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|Didanosine Chewable/Dispersible Buffered Tablets

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Didanosine Chewable/Dispersible Buffered Tablets

Generic Name: Didanosine Chewable/Dispersible Buffered Tablets (dye-DAN-oh-seen)
Brand Name: Videx

Didanosine Chewable/Dispersible Buffered Tablets may cause serious and sometimes fatal inflammation of the pancreas (pancreatitis). This has occurred in patients who have just started taking Didanosine Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets may cause severe and sometimes fatal lactic acidosis and liver problems. Fatal lactic acidosis has also occurred in pregnant women who have used Didanosine Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets is used for:

Treating HIV infection when used in combination with other medicines.

Didanosine Chewable/Dispersible Buffered Tablets is a nucleoside analogue reverse transcriptase inhibitor that stops the growth of HIV-1, the virus that causes AIDS.

Do NOT use Didanosine Chewable/Dispersible Buffered Tablets if:

you are allergic to any ingredient in Didanosine Chewable/Dispersible Buffered Tablets
you have pancreas problems (pancreatitis), enlarged liver, abnormal liver function tests, or lactic acidosis
you are taking allopurinol, aluminum salts (eg, aluminum hydroxide), or ribavirin

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

Before using Didanosine Chewable/Dispersible Buffered Tablets:

Some medical conditions may interact with Didanosine Chewable/Dispersible Buffered Tablets. 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, high blood amylase levels, or phenylketonuria
if you are overweight or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Didanosine Chewable/Dispersible Buffered Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Methadone because the effectiveness of Didanosine Chewable/Dispersible Buffered Tablets may be decreased
Allopurinol, ganciclovir, nucleotide reverse transcriptase inhibitors (eg, tenofovir), or ribavirin because side effects of Didanosine Chewable/Dispersible Buffered Tablets 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), anorexiants (eg, phentermine), or sympathomimetics (eg, albuterol, pseudoephedrine) because side effects may be increased by Didanosine Chewable/Dispersible Buffered Tablets
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 Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets:

Use Didanosine Chewable/Dispersible Buffered Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Didanosine Chewable/Dispersible Buffered Tablets comes with an additional patient leaflet. Read it carefully and reread it each time you get Didanosine Chewable/Dispersible Buffered Tablets refilled. Ask your doctor, nurse, or pharmacist any questions that you may have about Didanosine Chewable/Dispersible Buffered Tablets.
Take Didanosine Chewable/Dispersible Buffered Tablets on an empty stomach at least 1 hour before or 2 hours after eating.
Do not swallow tablets whole. Chew tablets thoroughly or crush the tablets and mix in at least 1 ounce (30 mL) of water. This mixture may be added to 1 ounce (30 mL) clear apple juice to improve taste. Make sure to stir well and drink the entire solution immediately.
Didanosine Chewable/Dispersible Buffered Tablets may reduce the effectiveness of certain other medicines when taken together. Ask your doctor or pharmacist if you should separate Didanosine Chewable/Dispersible Buffered Tablets from any other medicines that you are taking.
Continue taking Didanosine Chewable/Dispersible Buffered Tablets even if you feel better.
If you miss a dose of Didanosine Chewable/Dispersible Buffered Tablets, 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 Chewable/Dispersible Buffered Tablets. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Didanosine Chewable/Dispersible Buffered Tablets.

Important safety information:

Do not drink alcohol while you are taking Didanosine Chewable/Dispersible Buffered Tablets.
Didanosine Chewable/Dispersible Buffered Tablets 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 your health care provider.
Didanosine Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets.
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 Chewable/Dispersible Buffered Tablets 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.
Phenylketonurics - Didanosine Chewable/Dispersible Buffered Tablets contains phenylalanine.
LAB TESTS, including periodic 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 Chewable/Dispersible Buffered Tablets with caution in the ELDERLY because they may be more sensitive to its effects.
Use Didanosine Chewable/Dispersible Buffered Tablets with extreme caution in CHILDREN younger than 2 weeks of age; safety and effectiveness in this age group 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 Chewable/Dispersible Buffered Tablets during pregnancy. It is unknown if Didanosine Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets.

Possible side effects of Didanosine Chewable/Dispersible Buffered Tablets:

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; vomiting.

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; fever or chills; fast, slow, or irregular heartbeat; lightheadedness; low body temperature; nausea and 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 Chewable/Dispersible Buffered Tablets:

Store Didanosine Chewable/Dispersible Buffered Tablets at room temperature (59 to 86 degrees F; 15 to 30 degrees C) in a tightly-closed container. Store away from heat, moisture, and light. Do not store the tablets in a damp place, such as the bathroom, medicine cabinet, or near the kitchen sink. If the tablets are dispersed in water, the dose may be held for up to 1 hour at room temperature. Keep Didanosine Chewable/Dispersible Buffered Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Didanosine Chewable/Dispersible Buffered Tablets, please talk with your doctor, pharmacist, or other health care provider.
Didanosine Chewable/Dispersible Buffered Tablets 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 Chewable/Dispersible Buffered Tablets. 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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