DINEX EC 400

Product Description

DINEX EC 400 (DIDANOSINE 400MG)

What is Dinex EC (didanosine)?

Didanosine is an antiviral medicine that prevents human immunodeficiency virus (HIV) from multiplying in your body. Didanosine is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS. Didanosine is for use in adults and children who are at least 2 weeks old. Didanosine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Dinex EC (didanosine)?

DO NOT TAKE DIDANOSINE TOGETHER WITH ALLOPURINOL OR RIBAVIRIN.

Didanosine may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

This medicine can also cause severe or life-threatening effects on your liver or pancreas. Call your doctor at once if you have: severe pain in your upper stomach (may spread to your back), nausea and vomiting, fast heart rate, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

WHAT SHOULD I DISCUSS WITH MY HEALTHCARE PROVIDER BEFORE TAKING DINEX EC (DIDANOSINE)?

You should not use didanosine if you are allergic to it. Do not take didanosine together with allopurinol (Zyloprim, Lopurin, Aloprim) or ribavirin (Rebetol, Ribasphere, Copegus, Virazole). Some people taking didanosine to develop a serious condition called lactic acidosis. This may be more likely in women, in people who are overweight or have liver disease, and in people who have taken HIV/AIDS medication for a long time. Talk to your doctor about your risk.

To make sure didanosine is safe for you, tell your doctor if you have: liver disease or a history of pancreatitis (didanosine can cause severe or life-threatening effects on your liver or pancreas); kidney disease; a history of numbness or tingling in your hands or feet, including Raynaud’s syndrome; if you drink large amounts of alcohol; or if you also take stavudine (Zerit).

If you are pregnant, do not take didanosine together with stavudine. This combination of medicines can cause lactic acidosis or liver problems, which can be very dangerous during pregnancy.

HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection. Your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of didanosine on the baby. Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

HOW SHOULD I TAKE DINEX EC (DIDANOSINE)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Take didanosine on an empty stomach, at least 30 minutes before or 2 hours after a meal. Do not take with food. Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one. Do not crush, chew, break, or open a delayed-release capsule. Swallow it whole. HIV/AIDS is usually treated with a combination of drugs, but certain HIV medications or antibiotics should not be taken at the same time as didanosine.

THESE OTHER MEDICINES CAN AFFECT THE LEVELS OF DIDANOSINE IN YOUR BLOODSTREAM:

• Ciprofloxacin (Cipro) should be taken at least 2 hours before or 6 hours after you take didanosine.
• Delavirdine (Rescriptor) or indinavir (Crixivan) should be taken at least 1 hour before you take didanosine.
• Nelfinavir (Viracept) should be taken at least 1 hour after you take didanosine.
• Itraconazole (Sporanox) or ketoconazole (Nizoral) should be taken at least 2 hours before you take didanosine.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice. Every person with HIV or AIDS should remain under the care of a doctor. While using didanosine, you may need frequent blood tests. Your vision, kidney function, and liver function may also need to be checked. Store the tablets or capsules at room temperature in a tightly closed container, away from moisture and heat. Store the liquid form of didanosine in the refrigerator. Throw away any leftover didanosine liquid that is more than 30 days old.

WHAT HAPPENS IF I MISS A DOSE FOR DINEX EC (DIDANOSINE)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

WHAT HAPPENS IF I OVERDOSE FOR DINEX EC (DIDANOSINE)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

WHAT SHOULD I AVOID WHILE TAKING DINEX EC (DIDANOSINE)?

Do not drink alcohol. It may increase your risk of liver damage or pancreatitis. Avoid using antacids without your doctor’s advice while taking didanosine. Use only the specific type of antacid your doctor recommends. Taking this medicine will not prevent you from passing HIV to other people. Do not have unprotected s** or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during s**. Sharing drug or medicine needles is never safe, even for a healthy person.

WHAT IS SIDE EFFECTS FOR DINEX EC (DIDANOSINE)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have: severe pain in your upper stomach (may spread to your back), swelling around your stomach, nausea, vomiting, loss of appetite; fever, itching, tiredness, fast heart rate; numbness, tingling, or pain in your hands or feet; jaundice (yellowing of the skin or eyes); or dark urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Didanosine may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with didanosine. Tell your doctor if you have: signs of a new infection–fever, night sweats, swollen glands, mouth sores, diarrhea, stomach pain, weight loss; chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath; cold sores, sores on your genital or anal area; rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement; trouble speaking or swallowing, severe lower back pain, loss of bladder or bowel control; or swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in s**.

Common side effects may include numbness or tingling; vision changes; nausea, vomiting, diarrhea, stomach pain; rash; headache; or changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

WHAT OTHER DRUGS WILL AFFECT DINEX EC (DIDANOSINE)?

Tell your doctor about all your current medicines and any you start or stop using, especially: ganciclovir; hydroxyurea; methadone; tetracycline; tenofovir; or medicines that should not be taken at the same time as didanosine–ciprofloxacin, delavirdine, indinavir, itraconazole, ketoconazole, or nelfinavir. This list is not complete. Other drugs may interact with didanosine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.