Omeprazole | Omeprazole-Teva enteric capsules 40 mg 28 pcs.

Packing

28 pcs.

Pharmacological action

Omeprazole - proton-inhibiting proton pump, antiulcer.

Pharmacodynamics

Omeprazole inhibits the enzyme H + - K + -ATPase ("proton pump") in the parietal cells of the stomach and thereby blocks the final stage of hydrochloric acid synthesis. This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus. After a single oral administration, the action of omeprazole occurs within the first hour and lasts for 24 hours, the maximum effect is achieved after 2 hours. In patients with peptic ulcer of the duodenum, taking 20 mg of omeprazole maintains an intragastric pH = 3 for 17 hours. After discontinuation of the drug, secretory activity is fully restored after 3-5 days.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, Cmax in plasma is reached after 0.5–1 hours. Bioavailability is 30–40%. Plasma protein binding is about 90%. Omeprazole is almost completely metabolized in the liver. T1 / 2 - 0.5–1 hours. It is excreted mainly by the kidneys in the form of metabolites. In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance. In elderly patients, excretion decreases, bioavailability increases. With liver failure, bioavailability is 100%, T1 / 2 - 3 hours.

Indications

peptic ulcer of the stomach and duodenum

reflux esophagitis

erosive-ulcerative lesions of the stomach and duodenal ulcer associated with the administration of NSAIDs

stress ulcers of the gastric ulcer

Zollinger-Ellison syndrome.

Contraindications

hypersensitivity to the drug

children

pregnancy

lactation.

Use during pregnancy and lactation

Due to the lack of clinical experience, omeprazole is not recommended for use during pregnancy. If necessary, use during lactation should decide on the termination of breastfeeding.

Composition

1 capsule contains:

Active ingredient: omeprazole 40 mg

Excipients: gelatin glycerin nipagin nipazole sodium lauryl sulfate titanium dioxide water purified colorant E 129.

Dosage and administration

Inside, with a little water (do not chew the contents of the capsule).

Peptic ulcer of the duodenum in the exacerbation phase - 1 capsule (40 mg) per day for 2-4 weeks (in resistant cases - up to 2 capsules per day).

Peptic ulcer in the exacerbation phase and erosive-ulcerative esophagitis - 1-2 capsules per day for 4-8 weeks.

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

Eradication of Helicobacter pylori - 1 capsule 2 times a day for 7 days in combination with antibacterial agents.

Anti-relapse treatment of peptic ulcer of the 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 / day. If necessary, the dose is increased to 80-120 mg / day, in this case it is divided into 2 doses.

Side effects of

From the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disturbances, stomatitis, transient increase in plasma liver enzymes in patients with previous severe liver disease - hepatitis ( including with jaundice), impaired liver function.

From the nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations in patients with severe concomitant somatic diseases, in patients with previous severe liver disease - encephalopathy.

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

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

From the skin: itching rarely (in some cases) - photosensitivity, erythema multiforme, alopecia.

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

Other: visual impairment, peripheral edema, increased sweating, fever, gynecomastia rarely - the formation of gastric glandular cysts during prolonged treatment (due to inhibition of hydrochloric acid secretion, is benign reversible).

Drug Interaction

Long-term administration of omeprazole at a dose of 20 mg once daily in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, ethanol, cyclosporin concentrate .

No interaction with concurrent antacids was noted.

Changes the bioavailability of any drug, the absorption of which depends on the pH value (eg iron salts).

Overdose

Symptoms: impaired vision, drowsiness, agitation, confusion, headache, increased sweating, dry mouth, nausea, arrhythmia.

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

Storage conditions

In a dry, dark place at temperatures below 25 РC.

Expiration

2 Year

Pharmacy Terms

pharmacies Prescription

dosage form

dosage form

capsules

Teva Pharmaceutical Enterprise Co., Ltd., Israel