Esoferr 20 mg

Indonesia • Ferron Par Pharmaceuticals

Indikasi

Gastroesophageal Reflux Disease (GERD)

  • Pengobatan refluks esofagitis erosif
  • Penanganan jangka panjang pada pasien dengan esofagitis yang telah sembuh untuk mencegah kekambuhan
  • Pengobatan gejala penyakit gastroesophageal reflux disease (GERD)

Sebagai kombinasi dengan regimen terapi antibakteri yang sesuai untuk eradikasi Helicobacter pylori

  • Mengobati ulkus duodenum yang berhubungan dengan Helicobacter pylori

Pasien yang memerlukan terapi AINS lanjutan

  • Pengobatan ulkus lambung yang disebabkan oleh terapi AINS
  • Pencegahan ulkus lambung dan duodenum yang disebabkan oleh terapi AINS pada pasien yang memiliki risiko. Pasien dianggap memiliki risiko karena usia (>60 tahun) dan terdokumentasi memiliki riwayat ulkus peptik. Studi klinis terkontrol yang tersedia tidak diperpanjang melebihi 6 bulan

Pengobatan untuk sindrom Zollinger-Ellison

Komposisi

Esomeprazole 20 mg

Kemasan

3 blister berisi masing-masing 10 kapsul

Bentuk Sediaan

Kapsul Lepas Lambat

Klasifikasi ATC

A02B

Perhatian

Alkohol
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Alat Berat
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Masa Kehamilan
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Menyusui
Tidak Direkomendasikan
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Dosis

0 to 11 Years Old

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

12 to 18 Years Old

Symptomatic treatment of gastroesophageal reflux disease (GERD):
20 mg once daily in patients without esophagitis. If symptom control has not been achieved after four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using 20 mg once daily, under medical supervision.

18 Years Old and Above

Treatment of erosive reflux esophagitis:
40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom esophagitis has not healed or who have persistent symptoms.

Esomeprazole 40 mg should only be administered for patients with mucosal break of grade C and D under the LA classification system, the grade of which should be confirmed by endoscopical or radiological diagnosis. Patients who have GERD with erosive esophagitis of Grade A and B are recommended to be treated with esomeprazole 20 mg.

Long-term management of patients with healed esophagitis to prevent relapse:
20 mg once daily.

Symptomatic treatment of gastroesophageal reflux disease (GERD):
20 mg once daily in patients without esophagitis. If symptoms control has not been achieved after four 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.

In combination with an appropriate antibacterial therapeutic regimen for the eradication of Helicobacter pylori:

Healing of Helicobacter pylori associated duodenal ulcer:
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 patient at risk:
20 mg once daily.

Treatment of Zollinger-Ellison syndrome:
The recommended initial dosage is esomeprazole 40 mg twice daily. The dosage should then be individually adjusted and treatment continued as long as clinically indicated. 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.

Impaired Renal Function

Dose adjustment is not required in patients with impaired renal function. 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.