Country: United States
Language: English
Source: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Wockhardt USA LLC.
LANSOPRAZOLE
LANSOPRAZOLE 15 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release capsules, USP are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)]. Triple Therapy: lansoprazole/amoxicillin/clarithromycin Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.2)]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: lansoprazole/amoxicillin Lansoprazole in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithr
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 NDC 64679-669-01 Bottles of 30: 15 mg capsules NDC 64679-669-02 Bottles of 60: 15 mg capsules NDC 64679-669-07 Bottles of 90: 15 mg capsules NDC 64679-669-03 Bottles of 100: 15 mg capsules NDC 64679-669-04 Bottles of 500: 15 mg capsules NDC 64679-669-05 Bottles of 1000: 15 mg capsules NDC 64679-669-06 Unit dose package of 100: 15 mg capsules ● 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 NDC 64679-670-01 Bottles of 30: 30 mg capsules NDC 64679-670-02 Bottles of 60: 30 mg capsules NDC 64679-670-07 Bottles of 90: 30 mg capsules NDC 64679-670-03 Bottles of 100: 30 mg capsules NDC 64679-670-04 Bottles of 500: 30 mg capsules NDC 64679-670-05 Bottles of 1000: 30 mg capsules NDC 64679-670-06 Unit dose package of 100: 30 mg capsules Store at 20°-25°C (68°-77°F), [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Wockhardt USA LLC. ---------- MEDICATION GUIDE Lansoprazole (lan-SO-pruh-zole) Delayed-Release Capsules, USP What is the most important information that I should know about lansoprazole delayed-release capsules? You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed. Lansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Lansoprazole delayed-release capsules can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release capsules. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection (Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus . Lupus erythematosus is an autoimmune disorder (the body's immune cells attack other cells or organs in the body). Some people who take PPI medicines, including lansoprazole delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your ris Read the complete document
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE WOCKHARDT USA LLC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANSOPRAZOLE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Dosage and Administration Recommended Pediatric Dosage (2.2) 06/2018 Contraindications (4) 07/2017 Warnings and Precautions Interactions with Investigations for Neuroendocrine Tumors (5.8) 07/2017 Fundic Gland Polyps (5.11) 06/2018 INDICATIONS AND USAGE Lansoprazole delayed-release capsules, USP are proton pump inhibitors (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 non-steroidal 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 capsules 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 capsules_ Should be swallowed whole. See full prescribing information for alternative administration options. DOSAGE FORMS AND STRENGTHS Lansopraz Read the complete document