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 SULFATE 300 mg
ORAL
PRESCRIPTION DRUG
ZIAGEN Tablets and Oral Solution, 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 ZIAGEN for treatment of HIV-1 infection: - ZIAGEN is one of multiple products containing abacavir. Before starting ZIAGEN, 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. ZIAGEN is contraindicated in patients with previously demonstrated hypersensitivity to abacavir or any other component of the products. NEVER restart ZIAGEN 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)] . ZIAGEN is contraindicated in patients with moderate or severe hepatic impairment. Pregnancy Category C. Studies in pregnant rats showed that abacavir is transferred to the fe
ZIAGEN Tablets, containing abacavir sulfate equivalent to 300 mg abacavir are yellow, biconvex, scored, capsule-shaped, film-coated, and imprinted with “GX 623” on both sides. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP). ZIAGEN Oral Solution is a clear to opalescent, yellowish, strawberry-banana-flavored liquid. Each mL of the solution contains abacavir sulfate equivalent to 20 mg of abacavir. It is packaged in plastic bottles as follows: Bottles of 240 mL (NDC 0173-0664-00) with child-resistant closure. This product does not require reconstitution. Store at controlled room temperature of 20° to 25°C (68° to 77°F) (see USP). DO NOT FREEZE. May be refrigerated.
New Drug Application
ZIAGEN - ABACAVIR SULFATE TABLET, FILM COATED State of Florida DOH Central Pharmacy ---------- MEDICATION GUIDE ZIAGEN® (ZY-uh-jen) Tablets ZIAGEN® Oral Solution Generic name: abacavir (uh-BACK-ah-veer) sulfate tablets and oral solution Read the Medication Guide that comes with ZIAGEN before you start taking it and each time you get a refill because there may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Be sure to carry your ZIAGEN Warning Card with you at all times. What is the most important information I should know about ZIAGEN? • Serious Allergic Reaction to Abacavir. ZIAGEN contains abacavir (also contained in EPZICOM® and TRIZIVIR®). Patients taking ZIAGEN 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 than if you do not. Your doctor 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 ZIAGEN, call your doctor right away to determine if you should stop taking this medicine. 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. If you stop ZIAGEN because of an allergic reaction, NEVER take ZIAGEN (abacavir sulfate) or any other abacavir-containing medicine (EPZICOM and TRIZIVIR) again. If you take ZIAGEN 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 ZIAGEN for any other reason, even for a few days and you are not allergic to ZIAGEN, talk with your doctor before taking it again Preberite celoten dokument
ZIAGEN - 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 ZIAGEN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIAGEN. ZIAGEN (ABACAVIR SULFATE) TABLETS AND ORAL SOLUTION 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 ZIAGEN (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 ZIAGEN AS SOON AS A HYPERSENSITIVITY REACTION IS SUSPECTED. REGARDLESS OF HLA-B*5701 STATUS, PERMANENTLY DISCONTINUE ZIAGEN IF HYPERSENSITIVITY CANNOT BE RULED OUT, EVEN WHEN OTHER DIAGNOSES ARE POSSIBLE. (5.1) FOLLOWING A HYPERSENSITIVITY REACTION TO ABACAVIR, NEVER RESTART ZIAGEN 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 Boxed Warning July 2008 Dosage and Administration (2.2) December 2008 Warnings and Precautions (5.1, 5.5) July 2008 INDICATIONS AND USAGE ZIAGEN, a nucleoside analogue, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. (1) (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 Impairment: Mild hepatic impairment – 200 mg twice daily; moderate/severe hepatic imp Preberite celoten dokument