Lansoprazole

What it is used for

Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults Maintenance of healed duodenal ulcers in adults Treatment of active benign gastric ulcer in adults Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults Risk reduction of NSAID-associated gastric ulcer in adults Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.

Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. Maintenance of healing of EE in adults Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults 1.1 Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated 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 delayed-release capsules 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. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: lansoprazole/amoxicillin Lansoprazole delayed-release capsules 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 (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 delayed-release capsules are 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 delayed-release capsules are 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 delayed-release capsules are 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 delayed-release capsules are 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 delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 years to 17 years of age (up to eight weeks) and pediatric patients one year 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 delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 years to 17 years of age (up to eight weeks) and pediatric patients one year 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

How to take it

• adults 18 years of age and older
• this product is to be used once a day (every 24 hours), every day for 14 days
• it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

• swallow 1 capsule with a glass of water before eating in the morning
• take every day for 14 days
• do not take more than 1 capsule a day
• swallow whole. Do not crush or chew capsules.
• do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

• you may repeat a 14-day course every 4 months
• do not take for more than 14 days or more often than every 4 months unless directed by a doctor
• children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Side effects, and when to stop

• your heartburn continues or worsens
• you need to take this product for more than 14 days
• you need to take more than 1 course of treatment every 4 months
• you get diarrhea
• you develop a rash or joint pain

Who should not take it

• trouble or pain swallowing food, vomiting with blood, or bloody or black stools.
• heartburn with lightheadedness, sweating or dizziness
• chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
• frequent chest pain These may be signs of a serious condition. See your doctor

What to say before you start

• liver disease
• had heartburn over 3 months. This may be a sign of a more serious condition.
• frequent wheezing, particularly with heartburn
• unexplained weight loss
• nausea or vomiting
• stomach pain

• taking a prescription drug. Acid reducers may interact with certain prescription drugs.

If you are pregnant or breastfeeding

ask a healthcare professional before use.

Warnings

Allergy alert:

• do not use if you are allergic to lansoprazole
• lansoprazole may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If an allergic reaction occurs, stop use and seek medical help right away.

Keeping it away from children

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Active ingredient (in each capsule)

Lansoprazole USP, 15 mg

Use

• treats frequent heartburn (occurs 2 or more days a week)
• not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect