Omeprazol Sandoz of 40 mg

General characteristics. Structure:

Active ingredient: Omeprazol of 40 mg.
 
Excipients: The hypro rod low-replaced cellulose microcrystallic, lactose anhydrous, sodium of a kroskarmelloz, povidone, polysorbate 80, gipromelloza phthalate, дибутилсебакат, talc.
 
Structure of a cover of the capsule 
Gipromelloza, каррагинан, potassium chloride, titanium dioxide, gland (III) oxide yellow, gland (III) oxide red, water.
 
Ink for drawing a text 
Gland (III) oxide black (E172), shellac, ethanol anhydrous, isopropanol anhydrous, propylene glycol, butanol, ammonium hydroxide, potassium hydroxide, the water purified.

Pharmacological properties:

Pharmacokinetics. Absorption and metabolism
Absorption is high, the maximum levels of an omeprazol in plasma are created 0,5 - 3,5 hours later after intake.

Absolute bioavailability makes about 30-40%.

The elimination half-life (T 1/2 ) equals 0,5-1ch.

At patients with chronic diseases of a liver bioavailability considerably increases, and (T 1/2 ) drug from a blood plasma increases till 3 o'clock.

Communication with proteins of a blood plasma reaches 95%.

The anti-secretory effect of an omeprazol occurs within the first hour, reaching a maximum in 2 hours after oral administration.

The inhibition of 50% of the maximum secretion proceeds 24 hours.

The single dose in days provides quicker and the effective oppression of day and night gastric secretion reaching the maximum in 4 days of treatment and disappearing by the outcome 3-4 days after the end of reception.

Omeprazol is metabolized in a liver with education 6 pharmacological of inactive metabolites.
 
Removal
It is removed in the form of metabolites by kidneys (70 - 77%) and with bile (18 - 23%).
 
Pharmacokinetics in special clinical cases
At patients with chronic diseases of kidneys excretion is slowed down in proportion to decrease in clearance of creatinine. 
Inhibitor of the protonew pump, reduces a kislotoproduktion - brakes activity of N + / To + - ATP-ases in covering cells of a stomach and blocks thereby a final stage of secretion of hydrochloric acid.

Drug is pro-medicine and is activated in acid medium of secretory tubules of covering cells.

Reduces basal and stimulated secretion irrespective of the irritant nature.

Indications to use:

- Peptic ulcer of a stomach and duodenum (including prevention of a recurrence).
- Eradikation Helicobacter pylori at the infected patients with a peptic ulcer of a stomach and a 12-perstny gut (as a part of a combination therapy).
- Reflux esophagitis. 
- Hyper secretory states (Zollingera-Ellison's syndrome, polizndokrinny adenomatosis, system mastocytosis, stressful ulcers of digestive tract).
- Prevention and treatment of the injuries of a mucous membrane of a stomach and duodenum caused by reception of non-steroidal anti-inflammatory drugs (dyspepsia, erosion of a mucous membrane, a round ulcer).

Route of administration and doses:

Inside. Capsules Omeprazol Sandoz accept before food (usually in the morning before a breakfast).

The capsule should be swallowed entirely, washing down with enough liquid.

If the patient cannot swallow the capsule Omeprazol Sandoz entirely, it is possible to dissolve its contents in a small amount of water or fruit juice (for example, apple or orange).
Peptic ulcer of a duodenum
On 20 mg once a day within 2 weeks.

If after the first course of administration of drug there does not occur full scarring, appoint a repeated two-week course of therapy.

At a peptic ulcer of a duodenum, resistant to therapy, appoint Omeprazol Sandoz capsules of 40 mg of 1 times a day, the course of treatment can be prolonged up to 4 weeks.
 
Peptic ulcer of a stomach
On 20 mg of 1 times a day within 4 weeks.

If after the first course of administration of drug there does not occur full scarring, appoint a repeated four-week course of therapy.

At a peptic ulcer of a stomach, resistant to therapy, appoint Omeprazol Sandoz capsules of 40 mg of 1 times a day, the course of treatment can be prolonged up to 8 weeks.
 
Eradikation Helicobacter pylori as a part of a combination therapy
Omeprazol Sandoz of the capsule on 20 mg two times a day before food within 2 weeks in combination with antibacterial drugs.
 
Reflux esophagitis
20 mg once a day within 4 weeks.

If after the first course of administration of drug there does not come full treatment, appoint a repeated four-week course of therapy.

At severe forms of an ezofagealny reflux the course of treatment can be prolonged up to 8 weeks.
 
Hyper secretory states
The dose Omeprazol Sandoz and duration of a course of treatment for patients with Zollingera-Ellison's syndrome is selected individually.

The recommended initial dose for adults makes 60 mg once a day.

Maximum - 120 mg/days.

At purpose of the dose exceeding 80 mg/days it is divided into several receptions.
 
 Prevention and treatment of the injuries of a mucous membrane of a stomach and duodenum caused by reception of non-steroidal anti-inflammatory drugs (NPVP)
Prevention - on 1 capsule Omeprazol Sandoz of 20 mg daily before a breakfast during all course of treatment of NPVP.

Treatment - on 20 mg/days within 4-8 weeks.

The daily dose for patients of the senior age group and for patients with a serious illness of a liver should not exceed 20 mg.

For patients with renal failures of correction of doses it is not required.

Features of use:

Before therapy omeprazoly it is necessary to exclude existence of malignant process since treatment, masking symptomatology, can delay statement of the correct diagnosis.
Influence on ability to driving of motor transport and to control of mechanisms
There are no data on clinically significant influence of an omeprazol on ability to drive the car and mechanisms.

Side effects:

The side effects observed at drug use Omeprazol Sandoz are usually poorly expressed and have passing character.
 Allergic reactions
Seldom - urticaria, a skin itch.

Very seldom - an eosinophilia, fever, a Quincke's disease, a bronchospasm, anaphylactoid reactions, intersticial nephrite.
 
From digestive tract
Seldom - nausea, vomiting, an abdominal pain, diarrhea or a lock, a meteorism.

Very seldom - dryness in a mouth, stomatitis, increase in activity of an alkaline phosphatase and transaminases.

Patients with the previous serious illness of a liver have a hepatitis, an abnormal liver function.
 
From a nervous system
Patients with the serious accompanying somatopathies have a headache.

Seldom - dizziness, paresthesias, disturbance of flavoring feelings, drowsiness, sleeplessness.

Very seldom - excitement, a depression, reversible confusion of consciousness.

Against the background of heavy liver diseases - encephalopathy.
 
From integuments
Photosensitization, multiformny exudative erythema, alopecia.
 
From a musculoskeletal system
Mialgiya, arthralgia, in some cases muscular weakness.
 
From bodies of a hemopoiesis
In separate cases leukopenias, agranulocytosis, thrombocytopenia, pancytopenia.
 
Others
Sweating strengthening, peripheral hypostases, vision disorder, gynecomastia.

Seldom - formation of gastric glandulyarny cysts during prolonged treatment (a consequence of inhibition of secretion of HCI, has high-quality, reversible character).

Interaction with other medicines:

At simultaneous use with omeprazoly increase in an elimination half-life and increase in concentration of warfarin, diazepam, Phenytoinum, and also other drugs which are metabolized in a liver by means of CYP2C19 cytochrome is possible (decrease in doses of these drugs can be required).

Disturbance of absorption of drugs which bioavailability to a large extent is defined by acidity of a gastric juice can be observed (for example, a ketokonazola, an itrakonazola, ethers of ampicillin, salts of iron and cyanocobalamine). 

Bioavailability of digoxin at simultaneous use with omeprazoly increases by 10%.

Strengthens an inhibiting effect on system of a hemopoiesis of other medicines.

It is not established clinically significant interaction with antiacid drugs, theophylline, caffeine, quinidine, lidocaine, propranolol, metoprololy. ethanol.

Contraindications:

- Hypersensitivity to an omeprazol or other components of drug.
- Children's age.
- Lactation period.

With care:
- Liver failure.
- Renal failure.
Use at pregnancy and feeding by a breast
Pregnancy
Use of an omeprazol during pregnancy is possible only if the estimated advantage for mother exceeds potential risk for a fruit.
 
Lactation
At administration of drug in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Overdose:

Symptoms: dryness in a mouth, nausea, vomiting, sweating strengthening, a headache, drowsiness, confusion of consciousness, a vision disorder, tachycardia. 

Treatment: symptomatic. There is no specific antidote. The hemodialysis is inefficient for removal of an omeprazol from an organism in connection with high extent of linkng with proteins.

Storage conditions:

To store in the place protected from light, at a temperature not above 25 °C. Period of validity: 2 years. To store in places unavailable to children. Not to use after expiry date.

Issue conditions:

According to the recipe

Packaging:

In the blister of 7 tablets. In a cardboard pack 1 blister.