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언어: 영어
출처: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
REMEDYREPACK INC.
ABACAVIR SULFATE
ABACAVIR 300 mg
ORAL
PRESCRIPTION DRUG
Abacavir tablets, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV-1) infection. Abacavir tablets are contraindicated in patients: - who have the HLA-B*5701 allele [see Warnings and Precautions ( 5.1)]. - with prior hypersensitivity reaction to abacavir [see Warnings and Precautions ( 5.1)]. - with moderate or severe hepatic impairment [see Use in Specific Populations ( 8.6)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to abacavir during pregnancy. Healthcare Providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no difference in the overall risk of birth defects for abacavir compared with the background rate for birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The APR uses the MA
Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are yellow, biconvex, scored, modified capsule-shaped, film-coated tablets engraved with “APO” on one side and “AB” bisect “300” on the other side. They are packaged as follows: Bottles of 60 tablets (NDC 60505-3583-6). Unit Dose packs of 60 tablets (NDC 60505-3583-0). Each pack contains 6 blister cards of 10 tablets each. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in original container with attached prescribing information that contains the Medication Guide and a Warning Card.
Abbreviated New Drug Application
REMEDYREPACK INC. ---------- MEDICATION GUIDE Abacavir Tablets, USP (A bak' a vir) What is the most important information I should know about abacavir tablets? Abacavir can cause serious side effects, including: • Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with abacavir and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from two or more of the following groups while taking abacavir tablets, call your healthcare provider right away to find out if you should stop taking abacavir tablets. SYMPTOM(S) Group 1 Fever Group 2 Rash Group 3 Nausea, vomiting, diarrhea, abdominal (stomach area) pain Group 4 Generally ill feeling, extreme tiredness, or achiness Group 5 Shortness of breath, cough, sore throat A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop abacavir tablets because of an allergic reaction, never take abacavir tablets or any other abacavir-containing medicine (EPZICOM ®, TRIUMEQ ®, or TRIZIVIR ®) again. • If you have an allergic reaction, dispose of any unused abacavir. Ask your pharmacist how to properly dispose of medicines. • If you take abacavir tablets or any other abacavir-containing medicine again after you have had an allergic reaction, within hours you may get life-threatening symptoms that may include very low blood pressure or death. • If you stop abacavir tablets for any other reason, even for a few days, and you are not allergic to abacavir, talk with your healthcare provider before taking it again. Taking abacavir tablets again can cause a serious allergic or life-threatening reaction, even if you never had an allergic reaction to it before. If your healthcare provider tells you that you can take abacavir again, start taking it when you are around medical help o 전체 문서 읽기
ABACAVIR SULFATE- ABACAVIR SULFATE TABLET, FILM COATED REMEDYREPACK INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ABACAVIR TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABACAVIR TABLETS. ABACAVIR TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: HYPERSENSITIVITY REACTIONS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE OCCURRED WITH ABACAVIR. ( 5.1) HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. ( 5.1) PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT A HIGHER RISK OF EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. ( 5.1) ABACAVIR IS CONTRAINDICATED IN PATIENTS WITH A PRIOR HYPERSENSITIVITY REACTION TO ABACAVIR AND IN HLA- B*5701-POSITIVE PATIENTS. ( 4) DISCONTINUE ABACAVIR AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. ( 5.1) FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART ABACAVIR TABLETS OR ANY OTHER ABACAVIR-CONTAINING PRODUCT. ( 5.1) RECENT MAJOR CHANGES Boxed Warning 05/2018 Warnings and Precautions, Lactic Acidosis and Severe 05/2018 Hepatomegaly with Steatosis ( 5.2) Warnings and Precautions, Fat Redistribution (previous 5.4) Removed 05/2018 Warnings and Precautions, Myocardial Infarction ( 5.4) 05/2018 INDICATIONS AND USAGE Abacavir, a nucleoside analogue human immunodeficiency virus (HIV-1) reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. ( 1) DOSAGE AND ADMINISTRATION Before initiating abacavir, screen for the HLA-B*5701 allele. ( 2.1) Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. ( 2.2) Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. Dose should be calculated on body weight (kg) 전체 문서 읽기