HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for:
PREVACID (lansoprazole) Delayed-Release Capsules
PREVACID SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets
For oral administration
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
WARNINGS AND PRECAUTIONS
Concomitant Use of PREVACID with Methotrexate (5.4)
 5/2012
INDICATIONS AND USAGE
PREVACID is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. (1)
DOSAGE AND ADMINISTRATION
Indication Dose Frequency
Duodenal Ulcers (1.1, 1.3)
Short-Term Treatment 15 mg Once daily for 4 wks
Maintenance of Healed 15 mg Once daily
H. pylori Eradication to Reduce Recurrence of Duodenal Ulcer (1.2)
Triple Therapy: PREVACID
Amoxicillin
Clarithromycin 30 mg
1 gram
500 mg Twice daily for 10 or 14 days
Dual Therapy: PREVACID
Amoxicillin 30 mg
1 gram Three times daily for 14 days
Benign Gastric Ulcer (1.4)
Short-Term Treatment 30 mg Once daily up to 8 wks
NSAID-associated Gastric Ulcer (1.6)
Healing 30 mg Once daily for 8 wks
Risk Reduction 15 mg Once daily up to 12 wks
GERD (1.7)
Short-Term Treatment of Symptomatic GERD 15 mg Once daily up to 8 wks
Short-Term Treatment of EE 30 mg Once daily up to 8 wks
Pediatric (8.4)
(1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of EE
  ≤ 30 kg 15 mg Once daily up to 12 wks
  > 30 kg 30 mg Once daily up to 12 wks
(12 to 17 years of age) Short-Term Treatment of Symptomatic GERD
Nonerosive GERD 15 mg Once daily up to 8 wks
EE 30 mg Once daily up to 8 wks
Maintenance of Healing of EE (1.8) 15 mg Once daily
Pathological Hypersecretory Conditions (i.e., ZES) (1.9) 60 mg Once daily
DOSAGE FORMS AND STRENGTHS
Capsules and Tablets: 15 mg and 30 mg. (3)
CONTRAINDICATIONS
Contraindicated in patients with known severe hypersensitivity to any component of the PREVACID formulation. (4)
WARNINGS AND PRECAUTIONS
Symptomatic response with PREVACID does not preclude the presence of gastric malignancy. (5.1)
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (5.2)
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.3)
ADVERSE REACTIONS
Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Atazanavir: Do not co-administer with atazanavir. (7.1)
Drugs with pH-Dependent Absorption: May interfere with the absorption of drugs where gastric pH is important for bioavailability. (7.1)
Warfarin: Concomitant warfarin use may require monitoring for increases in INR and prothrombin time. (7.2)
Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. (7.3)
Theophylline: Titration of theophylline dosage may be required when concomitant PREVACID use is started or stopped. (7.4)
Methotrexate: PREVACID may increase serum levels of methotrexate. (7.6)
USE IN SPE