Lansoprazole DR

30mg

Product Details

Product Name:
Lansoprazole DR
Strength:
30mg
Count:
100
NDC:
42291-434-01
Class:
Rx
Brand Name(s):
Prevacid
Imprint Code:
KU;430
Color(s):
PINK
Shape:
CAPSULE
Score:
no score
Case Count:
Inactive Ingredients:
ammonium hydroxide, black iron oxide, FD&C Blue #1, FD&C Red #3, gelatin, hypromellose, magnesium carbonate, mannitol, methacrylic acid and ethyl acrylate copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac glaze, sodium lauryl sulfate, sodium starch glycolate, sugar spheres, talc, and titanium dioxide.
Indications and Usage:

1.1 Treatment of Active Duodenal Ulcer
Lansoprazole is indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.

1.2 Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: Lansoprazole/amoxicillin/clarithromycin

Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults 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.

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: Lansoprazole/amoxicillin

Lansoprazole in combination with amoxicillin as dual therapy is indicated in adults 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 (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

Please refer to the full prescribing information for amoxicillin.

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

1.4 Treatment of Active Benign Gastric Ulcer
Lansoprazole is indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer.

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

1.6 Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole is indicated in adults 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.

1.7 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole is indicated for the short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD.

1.8 Treatment of Erosive Esophagitis (EE)
Lansoprazole is indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.

For adults who do not heal with Lansoprazole for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of Lansoprazole may be considered.

1.9 Maintenance of Healing of EE
Lansoprazole is indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months.

1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole is indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

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