Lansoprazole (Page 2 of 12)

2.2 Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations (8.5, 8.6 and 8.7)] .

2.3 Important Administration Information

Administration Options

Lansoprazole Delayed-Release Capsules – Oral Administration
  • Lansoprazole delayed-release capsules should be swallowed whole.
  • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:
    • Open capsule.
    • Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
    • Swallow immediately.
  • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
    • Open capsule.
    • Sprinkle intact pellets 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, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.
Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥ 16 French) Administration
  • For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:
    • Open capsule.
    • Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
    • Inject through the nasogastric tube into the stomach.
    • Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

3 DOSAGE FORMS AND STRENGTHS

Lansoprazole Delayed-Release Capsules, USP are available containing 15 mg or 30 mg of lansoprazole, USP.

  • The 15 mg capsule is a hard-shell gelatin capsule with a green opaque cap and green opaque body filled with white to off-white pellets. The capsule is axially printed with MYLAN over 8015 in black ink on both the cap and the body.
  • The 30 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and pink opaque body filled with white to off-white pellets. The capsule is axially printed with MYLAN over 8030 in black ink on both the cap and the body.

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)] .

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 delayed-release capsules 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 delayed-release capsules. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue lansoprazole delayed-release capsules if acute interstitial nephritis develops [see Contraindications (4)] .

5.3 Clostridium difficile- Associated Diarrhea

Published observational studies suggest that proton pump inhibitor (PPI) therapy like lansoprazole delayed-release capsules 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 delayed-release capsules, refer to WARNINGS and PRECAUTIONS sections of those 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)] .

5.5 Cutaneous and Systemic Lupus Erythematosus

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including lansoprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE.

The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly. Generally, histological findings were observed without organ involvement.

Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE. Onset of SLE typically occurred within days to years after initiating treatment primarily in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving lansoprazole delayed-release capsules, discontinue the drug and refer the patient to the appropriate specialist for evaluation. Most patients improve with discontinuation of the PPI alone in four to 12 weeks. Serological testing (e.g., ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations.

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