Pylobact AM, combo set, 7pcs

Composition

Tablets

Active ingredient:

clarithromycin 500 mg;

Auxiliary substances:

MCC;

povidone;

magnesium stearate;

steric acid;

purified talc;

colloidal silicon dioxide;

croscarmellose sodium;

Film coating:

hypromellose; hyprolose; propylene glycol; sorbitan monooleate; titanium dioxide; yellow quinoline dye; vanillin; purified talc;

Composition of inscription ink:

Opacode S-1-27794 black ink (methylated alcohol IMS 74 OP,47.5% shellac solution in methylated alcohol IMS 74 OP, iron oxide black dye, n-butyl alcohol, propylene glycol, purified water);

Capsules

Active ingredient:

amoxicillin trihydrate 592.856 mg (equivalent to 500 mg of amoxicillin);

Auxiliary substances:

sodium lauryl sulfate;

colloidal silicon dioxide;

croscarmellose;

MCC;

magnesium stearate;

Capsule cap:

diamond blue dye; azorubin dye; quinoline yellow dye; titanium dioxide; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium lauryl sulfate; gelatin;

Capsule body:

dye sunset yellow; dye quinoline yellow; titanium dioxide; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium lauryl sulfate; gelatin;

Lettering ink:

dehydrated alcohol; butyl alcohol; shellac; iron oxide black dye; concentrated ammonia solution; propylene glycol;

Enteric capsules

Active ingredient:  

omeprazole 20 mg;

Auxiliary substances:  

Non Pareil Seeds (granules of sucrose and corn starch coated with enteric coating);

lactose;

corn starch;

mannitol;

povidone;

purified talc;

sodium lauryl sulfate;

sodium hydrophosphate (anhydrous);

Composition of the enteric shell:

hypromelose phthalate, dichloromethane*, isopropanol*, diethyl phthalate, titanium dioxide, shell of an empty solid gelatin capsule of size No. 2 with a dark blue lid and a transparent pink body;

Capsule cap:

diamond blue; carmoisine (azorubin); gelatin; methyl parahydroxybenzoate; propyl parahydroxybenzoate;

Capsule body:

carmoisine (azorubin); gelatin; methyl parahydroxybenzoate; propyl parahydroxybenzoate

Pharmacological action

Pylobact AM – antihelicobacteric, anti-ulcer.

Pharmacodynamics

Triple therapy, including omeprazole, clarithromycin and amoxicillin, can achieve a high percentage of Helicobacter pylori eradication (85-94%).

Omeprazole inhibits gastric acid secretion by specifically inhibiting H + K+ – ATPase, an enzyme found 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 dose, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved in 2 hours. After discontinuation of the drug, secretory activity is fully restored in 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 a microbial cell. It is 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 — semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. Antimicrobial action is associated with inhibition of peptidoglycan synthesis (cell wall support polymer) during division and growth. It has a pronounced activity against H. pylori. H. pylori resistance to amoxicillin is rare.

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

All three drugs included in Pylobact® AM have good oral absorption.

Omeprazole is rapidly absorbed after oral use, and its bioavailability is 30-40%. Food intake does not affect the bioavailability of omeprazole. _{Cmax of} the drug in plasma is reached after 0.5-1 h. Binding to plasma proteins is 90%. It is almost completely metabolized in the liver. The main route of excretion is in the urine (80%).

Clarithromycin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of 250 mg clarithromycin is approximately 50%. Food intake 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 use and is 0.6 and 0.7 mcg / ml for clarithromycin and its main metabolite. T_1/2 of clarithromycin is 3-4 h. 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). Concomitant use of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the average_{cmax value} increases by 10%, the minimum concentration-by 15% compared to the same indicators with clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa when administered simultaneously with omeprazole is also increased.

Amoxicillin is rapidly absorbed from the gastrointestinal tract. Food intake does not affect the absorption of amoxicillin. The bioavailability of amoxicillin is 75-90%. The drug is rapidly distributed in the body’s tissues. T_1/2 is 1-1.5 h. Protein binding is 20%. About 60% of the dose taken is excreted unchanged in the urine, and a small amount is excreted in the faeces.

Indications

H. pulori eradication therapy for duodenal ulcer.

Contraindications

• hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as to macrolide antibiotics;
• concomitant use with cisapride, pimozide, astemizole and terfenadine (see “Interaction”);
• pregnancy;
• breastfeeding;
• porphyria;
• childhood;
• renal or hepatic insufficiency.

Side effects

From the digestive system:  dysbiosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in the activity of liver enzymes in plasma, impaired liver function, rarely-pseudomembranous enterocolitis.

Nervous system disorders:  headache, dizziness, agitation, drowsiness, insomnia, ataxia, paresthesia, depression, confusion, hallucinations, epileptic reactions, peripheral neuropathy.

From the musculoskeletal system:  muscle weakness, myalgia, arthralgia.

From the hematopoietic system:  leukopenia, neutropenia, thrombocytopenia, thrombocytopenic purpura, anemia.

From the side of the skin:  pruritus; rarely-skin rash, in some cases — photosensitization, erythema multiforme, alopecia.

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

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

Interaction

Simultaneous use of theophylline and clarithromycin is accompanied by an increase in theophylline concentration.

Concomitant use of clarithromycin with terfenadine increases the concentration of the latter and may lead to prolongation of the QT interval.

Concomitant use of clarithromycin with indirect anticoagulants may potentiate the effect of the latter.

When administered concomitantly with clarithromycin, carbamazepine, cyclosporine, phenytoin, disopyramide, lovastatin, valproate, cisapride, pimozide, astemizole, digoxin levels may be increased.

Omeprazole may slow the elimination of phenytoin, diazepam, and warfarin, as well as affect the absorption of ketoconazole, ampicillin, and iron salts by inhibiting gastric acid secretion.

Concomitant use of amoxicillin with oral contraceptives may reduce the effect of the latter.

How to take it, course of use and dosage

Inside. Each strip containing tablets and capsules of the Pylobact®AM kit is designed for one day of treatment and consists of two parts: red — with the inscription “morning” and blue-with the inscription “evening”.

In the morning reception before eating, you should take the contents of the “morning” part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin). In the evening reception, before eating, you should take the contents of the “evening” part completely (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).

Tablets and capsules should not be broken or chewed, they should be swallowed whole. The duration of treatment is 7 days.

Special instructions

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

With caution, it is prescribed against the background of taking medications that are metabolized by the liver. In the case of co-use with warfarin or other indirect anticoagulants, PV should be monitored.

Concomitant use with terfenadine, cisapride, or astemizole is not recommended for patients with a history of heart disease.

Product form

combined set

Storage conditions

In a dry place, at a temperature not exceeding 25 °C.

Shelf life

2 years

Active ingredient

Amoxicillin, Clarithromycin, Omeprazole

Conditions of release from pharmacies

By prescription

Purpose

For adults as directed by your doctor

Indications

Gastric and duodenal ulcers, Gastrointestinal infections caused by Helicobacter Pylori