Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
Strides Pharma Science Limited
ABACAVIR SULFATE
ABACAVIR 300
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 tablets 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 MACDP as
Abacavir tablets USP 300 mg, containing abacavir sulfate equivalent to 300 mg abacavir are dark yellow coloured, biconvex, capsule shaped, film coated tablets with "AB" debossed on one side and break line on other side. They are packaged as follows: Bottles of 60 tablets (NDC 64380-717-03). Unit dose blister packs of 60 tablets (NDC 64380-717-01). Each pack contains 6 blister cards of 10 tablets each. Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP).
Abbreviated New Drug Application
ABACAVIR - ABACAVIR TABLET Strides Pharma Science Limited ---------- MEDICATION GUIDE Abacavir tablets USP 300 mg (A bak′ a vir) What is the most important information I should know about abacavir tablets? Abacavir tablets can cause serious side effects, including: • Serious allergic reaction (hypersensitivity reaction) that can cause death have happened with abacavir tablets 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 2 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 getlife-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 tablets, 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 a Lesen Sie das vollständige Dokument
ABACAVIR - ABACAVIR TABLET STRIDES PHARMA SCIENCE LIMITED ---------- 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 TABLETS 300 MG. (5.1) HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1) PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGHER RISK FOR 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 TABLETS 300 MG AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ABACAVIR TABLETS 300 MG IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. (5.1) FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART ABACAVIR TABLETS 300 MG OR ANY OTHER ABACAVIR-CONTAINING PRODUCT. (5.1) INDICATIONS AND USAGE Abacavir tablets, 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) (1) DOSAGE AND ADMINISTRATION Before initiating Abacavir tablets, 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) and should not exceed 600 mg daily. (2.3) Patients with Hepatic Impairment: Mild hepatic impairment – 200 mg twice daily. (2.4) DOSAGE FORMS AND STRENGTHS Tablets: 300 mg, scored (3) CONTRAINDICATIONS Presence of HLA-B*5701 alle Lesen Sie das vollständige Dokument