Ortanol, 20mg capsules, 28pcs

Composition

1 capsule contains:

Active ingredient:

omeprazole 20 mg;

Auxiliary substances:

low-substituted hyprolose;

MCC;

lactose anhydrous;

sodium croscarmellose;

povidone;

polysorbate 80;

hypromellose phthalate;

dibutyl sebacate;

talc;

Capsule shell:

hypromellose; carrageenan; potassium chloride; titanium dioxide; iron (III) oxide yellow; iron (III) oxide red; water; ink inscription (iron (III) oxide black (E 172), shellac, anhydrous ethanol, isopropanol anhydrous, propylene glycol, butanol, ammonium hydroxide, potassium hydroxide, purified water).

Pharmacological action

Orthanol is an inhibitory agent of H+, K+ – ATPASE.

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 secretion. This leads to a decrease in basal and stimulated secretion, regardless of the nature of the stimulus.

After a single oral dose, the effect of omeprazole occurs within the first hour and lasts for 24 hours. The maximum effect is achieved in 2 hours. After discontinuation of the drug, secretory activity is fully restored in 3-5 days.

Pharmacokinetics

Omeprazole is rapidly absorbed from the gastrointestinal tract, with_max in blood plasma reached in 0.5-3.5 hours. Bioavailability is 30-40%. The connection with plasma proteins is about 95%.

Omeprazole is almost completely metabolized in the liver with the participation of the CYP2C19 isoenzyme with the formation of 6 pharmacologically inactive enzymes. T_1/2 — 0,5–1 h.

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

In patients with hepatic insufficiency, bioavailability increases significantly, T_1/2increases to 3 hours.

In elderly patients, the rate of elimination decreases, and bioavailability increases.

Indications

Symptoms of gastroesophageal reflux, such as heartburn, acid belching.

Use during pregnancy and lactation

The results of three prospective epidemiological studies (more than 1000 observations) showed that the use of omeprazole in pregnant women does not adversely affect the course of pregnancy and the health of the fetus/newborn. However, before using the drug during pregnancy, it is recommended to consult a doctor.

Omeprazole passes into breast milk. If it is necessary to use the drug during lactation, the question of stopping breastfeeding should be decided.

Contraindications

• hypersensitivity to omeprazole or other components of the drug;
• age under 18 years;
• concomitant use with nelfinavir;
• rare hereditary forms of galactose intolerance, lactase deficiency or glucose/galactose malabsorption (because the composition contains lactose).

With caution:  before using the drug, you should consult your doctor in the following cases: :

• the presence of previously diagnosed gastric ulcer, severe liver disease, accompanied by liver failure, jaundice, previous surgery on the gastrointestinal tract;
• the presence of anxiety symptoms: significant weight loss, recurrent vomiting, vomiting blood (hematemesis), impaired swallowing, change in color of stool (black, tar-like stool — melena);
• the appearance of new symptoms or a change in existing symptoms of the gastrointestinal tract; symptomatic treatment of dyspepsia or heartburn for 4 weeks or more; the simultaneous use of one or more of the following drugs: atazanavir, clopidogrel, digoxin, erlotinib, ketoconazole, Itraconazole, warfarin, Cilostazol, diazepam, phenytoin, saquinavir, tacrolimus, clarithromycin, voriconazole, rifampin, St. John’s wort preparations Programing.

It is also recommended to consult your doctor before using Ortanol® during pregnancy and lactation.

Do not use the drug for preventive purposes.

Side effects

Allergic reactions:  infrequently — urticaria, skin rash, pruritus; rarely-fever, angioedema, anaphylactoid reactions; very rarely-eosinophilia.

From the gastrointestinal tract:  often — nausea, vomiting, abdominal pain, diarrhea or constipation, flatulence; infrequently-increased activity of transaminases and alkaline phosphatase; rarely-dry mouth, stomatitis, gastrointestinal candidiasis, hepatitis (with or without jaundice); very rarely — liver failure (in patients with previous severe liver disease).

Nervous system disorders:  often-headache; infrequently-dizziness, paresthesia, drowsiness, insomnia; rarely-agitation, reversible confusion, depression, impaired taste sensations; very rarely-aggression, hallucinations; against the background of severe liver disease — encephalopathy.

From the side of the skin:  infrequently-dermatitis; rarely-photosensitization, alopecia; very rarely-erythema multiforme, Stevens-Johnson syndrome (severe erythema multiforme, characterized by the appearance of spots and blisters on the skin and mucous membranes against a background of high fever and joint pain), toxic epidermal necrolysis.

From the side of the senses:  rarely-visual impairment.

From the musculoskeletal system:  rarely-myalgia, arthralgia; very rarely-muscle weakness.

Respiratory system disorders:  rarely-bronchospasm.

From the urinary system:  rarely-interstitial nephritis.

From the side of hematopoietic organs:  rarely-leukopenia, thrombocytopenia; very rarely-agranulocytosis, pancytopenia.

Other services:  infrequently-peripheral edema; rarely-increased sweating, hyponatremia; very rarely-hypomagnesemia, gynecomastia.

Interaction

You should consult your doctor before taking Orthanol® for treatment with one or more of the medications listed in this section.

When used concomitantly with omeprazole, there may be an increase or decrease in the absorption of drugs whose bioavailability is largely determined by the acidity of gastric juice (including erlotinib, ketoconazole, itraconazole, iron preparations and cyanocobalamin).

When used concomitantly with omeprazole, a significant decrease in the plasma concentration of atazanavir may occur. Simultaneous use is possible only as prescribed by a doctor (correction of the dosage and regimen of atazanavir is carried out if necessary).

The bioavailability of digoxin when used concomitantly with omeprazole increases by 10% (it may be necessary to adjust the dosage regimen of digoxin). Caution should be exercised when concomitantly using these drugs in elderly patients.

With the simultaneous use of omeprazole with clopidogrel, a decrease in the antiplatelet effect of the latter is observed.

When used concomitantly with omeprazole, it is possible to increase the plasma concentration and increase the T_1/2 of warfarin, cilostazol, diazepam, phenytoin, as well as other drugs that are metabolized in the liver by the CYP2C19 isoenzyme (it may be necessary to reduce the doses of these drugs).

Omeprazole, when used concomitantly, increases the plasma concentration of tacrolimus, which may require dose adjustment.

When used concomitantly with omeprazole, there is an increase in the plasma concentration of saquinavir/ritonavir up to 70%, while the tolerability of treatment in patients with HIV infection does not worsen.

Concomitant use with inhibitors of the CYP2C19 and CYP3A4 isoenzymes (such as clarithromycin, voriconazole) may lead to an increase in the plasma concentration of omeprazole, which may require dose adjustment of omeprazole in patients with severe hepatic insufficiency in the case of its long-term use.

Inducers of CYP2C19 and CYP3A4 isoenzymes (for example, rifampicin, Hypericum perforatum) can increase the metabolism of omeprazole, thereby reducing its concentration in plasma.

No clinically significant interaction of omeprazole with antacids, theophylline, caffeine, quinidine, lidocaine, propranolol, metoprolol, or ethanol has been established.

How to take it, course of administration and dosage

Inside, before eating.

The initial dose is 20 mg (2 capsules) once a day. When the symptoms begin to disappear, the dose can be reduced to 10 mg per day and again increased to 20 mg once a day in case of recurrent symptoms. You may need to take the drug for 3-4 days to achieve relief of symptoms.

The maximum daily dose of the drug should not exceed 20 mg.

The lowest effective dose should always be used. The maximum course of treatment is 14 days. The interval between 14-day courses of treatment without consulting a doctor should be at least 4 months.

If there is no relief of symptoms within 2 weeks or they worsen, you should consult your doctor.

The capsule should be swallowed whole, washed down with a sufficient amount of liquid. If the patient cannot swallow the whole Ortanol capsule, it is possible to dissolve its contents in a small amount of water or fruit juice (do not dissolve in carbonated drinks). The resulting solution of the drug should be drunk immediately after cooking, with an additional 1/2 cup of water.

Patients with impaired renal function: no dose adjustment is required.

Patients with impaired liver function: consult your doctor before use.

Elderly patients: despite the fact that the metabolic rate of omeprazole decreases in the elderly, dose adjustment is not required when using the drug in a daily dose of 20 mg or less.

Overdose

Symptoms: dry mouth, nausea, vomiting, excessive sweating, headache, drowsiness, confusion, visual disturbances, tachycardia.

Treatment: symptomatic. There is no specific antidote. Hemodialysis is ineffective.

Special instructions

Omeprazole is not intended for use in case of accidental heartburn (heartburn less than 2 times a week).

Before starting therapy with omeprazole, it is necessary to exclude the presence of a malignant process, since treatment, masking the symptoms, can delay the correct diagnosis.

Omeprazole reduces the acidity of gastric juice, which may slightly increase the risk of digestive tract infections.

Influence on the ability to drive vehicles and perform other activities that require concentration of attention and speed of psychomotor reactions

During treatment with omeprazole, dizziness, drowsiness, and visual impairment may occur, so caution should be exercised when driving vehicles and performing other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.

Special precautions when disposing of an unused product. Not required.

Form of production

Capsules

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Omeprazole

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

For pregnant women as prescribed by a doctor, For adults as prescribed by a doctor

Indications

Gastric and duodenal ulcers, GI infections caused by Helicobacter Pylori, Reflux Esophagitis