the package insert of the medicine Ulcozol.
The remedy Ulcozol serves for the treatment of ulcers gastric and duodenal; esophagitis reflux; Zollinger-Ellison syndrome; maintenance therapy for prevention of relapse in patients with duodenal ulcer; patients little responsive with gastric ulcer and maintenance treatment for patients with esophagitis of reflux healed; patients who present a risk of aspiration of gastric contents during general anaesthesia (prophylaxis of aspiration of acid); eradication of H. pylori associated with peptic ulcer.
When should I not use?
Hypersensitivity to omeprazole or any of the excipients.
How to use?
The usual dose of Ulcozol in cases of duodenal ulcer, gastric ulcer and esophagitis reflux is 20 mg orally before breakfast. In patients with duodenal ulcer, relief of symptoms is rapid and healing occurs within 2 weeks in most cases. For those patients that did not have healing in this period of time, it is recommended an additional period of 2 weeks within which usually occurs healing. In patients with gastric ulcer or esophagitis of reflux, the relief of symptoms is rapid and healing occurs within 4 weeks in most cases. For those patients that did not have healing in this period of time, it is recommended an additional period of 4 weeks within which usually occurs healing. For the sick little responsive with ulcer (gastric or duodenal) and patients with esophagitis of reflux severe, it is recommended that the daily dose of 40 mg, once a day, for a period of 4 weeks for those with duodenal ulcer and 8 weeks for the cases of gastric ulcer or esophagitis from severe reflux, which usually occurs healing. Eradication of H. pylori associated with peptic ulcer: treatment with a schema triple: omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg, twice a day, for a week. Omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg (or tinidazole 500 mg), twice a day, for a week. Omeprazole 40 mg once daily with amoxicillin 500 mg and metronidazole 400 mg both 3 times a day for a week. Treatment of dual therapy: omeprazole 40-80 mg/day, associated with 1.5 g/day of amoxicillin in divided doses for two weeks. In clinical studies have used daily doses of up to 1.5 to 3 g of amoxycillin. Omeprazole 40 mg/day associated with the 500 mg of clarithromycin three times a day, for two weeks. To ensure healing in patients with active peptic ulcer, see the dosage recommendations for duodenal ulcers and gastric. If the patient continues Helicobacter pylori-positive, therapy used can be repeated. Maintenance treatment: to prevent recurrence in patients little responsive with gastric ulcer, it is recommended for daily administration of 20 mg of Omeprazole. If necessary, the dose may be increased to 40 mg once a day. For the prevention of relapse in patients with duodenal ulcer and for maintenance treatment of patients with esophagitis of reflux healed, the recommended dose is 10 mg once a day. If necessary, the dose may be increased to 20-40 mg once a day. Prophylaxis of aspiration: we recommend 40 mg on the evening prior to surgery followed by 40 mg on the morning of the day of the surgery. In the Zollinger-Ellison syndrome the recommended initial dose of 60 mg, once a day, which should be adjusted individually, and for a period of time that will be determined by the clinical evolution of the patient. Doses above 80 mg daily should be divided into two jacks. It is not necessary to adjust doses in patients with renal function compromised. There is clinical experience enough with the use of omeprazole in children. – Overdosage: no information is available about the effects of excessive doses in humans and there are no recommendations specific to your treatment. Single-dose oral up to 160 mg and doses total of up to 360 mg/ day have been well tolerated. In a potential overdose, the treatment should be symptomatic and supportive. Elderly patients: it is not necessary to adjust the dose in elderly patients.
What are the evils that can cause me?
Omeprazole is well tolerated and adverse reactions are generally mild and reversible. The following reactions have been reported, however in many cases it was not possible to establish a relationship consistent with the treatment. Skin reactions: rarely occurred rash and / or pruritus; in isolated cases: photosensitivity, erythema multiforme and alopecia. Musculoskeletal: in isolated cases of arthralgia, muscular weakness and myalgia. Central and peripheral nervous system: Headache. Rarely dizziness, paraesthesia, somnolence, insomnia and vertigo. In isolated cases, have occurred the mental confusion, agitation, depression and hallucinations – especially in patients in serious condition. Gastrointestinal: diarrhea, constipation, abdominal pain, nausea, vomiting, and flatulence. Isolated reports of dry mouth, stomatitis and candidiasis gastrointestinal. Hepatic: rarely occurs increased liver enzymes. In isolated cases can occur encephalopathy in patients with severe hepatic impairment, preexisting; hepatitis with or without jaundice, liver failure. Endocrine: isolated reports of gynecomastia. Hematologic: isolated reports of leucopenia, thrombocytopenia, agranulocytosis and pancytopenia. Other: rarely, malaise. Can occur hypersensitivity reactions, for example, urticaria (rare), and, in isolated cases, angioedema, fever, bronchospasm, interstitial nephritis and anaphylactic shock. Isolated cases increased sweating, peripheral edema, clouding of vision, change of taste. During prolonged treatment, has been observed with high frequency in the appearance of cysts glandular stomach. These changes are consequences of the physiological of pronounced inhibition of acid, being benign, and appearing to be reversible. Have been reported isolated cases of visual disturbance irreversible in patients severely sick that received injection intravenous omeprazole, especially in high doses; however, has not been established a causal relationship.
Warnings and Precautions
what should I know before using?
When there is suspicion of gastric ulcer, the possibility of malignancy of the lesion should be early removed, as treatment with omeprazole may alleviate symptoms and delay diagnosis of this pathology. Drug interactions: absorption of some drugs may be changed due to the decrease of acidity intragástrica. Therefore, one can predict that during treatment with omeprazole the absorption of ketoconazole will decrease, as well as during treatment with other inhibitors of acid secretion or antacids. As omeprazole is metabolized by the liver, through the cytochrome P450, can prolong the elimination of diazepam, warfarin and phenytoin. Patients under treatment with warfarin or phenytoin should be monitored, and may require a reduction in dose of these drugs. However, in patients on continuous treatment with phenytoin, the concomitant treatment with omeprazole at a dosage of 20 mg/day did not alter the blood concentrations of phenytoin. Similarly, patients on continuous treatment with warfarin concomitantly with 20 mg/day of omeprazole did not show changes in the clotting time. During concomitant treatment of omeprazole with clarithromycin is an increase in the plasma concentrations of both substances. No interactions were observed with propranolol, metoprolol, theophylline, lidocaine, quinidine, or amoxicillin, but there can be drug interaction with other drugs that are also metabolized through the enzymatic system of cytochrome P450. No interactions were observed in the concomitant administration of omeprazole with antacids or food.