Universal reference book for medicines
Product name: OMIPIX (OMIPIX)

Active substance: omeprazole

Type: H + -K + -ATPase inhibitor.
Antiulcer drug
Manufacturer: MJ BIOPHARM (India)
Composition, form of production and packaging
Capsules
hard gelatinous, size 3, with a light cream casing and a light cream cap;
the contents of capsules are granules of almost white color.
1 caps.

omeprazole 10 mg

Excipients: hydroxypropylmethylcellulose, starch, sucrose, mannitol, lactose, sugar, talc, magnesium carbonate, eudragit, polyethylene glycol 6000, aerosil.

10 pieces.
- Strips (3) - packs of cardboard.
10 pieces.
- Strips (10) - packs of cardboard.
14 pcs.
- polyethylene containers (1) - packs of cardboard.
28 pcs.
- polyethylene containers (1) - packs of cardboard.
Hard gelatin capsules, size 2, with a light cream casing and a light cream cap;
the contents of capsules are granules of almost white color.
1 caps.

omeprazole 20 mg

Excipients: hydroxypropylmethylcellulose, starch, sucrose, mannitol, lactose, sugar, talc, magnesium carbonate, eudragit, polyethylene glycol 6000, aerosil.

10 pieces.
- Strips (3) - packs of cardboard.
10 pieces.
- Strips (10) - packs of cardboard.
14 pcs.
- polyethylene containers (1) - packs of cardboard.
28 pcs.
- polyethylene containers (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2008.

PHARMACHOLOGIC EFFECT

Antiulcer drug, inhibitor of H + -K + -ATPase.

It inhibits the activity of H + -K + -ATPase in parietal cells of the stomach and blocks the final stage of hydrochloric acid secretion.
This leads to a decrease in the level of basal and stimulated secretion, regardless of the nature of the stimulus.
After a single dose of the drug inside the therapeutic effect of omeprazole develops within the first hour, reaches a maximum after 2 hours and lasts for 24 hours.

In patients with duodenal ulcer, taking omeprazole at a dose of 20 mg allows you to maintain the pH of the contents of the stomach at level 3 for 17 hours. After discontinuance, the secretory activity is completely restored after 3-5 days.

PHARMACOKINETICS

Suction

After taking the drug, omeprazole is rapidly absorbed from the digestive tract.
C max in blood plasma is achieved after 0.5-1 h. Bioavailability is 30-40%.
Distribution

Binding to plasma proteins is about 90%.

Metabolism

Omeprazole is almost completely metabolized in the liver with the formation of 6 metabolites (including hydroxyomeprazole, sulfide and sulfone derivatives) that do not have pharmacological activity.

Excretion

T 1/2 is 0.5-1 h.

It is excreted by the kidneys - 70-80% and with bile - 20-30%.

Pharmacokinetics in special clinical cases

In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.

In elderly patients, excretion slows down, bioavailability rises.

With hepatic failure, the bioavailability is 100%, T 1/2 - 3 hours.

INDICATIONS

- Stomach ulcer and duodenal ulcer;

- reflux esophagitis;

- erosive and ulcerative lesions of the stomach and duodenum associated with the intake of NSAIDs;

- stress ulcers;

- erosive and ulcerative lesions of the stomach and duodenum, associated with Helicobacter pylori (as part of complex therapy);

- Zollinger-Ellison syndrome.

DOSING MODE

The drug is administered orally, with a small amount of water (the contents of the capsule can not be chewed).

With duodenal ulcer in the phase of exacerbation appoint 20 mg / day for 2-4 weeks, with insufficient effectiveness - up to 40 mg / day.

With gastric ulcer in the phase of exacerbation and erosive-ulcerative esophagitis appoint 20-40 mg / day for 4-8 weeks.

With erosive and ulcerative lesions of the gastrointestinal tract caused by the intake of NSAIDs - 20 mg / day for 4-8 weeks.

For the purpose of eradication, Helicobacter pylori is prescribed 20 mg twice a day for 7 days in combination with antibacterial agents.

For the prevention of recurrences of gastric ulcer and duodenal ulcer and reflux esophagitis - 10-20 mg / day for a long time.

In Zollinger-Ellison syndrome, the dose is set 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 divided doses.
In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.

SIDE EFFECT

On the part of the digestive system: diarrhea or constipation, nausea, vomiting, flatulence, abdominal pain, dry mouth, taste disorders, stomatitis, transient increase in hepatic transaminase activity;
in patients with a previous severe liver disease - hepatitis (including jaundice), a violation of liver function.
From the central nervous system and peripheral nervous system: headache, dizziness, agitation, drowsiness, insomnia, paresthesia, depression, hallucinations, in patients with severe concomitant somatic diseases, patients with previous severe liver diseases - encephalopathy.

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

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

Dermatological reactions: in some cases - photosensitivity, erythema multiforme, alopecia.

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

Other: visual impairment, peripheral edema, increased sweating, gynecomastia;
rarely - the formation of gastric glandular cysts during long-term treatment (the consequence of inhibiting the secretion of hydrochloric acid, is benign).
CONTRAINDICATIONS

- childhood;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to the drug.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

In chronic renal failure, excretion decreases in proportion to a decrease in creatinine clearance.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In case of liver failure, the bioavailability is 100%, T 1/2 - 3 hours. In patients with severe hepatic insufficiency, the daily dose should not exceed 20 mg.

SPECIAL INSTRUCTIONS

Before the start of therapy, it is necessary to exclude the presence of malignant process (especially with peptic ulcer disease), since
treatment, masking symptoms, can delay the establishment of the correct diagnosis.
Taking the drug simultaneously with food does not affect its effectiveness.

If difficulties arise with swallowing the whole capsule, you can take its contents after opening or dissolving the capsule, and you can mix the contents of the capsule with a slightly acidified liquid (juice, yogurt) and take the resulting suspension for 30 minutes.

OVERDOSE

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

Treatment: symptomatic therapy.
The specific antidote is unknown. Hemodialysis is not effective enough.
DRUG INTERACTION

With prolonged use of omeprazole at a dose of 20 mg 1 time / day in combination with caffeine, theophylline, piroxicam, diclofenac, naproxen, metoprolol, propranolol, cyclosporine, lidocaine, quinidine, estradiol, and ethanol there were no changes in their concentrations in the blood plasma.

With simultaneous use with antacids, drug interaction was not noted.

Omeprazole changes the bioavailability of any drug, the absorption of which depends on the pH (for example, iron salts).

With the simultaneous use of omeprazole and clarithromycin, there is an increase in plasma concentrations of both drugs.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature below 30 ° C.
Shelf life - 2 years.
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