Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Proficient Rx LP
LANSOPRAZOLE
LANSOPRAZOLE 30 mg
ORAL
PRESCRIPTION DRUG
Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14) ]. Triple Therapy: Lansoprazole delayed-release capsules USP/amoxicillin/clarithromycin Lansoprazole delayed-release capsules USP 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 delayed-release capsules USP/amoxicillin Lansoprazole delayed-release capsules USP in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-yea
Lansoprazole delayed-release capsules USP are available as follows: 30 mg - hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with “93” and “7351”, filled with off-white to beige pellets, in bottles of 30. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE Proficient Rx LP ---------- MEDICATION GUIDE Lansoprazole (lan soe pra zole) Delayed-Release Capsules USP Read this Medication Guide before you start taking lansoprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. What is the most important information that I should know about lansoprazole delayed-release capsules? 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: • Diarrhea. Lansoprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium Difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take lansoprazole delayed-release capsules. Lansoprazole delayed-release capsules can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release capsules?” What are lansoprazole delayed-release capsules? Lansoprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduce the amount of acid in your stomach. Lansoprazole delayed-release capsules are used in adults: • for 4 weeks for the healing and symptom relief of duodenal ulcers. The duod read_full_document
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP. LANSOPRAZOLE DELAYED-RELEASE CAPSULES USP FOR ORAL USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES WARNINGS AND PRECAUTIONS • • INDICATIONS AND USAGE Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. (1) DOSAGE AND ADMINISTRATION INDIC ATIO N DO SE 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 Delayed- Release Capsules 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Clarithromycin 500 mg Dual Therapy: Lansoprazole Delayed- Release Capsules 30 mg Three times daily for 14 days Amoxicillin 1 gram BENIGN GASTRIC ULCER (1.4) Short-Term Treatment 30 mg Once daily up to 8 wks NSAID-ASSOCIATED GASTRIC ULCER (1.6) He aling 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: 15 mg and 30 mg. (3) CONTRAINDICATIONS Contraindicated in patients with known severe hypersensitivity to any component of the la read_full_document