Lansoprazole (Page 2 of 12)

2.2 Recommended Pediatric Dosage by Indication

Pediatric Patients 1 to 11 Years of AgeIn clinical studies, Lansoprazole delayed-release capsules was 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
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

Pediatric Patients 12 to 17 Years of Age

Indication Recommended Dose Frequency
Pediatric (12 to 17 years of age)
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

Lansoprazole delayed-release capsules:

  • 30 mg: hard gelatin capsules N o 1, opaque white body and light blue cap, with black printing “A263” over “30 mg” on the body and cap containing white or almost white spherical pellets.

4 CONTRAINDICATIONS

  • Lansoprazole delayed-release capsules are contraindicated in patients with known severe 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, 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, 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.

5.2 Acute Tubulointerstitial Nephritis

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia). Discontinue Lansoprazole delayed-release capsules and evaluate patients with suspected acute TIN [see Contraindications ( 4)] .

5.3 Clostridium difficile -Associated Diarrhea

Published observational studies suggest that proton pump inhibitor (PPI) therapy like lansoprazole may be associated with an increased risk of Clostridium difficile associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ( 6.2)].

Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with lansoprazole, refer to WARNINGS and PRECAUTIONS sections of their prescribing information.

5.4 Bone Fracture

Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration ( 2) and Adverse Reactions ( 6.2)].

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