Dudencer

Dudencer

omeprazole

Manufacturer:

Stellapharm

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Contents
Omeprazole.
Description
Each capsule contains omeprazole (under the form of enteric-coated pellets) 20 mg.
Action
As a proton-pump inhibitor with action of antiulcer and hyposecretory.
Indications/Uses
Treatment of duodenal ulcer, gastric ulcer, reflux esophagitis and symptomatic treatment of gastroesophageal reflux disease.
Management of Zollinger-Ellison syndrome.
Dosage/Direction for Use
Dudencer is orally taken.
Duodenal ulcer: Recommended dosage: 20 mg once daily. Symptom relief is rapid and healing occurs within 2 weeks. Treatment of 2 weeks further may be required for patients who may not have fully healed after the initial course.
Dosage of 40 mg once daily has been given in patients with poorly responsive duodenal ulcer. Healing is usually achieved within 4 weeks.
The recommended dose of 10 mg once daily is given for the prevention of relapse in patients with duodenal ulcer. The dose may be increased if necessary to 20-40 mg once daily.
Gastric ulcer: Recommended dosage: 20 mg once daily. Symptom relief is rapid and healing occurs within 4 weeks. Treatment of 4 weeks further may be required for patients who may not have fully healed after the initial course.
Dosage of 40 mg once daily has been given in patients with poorly responsive gastric ulcer. Healing is usually achieved within 8 weeks.
The recommended dose of 20 mg once daily is given for the prevention of relapse in patients with poorly responsive gastric ulcer. The dose may be increased if necessary to 40 mg once daily.
Reflux esophagitis: Recommended dosage: 20 mg once daily. Symptom relief is rapid and healing occurs within 4 weeks. Treatment of 4 weeks further may be required for patients who may not have fully healed after the initial course.
Dosage of 40 mg once daily has been given in patients with severe reflux esophagitis. Healing is usually achieved within 8 weeks.
The recommended dose of 10 mg once daily is given for the long-term management of patients with healed reflux esophagitis. The dose may be increased if necessary to 20-40 mg once daily.
Symptomatic treatment of Gastroesophageal Reflux Disease: Recommended dosage: 20 mg daily. Symptom relief is rapid. Patients may respond adequately to 10 mg daily, and therefore individual dose adjustment should be considered.
Further investigation is recommended when symptom control has not been achieved after 4-week treatment with the recommended dosage.
Zollinger-Ellison Syndrome: Recommended initial dosage: 60 mg daily. Individual dose adjustment should be considered and treatment must be continued as long as clinically indicated. All patients with severe disease and inadequate response to other therapies have been effectively controlled and > 90% of the patients maintained on doses of 20-120 mg daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Impaired renal and liver function: Dose adjustment in patients with impaired renal or liver function is not required.
Children: There is no experience in children.
Elderly: No dose adjustment is necessary in the elderly.
Contraindications
Patients with known hypersensitivity to any ingredient of the drug.
Special Precautions
When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with proton-pump inhibitors for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the proton-pump inhibitor. For patients expected to be on prolonged treatment or who take proton-pump inhibitor with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. Diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of proton-pump inhibitor treatment and periodically.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Patients should use lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping Dudencer. SCLE after previous treatment with a proton-pump inhibitor may increase the risk of SCLE with other proton-pump inhibitors.
Use in Pregnancy & Lactation: As with all new drugs, Omeprazole should not be given during pregnancy and lactation unless its use is considered essential.
Side Effects
Rarely: nausea, headache, diarrhea, constipation and flatulence.
Skin rash has occurred in few patients.
Drug Interactions
Diazepam, Warfarin and Phenytoin: Since Omeprazole is metabolised in the liver via cytochrome P-450 2C19 (CYP2C19) enzyme system in the liver; therefore, it prolongs their elimination. Monitoring of patients also receiving Warfarin or Phenytoin is recommended and reduction of dose of Phenytoin and Warfarin may be necessary.
Propranolol, Theophylline: No interaction has been found out.
Antacids: No interactions have been found out when concomitantly administered.
Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart.
Decreased gastric acidity due to any means, including proton pump inhibitors, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Concomitant use of Proton Pump Inhibitors (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Storage
Protect from light and moisture. Do not store above 30°C.
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Cap 20 mg x 28's.
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