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Gastrointestinal System

Dudencer

 


Pack sizes:

Box of 3 blisters x 10 capsules.

Box of 4 blisters x 7 capsules.

 

Composition:

Each capsule contains omeprazole (pellets) 20 mg

(as omeprazole pellets 8.5%)

 

Shelf-life:  

36 months from the date of manufacturing.

Store in a well-closed container, in dry place. Protect from light and moisture.

Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Dudencer is administered orally. It should be swallowed whole and not crushed or chewed.

Adults:

  • Relief of acid-related dyspepsia.
    10 or 20 mg daily for 2 to 4 weeks.
  • Treatment of gastro-oesophageal reflux disease (GERD).
    The usual dose: 20 mg once daily for 4 weeks, followed by a further 4 to 8 weeks if not fully healed. In refractory oesophagitis, a dose of 40 mg daily may be used.
    Maintenance therapy after healing of oesophagitis is 20 mg once daily, and for acid reflux is 10 mg daily.
  • Management of peptic ulcer disease.
    A single daily dose of 20 mg, or 40 mg in severe cases. Treatment is continued for 4 weeks for duodenal ulcer and 8 weeks for gastric ulcer.
    Maintenance therapy: 10 to 20 mg once daily.
    For the eradication of Helicobacter pylori in peptic ulceration:
    Omeprazole may be combined with antibacterials in dual or triple therapy.
    Dual therapy: Omeprazole 20 mg twice daily for two weeks.
    Triple therapy: Omeprazole 20 mg twice daily for one week.
  • Treatment of NSAID-associated ulceration.
    20 mg daily; a dose of 20 mg daily may also be used for prophylaxis in patients with a history of gastroduodenal lesions who require continued NSAID treatment.
  • Zollinger-Ellison syndrome.
    60 mg once daily, adjusted as required. The majority of patients are effectively controlled by doses in the range 20-120 mg daily, but doses up to 120 mg three times daily have been used.
    Daily doses above 80 mg should be given as divided doses (usually 2).
  • Prophylaxis of acid aspiration during general anaesthesia.
    40 mg in the evening before surgery and a further 40 mg two to six hours before the procedure.
    Impaired renal function: Dose adjustment is not needed in patients with impaired renal function.

Impaired hepatic function:

  • A daily dose of 10-20 mg may be sufficient.

Elderly (> 65 years old):

  • Dose adjustment is not needed in the elderly.

Children:

  • There is limited experience with omeprazole in children.

 

Or as prescribed by physicians.


 

  • Patients with known hypersensitivity to the drug, esomeprazole, or other substituted benzimidazoles (e.g., lansoprazole, pantoprazole, rabeprazole), or to any ingredient of the drug.


 


Common

  • Headache, somnolence, dizziness.
  • Nausea, vomit, abdominal pain, diarrhoea, constipation, flatulence.

Less common

  • Insomnia, confusion, vertigo, fatigue.
  • Urticaria, itch, skin eruption.
  •  Rise in values of transaminase (reversible).

Rare

  • Increased sweating, peripheral oedema, hypersensitivity including angioedema, fever and anaphylactic shock.
  • Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia.
  • Reversible confusion, agitation, depression, hallucination in elderly patients, and especially in severely sick patients, hearing disturbances.
  • Gynecomastia.
  • Gastritis, infection by Candida, dry mouth.
  • Hepatitis with or without icterus, encephalopathy in patients with liver insufficiency.
  • Bronchospasm.
  • Arthralgia, myalgia.
  • Interstitial nephritis.
     

  • In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis.
  • Co-administration of atazanavir with proton pump inhibitors (PPIs) is not recommended. If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring (e.g. virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir, omeprazole should not be exceeded.
  • Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy.
  • Omeprazole is a CYP2C19 inhibitor. When starting or ending treatment with omeprazole, the potential for interactions with drugs metabolized through CYP2C19 should be considered. An interaction is observed between clopidogrel and omeprazole. The clinical relevance of this interaction is uncertain. As a precaution, concomitant use of omeprazole and clopidogrel should be discouraged.
  • Severe hypomagnesaemia has been reported in patients treated with PPIs like omeprazole for at least three months, and in most cases for a year. Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness and ventricular arrhythmia can occur but they may begin insidiously and be overlooked. In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
  • For patients expected to be on prolonged treatment or who take PPIs with digoxin or drugs that may cause hypomagnesaemia (e.g., diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
  • PPIs, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in the elderly or in presence of other recognised risk factors. Observational studies suggest that PPIs may increase the overall risk of fracture by 10-40%. Some of this increase may be due to other risk factors. Patients at risk of osteoporosis should receive care according to current clinical guidelines and they should have an adequate intake of vitamin D and calcium.
  • Pregnancy: Although experimental studies have not shown teratogenic and foetotocixity of omeprazole, it is not recommended during the pregnancy, particularly during the first trimester.
  • Lactation: The use of omeprazole in breast feeding mothers is not recommended.
  • Effects on ability to drive and use machines: Omeprazole is not likely to affect the ability to drive or use machines. Adverse drug reactions such as dizziness and visual disturbances may occur. If affected, patients should not drive or operate machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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