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Videx EC delayed-release enteric-coated capsules

Generic Name: didanosine (dye-DAN-oh-seen)
Brand Name: Videx EC

Videx EC delayed-release enteric-coated capsules may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Videx EC delayed-release enteric-coated capsules and in patients who have already been taking it. Contact your doctor right away if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Videx EC delayed-release enteric-coated capsules may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Videx EC delayed-release enteric-coated capsules along with certain other medicines for HIV (eg, stavudine). Tell your doctor if you are taking stavudine and you are pregnant or planning to become pregnant.


Videx EC delayed-release enteric-coated capsules is used for:

Treating HIV infection when used in combination with other medicines.

Videx EC delayed-release enteric-coated capsules is a nucleoside analogue reverse transcriptase inhibitor. It works by stopping the growth of HIV-1, the virus that causes AIDS.

Do NOT use Videx EC delayed-release enteric-coated capsules if:

  • you are allergic to any ingredient in Videx EC delayed-release enteric-coated capsules
  • you have pancreas inflammation (pancreatitis), certain liver problems (eg, enlarged liver, portal hypertension), abnormal liver function tests, or lactic acidosis
  • you are taking allopurinol or ribavirin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Videx EC delayed-release enteric-coated capsules:

Some medical conditions may interact with Videx EC delayed-release enteric-coated capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of heart problems (eg, heart attack)
  • if you have advanced HIV infection (AIDS), kidney problems, liver problems (eg, hepatitis), gallstones, nerve problems (neuropathy), high blood cholesterol or lipid levels, or high blood amylase levels
  • if you are overweight or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Videx EC delayed-release enteric-coated capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Hydroxyurea because the risk of pancreatitis may be increased
  • Allopurinol, ganciclovir, nucleotide reverse transcriptase inhibitors (eg, tenofovir), or ribavirin because they may increase the risk of Videx EC delayed-release enteric-coated capsules's side effects
  • Methadone because it may decrease Videx EC delayed-release enteric-coated capsules's effectiveness
  • Aluminum salts (eg, aluminum hydroxide) because the risk of their side effects may be increased by Videx EC delayed-release enteric-coated capsules
  • Azole antifungals (eg, itraconazole, ketoconazole), delavirdine, HIV protease inhibitors (eg, indinavir, lopinavir, nelfinavir), lithium, quinolones (eg, ciprofloxacin, levofloxacin), sulfones (eg, dapsone), or tetracyclines (eg, doxycycline) because their effectiveness may be decreased by Videx EC delayed-release enteric-coated capsules
  • Stavudine because the risk of pancreatitis or fatal lactic acidosis in pregnant women may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Videx EC delayed-release enteric-coated capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Videx EC delayed-release enteric-coated capsules:

Use Videx EC delayed-release enteric-coated capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Videx EC delayed-release enteric-coated capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Videx EC delayed-release enteric-coated capsules refilled.
  • Take Videx EC delayed-release enteric-coated capsules by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
  • Swallow Videx EC delayed-release enteric-coated capsules whole. Do not break, crush, or chew before swallowing.
  • Videx EC delayed-release enteric-coated capsules may reduce the effectiveness of certain other medicines when taken together. Ask your doctor or pharmacist if you should separate Videx EC delayed-release enteric-coated capsules from any other medicine that you are taking.
  • Continue to take Videx EC delayed-release enteric-coated capsules even if you feel well. Do not miss any doses.
  • If you miss a dose of Videx EC delayed-release enteric-coated capsules, take it as soon as you remember. If it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. It is important not to miss doses of Videx EC delayed-release enteric-coated capsules. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Videx EC delayed-release enteric-coated capsules.

Important safety information:

  • Do not drink alcohol while you are taking Videx EC delayed-release enteric-coated capsules.
  • Videx EC delayed-release enteric-coated capsules is not a cure for HIV infection. Patients may still get illnesses and infections associated with HIV. Remain under the care of your doctor.
  • Videx EC delayed-release enteric-coated capsules does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors.
  • When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Videx EC delayed-release enteric-coated capsules, even for a short period of time. If you do, the virus may grow resistant to the medicine and become harder to treat.
  • Tell your doctor or dentist that you take Videx EC delayed-release enteric-coated capsules before you receive any medical or dental care, emergency care, or surgery.
  • The risk of severe side effects (eg, lactic acidosis, severe liver problems) may be greater in women, patients who are overweight (obese), and patients who have taken reverse transcriptase inhibitors (eg, emtricitabine, tenofovir) for a long time. Talk with your doctor if you have questions about your risk of severe side effects from Videx EC delayed-release enteric-coated capsules.
  • Changes in body fat (eg, an increased amount of fat in the upper back, neck, breast, and trunk, and loss of fat from the legs, arms, and face) may occur in some patients taking Videx EC delayed-release enteric-coated capsules. The cause and long-term effects of these changes are unknown. Discuss any concerns with your doctor.
  • Videx EC delayed-release enteric-coated capsules may improve immune system function. This may reveal hidden infections in some patients. Tell your doctor right away if you notice symptoms of infection (eg, fever, sore throat, weakness, cough, shortness of breath) after you start Videx EC delayed-release enteric-coated capsules.
  • Lab tests, including eye exams, liver function, complete blood cell counts, and blood clotting (eg, international normalized ratio [INR]), may be performed while you use Videx EC delayed-release enteric-coated capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Videx EC delayed-release enteric-coated capsules with caution in the ELDERLY; they may be more sensitive to its effects.
  • Use Videx EC delayed-release enteric-coated capsules with extreme caution in CHILDREN weighing less than 44 lb; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Videx EC delayed-release enteric-coated capsules while you are pregnant. It is not known if Videx EC delayed-release enteric-coated capsules is found in breast milk. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Videx EC delayed-release enteric-coated capsules to the baby.

Possible side effects of Videx EC delayed-release enteric-coated capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast enlargement; changes in body fat; darkened complexion with purple markings; diarrhea; dry mouth; headache; itching; muscle pain; skin and facial wasting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in the vomit or vomit that looks like coffee grounds; blurred vision or other vision changes; chest pain or discomfort, numbness of an arm or leg, or shortness of breath; confusion; dark urine; dizziness; fainting; fast, shallow breathing; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in the hands or feet; pale stools; seizures; severe muscle pain or cramping; stomach pain or swelling; tiredness; unusual bruising or bleeding; weakness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dark urine; diarrhea; pale stools; severe stomach pain with nausea and vomiting; tingling, burning, or numbness in the hands or feet; unusual fatigue; yellowing of the skin or eyes.

Proper storage of Videx EC delayed-release enteric-coated capsules:

Store Videx EC delayed-release enteric-coated capsules at room temperature, between 59 and 77 degrees F (15 and 25 degrees C), in a tightly closed container. Brief storage at temperatures of up to 86 degrees F (30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Videx EC delayed-release enteric-coated capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Videx EC delayed-release enteric-coated capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Videx EC delayed-release enteric-coated capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Videx EC delayed-release enteric-coated capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Videx EC delayed-release enteric-coated capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Videx EC delayed-release enteric-coated capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Videx EC delayed-release enteric-coated capsules.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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