el-GRen-US

 

Name of the medicinal product: OPRAZIUM

Content: Each capsule contains 40 mg of Omeprazole

Pharmaceutical Form: Hard gastro-resistant capsule

Pharmacotherapeutic group: Proton pump inhibitors

Packaging Description:  Plastic bottle of high density polyethylene (HDPC) with special safety cap with integrated desiccant (silica gel), which contains 28 capsules. The vial with the operating instructions are packed in a cardboard box.

OPRAZIUM reduces the amount of acid produced in the stomach.
OPRAZIUM is used for treating the following diseases and conditions:
  • Duodenal ulcer (ulcer in the first part of the small intestine)
  • Stomach ulcer (benign gastric ulcer)
  • Duodenal and / or gastric ulcer associated with a microbe called Helicobacter pylori in combination with other drugs
  • Inflammation of the esophagus, which is caused by reflux of stomach content (Gastroesophageal reflux disease -GERD)
  • Treating GERD symptoms
  • Production of excessive amount of acid of the stomach caused by the influence of hormones, which are secreted by tumors of the pancreas. (Syndrome Zollinger-Ellison)
  • Aspiration of acidic gastric contents during general anesthesia. (Prophylaxis of aspiration)
  • Maintenance therapy (to prevent recurrence in patients resistant to standard treatment peptic ulcer or severe reflux oesophagitis)
  • Treatment of gastric and duodenal ulcers or erosions associated with nonsteroidal antiinflammatory drugs
  • Prevention of gastric and duodenal ulcers or erosions associated with nonsteroidal anti-inflammatory drugs, in particular:
    • In asymptomatic patients with newly diagnosed ulcer regardless of age and particularly those over 70 years
    • In women older than 70 years without a history of ulcers, because of the 5-fold higher relative risk of peptic ulcer development compared with males of the same age.
    • In patients with a history ulcerous diseases, the long-term use of nonsteroidal antiinflammatory drugs are necessary
Medications can help the sick, but can cause problems when they are not taken as directed.
For this drug you should, before get it, to tell your doctor in the following cases:
If you have ever had an allergic reaction or an unusual reaction to this drug or to any of the substances in medicine or any other medicines.
Oral administration
The dose of OPRAZIUM is recommended to be taken in the morning.

Duodenal ulcer:
The recommended dosage is 20mg OPRAZIUM once a day. Relief of symptoms is rapid and in most patients healing occurs within two weeks. For those patients not fully healed after the initial treatment, this usually occurs after a further two weeks treatment. In patients resistant to other treatment regimens, the daily dose of OPRAZIUM is 40mg once a day, and the healing of duodenal ulcers usually achieved within 4 weeks.

For recurrence prevention in patients with peptic ulcer the recommended dose is 10mg once a day. The dose may be increased to 20mg once daily, if symptoms reappear.

Benign gastric ulcer:
The recommended dosage is 20mg OPRAZIUM once a day. Relief of symptoms is rapid and in most patients healing occurs within four weeks. For those patients not fully healed after the initial treatment, this usually occurs after a further 4 weeks treatment.

In patients refractory to other therapeutic regimens OPRAZIUM at a dose 40mg once a day, achieves the healing of gastric ulcers, usually within 8 weeks.

To prevent relapses in patients resistant to conventional therapy benign gastric ulcer, recommended 20mg dose once a day (may be increased to 40mgmia once a day in case of relapse).

Treatment or prevention of gastric and duodenal ulcers or erosions associated with nonsteroidal antiinflammatory drugs (NSAIDs):
For the treatment of gastric and duodenal ulcers or erosions associated with the use of NSAIDs in patients with continuous or intermittent treatment with NSAIDs, the recommended dosage is 20mg OPRAZIUM once daily. Relief of symptoms is rapid and in most patients healing occurs within four weeks..

For those patients not fully healed after the initial treatment, this is usually achieved after an additional 4 weeks of treatment.

For the prevention of gastric and duodenal ulcers or erosions associated with the use of NSAIDs, the recommended dosage is 20mg OPRAZIUM once daily

Esophagitis from gastroesophageal reflux disease:

Adults:

The recommended dosage is 20mg OPRAZIUM once a day. Relief of symptoms is rapid and in most patients healing occurs within four weeks. For those patients not fully healed after the initial treatment, this usually occurs after a further 4 weeks treatment. In patients with severe esophagitis from gastroesophageal reflux, which do not respond to other treatments, the OPRAZIUM dosed 40mgtin day achieves healing of esophagitis, usually within 8 weeks.

For long-term maintenance therapy to prevent relapse 10mg is a recommended dosage for once daily (can be increased to 20-40mg once a day in case of relapse).

Children older than 2 years with severe esophagitis from gastroesophageal reflux disease:

Clinical experience in children is limited. In children, omeprazole should only be used in cases of severe esophagitis from gastroesophageal reflux disease, which is resistant to other therapeutic measures.

Therapy should be initiated by a hospital pediatrician.

For the monitoring of patients, determining the dose and duration of treatment, and to achieve the optimal therapeutic effect, is recommended where appropriate, periodic (24hours) measurement of pH, to be maintained above 4. Molecular or acquired disorders of CYP2C19 should be considered in the treatment, where feasible.

Dosage: 0,7-1,4mg / kg B.W.

Duration of treatment 4-8 weeks and should not exceed 12 weeks.

In refractory cases the dose increase to 2,5mg / kg.

Treating GERD symptoms:

The recommended dosage is 20mg OPRAZIUM once a day. Relief of symptoms is rapid. Many patients may respond satisfactorily to a dosage of 10mg OPRAZIUM once daily, so it should be taken into account the individualization of dosage.

If symptom control has not been achieved after four weeks treatment with 20mg OPRAZIUM daily, further investigation is recommended.

Syndrome ZOLLINGER-ELLISON:
The recommended initial dose is 60mg OPRAZIUM per day. The dosage should be individualized and the treatment duration depends on the clinical indication.

In doses of 20-120mg per day, the majority of patients responds. If the total daily dose exceeds 80mg, should be divided into two shots per day.

Eradication of Helicobacter pylori in duodenal ulcer and benign gastric ulcer:
Examples of triple regimens (one-week):

Amoxicillin 500mg, three times daily and
Metronidazole 400mg, three times daily and
Omeprazole20mg, δύο φορές την ημέρα ή 40mg μία φορά την ημέρα για επτά (7) ημέρες.

Clarithromycin 250mg, twice daily and
Metronidazole 400mg, twice daily and
Omeprazole20mg, twice per day or 40mg once per day for seven (7) days.

Amoxicillin 1gr, twice daily and
Clarithromycin 500mg, twice daily and
Omeprazole 20mg, twice daily or 40mg once per day for seven (7) days.

Examples of double regimens (lasting two weeks):

Clarithromycin 500mg, three times daily and
Omeprazole 20mg, twice daily or 40mg once daily for 14 days.

Amoxicillin 750mg (or 1g), twice daily and
Omeprazole20mg, twice daily or 40mg once daily for 14 days.

To ensure healing in patients with active peptic ulcer disease, see the above recommended dosage for duodenal and benign gastric ulcer.

If, after treatment with any of these regimens, the patient remains positive in Helicobacter pylori, treatment can be repeated.

Prevention of aspiration:
40mg the night before surgery and then 40mg 1-4 hours before surgery.

Use in renal impairment:
In kidney patients do not need dose adjustment.

Use in hepatic impairment:
Because the bioavailability and plasma half-life of omeprazole is increased in patients with liver failure, the daily dose of 20mg usually suffice.

Children:
Safety and efficacy of the use of OPRAZIUM in children has not been demonstrated, except use for severe esophagitis from gastroesophageal reflux disease in children over 2 years.

Elderly:
The elderly do not need dose adjustment.