Instructions for Pylobact AM (Omeprazole, Clarithromycin, Amoxicillin)
Pylobact AM is a drug for the treatment of peptic ulcers.
Pylobact AM Composition and form of release:
Pills and capsules set Film-coated tablets 1 tab.
clarithromycin 500 mg
excipients:
MCC; povidone; magnesium stearate; steric acid; talcum powder; colloidal silicon dioxide; croscarmellose sodium film coating: hypromellose; hyprolosis; propylene glycol; sorbitan monooleate; titanium dioxide; dye quinoline yellow; vanillin; talcum powder composition of ink for inscription: black ink Opacode S-1-27794 (methylated alcohol IMS 74 OP, 47.5% shellac solution in methylated alcohol IMS 74 OP, iron dye black oxide, n-butyl alcohol, propylene glycol, purified water) Capsules 1 caps.
amoxicillin trihydrate 592.856 mg
(corresponds to 500 mg of amoxicillin) excipients: sodium lauryl sulfate; colloidal silicon dioxide; croscarmellose; MCC; magnesium stearate capsule composition: cap: brilliant blue dye; dye azorubin; dye quinoline yellow; titanium dioxide; methyl parahydroxybenzoate; propyl parahydroxybenzoate; sodium lauryl sulfate; gelatin 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 dye black oxide; concentrated ammonia solution; propylene glycol Enteric capsules 1 caps.
omeprazole 20 mg
excipients:
Non Pareil Seeds (enteric coated sucrose and corn starch granules); lactose; corn starch; mannitol; povidone; talcum powder; sodium lauryl sulfate; sodium hydrogen phosphate (anhydrous) composition of the enteric shell: hypromelose phthalate, dichloromethane *, isopropanol *, diethyl phthalate, titanium dioxide, shell of an empty hard gelatin capsule size 2 with a dark blue lid and a transparent pink body capsule shell: cap: brilliant blue; carmoisine (azorubin); gelatin; methyl parahydroxybenzoate; propyl parhydroxybenzoate body: carmoisin (azorubin); gelatin; methyl parahydroxybenzoate; propyl parhydroxybenzoate
set of 2 tab. clarithromycin, 2 caps. omeprazole and 4 caps. amoxicillin; in a strip 1 set, in a cardboard box 7 strips.
Description of the dosage form Pylobact AM:
Clarithromycin, film- coated tablets: light yellow, oval, biconvex, film-coated, with the inscription "CXT 500" printed in black ink on one side.
Amoxicillin, capsules: hard, gelatinous, size "0 el" (capsule cap diameter - 7.57-7.71 mm, capsule body diameter 7.27-7.41 mm, capsule cap length - 11.22-12.30 mm, capsule body length - 19.70–20.70 mm), yellow body, brown cap with the inscription "500" printed in black ink on the cap and body. The contents of the capsule are white or off-white granular powder / pellets.
Omeprazole capsules: hard, gelatinous, with a "lock", size No. 2 with a dark blue cap and a transparent pink body, containing white or almost white spherical granules, coated with an enteric coating.
Pylobact AM pharmachologic effect:
Pharmacological action - anti-Helicobacter, antiulcer .
Pharmacodynamics: Pylobact AM
Triple therapy, including omeprazole, clarithromycin and amoxicillin, can achieve a high percentage of Helicobacter pylori eradication (85–94%).
Omeprazole inhibits gastric acid secretion due to specific inhibition of H + K + -ATPase, an enzyme found in the parietal cell membranes of the gastric mucosa. Reduces basal and stimulated secretion regardless of the nature of the stimulus. After a single oral administration of the drug, the effect of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. After the drug is discontinued, the secretory activity is fully restored after 3-5 days .
Clarithromycin is an 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. Effective against a large number of gram-positive, gram-negative aerobic and anaerobic microorganisms, including H. pylori . The metabolite formed in the body - 14-hydroxyclarithromycin - also has a pronounced antimicrobial activity.
Amoxicillin is a semi-synthetic penicillin, has a bactericidal effect, has a wide spectrum of action. The antimicrobial effect is associated with inhibition of the synthesis of peptidoglycan (a supporting polymer of the cell wall) during the period of division and growth. Possesses a pronounced activity in relation to H. pуlori . Resistance N.pulori to amoxicillin occurs only occasionally.
The combination of amoxicillin and clarithromycin has a potentiated antimicrobial effect against H. pylori .
Pylobact AM Pharmacokinetics:
All three drugs that make up Pylobact AM have good oral absorption.
Omeprazole is rapidly absorbed after oral administration, and its bioavailability is 30-40%. Food intake does not affect the bioavailability of omeprazole. C max of the drug in plasma is achieved in 0.5-1 hours. Plasma protein binding 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 down the onset of clarithromycin absorption and the formation of 14-hydroxyclarithromycin, but does not affect bioavailability. When taken on an empty stomach, C max in serum is reached within 2 hours after oral administration and is 0.6 and 0.7 μg / ml for clarithromycin and its main metabolite. T 1/2clarithromycin is 3-4 hours. Clarithromycin is widely distributed in the body. The concentration of clarithromycin in the tissues is higher than that in the serum. Protein binding is 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 administration of clarithromycin and omeprazole improves the pharmacokinetic properties of clarithromycin: the average C max value increases by 10%, the minimum concentration - by 15% compared with the same indicators for clarithromycin monotherapy. The concentration of clarithromycin in the gastric mucosa is also increased when administered simultaneously with omeprazole.
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 tissues of the body. T 1/2 is 1-1.5 hours. Protein binding - 20%. About 60% of the dose taken is excreted in the urine unchanged, a small amount in the feces.
Pylobact AM Indications of the drug
Eradication therapy of N. pуlori for duodenal ulcer.
Contraindications
hypersensitivity to omeprazole, clarithromycin or amoxicillin, as well as macrolide
combined use with cisapride, pimozide, astemizole and terfenadine (see "Interaction");
pregnancy;
breast-feeding
porphyria;
childhood;
renal or hepatic impairment.
Contraindicated in pregnancy and lactation.
Pylobact AM Side effects:
On the part of the digestive system: dysbiosis, diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, a transient increase in the activity of liver enzymes 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 hematopoietic 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.
Others: tachycardia, interstitial nephritis, visual impairment, peripheral edema, increased sweating, fever, gynecomastia.
How to take the drug:
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 words "morning" and blue - with the words "evening".
When taking a morning meal, be sure to completely take the contents of the "morning" part (one capsule of omeprazole
One clarithromycin tablet and two amoxicillin capsules). When taken in the evening, the entire contents of the "evening" part should also be taken before meals (one capsule of omeprazole, one tablet of clarithromycin and two capsules of amoxicillin).
Tablets and capsules should not be crushed or chewed and should be swallowed whole with water.
Duration of treatment is seven days.
