Cisagast - instructions for use, dose, side effects, contraindications

sugar granules (sucrose, corn starch, purified water), hypromellose, mannitol, sodium hydrophosphate, sodium lauryl sulfate. talc, macrogol-6000, polysorbate- 80. titanium dioxide, methacrylic acid and ethyl acrylate copolymer (1: 1), dispersion 30%, gelatin, purified water, dye quinoline yellow (for dosages of 10 and 20 mg), indigo carmine dye dosages of 10 and 40 mg).

Description:

Capsules 10 mg - solid opaque capsules with a lid green and a white body, capsule size - 3

Capsules 20 mg - hard opaque capsules with a lid and a yellow body, capsule size - 2

Capsules 40 mg - solid opaque capsules with a lid of blue color and white body, capsule size - 0

Contents of capsules: The spherical microgranules are white or almost white with a yellowish hue of 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:

Anti-ulcer drug, proton pump inhibitor, reduces acid production - inhibits activity of H⁺/TO⁺ ATPase in parietal cells of the stomach and thereby blocking the final stage of hydrochloric acid secretion (HC1). Effect of omeprazole on the last stage of the formation of HCI is dose-dependent and provides effective suppression of basal and stimulated secretion, regardless of the nature of the stimulating factor.

The antisecretory effect after taking 20 mg occurs within the first hour, the maximum

- After 2 hours Inhibition of 50% of the 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 and disappearing by the end of 3-4 days after the end of admission.

Due to a one-time oral intake of 20 mg of the drug, a steady decrease in acidity is not less than 80% for 24 hours in patients with duodenal ulcer and an average decrease in the maximum concentration of HCI after stimulation with pentagastrin. In patients with peptic ulcer 12-finger

guts intake of 20 mg of Cisagasta maintains within the gastric pH at level 3 for 17 hours.

Pharmacokinetics:Absorption is high, bioavailability is 30-40%.after repeated intake increases to 60%. Simultaneous food intake does not affect the bioavailability of omeprazole. It has high lyufiliyuyu, easily penetrates into the parietal cells of the stomach, binds to plasma proteins about 95% (albumin and acid alpha 1-glycoprotein). The half-life (T_1/2) - 0.5-1 hour. It is almost completely metabolized in the liver with the participation of the enzymatic system of cytochrome P₄₅₀ (CYP₂C₁₉) from education 6 metabolites (hydroxyomeprazole, sulfide and sulphonic derivatives, etc.). pharmacologically inactive. It is an inhibitor of the enzyme system CYP₂C₁₉. The drug is excreted by the kidneys (70-80%) and with bile (20-30%). With hepatic insufficiency, the bioavailability of omeprazole increases almost to 100%, the half-life is 3 hours.

Indications:

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

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

- eradication Hclicobacler pylori with erosive and ulcerative lesions of the stomach and duodenum (as part of complex therapy);

- reflux esophagitis;

- hypersecretory conditions (Zollinger-Ellison syndrome, stress ulcers of the gastrointestinal tract (GIT), polyendocrine adenomatosis, systemic mastonitis);

- gastro-oesophageal reflux disease (GERD);

- dyspepsia associated with increased acidity;

- prevention of aspiration of acidic stomach contents with general anesthesia.

Contraindications:

Hypersensitivity to omeprazole and other constituent components of the drug, child age, pregnancy, lactation.

Carefully:

Renal and / or hepatic insufficiency.

Pregnancy and lactation:

Omeprazole is not prescribed during pregnancy and lactation.

Dosing and Administration:

Capsules take inside, not chewing, squeezed a small amount of liquid. In case of difficulty swallowing, open the capsule, dissolve the contents in a glass of water and take the resulting suspension for 30 minutes. The contents of the opened capsule must not be chewed.

Usually capsules are taken in the morning immediately before meals or during meals.

Duodenal ulcer in the phase of exacerbation - 20 mg I once a day. Patients who are resistant to treatment with other antiulcer drugs are prescribed 40 mg I once a day. The course of treatment is 2-3 weeks, if necessary

- 5-6 weeks.

Stomach ulcer in the phase of exacerbation, erosive-ulcerative esophagitis - on 20-40 mg, I once a day for 4-8 weeks.

Anti-relapse treatment of peptic ulcer and duodenal ulcer - 10-20 mg once a day.

Anti-relapse treatment of reflux esophagitis - 10-20 mg once a day for a long time.

The NSAID- associated gastroduodenal ulcers or erosion - 20 mg once a day. Symptomatic gastro-oesophageal reflux disease - The recommended dose is 20 mg once a day. The drug provides rapid relief of symptoms of GERD. If after 4 weeks of therapy the symptoms do not disappear, an additional examination of the patient is recommended.

Dyspepsia associated with increased production of hydrochloric acid - with heartburn, pain syndrome and / or a feeling of discomfort in the epigastric region, 20 mg once a day are prescribed. If after 4 weeks of treatment the symptoms do not disappear, an additional examination of the patient is recommended.

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 prescribed in 2-3 sessions). Treatment continues for as long as necessary.

Prevention of aspiration of acidic stomach contents in general anesthesia Assign 40 mg in the evening on the eve of surgery and on the day of the operation, 2-6 hours before its onset.

For eradication Helicobacter pylori use "triple" therapy (for 1 week: Cisagast 20 mg, amoxicillin 1 g, clarithromycin 500 mg - twice a day; either Cisagast 20 mg, clarithromycin 250 mg, metronidazole 400 mg - twice a day; or Cisagast 40 mg once a day, amoxicillin 500 mg and metronidazole 400 mg - 3 times a day).

If after the treatment the test is Helicobacter pylori remains positive, the course of treatment can be repeated.

If there is a violation of kidney function and in elderly patients, correction of the dosing regimen will be required. With hepatic insufficiency appoint 10-20 mg once a day.

Side effects:

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

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 (incl.with jaundice), a dysfunction of the liver.

From the hematopoiesis: in some cases - leukopenia,

thrombocytopenia. agranulocytosis. pancytopenia.

From 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 - a skin rash and / or itching. in some cases - photosensitivity, multiforme 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. Single oral doses of omeprazole in a dose of up to 400 mg did not cause any serious symptoms. With increasing dose, the rate of excretion of the drug remains unchanged (kinetics of the first order). There is no specific antidote. High association with proteins (95%) excludes hemodialysis.

Interaction:

Long-term use of omeprazole at a dose of 20 mg 1 time per day in combination with caffeine, theophylline, piroxicam, diclofenac. naproxen, metoprolol, propranolol. ethanol, cyclosporin, lidocaine, quinidine and estradiol did not lead to a change in their plasma concentration.

No interaction with concomitant antacids was noted.

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 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.

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. Admission simultaneously with food does not affect its effectiveness. The drug contains carbohydrates, which must be taken into account when prescribing omeprazole to patients with diabetes mellitus. 1 capsule of the drug in a dosage of 10 mg contains 0.006 bread units (XE), in a dosage of 20 mg - 0.0125 XE, in a dosage of 40 mg

- 0.025 XE.

Form release / dosage:

Capsules of 10 mg. 20 mg and 40 mg.

Packaging:For 7 capsules in a blister, 2 or 4 blisters with instructions for use in a cardboard bundle.

Storage conditions:

List B. In dry the dark place at a temperature of up to 30 ° 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:LSR-010917/09

Date of registration:31.12.2009

The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic

Manufacturer: & nbsp

PRO.MED.CS Praha, a.s. Czech Republic

Representation: & nbspPRO.MED.CS Prague as. PRO.MED.CS Prague as. Czech Republic

Information update date: & nbsp31.12.2009

Illustrated instructions

Instructions

Cisagast (Cisagast)