Ahngook Pharm


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Ahngook Lansoprazole tab.



		proton pump inhibitor (PPI)

		Short-Term Treatment of Active Duodenal Ulcer,H. pyloriEradication to Reduce the Risk of Duodenal Ul

		Lansoprazole



		Ethical the Counter(ETC)

1) Composition
Lansoprazole-------------30.0mg

2) Indications
Short-Term Treatment of Active Duodenal Ulcer
Ahngook Lansoprazole tab. is indicated for short-term treatment (for 4 weeks) for
healing and symptom relief of active duodenal ulcer.

H. pyloriEradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: Ahngook Lansoprazole tab. /amoxicillin/clarithromycin

Ahngook Lansoprazole tab. in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Dual Therapy: PREVACID/amoxicillin
Ahngook Lansoprazole tab. in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Maintenance of Healed Duodenal Ulcers
Ahngook Lansoprazole tab. is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months.

Short-Term Treatment of Active Benign Gastric Ulcer
Ahngook Lansoprazole tab. is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer.

Healing of NSAID-Associated Gastric Ulcer
Ahngook Lansoprazole tab. is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks.

Risk Reduction of NSAID-Associated Gastric Ulcer
Ahngook Lansoprazole tab. is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks.

Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
Ahngook Lansoprazole tab. is indicated for the treatment of heartburn and other symptoms associated with GERD.

Short-Term Treatment of Erosive Esophagitis
Ahngook Lansoprazole tab. is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis.

For patients who do not heal with Ahngook Lansoprazole tab. for 8 weeks (5-10%), it may be helpful to give an additional 8 weeks of treatment.

If there is a recurrence of erosive esophagitis an additional 8-week course of Ahngook Lansoprazole tab. may be considered.

Maintenance of Healing of Erosive Esophagitis
Ahngook Lansoprazole tab. is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
Ahngook Lansoprazole tab. is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

3)Dosage & Administration
Indication
Recommended
Dose
Frequency

Duodenal Ulcers
Short-Term Treatment
15 mg
Once daily for 4 weeks

Maintenance of Healed
15 mg
Once daily

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy:
Lansoprazole 30 mg
Twice daily (q12h) for 10 or 14 days

Amoxicillin
1 gram
Twice daily (q12h) for 10 or 14 days

Clarithromycin 500 mg
Twice daily (q12h) for 10 or 14 days

Dual Therapy:
Lansoprazole 30 mg
Three times daily (q8h) for 14 days

Amoxicillin
1 gram
Three times daily (q8h) for 14 days

Benign Gastric Ulcer

Short-Term Treatment 30 mg
Once daily for up to 8 weeks

NSAID-associated Gastric Ulcer

Healing
30 mg
Once daily for 8 weeks

Risk Reduction
15 mg
Once daily for up to 12 weeks

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of
Symptomatic GERD
15 mg
Once daily for up to 8 weeks

Short -Term Treatment
of Erosive Esophagitis
30 mg
Once daily for up to 8 weeks

Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis

�� 30 kg
15 mg
Once daily for up to 12 weeks

> 30 kg
30 mg
Once daily for up to 12 weeks

(12 to 17 years of age)
Short-Term Treatment of Symptomatic GERD
Nonerosive GERD
15 mg
Once daily for up to 8 weeks

Erosive Esophagitis
30 mg
Once daily for up to 8 weeks

Maintenance of Healing of Erosive Esophagitis
15 mg
Once daily

Pathological Hypersecretory
Conditions Including
Zollinger-Ellison Syndrome
60 mg
Once daily

4)Package

100T

5)Storage

tight container, at room temperature