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

Composition:Each capsule contains: in the core of pellets: active substance: omeprazole 20 mg; Excipients: granules / pellets from sucrose and starch - 61.5 mg, sucrose - 80.0 mg, corn starch - 5.0 mg, mannitol - 30.0 mg, povidone - 15.0 mg, talc purified - 14.5 mg, sodium lauryl sulfate - 1.10 mg, sodium hydrogen phosphate - 4.5 mg; in the enteric coating: hypromellose phthalate - 32.0 mg, diethyl phthalate - 5.0 mg, titanium dioxide -1.40 mg; in the capsule shell (cap (blue)): blue diamond dye E133 - 0.1072mg, gelatin - 21,4327 mg, dye azorubin Е 122 - 0,0107 mg, methylparahydroxybenzoate - 0,1372 mg, propyl parahydroxybenzoate - 0,0343 mg;

in the capsule shell (body (transparent pink)):

gelatin - 32,7456 mg, dye azorubin Е 122 - 0,0098 mg, methylparahydroxybenzoate - 0.2096 mg, propyl parahydroxybenzoate - 0.0523 mg.

Description:Hard gelatin capsules No. 2 with a transparent pink body and a blue lid. Contents of capsules: spherical granules of white or almost white color.

Pharmacotherapeutic group:a means of reducing the secretion of the glands of the stomach - the proton pump inhibitor.

ATX: & nbsp

A.02.B.C.01 Omeprazole

Pharmacodynamics:

Omeprazole inhibits the enzyme H⁺/TO⁺ATP-asu ("proton pump") in parietal cells of the stomach and blocks the final stage of synthesis of hydrochloric acid.

This leads to a decrease in 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. Patients with duodenal ulcer

20 mg of omeprazole maintains an intragastric pH of 3.0 for 17 hours. After discontinuation of the drug secretory activity of the stomach is completely restored after 3-5 days.

Pharmacokinetics:

- suction: rapidly absorbed from the gastrointestinal tract, the maximum concentration in the plasma is achieved in 0.5 -1h. Bioavailability is 30-40% (with liver failure increases almost to 100%), having a high lipophilicity, easily penetrates into the parietal cells of the stomach.

- distribution: association with plasma proteins - about 90% (albumin and acid alpha-1 glycoprotein).

- metabolism: almost completely metabolized in the liver with the participation of the enzyme system CYP2C19, with the formation of 6 metabolites (hydroxyomeprazole, sulfide and sulfone derivatives, etc.), pharmacologically inactive. Is an inhibitor of isoenzyme CYP2C19. The half-life 0.5-1 hours (with liver failure - 3 h) clearance - 500-600 ml / min.

- excretion: is excreted mainly by the kidneys (70-80%) in the form of metabolites 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:

Gastric ulcer and duodenum 12 (including prevention of relapse), reflux esophagitis, hypersecretory conditions (Zollinger-Ellison syndrome, gastrointestinal stress ulcers, polyendocrine adenomatosis, systemic mastocytosis). Prevention of aspiration of acidic stomach contents in the respiratory tract during general anesthesia (Mendelssohn syndrome).

NSAIDs are gastropathy.

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

Contraindications:

Hypersensitivity to the drug, children's age, lactation period, the deficit sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption.

During lactation it is necessary to solve the problem

on the termination of breastfeeding or discontinuation of the drug.

Carefully:pregnancy

Pregnancy and lactation:with caution take the drug during pregnancy. Contraindicated in lactation

Dosing and Administration:

Inside, capsules are usually taken in the morning, capsules can not be chewed, 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 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 who are resistant to treatment with other antiulcer drugs are prescribed 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; if necessary, increase the dose to 80-120 mg / day (in this case, it is prescribed in 2-3 sessions).

Prevention of Mendelssohn syndrome - 40 mg for 1 hour before surgery (in case of an operation longer than 2 hours, the necessary dose of the drug should be re-entered).

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

For eradication Helicobacter pylori use "triple" therapy (within 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 (within 2 weeks: omeprazole 20-40 mg and amoxicillin 750 mg - twice a day or omeprazole 40 mg -1 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, 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 concomitant somatic diseases, patients with previous severe liver disease - encephalopathy.

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

On the part of the hematopoiesis system: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.

From the skin: itching; rarely, photosensitization, multiforme

erythema, alopecia.

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

Other: impaired vision, peripheral edema, increased sweating, fever, gynecomastia; rarely - the formation of gastric glandular cysts during long-term treatment (consequence of inhibiting the secretion of hydrochloric acid, is benign, reversible), malaise.

Overdose:

Symptoms of overdose are visual impairment, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

There is no specific antidote. Treatment is 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).

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 by isoenzyme CYP2C19), that in some cases may require lowering the doses of these medicines.

At the same time, the 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.

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

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 a stomach ulcer), as treatment, masking the symptoms, can delay the establishment of the correct diagnosis.

Admission simultaneously with food does not affect its effectiveness.

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

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

Care must be taken when driving vehicles and taking other potentially hazardous activities that require increased concentration of attention and quick response, since with the administration of omeprazole, side effects from the nervous system or visual impairment may occur.

Form release / dosage:

Capsules enteric in solution 20 mg.

Packaging:10 capsules per strip of aluminum laminated with polyethylene. 1,2,3 Strip in a cardboard box with instructions for use.

Storage conditions:

In a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N 015735/01

Date of registration:14.05.2009

The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India

Manufacturer: & nbsp

RANBAXY LABORATORIES, Ltd. India

Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED

Information update date: & nbsp11.09.2012

Illustrated instructions

Instructions

Romesque® (Romesec®)