the AUC of omeprazole. Due to the good tolerance of high doses of omeprazole, short-term joint use of these drugs does not require dose adjustment of omeprazole.

Co-administration of omeprazole with amoxicillin or metronidazole does not affect the concentration of omeprazole in the blood plasma.

Drugs that induce CYP2C19 and CYP3A4 isoenzymes. such as rifampicin and St. John's wort preparations, when used together with omeprazole, can lead to a decrease in the concentration of omeprazole in the blood plasma by accelerating the metabolism of omeprazole.

Tinidazole

Tinidazole enhances the effect of indirect anticoagulants and the effect of ethanol - disulfiram-like reactions are possible. Compatible with sulfonamides and antibiotics (aminoglycosides, erythromycin, rifampicin, cephalosporins). It is not recommended to administer together with ethionamide. Phenobarbital accelerates the metabolism of tinidazole.

Pharmacodynamics and pharmacokinetics

It contains three active components - omeprazole, tinidazole and clarithromycin. The drug has antiulcer and antimicrobial effects. Under the influence of omeprazole, the secretion and acidity of hydrochloric acid decreases (due to the inhibition of a special enzyme located in the membranes of parental cells in the gastric mucosa), and the level of stimulated and basal secretion . Oral administration of omeprazole inhibits the secretion of gastric juice after an hour, the effect persists throughout the day. A 97% reduction in gastric acidity is achieved by repeated administration of 20 mg of omeprazole during the day.

The second component of the drug Pilobact is clarithromycin , a semi-synthetic derivative of erythromycin A, an antibiotic of the macrolide , which acts on Helicobacter pylori , anaerobic microorganisms, gram-negative and gram-positive flora.

The third component of the drug Pilobact is tinidazole ; acts on Giardia, amoebas, Trichomonas , Helicobacter pylori, causative agents of anaerobic infections, and has an antiprotozoal effect.

Pilobact AM additionally contains amoxicillin (an antibiotic). Pilobact NEO is used for triple Helicobacter pylori therapy.

Pilobact, instructions for use (Method and dosage)

The medicine is taken orally.

Each blister contains 2 capsules of omeprazole at a dose of 20 mg, 2 tablets of tinidazole at a dose of 500 mg and 2 tablets of clarithromycin at a dose of 250 mg.

Each blister is designed for 1 day of antiulcer therapy. According to the instructions, you need to take 1 capsule of omeprazole, 1 tablet of tinidazole and 1 tablet of clarithromycin in the morning (the capsule and tablets are located in the orange part of the blister), repeat the procedure in the evening (the capsule and tablets are located in the blue part of the blister).

Each package contains 7 blisters, designed for a weekly course of antiulcer therapy.

After completion of treatment, it is recommended to take omeprazole at a dose of 20 mg per day for three weeks.

special instructions

Tinidazole may cause urine to turn dark.

Throughout the entire course of antiulcer therapy, complete abstinence from drinking alcoholic beverages is required due to the risk of developing disulfiram-like reactions .

In case of chronic pathology of the hepatic system, periodic monitoring of the level of liver enzymes is mandatory.

Before starting therapy, the attending physician must exclude the presence of malignant neoplasms (taking omeprazole may mask the clinical manifestations of cancer).

Interaction

Clarithromycin, which is part of the drug Pilobact, can cause an increase in the level of theophylline and terfenadine in the blood (a prolongation of the QT interval is recorded on the ECG).

An enhanced effect of the drug is observed with simultaneous therapy with oral forms of anticoagulants .

When treated with digoxin, astemizole, phenytoin, carbamazepine, cisapride , pimozide, valproate, Lovastatin , disopyramide, cyclosporine , an increase in the concentration of the above drugs is observed.

Omeprazole can reduce the rate of metabolic processes when taking diazepam and phenytoin.

Pilobact reduces the absorption of iron salts (reducing acid production in the stomach), ampicillin, ketoconazole .

Pilobact price, where to buy

The price of Pilobact is approximately 1250 rubles per set.

Online pharmacies in RussiaRussia
Online pharmacies in UkraineUkraine
Online pharmacies in KazakhstanKazakhstan

ZdravCity

Pilobact AM set of tablets and capsules No. 7 Sun Pharmaceutical Industries Ltd.
RUB 1,286 order
Pilobact combination set n42 (6 pcs x 7 blister)SUN Pharmaceutikal Industries Ltd.
RUB 1,234 order
Pilobact am combination set n56 (8 pcs x 7 strips) SUN Pharmaceutikal Industries Ltd.
RUB 1,272 order

Pharmacy Dialogue

Pilobact combined set (set No. 7)Ranbaxy
RUR 1,278 order
Pilobact combiner AM (set No. 7)Ranbaxy
RUB 1,322 order

Pharmacy24

Pilobact NEO N42 set of tablets Sun Pharmaceutical Industries Ltd, India
464 UAH.order

PaniPharmacy

Pilobact neo tablets Pilobact Neo comb. table No. 42 India, SUN
476 UAH. order

Contraindications

Pilobact is not prescribed for porphyria , breastfeeding, chronic diseases of the hepatic system, intolerance to active components (omeprazole, tinidazole, clarithromycin, for Pilobact AM - amoxicillin), during pregnancy, severe renal, liver failure, when taking ethanol (the risk of developing disulfiram-like disorders increases). reactions), children under twelve years of age.

Side effects

Omeprazole, which is part of Pilobact, can cause headaches, increased gas formation, diarrhea, weakness, dizziness, epigastric pain, constipation, nausea, thrombocytopenia, increased levels of liver enzymes, eosinocytopenia , neutropenia, leukopenia, skin rashes.

Tinidazole can cause cholestatic jaundice , gastralgia, nausea, headache, allergic reaction in the form of itching and rash, pseudomembranous enterocolitis , diarrhea, vomiting, and the development of secondary resistance of microbial flora. Side effects of tinidazole: skin itching, vomiting, leukopenia, unpleasant taste in the mouth, appetite disturbances, headaches, urticaria.