Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
didanosine (UNII: K3GDH6OH08) (didanosine - UNII:K3GDH6OH08)
Bristol-Myers Squibb Company
didanosine
didanosine 125 mg
ORAL
PRESCRIPTION DRUG
VIDEX® EC (didanosine, USP), also known as ddI, in combination with other antiretroviral agents is indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14) ]. VIDEX EC is contraindicated when coadministered with the following medications: - Stavudine- potential for serious and/or life-threatening events, notably pancreatitis, lactic acidosis, hepatotoxicity, and peripheral neuropathy [see Warnings and Precautions (5.1, 5.2, 5.3, 5.5) ]. - Allopurinol- systemic exposures of didanosine are increased, which may increase didanosine-associated toxicity [see Clinical Pharmacology (12.3) ]. - Ribavirin- exposures of the active metabolite of didanosine (dideoxyadenosine 5′-triphosphate) are increased. Fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported in patients receiving both didanosine and ribavirin. There is a pregnancy exposure registry that monitors pregnancy outcomes in indivi
VIDEX EC (didanosine, USP) Delayed-Release Capsules are white, opaque capsules that are packaged in bottles with child-resistant closures as described in Table 14. 125 mg capsule imprinted with “BMS 125 mg 6671” in Tan NDC No. 0087-6671-17 30 capsules/bottle 200 mg capsule imprinted with “BMS 200 mg 6672” in Green NDC No. 0087-6672-17 30 capsules/bottle 250 mg capsule imprinted with “BMS 250 mg 6673” in Blue NDC No. 0087-6673-17 30 capsules/bottle 400 mg capsule imprinted with “BMS 400 mg 6674” in Red NDC No. 0087-6674-17 30 capsules/bottle Storage The capsules should be stored in tightly closed containers at 25° C (77° F). Excursions between 15° C and 30° C (59° F and 86° F) are permitted (see USP Controlled Room Temperature).
New Drug Application
VIDEX EC- DIDANOSINE CAPSULE, DELAYED RELEASE Bristol-Myers Squibb Company ---------- Medication Guide VIDEX EC (VY-dex Ee-see) (didanosine, USP) Delayed-Release Capsules Enteric-Coated Beadlets What is the most important information I should know about VIDEX EC? VIDEX EC can cause serious side effects, including: • Inflammation of your pancreas (pancreatitis) can happen in people who take VIDEX EC and can lead to death. People who take VIDEX EC in combination with the medicine stavudine may be at an increased risk for pancreatitis. Do not take VIDEX EC with stavudine. Call your healthcare provider right away if you have any of the following symptoms of pancreatitis: • severe stomach (abdomen) pain • nausea and vomiting • swelling of your stomach • fever • Build-up of an acid in your blood (lactic acidosis). Lactic acidosis can happen in some people who take VIDEX EC or similar medicines (nucleoside analogues). Lactic acidosis is a serious medical emergency that can lead to death. There have been deaths reported in pregnant women who get lactic acidosis after taking VIDEX EC and stavudine. Do not take VIDEX EC with stavudine. Call your healthcare provider right away if you have any of the following symptoms which could be signs of lactic acidosis: • feel weak or tired • feel cold, especially in your arms and legs • have unusual (not normal) muscle pain • feel dizzy or light-headed • have trouble breathing • have a fast or irregular heartbeat • have stomach pain with nausea and vomiting • weight loss • Severe liver problems, including liver failure, can happen in people who take VIDEX EC. Your liver may become large (hepatomegaly), you may develop fat in the liver (steatosis), or you may have high blood pressure in the large vein of the liver (portal hypertension). Severe liver problems can lead to liver transplantation or death in some people taking VIDEX EC. Taking VIDEX EC with medicines that contain hydroxyurea or stavudine may increase your risk for liver problems. You may be mor Baca dokumen lengkapnya
VIDEX EC- DIDANOSINE CAPSULE, DELAYED RELEASE BRISTOL-MYERS SQUIBB COMPANY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VIDEX EC SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIDEX EC. VIDEX EC (DIDANOSINE, USP) DELAYED-RELEASE CAPSULES ENTERIC-COATED BEADLETS INITIAL U.S. APPROVAL: 1991 WARNING: PANCREATITIS, LACTIC ACIDOSIS AND HEPATOMEGALY WITH STEATOSIS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ Fatal and nonfatal pancreatitis. VIDEX EC should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis. (5.1) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur. Fatal lactic acidosis has been reported in pregnant individuals who received the combination of didanosine and stavudine. (5.2) Coadministration of VIDEX EC with stavudine is contraindicated. (4) INDICATIONS AND USAGE VIDEX EC (didanosine, USP) is a nucleoside reverse transcriptase inhibitor for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection. (1) DOSAGE AND ADMINISTRATION • • BODY WEIGHT DO SE 20 kg to less than 25 kg 200 mg once daily 25 kg to less than 60 kg 250 mg once daily at least 60 kg 400 mg once daily • • DOSAGE FORMS AND STRENGTHS Capsules: 125 mg, 200 mg, 250 mg, 400 mg (3) CONTRAINDICATIONS Coadministration with stavudine, allopurinol or ribavirin is contraindicated. (4) WARNINGS AND PRECAUTIONS Pancreatitis: Suspension or discontinuation of didanosine may be necessary. (5.1) Coadministration of VIDEX EC with stavudine is contraindicated. (4) Lactic acidosis and severe hepatomegaly with steatosis: Suspend didanosine in patients who develop clinical symptoms or signs with or without laboratory findings. (5.2) Hepatic toxicity: Interruption or discontinuation of didano Baca dokumen lengkapnya