Composition, form of production and packaging
Capsules are hard gelatinous, with a light brownish-yellow body and a light orange lid; the contents of the capsules are white or almost white spherical pellets.
1 caps.
omeprazole 10 mg
Auxiliary substances: sucrose, corn starch, purified water, lactose, hypromellose, hydroxypropylmethylcellulose, sodium lauryl sulfate, sodium phosphate dihydrate, hypromellose phthalate, diethyl phthalate, iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin.
14 pcs. - bottles of dark glass (1) - packs of cardboard.
28 pcs. - bottles of dark glass (1) - packs of cardboard.
Capsules are hard gelatinous, with a light brownish-yellow body and a light brown lid; the contents of the capsules are white or almost white spherical pellets.
1 caps.
omeprazole 20 mg
Auxiliary substances: sucrose, corn starch, purified water, lactose, hypromellose, hydroxypropylmethylcellulose, sodium lauryl sulfate, sodium phosphate dihydrate, mannitol, hypromellose phthalate, diethyl phthalate, iron oxide black, iron oxide red, iron oxide yellow, titanium dioxide, gelatin.
14 pcs. - bottles of dark glass (1) - packs of cardboard.
28 pcs. - bottles of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2005.
PHARMACHOLOGIC EFFECT
The H + -K + -ATPase inhibitor in parietal cells of the gastric mucosa suppresses the final stage of hydrochloric acid secretion, resulting in a decrease in the level of basal and stimulated (irrespective of the nature of the stimulus) secretion. Does not inhibit the secretion of pepsin. After a single dose of a single dose, the drug remains for 24 hours.
PHARMACOKINETICS
Suction
After taking the drug inside, omeprazole is absorbed into the small intestine and enters the systemic circulation in an inactive form.
Distribution and Metabolism
It is concentrated in parietal cells of the gastric mucosa, where it is converted into an active sulfenamide derivative. Metabolised in the liver.
Excretion
T 1/2 is 0.5-1 hours. 75-80% of the active substance is excreted in the form of metabolites with urine, the rest - with feces.
INDICATIONS
The drug is used for treatment and prevention:
- ulcer disease of the stomach and duodenum;
reflux-esophagitis;
Zollinger-Ellison syndrome;
-Arosive-ulcerative gastrointestinal lesions on the background of NSAIDs.
DOSING MODE
In the treatment of peptic ulcer of the stomach and duodenal ulcer in the phase of exacerbation, erosive and ulcerative lesions of the stomach and duodenum caused by the intake of NSAIDs, reflux-esophagitis drug is prescribed in a dose of 20 mg 1 time / day, in the morning. If necessary, the dose can be increased to 40 mg 1 time / day.
The duration of treatment depends on the duration of healing of the ulcer or erosion, as determined by endoscopic examination, and is usually 2 to 4 weeks with duodenal ulcer, 4-8 weeks with gastric ulcer, 8-12 weeks with reflux esophagitis.
For the prevention of recurrences of peptic ulcer of the stomach and duodenum, erosive and ulcerative lesions of the stomach and duodenum caused by the intake of NSAIDs, reflux esophagitis, the drug is prescribed in a dose of 10-20 mg 1 time / day. If necessary, the dose can be increased to 40 mg 1 time / day.
In this case, the lowest effective dose should be selected, taking into account the data of the endoscopic study.
If the need for long-term treatment and prevention of mild forms of reflux esophagitis, erosive and ulcerative lesions of the stomach and duodenum caused by the intake of NSAIDs, the drug is prescribed at a dose of 10 mg.
In the treatment of Zollinger-Ellison syndrome, the initial dose of the drug is 60 mg / day, if necessary, the daily dose can be increased to 80 mg. The dose is selected individually before the level of basal acid production reaches less than 10 mmol / h (in patients who underwent gastrectomy, less than 5 mmol / h). When appointing the drug at a dose of 80 mg / day, the daily dose should be divided into 2 divided doses at an interval of 12 hours. The duration of treatment is determined individually.
If Helicobacter pylori is present in a patient, the Helicide is prescribed in combination with antimicrobials.
Capsules should be taken in the morning, swallowed whole, washed down with a small amount of liquid.
SIDE EFFECT
Side effects are observed in 1% of patients.
From the side of the digestive system: a feeling of heaviness in the epigastrium, nausea, flatulence, diarrhea; rarely - increased activity of liver enzymes, taste disorders; in some cases - dry mouth, stomatitis. In patients with previous severe liver disease, signs of encephalopathy, hepatitis, and liver failure may appear.
On the part of the hematopoiesis system: in some cases - leukopenia, thrombocytopenia, agranulocytosis, pancytopenia.
From the side of the central nervous system: in patients with severe concomitant somatic diseases, dizziness, headache, agitation, depression are possible.
From the musculoskeletal system: rarely - arthralgia, muscle weakness, myalgia.
Allergic reactions: skin rash and / or itching, photosensitivity, erythema, alopecia.
Other: rarely - gynecomastia, a feeling of general malaise, impaired hematopoiesis.
Possible side effects are easy and reversible.
CONTRAINDICATIONS
-increased sensitivity to the drug.
It is not recommended to prescribe the drug to children and adolescents under the age of 18 years.
PREGNANCY AND LACTATION
The use of Helicides during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or newborn, due to the lack of reliable clinical data confirming the safety of the drug during these periods.
APPLICATION FOR CHILDREN
It is not recommended to prescribe the drug to children and adolescents under the age of 18 years.
SPECIAL INSTRUCTIONS
Before the start of therapy, the presence of a malignant process (especially in patients with gastric ulcer) should be excluded based on endoscopic findings with biopsy. treatment with the drug can mask symptoms and delay correct diagnosis.
OVERDOSE
Signs of an overdose were noted after taking the drug at a dose of 320 mg to 900 mg (ie at doses 16-45 times higher than therapeutic).
Symptoms: visual disturbances, confusion, increased sweating, drowsiness, dry mouth, headache, nausea, tachycardia, arrhythmia.
Treatment: spend symptomatic therapy on the background of monitoring the indicators of vital body functions. Conducting hemodialysis is not sufficiently effective due to the high degree of binding of omeprazole to blood plasma proteins.
DRUG INTERACTION
With the simultaneous application of Helicidum, the elimination is slowed down and the concentration in the plasma of diazepam, warfarin, phenytoin, and also other drugs metabolized by oxidation in the liver increases.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from the light at a temperature of 10 В° to 25 В° C.
The bottle with capsules should be immediately closed tightly with a lid containing a moisture drier after each dose.
