দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
lesinurad (UNII: 09ERP08I3W) (lesinurad - UNII:09ERP08I3W)
Ironwood Pharmaceuticals, Inc.
lesinurad
lesinurad 200 mg
ORAL
PRESCRIPTION DRUG
ZURAMPIC is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone [see Clinical Studies (14) ]. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia. ZURAMPIC should not be used as monotherapy [see Warnings and Precautions (5.1) ]. The use of ZURAMPIC is contraindicated in the following conditions: - Severe renal impairment (eCLcr less than 30 mL/min), end stage renal disease, kidney transplant recipients, or patients on dialysis [see Use in Specific Populations (8.6) ] - Tumor lysis syndrome or Lesch-Nyhan syndrome [see Use in Specific Populations (8.8) ]. Risk Summary There are no available human data on use of ZURAMPIC in pregnant women to inform a drug-associated risk. No teratogenicity or effects on fetal development were observed in embryo-fetal development studies with oral administration of lesinurad to pregnant rats
ZURAMPIC Tablets, 200 mg are blue in color, oval shaped, debossed with "LES200" and are supplied as follows: Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature ].
New Drug Application
Ironwood Pharmaceuticals, Inc. ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration Revised:January 2018 MEDICATION GUIDE ZURAMPIC (zer-AM-pik) (lesinurad) tablets What is the most important information I should know about ZURAMPIC? Some patients taking ZURAMPIC may have kidney problems such as a sudden decrease in kidney function (acute kidney failure). This is more common when you take ZURAMPIC without a xanthine oxidase inhibitor. You should always take ZURAMPIC with a xanthine oxidase inhibitor. What is ZURAMPIC? • ZURAMPIC is a prescription medicine used together with a xanthine oxidase inhibitor to lower uric acid levels in the blood in adult patients with gout. • ZURAMPIC should not be taken without a xanthine oxidase inhibitor such as allopurinol or febuxostat. • ZURAMPIC helps the kidneys remove uric acid from the body and is added to a xanthine oxidase inhibitor, which decreases the amount of uric acid your body makes. • It is not known if ZURAMPIC is safe and effective in children under 18 years of age. Who should not take ZURAMPIC? Do not take ZURAMPIC if you have: • severe kidney problems, received a kidney transplant or you are on dialysis • a fast breakdown of cancer cells that can lead to high uric acid (Tumor lysis syndrome) • a rare inherited condition that causes too much uric acid in the blood (Lesch Nyhan syndrome) Before taking ZURAMPIC, tell your healthcare provider about all of your medical conditions, including if you: • are pregnant or plan to become pregnant. It is not known if ZURAMPIC will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if ZURAMPIC passes into your breast milk. You and your healthcare provider should decide if you should take ZURAMPIC while breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements. ZURAMPIC may affect the way other medicines work, and other medicines may সম্পূর্ণ নথি পড়ুন
ZURAMPIC- LESINURAD TABLET, FILM COATED IRONWOOD PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZURAMPIC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZURAMPIC. ZURAMPIC (LESINURAD) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2015 WARNING: RISK OF ACUTE RENAL FAILURE, MORE COMMON WHEN USED WITHOUT A XANTHINE OXIDASE INHIBITOR _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ACUTE RENAL FAILURE HAS OCCURRED WITH ZURAMPIC AND WAS MORE COMMON WHEN ZURAMPIC WAS GIVEN ALO NE . ZURAMPIC SHOULD BE USED IN COMBINATION WITH A XANTHINE OXIDASE INHIBITOR. (1.1, 5.1, 6.1) INDICATIONS AND USAGE ZURAMPIC is a URAT1 inhibitor indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone. (1) Limitations of Use: ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia. (1.1) ZURAMPIC should not be used as monotherapy. (1.1, 5.1) DOSAGE AND ADMINISTRATION ZURAMPIC is recommended at 200 mg once daily in combination with a xanthine oxidase inhibitor, including allopurinol or febuxostat. The maximum daily dose of ZURAMPIC is 200 mg. (2.1) Failure to take ZURAMPIC with a xanthine oxidase inhibitor may increase the risk of renal adverse reactions. (2.1, 5.1) ZURAMPIC tablets should be taken in the morning with food and water. (2.1) Patients should be instructed to stay well hydrated. (2.1) Assess renal function before initiating ZURAMPIC. Do not initiate ZURAMPIC if eCLcr is below 45 mL/min. (2.2) Discontinue ZURAMPIC if eCLcr persistently falls below 45 mL/min. (2.2) DOSAGE FORMS AND STRENGTHS Tablet: 200 mg. (3) CONTRAINDICATIONS Severe renal impairment, end stage renal disease, kidney transplant recipients, or patients on dialysis. (4, 8.6) Tumor lysis syndrome or Lesch-Nyhan syndrome. (4) WARNINGS AND PRECAUTIONS _Renal events_: Adverse rea সম্পূর্ণ নথি পড়ুন