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|Didanosine Delayed-Release Enteric-Coated Capsules

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Didanosine Delayed-Release Enteric-Coated Capsules

Generic Name: Didanosine Delayed-Release Enteric-Coated Capsules (dye-DAN-oh-seen)
Brand Name: Videx EC

Didanosine 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 Didanosine Delayed-Release Enteric-Coated Capsules and in patients who have already been taking it. Contact your doctor immediately if you experience sudden stomach or back pain, swelling of the stomach, fever or chills, nausea or vomiting, or fast heartbeat.

Didanosine 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 Didanosine 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 plan to become pregnant.

Didanosine Delayed-Release Enteric-Coated Capsules is used for:

Treating HIV infection in adults when used in combination with other medicines.

Didanosine Delayed-Release Enteric-Coated Capsules is a nucleoside analogue reverse transcriptase inhibitor that stops the growth of HIV-1, the virus that causes AIDS.

Do NOT use Didanosine Delayed-Release Enteric-Coated Capsules if:

you are allergic to any ingredient in Didanosine Delayed-Release Enteric-Coated Capsules
you have pancreas problems (pancreatitis), enlarged liver, 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.

Before using Didanosine Delayed-Release Enteric-Coated Capsules:

Some medical conditions may interact with Didanosine 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 advanced HIV infection (AIDS), kidney problems, liver problems, 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 Didanosine Delayed-Release Enteric-Coated Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Methadone because the effectiveness of Didanosine Delayed-Release Enteric-Coated Capsules may be decreased
Allopurinol, ganciclovir, nucleotide reverse transcriptase inhibitors (eg, tenofovir), or ribavirin because side effects of Didanosine Delayed-Release Enteric-Coated Capsules may be increased
Hydroxyurea because the risk of pancreatitis may be increased
Stavudine because the risk of pancreatitis or fatal lactic acidosis in pregnant women may be increased
Aluminum salts (eg, aluminum hydroxide) because side effects may be increased by Didanosine 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 the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Didanosine 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 Didanosine Delayed-Release Enteric-Coated Capsules:

Use Didanosine Delayed-Release Enteric-Coated Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Didanosine Delayed-Release Enteric-Coated Capsules comes with an additional patient leaflet. Read it carefully and reread it each time you get Didanosine Delayed-Release Enteric-Coated Capsules refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about Didanosine Delayed-Release Enteric-Coated Capsules.
Take Didanosine Delayed-Release Enteric-Coated Capsules on an empty stomach at least 1 hour before or 2 hours after eating.
Swallow Didanosine Delayed-Release Enteric-Coated Capsules whole. Do not break, crush, or chew before swallowing.
Didanosine 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 Didanosine Delayed-Release Enteric-Coated Capsules from any other medicine that you are taking.
Continue taking Didanosine Delayed-Release Enteric-Coated Capsules even if you feel better.
If you miss a dose of Didanosine 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 Didanosine 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 Didanosine Delayed-Release Enteric-Coated Capsules.

Important safety information:

Do not drink alcohol while you are taking Didanosine Delayed-Release Enteric-Coated Capsules.
Didanosine Delayed-Release Enteric-Coated Capsules is not a cure for HIV infection and patients may continue to acquire illnesses/infections associated with HIV infection (the virus that causes AIDS). Remain under the care of our healthcare provider.
Didanosine Delayed-Release Enteric-Coated Capsules offers no protection from the transmission of HIV (the virus that causes AIDS) to others through sexual contact or blood contamination. Use barrier forms of contraception (eg, condoms) if you are infected with HIV.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Didanosine Delayed-Release Enteric-Coated Capsules.
When your medicine supply begins to run low, get more from your doctor or pharmacy as soon as possible. The virus may develop resistance to Didanosine Delayed-Release Enteric-Coated Capsules if you stop taking it, even for a short period of time, and may become harder to treat.
Changes in body fat may occur in some patients taking this type of medicine. These changes may include increased amount of fat in the upper back and neck, breast, and around the trunk, and loss of fat from the legs, arms, and face. The cause and long-term effects are unknown. Discuss any concerns with your doctor.
LAB TESTS, including eye exams, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
Use Didanosine Delayed-Release Enteric-Coated Capsules with caution in the ELDERLY because they may be more sensitive to its effects.
Didanosine Delayed-Release Enteric-Coated Capsules is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Didanosine Delayed-Release Enteric-Coated Capsules during pregnancy. It is unknown if Didanosine Delayed-Release Enteric-Coated Capsules is excreted in breast milk. HIV-infected mothers should not breast-feed their infants because of the risk of transmitting the HIV infection or Didanosine Delayed-Release Enteric-Coated Capsules.

Possible side effects of Didanosine 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; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; changes in vision; confusion; dark urine; dizziness; fast, shallow breathing; fast, slow, or irregular heartbeat; fever or chills; lightheadedness; low body temperature; nausea or vomiting; numbness, tingling, or pain in hands or feet; seizures; severe muscle pain or cramping; stomach pain; tiredness; weakness; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of Didanosine Delayed-Release Enteric-Coated Capsules:

Store Didanosine Delayed-Release Enteric-Coated Capsules at room temperature (59 to 77 degrees F; 15 to 25 degrees C) in a tightly-closed container. Store away from heat, moisture, and light. Brief storage up to 86 degrees F is permitted. Do not store in the bathroom. Keep Didanosine Delayed-Release Enteric-Coated Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Didanosine Delayed-Release Enteric-Coated Capsules, please talk with your doctor, pharmacist, or other health care provider.
Didanosine 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.

This information is a summary only. It does not contain all information about Didanosine Delayed-Release Enteric-Coated Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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