Omesel hard capsules Omesel 20 Roussel treat and prevent recurrence of stomach ulcers (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Omeprazol

Ingredient

Composition information	Content
Omeprazol	20mg

Uses

indications

Omesel® 20 drugs are indicated in the following cases:

Treatment as well as prevent recurrent stomach ulcers, heartburn, gastroesophageal reflux (gerd).

When it is necessary to reduce the level of gastric acid secretion for patients. (NSAID).

Treatment of Zollinger - Ellison syndrome.

The main substance of Omesel 20 is Omeprazol, a derivative of the benzimidazol group.

Omeprazole inhibits gastric acid secretion according to the selective and unsalting mechanism of the proton pump. The drug has a specific affinity for H+, K+ ATPASE enzyme (proton pump) in the stomach lining cells. This enzyme controls the final stage of gastric acid secretion, so Omeprazole inhibits both basic acid secretion as well as any stimulation. Omesel 20 works quickly after drinking. Because the drug is not reversible in H+, K+ ATPASE, the effect of the drug still lasts at least 72 hours after stopping the drug.

pharmacokinetics

The drug is quickly absorbed through the gastrointestinal tract. The effect is shown within 1 hour after drinking. The drug is distributed into tissues, especially into the cells into the stomach. The drug is very cohesive on plasma proteins (95%). The drug is metabolized in the liver thanks to the cytochrome P450 enzyme system. The sale time of the drug is about 30 minutes to 1 hour in normal people and about 3 hours in liver disability.

Despite the short excretion time, the acid excretion inhibitory effect is prolonged, so it can be used only once a day. The drug is eliminated mainly through the kidneys (70 - 77%) and through feces (18 - 23%). The drug is not eliminated from the body when dialysis or blood separation. The pharmacokinetics of the drug are not significantly changed in the elderly or patients with renal function.

Before taking Omesel hard capsules Omesel 20 Roussel treat and prevent recurrence of stomach ulcers (3 blisters x 10 tablets)

How to use

Omesel® 20 drugs for oral.

Take the whole pill, do not chew. Drink before meals (preferably before breakfast).

Dosage

Dosage and medication time for each specific case as directed by the treating doctor.

Dosage for usual adults

Gastroesophageal reflux: 20 mg - 40 mg/time/day continuously for 4 to 8 weeks. It is then for maintenance of 20 mg/day/day.

ulcer: 20 mg/day/day (case of severe use of 40 mg) continuously for 4 weeks if duodenal ulcer, 8 weeks if stomach ulcer.

Stomach ulcer caused by Helicobacfer pylori: There are 2 regimens:

The 2 -drug regimen: 20 mg x 2 times/day or 40 mg/day/day in combination with Clarithromycin 500 ng 3 times/day; or 20 mg of omeprazol and amoxicillin 750 - 1000 mg orally twice a day in a row for 2 weeks.

3 drug regimen: 20 mg omeprazol, amoxicillin 1 g and Clarithromycin 500 mg; or 20 mg omeprazol, Clarithromycin 250 mg and Metronidazol 400 mg (or Tinidazol 500 mg) orally twice a day for 1 week.

Zollinger - Ellison syndrome: 60 mg once a day (20 - 120 mg per day); If the dose is higher than 80 mg, divide 2 times daily. The dosage should be calculated for specific cases and the therapy may last depending on the clinical requirements. Do not stop the drug suddenly.

Children from 1 or more weighing more than 20 kg

Gastroesophageal reflux - esophagus: 20 mg/time/day.

Patients with liver failure

The maximum dose is 20 mg/day.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What to do when overdose?

When overdose, only symptomatic treatment, no specific treatment.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Omesel® 20, you may experience unwanted effects (ADR).

omesel 20 is well tolerated, unwanted effects are usually mild and can recover after stopping the drug.

Systemic: headache, drowsiness, dizziness. Rarely sweat, angioedema, fever, anaphylaxis.

On the skin: rarely rash or itching.

Digestive system: diarrhea, constipation, abdominal pain and may be flatulent. Rarely gastritis, candidiasis, dry mouth.

Liver: temporarily increased transaminase. Rarely hepatitis jaundice or no jaundice, cerebral disease in people with liver failure.

Nervous system: less eye -catching eyes, sensory disorders, fatigue, dizziness. Rarely confuse recovery, agitation, depression, hallucinations in elderly patients and especially in serious patients, hearing disorders.

Hematology: Rarely leukopenia, thrombocytopenia, reducing all blood cells, peripheral, and grain leukocytes.

Endocrine: rarely big breasts in men.

Respiratory: rarely bronchospasm.

muscle - bone: rarely joint pain, muscle pain.

Urinary - Sex: rarely interstitial nephritis.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Omesel® 20 drug is contraindicated in the following cases:

Patients sensitive to omeprazol.

Cases of severe hepatitis.

Be cautious when using

eliminate the possibility of malignant tumors before giving stomach ulcer using omeprazol.

Patients with liver failure: The dose must be reduced depending on the degree of liver disease.

The ability to drive and operate machinery

No report.

Pregnancy

There is no complete research on pregnant women. Do not use for pregnant women, especially in the first 3 months.

Risk of pregnancy according to FDA: level C.

The period of breastfeeding

should not be used in breastfeeding women.

Drug interaction

omeprazol inhibits drug metabolism in the liver microsome (cytochrome p450 enzyme system), so the process of eliminating other drugs that they are metabolized by cytochrome P450 or drugs that are mainly eliminated through the liver will be slowed if used simultaneously with omeprazol. This effect can be seen by prolonging the time of elimination, increasing blood concentration of diazepam, phenytoin and anticoagulants such as warfarin (need to monitor blood levels or monitor prothrombin time for the use of anticoagulants according to the instructions on quantitative parameters and may change the dose during the shared use of omeprazol).

Omeprazol has the potential to affect the bioavailability of drugs that the absorption depends on the pH because it increases the pH of the stomach and so omeprazol can prevent the decomposition of non -durable drugs in the acidic environment. Therefore, when shared with omeprazol with otraconazole and ketoconazole, it leads to a reduction in the absorption of these drugs.

omeprazol increases the effect of antibiotic eradication H. pylori.

omeprazol increases Dicoumarol's anticoagulant effect.

omeprazol reduces nifedipine metabolism at least 20% and may increase the effect of nifedipine.

When using simultaneously clarithromycin or erythromycin with omeprazol, the concentration of omeprazol in plasma increases. Voriconazole increases Omeprazol's AUC to 280%. In the case of simultaneous treatment of voriconazole and omeprazol, omeprazole should be adjusted in patients with significant impaired liver function or in the case of long -term treatment. Simultaneous use of omeprazol with afazanavir reduces the concentration of afazanavir in plasma. Do not use omeprazol simultaneously with afazanavir.

Storage

In a dry place, temperatures below 300C, avoid light.

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