RX ITEM-Lansoprazole 30MG ODT 100 (10X10) UD By Zydus Pharma

These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS.

LANSOPRAZOLE delayed-release orally disintegrating tablets, for oral use
Initial U.S. Approval: 1995
RECENT MAJOR CHANGES
Warnings and Precautions,
Acute Tubulointerstitial Nephritis (5.2)
11/2020
Risk of Heart Valve Thickening in Pediatric Patients Less than One Years of Age (5.12)
09/2020
INDICATIONS AND USAGE

Lansoprazole delayed-release orally disintegrating tablets are proton pump inhbitors (PPIs) indicated for the:

Treatment of active duodenal ulcer in adults. (1.1)
Eradication of H.pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2)
Maintenance of healed duodenal ulcers in adults. (1.3)
Treatment of active benign gastric ulcer in adults. (1.4)
Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5)
Risk reduction of NSAID-associated gastric ulcer in adults. (1.6)
Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7)
Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8)
Maintenance of healing of EE in adults. (1.9)
Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10)

DOSAGE AND ADMINISTRATION

Recommended Dosage:

See full prescribing information for complete dosing information for lansoprazole delayed-release orally disintegrating tablets by indication and age group and dosage adjustment in patients with severe hepatic impairment. (2.1, 2.2, 2.3)

Administration Instructions (2.4):

Lansoprazole delayed-release orally disintegrating tablets

Should not be broken or cut.
Should not be chewed.
Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
See full prescribing information for alternative administration options.

DOSAGE FORMS AND STRENGTHS

Delayed-Release Orally Disintegrating Tablets: 15 mg and 30 mg. (3)
CONTRAINDICATIONS

Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release orally disintegrating tablets formulation. (4)
Patients receiving rilpivirine-containing products. (4, 7)

WARNINGS AND PRECAUTIONS

Gastric Malignancy: In adults, symptomatic response with lansoprazole delayed-release orally disintegrating tablets does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. (5.1)
Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients. (5.2)
Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. (5.3)
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. (5.4)
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue lansoprazole delayed-release orally disintegrating tablets and refer to specialist for evaluation. (5.5)
Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. (5.6)
Hypomagnesemia: Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. (5.7)
Interactions with Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. (5.8, 7)
Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of lansoprazole. (5.9, 7)
Patients with Phenylketonuria: Each 15 mg lansoprazole delayed-release orally disintegrating tablets contain 1.6 mg and each 30 mg lansoprazole delayed-release orally disintegrating tablets contain 3.28 mg of phenylalanine. (5.10)
Fundic Gland Polyps: Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy. (5.11)

ADVERSE REACTIONS

Most commonly reported adverse reactions (≥ 1%): diarrhea, abdominal pain, nausea and constipation. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions. (7)
USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause adverse effects on fetal bone growth and development. (8.1)
Pediatrics: Use is not recommended for the treatment of symptomatic GERD in patients 1 month to less than 1 year of age; efficacy was not demonstrated and nonclinical studies have demonstrated adverse effects in juvenile rats. (5.12,8.4)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 1/2021

RX ITEM-Lansoprazole 30MG ODT
Lansoprazole 30MG ODT 100 (10X10) UD By Zydus Pharma, item No.:RX68382-0772-77/PS UPC No.:3-68382-77277-0 368382-772770368382772770 NDC No. 68382-0772-77 68382-772-77 6838277277 68382077277

Lansoprazole 15Mg Cap 30 By Zydus Pharma
BRAND: LANSOPRAZOLE NDC: 68382-0543-06,68382054306 UPC: , Zydus Pharmaceuticals

LANSOPRAZOLE ORAL CAPSULE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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