person that [400:<50 copies/mL, are on their original study medication (except stavudine-zidovudine switches), and have not experienced an AIDS-defining event. Table 15: Outcomes of Randomized Treatment Through Week 48, AI454-148 Week 48 Status Percent of Patients with HIV-1 RNA less than 400 copies/mL (less than 50 copies/mL) didanosine/stavudine/nelfinavir n=503 lamivudine/zidovudine/nelfinavir n=253 * p less than 0.05 for the differences between treatment groups, by Cochran-Mantel-Haenszel test. a Patients achieved virologic response [two consecutive viral loads less than 400 (less than 50) copies/mL] and maintained it to Week 48. b Includes viral rebound and failing to achieve confirmed less than 400 (less than 50) copies/mL by Week 48. c Includes lost to follow-up, noncompliance, withdrawal, and pregnancy. Responder a 50* (34*) 59 (47) Virologic failure b 36 (57) 32 (48) Death or disease progression less than 1 (less than 1) 1 (less than 1) Discontinued due to adverse events 4 (2) 2 (less than 1) Discontinued due to other reasons c 6 (3) 4 (2) Never initiated treatment 4 (4) 2 (2) Monotherapy The efficacy of didanosine was demonstrated in two randomized, double-blind studies comparing didanosine, given on a twice-daily schedule, to zidovudine, given three times daily, in 617 (ACTG 116A, conducted 1989 to 1992) and 913 (ACTG 116B/117, conducted 1989 to 1991) patients with symptomatic HIV infection or AIDS who were treated for more than one year. In treatment-naive patients (ACTG 116A), the rate of HIV disease progression or death was similar between the treatment groups; mortality rates were 26% for patients receiving didanosine and 21% for patients receiving zidovudine. Of the patients who had received previous zidovudine treatment (ACTG 116B/117), those treated with didanosine had a lower rate of HIV disease progression or death (32%) compared to those treated with zidovudine (41%); however, survival rates were similar between the treatment groups. Studies have demonstrated that the clinical benefit of monotherapy with antiretrovirals, including didanosine, was time limited. Pediatric Patients Efficacy in pediatric patients was demonstrated in a randomized, double-blind, controlled study (ACTG 152, conducted 1991 to 1995) involving 831 patients 3 months to 18 years of age treated for more than 1.5 years with zidovudine (180 mg/m 2 every 6 hours), didanosine (120 mg/m 2 every 12 hours), or zidovudine (120 mg/m 2 every 6 hours) plus didanosine (90 mg/m 2 every 12 hours). Patients treated with didanosine or didanosine plus zidovudine had lower rates of HIV-1 disease progression or death compared with those treated with zidovudine alone. How Supplied/Storage and Handling Didanosine Tablets for Oral Suspension USP, 100 mg are white to off-white, slightly mottled, round, flat faced beveled edge tablets with debossing D on one side and 45 on other side. The tablets are packaged in bottles with child-resistant closures. Bottles of 60 NDC 65862-092-60 Didanosine Tablets for Oral Suspension USP, 150 mg are white to off-white, slightly mottled, round, flat faced beveled edge tablets with debossing D on one side and 46 on other side. The tablets are packaged in bottles with child-resistant closures. Bottles of 60 NDC 65862-093-60 Didanosine Tablets for Oral Suspension USP, 200 mg are white to off-white, slightly mottled, round, flat faced beveled edge tablets with debossing D on one side and 47 on other side. The tablets are packaged in bottles with child-resistant closures. Bottles of 60 NDC 65862-094-60 Storage Store in tightly closed bottles at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. If dispersed in water, the dose may be held for up to 1 hour at ambient temperature. Patient Counseling Information See Medication Guide . Pancreatitis Patients should be informed that a serious toxicity of didanosine, used alone and in combination regimens, is pancreatitis, which may be fatal. Peripheral Neuropathy Patients should be informed that peripheral neuropathy, manifested by numbness, tingling, or pain in hands or feet, may develop during therapy with didanosine. Patients should be counseled that peripheral neuropathy occurs with greatest frequency in patients with advanced HIV-1 disease or a history of peripheral neuropathy, and that discontinuation of didanosine may be required if toxicity develops. Lactic Acidosis and Severe Hepatomegaly with Steatosis Patients should be informed that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Hepatic Toxicity Patients should be informed that hepatotoxicity including fatal hepatic adverse events were reported in patients with preexisting liver dysfunction. The safety and efficacy of didanosine have not been established in HIV-infected patients with significant underlying liver disease. Non-cirrhotic Portal Hypertension Patients should be informed that non-cirrhotic portal hypertension has been reported in patients taking didanosine, including cases leading to liver transplantation or death. Retinal Changes and Optic Neuritis Patients should be informed that retinal changes and optic neuritis have been reported in adult and pediatric patients. Fat Redistribution Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time. Concomitant Therapy Patients should be informed that when didanosine is used in combination with other agents with similar toxicities, the incidence of adverse events may be higher than when didanosine is used alone. These patients should be followed closely. Patients should be cautioned about the use of medications or other substances, including alcohol, which may exacerbate didanosine toxicities. General Information Didanosine is not a cure for HIV-1 infection, and patients may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections. Therefore, patients should remain under the care of a physician when using didanosine. Patients should be advised to avoid doing things that can spread HIV-1 infection to others. Do not share needles or other injection equipment. Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. Do not breastfeed. It is not known if didanosine can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in breast milk. Patients should be informed that the preferred dosing frequency of didanosine is twice daily because there is more evidence to support the effectiveness of this dosing frequency. Once-daily dosing should be considered only for patients whose management requires once-daily dosing of didanosine. Patients should be instructed to not miss a dose but if they do, patients should take didanosine as soon as possible. Patients should be told that if it is almost time for the next dose, they should skip the missed dose and continue with the regular dosing schedule. Patients should be advised that to ensure proper acid neutralization in the stomach they must take at least two of the appropriate strength didanosine tablets at each dose. To reduce the risk of gastrointestinal side effects from excess antacid, patients should take no more than four didanosine tablets at each dose. Patients should be instructed to contact a poison control center or emergency room right away in case of an overdose. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India Issued: November 2011 Medication Guide Didanosine Tablets for Oral Suspension, USP (didanosine, also known as ddI) Phenylketonurics Phenylalanine is a component of aspartame. Each Didanosine Tablets for Oral Suspension USP, 100 mg, 150 mg, and 200 mg contains phenylalanine 73 mg per 2 tablet dose. Read this Medication Guide before you start taking didanosine tablets for oral suspension and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. You and your healthcare provider should talk about your treatment with didanosine tablets for oral suspension before you start taking them and at regular check-ups. You should stay under your healthcare provider s care when taking didanosine tablets for oral suspension. What is the most important information I should know about didanosine tablets for oral suspension? Didanosine tablets for oral suspension may cause serious side effects, including: 1. Swelling of your pancreas (pancreatitis) that may cause death. Pancreatitis can happen at any time during your treatment with didanosine tablets for oral suspension. Before you start taking didanosine tablets for oral suspension, tell your healthcare provider if you: have had pancreatitis have advanced HIV (human immunodeficiency virus) infection have kidney problems drink alcoholic beverages take a medicine called ZERIT (stavudine) It is important to call your healthcare provider right away if you have: stomach pain swelling of your stomach nausea and vomiting fever 2. Build-up of acid in your blood (lactic acidosis). Lactic acidosis must be treated in the hospital as it may cause death. The risk for lactic acidosis may be higher if you: have liver problems are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking didanosine tablets for oral suspension and ZERIT (stavudine). are overweight have been treated for a long time with other medicines to treat HIV It is important to call your health care provider right away if you: feel weak or tired have unusual (not normal) muscle pain have trouble breathing have stomach pain with nausea and vomiting feel cold, especially in your arms and legs feel dizzy or light-headed have a fast or irregular heartbeat 3. Liver problems. Some people (including pregnant women) who have taken didanosine tablets for oral suspension have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and 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 didanosine tablets for oral suspension. Your healthcare provider should check your liver function while you are taking didanosine tablets for oral suspension. You should be especially careful if you have a history of heavy alcohol use or liver problems. It is important to call your healthcare provider right away if you have: yellowing of your skin or the white of your eyes (jaundice) dark urine pain on the right side of your stomach swelling of your stomach easy bruising or bleeding loss of appetite nausea or vomiting vomiting blood or dark colored stools (bowel movements) What are didanosine tablets for oral suspension? Didanosine tablets for oral suspension are a prescription medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV) infection in children and adults. Didanosine tablets for oral suspension belong to a class of drugs called nucleoside analogues. Didanosine tablets for oral suspension will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking didanosine tablets for oral suspension, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your healthcare provider regularly and report any medical problems that occur. Who should not take didanosine tablets for oral suspension? Do not take didanosine tablets for oral suspension if you take: ZYLOPRIM , LOPURIN , ALOPRIM (allopurinol) COPEGUS , REBETOL , RIBASPHERE , RIBAVIRIN , VIRAZOLE (ribavirin) What should I tell my healthcare provider before taking didanosine tablets for oral suspension? Before you take didanosine tablets for oral suspension, tell your healthcare provider if you: have or had kidney problems have or had liver problems (such as hepatitis) have or had persistent numbness, tingling, or pain in the hands or feet (neuropathy) have any other medical conditions are pregnant or plan to become pregnant. It is not known if didanosine tablets for oral suspension will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking didanosine tablets for oral suspension. You and your healthcare provider will decide if you should take didanosine tablets for oral suspension while you are pregnant. Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry. are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if didanosine can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Didanosine tablets for oral suspension may affect the way other medicines work, and other medicines may affect how didanosine tablets for oral suspension work. Especially tell your healthcare provider if you take: VIREAD (tenofovir disoproxil fumarate) DROXIA , HYDREA (hydroxyurea) RESCRIPTOR (delavirdine mesylate) CYTOVENE , VALCYTE (ganciclovir) CRIXIVAN (indinavir) DOLOPHINE HYDROCHLORIDE, METHADOSE (methadone) VIRACEPT (nelfinavir) antacids antifungal medicines such as NIZORAL (ketoconazole) or SPORANOX (itraconazole) quinolone antibiotics such as CIPRO , PROQUIN XR (ciprofloxacin) tetracycline antibiotics such as BRISTACYCLINE , SUMYCIN (tetracycline) alcoholic beverages Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Ask your healthcare provider if you are not sure if you take one of the medicines listed above. How should I take didanosine tablets for oral suspension? Take didanosine tablets for oral suspension exactly as your healthcare provider tells you to take them. Your healthcare provider will tell you how much didanosine tablets for oral suspension to take and when to take them. Your healthcare provider may change your dose. Do not change your dose of didanosine tablets for oral suspension without talking to your healthcare provider. Do not take didanosine tablets for oral suspension with food. Take didanosine tablets for oral suspension on an empty stomach at least 30 minutes before or 2 hours after you eat. Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Some medicines should not be taken at the same time of day that you take didanosine tablets for oral suspension. Check with your healthcare provider. If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take didanosine tablets for oral suspension. Your healthcare provider may also lower your dosage of didanosine tablets for oral suspension if your kidneys are not working well. If you take too much didanosine tablets for oral suspension, contact a poison control center or emergency room right away. What should I avoid while taking didanosine tablets for oral suspension? Alcohol. Do not drink alcohol while you take didanosine tablets for oral suspension. Alcohol may increase your risk of getting pain and swelling of your pancreas (pancreatitis) or may damage your liver. What are the possible side effects of didanosine tablets for oral suspension? Didanosine tablets for oral suspension can cause pancreatitis, lactic acidosis, and liver problems. See What is the most important information I should know about didanosine tablets for oral suspension? at the beginning of this Medication Guide. Vision changes. You should have regular eye exams while you take didanosine tablets for oral suspension. Peripheral neuropathy. Symptoms include: numbness, tingling, or pain in your hands or feet. This condition is more likely to happen in people who have had it before, in patients taking medicines that affect the nerves, and in people with advanced HIV disease. A child may not notice these symptoms. Ask your child s healthcare provider for the signs and symptoms of peripheral neuropathy in children. Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking HIV medicine. Changes in body fat (fat redistribution). Changes in body fat have been seen in people who take antiretroviral medicines. These changes may include: more fat in or around your - upper back and neck (buffalo hump) - breasts or chest - trunk less fat in your - legs - arms - face Tell your healthcare provider if you have any of the symptoms listed above. The most common side effects of didanosine tablets for oral suspension include: diarrhea stomach pain nausea vomiting headache rash Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of didanosine tablets for oral suspension. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at l-800-FDA-1088. How should I store didanosine tablets for oral suspension? Store didanosine tablets for oral suspension in tightly closed bottles at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F). If dispersed in water, the dose may be held for up to 1 hour at ambient temperature. Safely throw away any unused didanosine tablets for oral suspension after 30 days. Keep didanosine tablets for oral suspension and all medicines out of the reach of children and pets. General information about the safe and effective use of didanosine tablets for oral suspension Avoid doing things that can spread HIV-1 infection to others. Do not share needles or other injection equipment. Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use didanosine tablets for oral suspension for a condition for which it was not prescribed. Do not give didanosine tablets for oral suspension to other people, even if they have the same symptoms as you have. They may harm them. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place didanosine tablets for oral suspension in an unrecognizable closed container in the household trash. This Medication Guide summarizes the most important information about didanosine tablets for oral suspension. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about didanosine tablets for oral suspension that is written for health professionals. For more information, call 1-866-850-2876. What are the ingredients in didanosine tablets for oral suspension? Active Ingredient: didanosine Inactive Ingredients: Each tablet is buffered with calcium carbonate and magnesium hydroxide. Didanosine tablets also contain aspartame, crospovidone, magnesium stearate, microcrystalline cellulose, orange flavor, and sorbitol. All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 072, India Issued: November 2011 This Medication Guide has been approved by the U.S. Food and Drug Administration. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg (60 Tablet Bottle) NDC 65862-092-60 Didanosine Tablets for Oral Suspension, USP [Formerly: Didanosine Tablets (Chewable, Dispersible, Buffered)] 100 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 60 Tablets AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 150 mg (60 Tablet Bottle) NDC 65862-093-60 Didanosine Tablets for Oral Suspension, USP [Formerly: Didanosine Tablets (Chewable, Dispersible, Buffered)] 150 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 60 Tablets AUROBINDO PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 200 mg (60 Tablet Bottle) NDC 65862-094-60 Didanosine Tablets for Oral Suspension, USP [Formerly: Didanosine Tablets (Chewable, Dispersible, Buffered)] 200 mg PHARMACIST: Dispense the accompanying Medication Guide to each patient. Rx only 60 Tablets AUROBINDO DIDANOSINE Didanosine Tablet, for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-092 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDANOSINE (DIDANOSINE) DIDANOSINE 100 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE MAGNESIUM HYDROXIDE ASPARTAME CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE ORANGE SORBITOL Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND (Flat Faced Beveled Edge) Size 20mm Flavor ORANGE Imprint Code D;45 Contains Packaging # Item Code Package Description 1 NDC:65862-092-60 60 TABLET, FOR SUSPENSION in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077275 08/14/2012 DIDANOSINE Didanosine Tablet, for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-093 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDANOSINE (DIDANOSINE) DIDANOSINE 150 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE MAGNESIUM HYDROXIDE ASPARTAME CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE ORANGE SORBITOL Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND (Flat Faced Beveled Edge) Size 20mm Flavor ORANGE Imprint Code D;46 Contains Packaging # Item Code Package Description 1 NDC:65862-093-60 60 TABLET, FOR SUSPENSION in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077275 08/14/2012 DIDANOSINE Didanosine Tablet, for suspension Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-094 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDANOSINE (DIDANOSINE) DIDANOSINE 200 mg Inactive Ingredients Ingredient Name Strength CALCIUM CARBONATE MAGNESIUM HYDROXIDE ASPARTAME CROSPOVIDONE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE ORANGE SORBITOL Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND (Flat Faced Beveled Edge) Size 20mm Flavor ORANGE Imprint Code D;47 Contains Packaging # Item Code Package Description 1 NDC:65862-094-60 60 TABLET, FOR SUSPENSION in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077275 08/14/2012 Labeler - Aurobindo Pharma Limited (650082092) Establishment Name Address ID/FEI Operations Aurobindo Pharma Limited 918917642 ANALYSIS(65862-092, 65862-093, 65862-094), MANUFACTURE(65862-092, 65862-093, 65862-094) Establishment Name Address ID/FEI Operations Aurobindo Pharma Limited 918917662 API MANUFACTURE(65862-092, 65862-093, 65862-094) Revised: 08/2012 Aurobindo Pharma Limited Next Interactions Print this page Add to My Med List More about didanosine Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: nucleoside reverse transcriptase inhibitors (NRTIs) Consumer resources Didanosine ... +3 more Professional resources Didanosine (AHFS Monograph) Didanosine (FDA) Didanosine Oral Solution (FDA) Didanosine (Wolters Kluwer) Other brands: Videx , Videx EC Related treatment guides HIV Infection Nonoccupational Exposure> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturers Mylan Pharmaceuticals Inc. Teva Pharmaceuticals USA, Inc. Aurobindo Pharma Limited Drug Class Nucleoside reverse transcriptase inhibitors (NRTIs) Related Drugs nucleoside reverse transcriptase inhibitors (NRTIs) Viread , lamivudine , abacavir , entecavir , tenofovir , Baraclude HIV Infection Truvada , Atripla , Norvir , Viread , Isentress , Prezista , Stribild , lamivudine , abacavir , tenofovir , Reyataz , Epzicom , More... Nonoccupational Exposure Truvada , Atripla , Viread , lamivudine , abacavir , tenofovir , Epzicom , Reyataz , zidovudine , emtricitabine , Kaletra , Sustiva , More... Didanosine Rating No Reviews - Be the first! 9.0 /10 No Reviews - Be the first! 9.0 Rate it! Didanosine Images Didanosine systemic 200 mg (barr 200mg 588) View all images} } fees
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