VIROM Capsule

Duodenal Ulcer

Omeprazole capsules are indicated for short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks.

Gastric Ulcer

Omeprazole capsules are indicated for the short-term treatment (4-8 weeks) of active benign gastric ulcer.

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD: Omeprazole capsules are indicated for the treatment of heartburn and other symptoms associated with GERD.

Erosive Esophagitis:

Omeprazole capsules are indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.

The efficacy of omeprazole used for longer than 8 weeks in these patients has not been established.

In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g. heartburn), additional 4-8 week courses of omeprazole may be considered.

Maintenance of Healing of Erosive Esophagitis

Omeprazole capsules are indicated to maintain healing of erosive esophagitis.

Pathological Hypersecretory Conditions

Omeprazole capsules are indicated for the long-term treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis).

Dosage and administration

Oral Route.

Dosage:

Duodenal Ulcer

Short-Term Treatment of Active Duodenal Ulcer: The recommended adult oral dose of omeprazole is 20mg once daily. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy.

Gastric Ulcer

The recommended adult oral dose is 40mg once a day for 4-8 weeks.

GERD

The recommended adult oral dose for the treatment of patients with symptomatic GERD and no esophageal lesions is 20mg daily for up to 4 weeks. The recommended adult oral dose for the treatment of patients with erosive esophagitis and accompanying symptoms due to GERD is 20mg daily for 4-8 weeks.

Maintenance of Healing of Erosive Esophagitis

The recommended adult oral dose is 20mg daily.

Pathological Hypersecretory Conditions

The dosage of omeprazole in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 120mg t.i.d have been administered. Daily dosages of greater than 80mg should be administered in divided doses.

In patients with known hypersensitivity to any component of the formulation.

Body As A Whole, Site Unspecified: Abdominal Pain, Asthenia

Digestive System: Constipation, Diarrhea, Flatulence, Nausea, Vomiting, Acid regurgitation.

Nervous System/Psychiatric: Headache.

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolized via the CYP450 system (e.g. cyclosporine, disulfiram, benzodiazepines). Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with omeprazole.

Because of its profound and long lasting inhibition of gastric acid secretion, it is theoretically possible that omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g. ketoconazole, ampicillin esters, and iron salts). In the clinical trials, antacids were used concomitantly with the administration of omeprazole.

Omeprazole should not be used during pregnancy without consultation of the doctor. If discover that you are pregnant during the treatment, consult your doctor for the necessity to follow the treatment.

Omeprazole can pass through breast milk, avoid breast feeding.

It is advisable to consult your doctor or pharmacist during pregnancy or feeding before the use of the medicine.

Omeprazole capsules should be taken before eating. Patients should be cautioned that the omeprazole capsule should not be opened, chewed or crushed, and should be swallowed whole.

General Precautions: Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

Omeprazole belongs to a new class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.