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Gastrointestinal System

Esomeprazol STADA® 20 mg

 

Pack size: 

Box of 4 blisters x 7 capsules

 

Composition: 

Each capsule contains esomeprazole 20 mg

(as esomeprazole (magnesium dihydrate) pellets 22%)

 

Shelf-life: 

24 months from the date of manufacturing. 

Store in a well-closed container, in a dry place, protect from light. Do not store above 30ºC.

 

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


The capsules should be swallowed whole with some water, not be chewed or crushed.

Adults and adolescents from the age of 12 years

  • Gastro-oesophageal reflux disease (GORD):
    Treatment of erosive reflux oesophagitis: 40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
    Long-term management of patients with healed oesophagitis to prevent relapse: 20 mg once daily.
    Symptomatic treatment of gastro-oesophageal reflux disease (GORD): 20 mg once daily in patients without oesophagitis. If symptom control has not been achieved after 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily. In adults, an on-demand regimen taking 20 mg once daily, when needed, can be used. In NSAID treated patients at risk of developing gastric and duodenal ulcers, subsequent symptom control using an on-demand regimen is not recommended.

Adults

  • In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori, healing of Helicobacter pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcers:
    20 mg esomeprazole with 1 g amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
  • Patients requiring continued NSAID therapy:
    Healing of gastric ulcers associated with NSAID therapy: The usual dose is 20 mg once daily. The treatment duration is 4-8 weeks.
    Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk: 20 mg once daily.
  • Treatment of Zollinger-Ellison syndrome:
    Initial dosage: 40 mg twice daily. The dosage should then be individually adjusted and treatment continues as long as clinically indicated. Based on the clinical data available, the majority of patients can be controlled on doses between 80 to 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice-daily.

Children below the age of 12 years

  • Esomeprazole should not be used in children younger than 12 years since no data is available.

Impaired renal function

  • Dose adjustment is not required. Due to limited experience in patients with severe renal insufficiency, such patients should be treated with caution.

Impaired hepatic function

  • Dose adjustment is not required in patients with mild to moderate liver impairment. For patients with severe liver impairment, a maximum dose of 20 mg esomeprazole should not be exceeded.

Elderly

  • Dose adjustment is not required.


Or as prescribed by physicians.

 

  • Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation.  
  • Pregnancy in the first trimester.

     

Common

  • Headache, vertigo, skin rashed.
  • Nausea, vomiting abdominal pain, diarrhea, constipation, flatulence, dry mouth.

Uncommon

  • Fatigue, insomnia, rash, pruritus, abnormal vision.

Rare

  • Fever, increased sweating, peripheral oedema, photosensitivity, hypersensitivity reactions (e.g. urticaria, angioedema, bronchospasm and anaphylactic reaction/shock).
  • Agitation, depression, reversible confusion, hallucinations.
  • Agranulocytosis, leukopenia, thrombocytopenia.
  • Increased liver enzymes, hepatitis, jaundice, impaired hepatic function.
  • Taste disturbance.
  • Arthralgia, myalgia.
  • Interstitial nephritis.
  • Bullous eruption, Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis.
  • By decreasing gastric acidity, proton pump inhibitors may increases the risk of gastrointestinal infections.
     

  • In the presence of any alarm symptom (e.g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with esomeprazole may alleviate symptoms and delay diagnosis.
  • Proton pump inhibitors (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 regconised risk factors. Observational studies suggest that proton pump inhibitors 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.
  • When prescribing esomeprazole for eradication of Helicobacter pylori, possible drug interactions for all components in the triple therapy should be considered. Clarithromycin is a potent inhibitor of CYP3A4 and hence contraindications and interactions for clarithromycin should be considered when the triple therapy is used in patients concurrently taking other drugs metabolised via CYP3A4 such as cisapride.
  • 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.
  • 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.
  • Pregnancy: There are no adequate and controlled studies to date using esomeprazole in pregnant women, and the drug should be used during pregnancy only when clearly needed.
  • Lactation: It is not known whether esomeprazole is excreted in human breast milk. No studies in lactating women have been performed. Therefore esomeprazole should not be used during breast-feeding.
  • Patients who experience vertigo or hallucinations while taking esomeprazole should refrain from driving or using machines.

     

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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