Primez - instructions for use, doses, side effects, contraindications

Hard gelatin capsules with a pink lid and a body almost white, transparent, size "2". The contents of the capsules are granules of white or white with a yellowish hue of color with an enteric-dissolvable coating.

Pharmacotherapeutic group:a drug that reduces the secretion of the glands of the stomach - a proton pump inhibitor.

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

Inhibits the enzyme H⁺ TO⁺ ATP-ase ("proton pump") in

parietal cells of the stomach and thereby blocks the final stage of the synthesis of hydrochloric acid. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single intake 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.

Pharmacokinetics:Omeprazole is rapidly absorbed from the gastrointestinal tract, the maximum concentration in the plasma is reached after 0.5-1 hour. Bioavailability is 30 - 40%. The connection with plasma proteins is about 90%. Omeprazole almost completely metabolized in the liver. It is an inhibitor of the enzyme system CYP2C19. Half-life is 0.5-1 hour. It is excreted by the kidneys (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. With hepatic failure, bioavailability is 100%, half-life is 3 hours.

Indications:

- Peptic ulcer of the stomach and duodenum (in the phase of exacerbation and anti-tertiary treatment), incl. associate with Helycobacter pylori (as part of complex therapy);

-Reflux-esophagitis;

-Erosis and ulcerative lesions of the stomach and duodenum associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);

Zollinger-Ellison syndrome.

Contraindications:

Hypersensitivity to the drug, children's age, lactation.

Carefully:

renal and / or liver failure.

Pregnancy and lactation:

The use of omeprazole during pregnancy is possible in cases where the expected benefit to the mother exceeds the potential risk to the fetus.

Dosing and Administration:

Inside, squeezed with a small amount of water (the contents of the capsule can not be chewed).

Peptic ulcer of duodenal ulcer in the phase of exacerbation - at 20 mg per day for 2-4 weeks (in resistant cases, up to 40 mg per day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis - 20-40 mg per day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - at 20 mg per day for 4-8 weeks.

Eradication Helicobacter pylori - 20 mg twice a day for 7 or 14 days (depending on the treatment regimen used) in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of stomach and duodenum - 20 mg per day.

Anti-relapse treatment of reflux esophagitis - 20 mg per day for a long time (up to 6 months). Reception on demand (symptomatic treatment).

Zollinger-Ellison Syndrome - the dose is selected individually depending on the initial level of gastric secretion, usually starting at 60 mg per day.If necessary, increase the dose to 80 - 120 mg per day, in this case, it is divided into 2 divided doses.

In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.

Side effects:

In rare cases, the following, usually reversible, side reactions may occur:

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

From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations; in patients with severe comorbid medical illness, patients with previous severe liver disease - encephalopathy.

From the musculoskeletal system: muscle weakness, myalgia,

arthralgia.

On the part of the hematopoiesis system: leukopenia, thrombocytopenia; in some cases - agranulocytosis, pancytopenia.

From the skin: itching, skin rash; in some cases - photosensitivity,multiforme exudative erythema, alopecia.

Allergic reactions: urticaria, angioedevrichesky edema, bronchospasm,

interstitial nephritis, anaphylactic shock, fever.

Other: impaired vision, peripheral edema, increased sweating,

gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibition of the secretion of hydrochloric acid, is benign, reversible).

Overdose:

Symptoms of an overdose of omeprazole are: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

There is no specific antidote. Treatment is symptomatic. Hemodialysis is not effective enough.

Interaction:

Long-term use of omeprazole 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporine, lidocaine, quinidine and estradiol did not change their plasma concentration.

No interaction with concomitant antacids was noted.

Maybe withbottomabsorption of ampicillin esters, iron salts, itraconazole and ketoconazole (omeprazole increases the pH of the stomach). Being an inhibitor of cytochrome P450, it can increase the concentration and reduce the excretion of diazepam, anticoagulants of indirect action, 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. Increases the inhibitory effect on the hemopoietic system of other drugs.

Special instructions:

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

Admission simultaneously with food does not affect its effectiveness.

With the returnNicknewthe difficulty in swallowing the whole capsule, you can swallow its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidic liquid (juice, yogurt) and use the resulting suspension for 30 minutes.

Effect on the ability to drive transp. cf. and fur:

In normal dosages, the drug does not affect the speed of psychomotor reactions and concentration of attention.

Form release / dosage:

Capsules 20 mg.

Packaging:

Primary packaging: 10 capsules in an aluminum foil strip.Consumer packaging: 3 strips in a pack of cardboard, along with instructions for medical use in Russian.

Packing for hospitals: 10, 14 capsules in a strip of aluminum foil. One strip (14 capsules) or 3, 5, 10 strips (10 capsules each) in a pack of cardboard along with instructions for medical use.

Storage conditions:

List B. Store in a dry place, protected from light, out of reach of children, at a temperature of no higher than 25 ° C.

Shelf life:

2 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012275 / 01

Date of registration:13.08.2007

The owner of the registration certificate:Protek Biosystems Pvt. Ltd.Protek Biosystems Pvt. Ltd. India

Manufacturer: & nbsp

PROTECH BIOSYSTEMS, PVT. Ltd. India

Representation: & nbspProtekh Biosystems Pvt.LtdProtekh Biosystems Pvt.LtdRussia

Information update date: & nbsp13.08.2007

Illustrated instructions

Instructions

Pomez (Promes)