Lansoprazole: Package Insert and Label Information

LANSOPRAZOLE — lansoprazole capsule, delayed release
Quallent Pharmaceuticals Health LLC

1 INDICATIONS AND USAGE

1.1 Treatment of Active Duodenal Ulcer

Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1)].

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

Triple Therapy: Lansoprazole delayed-release capsules/amoxicillin/clarithromycin
Lansoprazole delayed-release capsules 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 [see Clinical Studies ( 14.2)].
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: Lansoprazole delayed-release capsules/amoxicillin
Lansoprazole delayed-release capsules 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 [see Clinical Studies ( 14.2)]. 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 [see Clinical Studies ( 14.3)] .

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 [see Clinical Studies ( 14.4)]

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 [see Clinical Studies ( 14.5)] .

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 [see Clinical Studies ( 14.6)] .

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 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 [see Clinical Studies ( 14.7)] .

1.8 Treatment of Erosive Esophagitis (EE)

Lansoprazole delayed-release capsules are 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 delayed-release capsules 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 delayed-release capsules may be considered [see Clinical Studies ( 14.8)] .

1.9 Maintenance of Healing of EE

Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months [see Clinical Studies ( 14.9)] .

1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)


Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies ( 14.10)] .

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Adult Dosage by Indication

Indication Recommended Dose Frequency
Duodenal Ulcers
Short-Term Treatment Maintenance of Healed 15 mg 15 mg Once daily for 4 weeks Once daily
Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy: Lansoprazole delayed- release capsules Amoxicillin Clarithromycin Dual Therapy: Lansoprazole delayed- release capsules Amoxicillin 30 mg 1 gram 500 mg 30 mg 1 gram Twice daily for 10 or 14 days Twice daily for 10 or 14 days Twice daily for 10 or 14 days Three times daily for 14 days Three times daily for 14 days
Benign Gastric Ulcer
Short-Term Treatment 30 mg Once daily for up to 8 weeks
NSAID-Associated Gastric Ulcer
Healing Risk Reduction 30 mg 15 mg Once daily for 8 weeks Once daily for up to 12 weeks
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD Short-Term Treatment of Erosive Esophagitis 15 mg 30 mg Once daily for up to 8 weeks 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 §

*Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients.
Controlled studies did not extend beyond indicated duration.
For patients who do not heal with lansoprazole delayed- release capsules 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 delayed- release capsules may be considered.
§ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than four years. Controlled studies did not extend beyond 12 months.

2.2 Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of Age In clinical studies, lansoprazole delayed-release capsules were not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole delayed-release capsules are safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations ( 8.4)].

Indication Recommended Dose Frequency
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

Pediatric Patients 12 to 17 Years of Age

Indication Recommended Dose Frequency
Short-Term Treatment of Symptomatic GERD
Non-erosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks

2.3 Hepatic Impairment

The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations ( 8.6)]

2.4 Important Administration Information


• Take lansoprazole delayed-release capsules before meals.
• Do not crush or chew lansoprazole delayed-release capsules.
• Take lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate [see Drug Interactions ( 7)].
• Antacids may be used concomitantly with lansoprazole delayed-release capsules.
• Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
Lansoprazole delayed-release capsules
• Swallow whole; do not chew.
• For patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered orally or via a nasogastric tube in the soft foods or liquids specified below.
• Administration of lansoprazole delayed-release capsules in foods or liquids other than those discussed below have not been studied clinically and therefore are not recommended.
Administration in Soft Foods (applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears):
1. Open capsule.
2. Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3. Swallow immediately.
Administration in Liquids (apple juice, orange juice or tomato juice):
1. Open capsule.
2. Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces).
3. Mix briefly.
4. Swallow immediately.
5. To ensure complete delivery of the dose, rinse the glass with two or more volumes of juice and swallow the contents immediately.
Administration with Apple Juice Through a Nasogastric Tube (≥16 French)
1. Open capsule.
2. Sprinkle intact granules into 40 mL of apple juice.
3. Mix briefly.
4. Using a catheter-tipped syringe, draw up the mixture.
5. Inject through the nasogastric tube into the stomach.
6. Flush with additional apple juice to clear the tube.

3 DOSAGE FORMS AND STRENGTHS

• 15 mg capsules are pink/green colored size ‘3’ hard gelatin capsules imprinted with ‘H’ on cap and ‘166’ on body filled with white to off white pellets. • 30 mg capsules are pink/black colored size ‘1’ hard gelatin capsules imprinted with ‘H’ on cap and ‘167’ on body filled with white to off white pellets.

4 CONTRAINDICATIONS

Lansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2), Adverse Reactions ( 6)].
• Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7)]. • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the Contraindications section of their prescribing information.

5 WARNINGS AND PRECAUTIONS

5.1 Presence of Gastric Malignancy

In adults, symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

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