Pleom-20 - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate, lactose, acrylic acid copolymer, sodium lauryl sulfate, distilled water, titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, dye patented blue, gelatin, shellac, ethanol.

Description:

Hard gelatin transparent capsules of blue color, with an inscription in white ink "plethico" on the lid and body, the size of "2" containing granules of a white-yellow color.

Pharmacotherapeutic group:An agent that reduces the secretion of the glands of the stomach is a proton pump inhibitor.

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

Omeprazole inhibits the enzyme H + / K + -ATPase ("proton pump") in parietal cells of the stomach and blocks the final stage of the synthesis of hydrochloric acid. Reduces basal and stimulated secretion irrespective of the nature of the stimulus. After a single dose of 20 mg of the drug inside, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. Inhibition of 50% of maximum secretion lasts 24 hours.

A single dose per day provides rapid and effective suppression of day and night gastric secretion, reaching its maximum after 4 days of treatment. In patients with duodenal ulcer, taking 20 mg of omeprazole maintains an intragastric pH at level 3 for 17 hours. After discontinuation of the drug secretory activity is completely restored by the end of 3-4 days.

Pharmacokinetics:

Omeprazole is rapidly absorbed from the digestive tract, the peak concentration in the plasma is achieved after 0.5-3 hours. Bioavailability is 30-40%. At repeated reception bioavailability reaches 60-70% and depends on the accepted dose. With hepatic insufficiency increases to almost 100%. Binding to plasma proteins is 95-97%. T1/2 is 0.5-1 hour. It is almost completely metabolized in the liver. It is excreted mainly in the form of metabolites 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 is increasing.

Indications:

- peptic ulcer of the stomach and duodenum;

- reflux esophagitis;

- erosive and ulcerative lesions of the stomach and duodenum

guts associated with the use of non-steroidal anti-inflammatory drugs, stress ulcers;

- erosive and ulcerative lesions of the stomach and duodenum

intestines associated with Helicobacter pylori (as part of an integrated

therapy);

- Zollinger-Ellison syndrome.

Contraindications:

- increased sensitivity to omeprazole or other components of the drug;

- children's age (up to 18 years);

- pregnancy;

- lactation period.

Dosing and Administration:

Inside, in the morning, immediately before meals or during a meal, the capsules are not chewed, washed down with a small amount of water.

Peptic ulcer of duodenum in the phase of exacerbation - 1 capsule (20 mg) per day for 2-5 weeks (in resistant cases, up to 2 capsules per day).

Stomach ulcer in the phase of exacerbation and erosive-ulcerative esophagitis

- 1-2 capsules per day for 4-8 weeks.

Erosive-ulcerative lesions of the gastrointestinal tract, caused by intake of NSAIDs - 1 capsule per day for 4-8 weeks.

Eradication Helicobacter pylori - use "triple" therapy for 1 week (omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; or omeprazole 20 mg, clarithromycin 250 mg, metronidazole 400 mg - twice a day; or omeprazole 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day) or "double" therapy for 2 weeks (omeprazole 20-40 mg and amoxicillin 750 mg twice a day; or omeprazole 40 mg - once a day and clarithromycin 500 mg - 3 times a day or amoxicillin 0,75-1,5 g - 2 times a day).

Anti-relapse treatment of peptic ulcer of stomach and duodenum

- 1 capsule per day.

Anti-relapse treatment of reflux esophagitis - 1 capsule per day for a long time (up to 6 months).

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 2-3 doses.

In patients with severe liver dysfunction, the daily dose should not exceed 20 mg.

Side effects:

On the part of the digestive system: diarrhea or constipation, abdominal pain, nausea, flatulence; rarely - a violation of taste, transient increase in the level of "liver" enzymes, very rarely - dry mouth, in patients with a previous severe liver disease - stomatitis, hepatitis (incl.with jaundice), a dysfunction of the liver.

From the nervous system: in patients with severe concomitant somatic diseases - headache, dizziness, agitation, sleep disturbances, depression, in patients with previous liver diseases - encephalopathy.

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

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

From the skin: rarely - a skin rash and / or itching, in some cases - photosensitization, multiforme exudation of erythema, alopecia.

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

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

Overdose:

Symptoms: impaired vision, drowsiness, agitation, headache, increased sweating, dry mouth, nausea, tachycardia, arrhythmia. Treatment: symptomatic.There is no specific antidote. Hemodialysis is not effective enough.

Interaction:

In connection with an increase in the pH of the stomach omeprazole can reduce the absorption of ampicillin, iron salts, itraconazole and ketoconazole.

It can reduce the excretion and increase the concentration of diazepam, anticoagulants of indirect action, phenytoin, which in some cases necessitates a reduction in the doses of these drugs.

Increases the inhibitory effect on the hemopoietic system of other drugs.

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

Special instructions:

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

If it is necessary to prescribe the drug during lactation, it is necessary to solve the problem of stopping breastfeeding.

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

Taking omeprazole simultaneously with food does not affect its effectiveness.

Form release / dosage:

Capsules 20 mg.

Packaging:

10 capsules per strip of aluminum foil. 1 or 3 strips in a cardboard box together with instructions for use.

Storage conditions:

AT dry, protected from light, at a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N013362 / 01

Date of registration:10.06.2008

The owner of the registration certificate:Plethiko Pharmaceuticals Co., Ltd. Plethiko Pharmaceuticals Co., Ltd. India

Manufacturer: & nbsp

PLETHICO PHARMACEUTICALS, Ltd. India

Information update date: & nbsp12.01.2010

Illustrated instructions

Instructions

Pleom-20 (Pleom-20)