Omeprazol-Akrihin - instructions for use, dose, side effects, contraindications

Excipients: mannitol, sucrose, sodium hydrogen phosphate (sodium phosphate disubstituted), sodium lauryl sulfate, lactose, calcium carbonate, hypromellose (hydroxypropyl methylcellulose), methacrylic acid copolymer, propylene glycol, diethylphthalate, cetyl alcohol, sodium hydroxide (sodium hydroxide), polysorbate tween-80), povidone (polyvinylpyrrolidone), titanium dioxide, talc.

Capsule composition: titanium dioxide (capsule body, cap capsule), iron oxide yellow (capsule body, cap capsule), iron oxide black (cap capsule), indigotine (cap capsule), gelatin (capsule body, cap capsule).

Description:

Hard gelatinous two-color capsules № 1: the case is yellowish-cream color with a lid of dark green color. The contents of the capsules are pellets from almost white to creamy white or yellowish white.

Pharmacotherapeutic group:glands of the stomach secretion-lowering agent - proton pump inhibitor

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

The proton pump inhibitor reduces acid production - inhibits the activity of H + / K + -ATPase in the parietal cells of the stomach and blocks the final stage of hydrochloric acid secretion.The drug is a prodrug and is activated in the acidic environment of the secretory tubules of parietal cells. Reduces basal and stimulated secretion irrespective of the nature of the stimulus. The antisecretory effect after taking 20 mg occurs within the first hour, a maximum after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours.

A single dose per day provides fast and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of treatment and disappearing by the end of 3-4 days after the end of the admission. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH at 3.0 for 17 hours.

Pharmacokinetics:

Absorption is high, the maximum concentration in blood plasma is reached within 0.5-3.5 h, bioavailability is 30-40 % (with liver failure increases almost to 100%); possessing high lipophilicity, the drug easily penetrates into the parietal cells of the stomach, the connection with plasma proteins - 90-95% (albumin and acid alpha-1 glycoprotein).

The half-life is 0.5-1 h (with hepatic insufficiency - 3h), the clearance is 500-600 ml / min.Almost completely metabolized in the liver with the participation of the enzyme system CYP2C19, with the formation of several metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.), pharmacologically inactive. Is an inhibitor of isoenzyme CYP2C19. Kidney excretion (70-80%) and with bile (20-30%).

In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients excretion decreases, bioavailability increases.

Indications:

- peptic ulcer of stomach and duodenum (including prevention of relapses);

- reflux esophagitis;

- Zollinger-Ellison syndrome;

- stress ulcers of the gastrointestinal tract (GIT);

- polyendocrine adenomatosis;

- systemic mastocytosis;

- gastropathy, caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs-gastropathy);

- eradication Helicobacter pylori in infected patients with peptic ulcer and duodenal ulcer (as part of combination therapy).

Contraindications:

- hypersensitivity;

- childhood;

- pregnancy;

- lactation period.

Carefully:

Renal and / or hepatic insufficiency.

Pregnancy and lactation:contraindicated

Dosing and Administration:

Inside, do not chew. Capsules are usually taken in the morning, washed down with a small amount of water (immediately before meals or during meals).

With exacerbation of peptic ulcer, reflux-esophagitis and NSAID-gastropathy - 20 mg once a day. For patients with severe reflux esophagitis, the dose of omeprazole-acrychin® is increased to 40 mg once a day. The course of treatment for duodenal ulcer is 2-3 weeks, if necessary - 4-5 weeks; with peptic ulcer and esophagitis - 4-8 weeks.

Patients resistant to treatment with other antiulcer drugs, omeprazole-acrychin® are prescribed at 40 mg / day. The course of treatment for peptic ulcer is 4 weeks, with peptic ulcer and reflux esophagitis 8 weeks.

With Zollinger-Ellison syndrome - 60 mg / day; if necessary, increase the dose to 80-120 mg / day (in this case, it is prescribed in 2-3 sessions).

For the prevention of recurrences of peptic ulcer-10 mg once a day.

For eradication Helicobacter pylori use "triple" therapy (within 1 week: Omeprazole-Akrihin® 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; or Omeprazole-Acrychin® 20 mg, clarithromycin 250 mg, metronidazole 400 mg - twice a day; whetheromeprazole-acrychin® 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or "double" therapy (within 2 weeks: Omeprazole-Akrihin® 20-40 mg and amoxicillin 750 mg - twice a day or Omeprazole-Acrychin® 40 mg - once a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0,75-1,5 g - 2 times a day).

Side effects:

From the digestive system: diarrhea or constipation, abdominal pain, nausea, vomiting, flatulence; in rare cases - increased activity of "liver" enzymes, taste disorders; in some cases - dry mouth, stomatitis, in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function.

From the hematopoiesis: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the side of the nervous system: in patients with severe concomitant somatic diseases - dizziness, headache, agitation, depression, in patients with a previous severe liver disease - encephalopathy.

From the musculoskeletal system: in some cases - arthralgia, myasthenia gravis, myalgia.

From the skin: rarely - skin rash and / or itching, in some cases - photosensitization, multiform exudative erythema, alopecia.

Allergic reactions: urticaria, angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock.

Other: rarely - gynecomastia, malaise, visual impairment, peripheral edema, increased sweating, the formation of gastric glandular cysts during long-term treatment (consequence of inhibition of HC1 secretion, is benign, reversible).

Overdose:

Symptoms: confusion, blurred vision, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.

Treatment: symptomatic. Hemodialysis is not effective enough.

Interaction:

Can reduce the absorption of esters of ampicillin, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach).

As an inhibitor of cytochrome P450, omeprazole-acrychin® can increase the concentration and reduce the excretion of diazepam, indirect anticoagulants, phenytoin (drugs that are metabolized in the liver via cytochrome CYP2C19), which in some cases may require a reduction in the doses of these drugs.

At the same time, the long-term use of omeprazole-acrychin® at a dose of 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not result to a change in their concentration in the plasma.

No interaction with concomitant antacids was noted.

Special instructions:

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

Form release / dosage:

Capsules 20 mg.

Packaging:

10 capsules per contour cell package. 1, 2 or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

List B. In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000768 / 01

Date of registration:09.11.2007

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp09.06.2015

Illustrated instructions

Instructions

Omeprazole-Acrychin® (Omeprazolum-Akrihin®)