Lansoprazole (Page 2 of 12)
2.2 Recommended Pediatric Dosage by Indication
Pediatric Patients 1 to 11 Years of Age In clinical studies, lansoprazole delayed-release capsules, USP was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole delayed-release capsules, USP is 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 |
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, USP before meals.
- Do not crush or chew lansoprazole delayed-release capsules, USP.
- Take lansoprazole delayed-release capsules, USP at least 30 minutes prior to sucralfate [see Drug Interactions (7)].
- Antacids may be used concomitantly with lansoprazole delayed-release capsules, USP.
- 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, USP
- Swallow whole; do not chew.
- For patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules, USP 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, USP 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):
- Open capsule.
- Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
- Swallow immediately.
Administration in Liquids (apple juice, orange juice or tomato juice):
- Open capsule.
- Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces).
- Mix briefly.
- Swallow immediately.
- 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)
- Open capsule.
- Sprinkle intact granules into 40 mL of apple juice.
- Mix briefly.
- Using a catheter tipped syringe, draw up the mixture.
- Inject through the nasogastric tube into the stomach.
- Flush with additional apple juice to clear the tube.
3 DOSAGE FORMS AND STRENGTHS
Lansoprazole delayed-release capsules, USP are available containing 15 mg or 30 mg of lansoprazole, USP.
● 15 mg capsules are opaque dark pink cap and opaque dark green body, size ‘3’ empty hard gelatin capsules imprinted with W on cap with black ink.
669
● 30 mg capsules are opaque dark pink cap and opaque dark black body, size ‘1’ empty hard gelatin capsules imprinted with W on cap with black ink.
670
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 interstitial nephritis, and urticaria [see 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, 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 Interstitial Nephritis
Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue lansoprazole if acute interstitial nephritis develops [see Contraindications (4)].
5.3 Clostridium difficile-Associated Diarrhea
Published observational studies suggest that 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 section 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), Adverse Reactions (6.2)].
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