Clinical Information
Gen. Code and Des.
20526 antivenin,Crotalidae (equine) INJECTION VIAL
GCN and Des.
48379 antivenin,Crotalidae (equine) INJECTION VIAL
Strength
Dose Form
VIAL (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
80040000 ANTITOXINS AND IMMUNE GLOBULINS
Active Ingredients
3081 antivenin, Crotalidae polyvalent(equine)
Inactive Ingredients
2598 sucrose 57501
3199 phenol 108952
Item info. These highlights do not include all the info. needed to use ZIVIR safely and effectively. See full prescribing info. for lamivudine, and zidovudine) Tablets, for TRI TRIZIVIR. TRIZIVIR (abacavir sulfate oral use Initial U.S. Approval: 2000 WARNING: RISK OF HYPERSENSITIVITY REACTIONS, HEMATOLOGIC TOXICITY, MYOPATHY, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, EXACERBATIONS OF HEPATITIS See full prescribing info. for complete boxed warning. Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir-containing products. Hypersensitivity to abacavir is multi-organ clinical syndrome. Patients who carry the HLA-B*5701 allele are at high risk for experiencing hypersensitivity reaction to abacavir. Discontinue TRIZIVIR as soon as hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue TRIZIVIR if hypersensitivity cannot be ruled out. Following hypersensitivity reaction to abacavir, NEVER restart TRIZIVIR or any other abacavir-containing product. Hematologic toxicity, including neutropenia and anemia, has been associated with the use of zidovudine, component of TRIZIVIR. Symptomatic myopathy associated with prolonged use of zidovudine. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. Severe acute exacerbations of hepatitis have been reported in patients who are co-infected with hepatitis virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, component of TRIZIVIR. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis treatment. -INDICATIONS AND USAGE TRIZIVIR, combination of abacavir, lamivudine, and zidovudine, each nucleoside analogue HIV-1 reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 pensed with each new equiring dosage adjustment or patients with hepatic impairment. mg abacavir, 150 mg of lamivudine, and 300 mg of vity to abacavir or any other (4, 5.1, 6) .2, were nausea, headache, malaise and fatigue, and nausea and vomiting. 872 or FDA at 1-800-FDA-1088 or voided: stavudine gic methadone dose may be required in small PATIENT COUNSELING info. Guide. Revised: 05/2013 infection. DOSAGE AND ADMINISTRATION ? medication guide and warning card should be dis prescription and refill. Adults and Adolescents: tablet twice daily. Not recommended in adolescents who weigh less than 40 kg. Do not prescribe for patients DOSAGE FORMS AND STRENGTHS Tablets contain 300 zidovudine. CONTRAINDICATIONS Previously demonstrated hypersensiti component of the product. Hepatic impairment. WARNINGS AND PRECAUTIONS ? See boxed warning for info. about the following: hypersensitivity reactions, hematologic toxicity, myopathy, lactic acidosis and severe hepatomegaly, and severe acute exacerbations of hepatitis B. (5.1, 5.3, 5.4, 5.5) Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy and interferon alfa with or without ribavirin. Discontinue TRIZIVIR as medically appropriate and consider dose reduction or discontinuation interferon alfa, ribavirin, or both. Exacerbation of anemia has been reported in HIV-1/HCV co-infected patients receiving ribavirin and zidovudine. Coadministration of ribavirin and zidovudine is not advised. Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy. TRIZIVIR should not be administered with other products containing abacavir, lamivudine, or zidovudine; or with emtricitabine. (5.11)
