Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
NuCare Pharmaceuticals, Inc.
LANSOPRAZOLE
LANSOPRAZOLE 30 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release capsules are indicated for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [ see Clinical Studies ( 14) ]. Triple Therapy: Lansoprazole/amoxicillin/clarithromycin Lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated 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) ]. 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 for the treatment of patients with H. pylori
Lansoprazole Delayed-release Capsules USP, 30 mg are enteric-coated pellets filled in size '1' hard gelatin capsules with standard pink opaque colored cap printed with "ZA -51" in black ink and white opaque body printed with "30 mg" in black ink and are supplied as follows: NDC 68071-3019-3 bottle of 30 NDC 68071-3019-7 bottle of 7 NDC 68071-3019-6 bottle of 60 Storage Store at 20 ο to 25 ο C (68 ο to 77 ο F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS NuCare Pharmaceuticals, Inc. ---------- Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: • Hypersensitivity Reactions [see Contraindications • Acute Interstitial Nephritis [see Warnings and Precautions > ] • Clostridium difficile-Associated Diarrhea [see Warnings and • Bone Fracture [see Warnings and Precautions ( ] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and • Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions • Hypomagnesemia [see Warnings and Precautions ( 5.7) ] Administration Lansoprazole is available as capsules in 15 mg and 30 mg strengths. Direction for use specific to the route and available methods of administration of this dosage form is presented below [see Dosage and Administration ( 2.3) ]. • Lansoprazole should be taken before eating. • Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. 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: о Open capsule. о Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. о 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: о Open capsule. о Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces). о Mix briefly. о Swallow immediately. о To ensure complete delivery of the dose, the glass should be rinsed with t সম্পূর্ণ নথি পড়ুন
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS NUCARE PHARMACEUTICALS, INC. ---------- 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 INDICATIONS AND USAGE Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for: Short-Term Treatment of Active Duodenal Ulcer ( 1.1) _H. pylori_ Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.2) Maintenance of Healed Duodenal Ulcers ( 1.3) Short-Term Treatment of Active Benign Gastric Ulcer ( 1.4) Healing of nonsteroidal anti-inflammatory drugs (NSAID)-Associated Gastric Ulcer ( 1.5) Risk Reduction of NSAID-Associated Gastric Ulcer ( 1.6) Gastroesophageal Reflux Disease (GERD) ( 1.7) Maintenance of Healing of Erosive Esophagitis (EE) ( 1.8) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) ( 1.9) 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: Lansoprazole Amoxicillin Clarithromycin 30 mg 1 gram 500 mg Twice daily for 10 or 14 days Dual Therapy: Lansoprazole 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 Risk Reduction 30 mg 15 mg Once daily for 8 wks 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 সম্পূর্ণ নথি পড়ুন