Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LANSOPRAZOLE (UNII: 0K5C5T2QPG) (LANSOPRAZOLE - UNII:0K5C5T2QPG)
Preferred 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)] . Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy are 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. Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy are indicated 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 clarithromycin or in whom resistance to clarithromycin is known or suspected (see the c
Lansoprazole Delayed-Release Capsules, USP are available containing 15 mg or 30 mg of lansoprazole, USP. The 30 mg capsule is a hard-shell gelatin capsule with a pink opaque cap and pink opaque body filled with white to off-white pellets. The capsule is axially printed with MYLAN over 8030 in black ink on both the cap and the body. They are available as follows: Bottle of 14 - 68788-9269-1 Bottle of 30 - 68788-9269-3 Bottle of 60 - 68788-9269-6 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS Preferred Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Lansoprazole Delayed-Release Capsules, USP (lan soe′ pra zole) 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: • 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. 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. 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 PPI 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. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s i Baca dokumen lengkapnya
LANSOPRAZOLE- LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS PREFERRED 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 RECENT MAJOR CHANGES Warnings and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5) 10/2016 INDICATIONS AND USAGE Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for: • • • • • • • • • 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) T riple The rapy: Lansoprazole Amoxicillin Clarithromycin 30 mg 1 gram 500 mg Twice daily for 10 or 14 days Dual The rapy: 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) 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 60 mg Once daily 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) Baca dokumen lengkapnya