PARIET^®

Sodium Rabeprazole Preparation

1. Composition

Tablets 10 mg:

Each light yellow, film-coated tablet (enteric coated tablet) contains 10 mg of sodium rabeprazole.

Tablets 20 mg:

Each light yellow, film-coated tablet (enteric coated tablet) contains 20 mg of sodium rabeprazole.

2. Product description

Brand name	Dosage form and identification code	Appearance			Description
		Face	Reverse	Lateral
PARIET® Tablets 10 mg	Film-coated tablets				Light yellow
	∈240	Diameter (mm) 6.7	Weight (mg) 132	Thickness (mm) 3.6
PARIET® Tablets 20 mg	Film-coated tablets				Light yellow
	∈243	Diameter (mm) 7.2	Weight (mg) 163	Thickness (mm) 3.6

[INDICATIONS]

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)

PARIET^® is indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of PARIET® may be considered.

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)

PARIET® is indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD maintenance).

Healing of Duodenal Ulcers

PARIET® is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome

PARIET^® is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.

Symptomatic treatment of moderate to very severe Gastroesophageal reflux disease (symptomatic GERD)

PARIET^® is indicated for the symptomatic treatment of moderate to very severe GERD.

[DOSAGE AND ADMINISTRATION]

The usual adult dose for oral use is 10 mg of sodium rabeprazole administered once daily. However, the dosage may be increased up to 20 mg orally once daily depending on the severity of symptoms.

Symptomatic treatment of moderate to very severe Gastroesophageal reflux disease (symptomatic GERD):

10mg, once daily in patients without esophagitis. If symptom control has not been achieved during 4 weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.

<Precaution> The patient should be carefully observed during administration and the cumulative dose should be kept to a minimum for the particular symptoms being treated.

[PRECAUTIONS]

1. Contraindication

Patients with a history of hypersensitivity to sodium rabeprazole.

2. Careful Administration (PARIET^® should be administered with care in the following patients.)

(1) Patients with a history of drug hypersensitivity

(2) Patients with hepatic function disorder [Psychoneurotic adverse reactions have been reported in patients with liver cirrhosis. (See "Adverse Reactions" section.)]

(3) Elderly patients (See "Use in the Elderly" section.)

3. Important Precautions

PARIET^® can be administered at a dose of 20 mg once daily in the case of severe, recurrent and intractable conditions.

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