AMALGARD-DSR Capsules

Rabeprazole 20 mg + Domperidone 30 mg (Sustained Release)

RABEPRAZOLE

Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + /K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton pump inhibitor. Rabeprazole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfenamide.

DOMPERIDONE

Domperidone is a derivative of benzimidazole that possesses both prokinetic and antiemetic properties due to its inhibitory action at dompamine D 2 receptors.

INDICATIONS

AMALGARD-D / DSR is indicated for the relief of symptoms of

i.) Dyspepsia
ii.) GERD
iii.) Nausea associated with acid peptic disorders
iv.) Post-operative nausea and vomiting
v.) Chronic gastritis

DOSAGE AND ADMINISTRATION

One Tablet / Capsule once daily.

Short-term Treatment of Gastroesophageal Reflux Disease (GERD) in Adolescent Patients 12 years of Age and Above The recommended oral dose for adolescents 12 years and above is one tablet of AMALGARD 20 mg once daily for up to 8 weeks.

Elderly, Renal and Hepatic Impaired Patients No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.

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