Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
ABACAVIR SULFATE (UNII: J220T4J9Q2) (ABACAVIR - UNII:WR2TIP26VS)
State of Florida DOH Central Pharmacy
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. Additional important information on the use of abacavir tablets for treatment of HIV-1 infection: - Abacavir tablets are one of multiple products containing abacavir. Before starting abacavir tablets, review medical history for prior exposure to any abacavir-containing product in order to avoid reintroduction in a patient with a history of hypersensitivity to abacavir [see Warnings and Precautions (5.1), Adverse Reactions (6)]. Abacavir tablets are contraindicated in patients with: - previously demonstrated hypersensitivity to abacavir or any other component of the products. NEVER restart abacavir tablets or any other abacavir-containing product following a hypersensitivity reaction to abacavir, regardless of HLA-B*5701 status [see Warnings and Precautions (5.1), Adverse Reactions (6)]. - moderate or severe hepatic impairment [see Dosage and Administration (2.3)
Abacavir Tablets, USP are available containing abacavir sulfate, USP equivalent to 300 mg of abacavir. The 300 mg tablets are peach film-coated, capsule shaped, scored tablets debossed with M on one side of the score and 120 on the other side of the score on one side of the tablet and blank on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°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
State of Florida DOH Central Pharmacy ---------- MEDICATION GUIDE ABACAVIR TABLETS, USP (a bak′ a vir sul′ fate) 300 mg Read this Medication Guide before you start taking abacavir tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. Be sure to carry your Abacavir Tablets Warning Card with you at all times. What is the most important information I should know about abacavir tablets? 1. Serious allergic reaction (hypersensitivity reaction). Abacavir tablets contain abacavir (also contained in EPZICOM®** and TRIZIVIR®**). Patients taking abacavir tablets may have a serious allergic reaction (hypersensitivity reaction) that can cause death. 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 (abacavir sulfate) or any other abacavir-containing medicine (EPZICOM®** and TRIZIVIR®**) again. 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 hea Preberite celoten dokument
ABACAVIR SULFATE - ABACAVIR SULFATE TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- 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, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1998 WARNING: HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS, AND SEVERE HEPATOMEGALY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. SERIOUS AND SOMETIMES FATAL HYPERSENSITIVITY REACTIONS HAVE BEEN ASSOCIATED WITH ABACAVIR (ABACAVIR SULFATE). (5.1) HYPERSENSITIVITY TO ABACAVIR IS A MULTI-ORGAN CLINICAL SYNDROME. (5.1) PATIENTS WHO CARRY THE HLA-B*5701 ALLELE ARE AT HIGH RISK FOR EXPERIENCING A HYPERSENSITIVITY REACTION TO ABACAVIR. (5.1) 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) LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING FATAL CASES, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES. (5.2) RECENT MAJOR CHANGES Dosage and Administration (2) 05/2012 Warnings and Precautions, Hypersensitivity Reaction (5.1) 05/2012 Warnings and Precautions, Immune Reconstitution Syndrome (5.3) 11/2011 INDICATIONS AND USAGE Abacavir, a nucleoside analogue, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) DOSAGE AND ADMINISTRATION A medication guide and warning card should be dispensed with each new prescription and refill. (2) Adults: 600 mg daily, administered as either 300 mg twice daily or 600 mg once daily. (2.1) Pediatric Patients Aged 3 Months and Older: Dose should be calculated on body weight (kg) and should not exceed 300 mg twice daily. (2.2) Patients with Hepatic Preberite celoten dokument