Videx EC

DRUG DESCRIPTION

VIDEX® EC is the brand name for an enteric-coated formulation of didanosine, USP, a synthetic purine nucleoside analogue active against HIV-1. VIDEX EC Delayed-Release Capsules, containing enteric-coated beadlets, are available for oral administration in strengths of 125, 200, 250, and 400 mg of didanosine. The inactive ingredients in the beadlets include carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, and talc. The capsule shells contain gelatin and titanium dioxide. The capsules are imprinted with edible inks.

Didanosine is also available in a powder formulation. Please consult the prescribing information for VIDEX (didanosine) Pediatric Powder for Oral Solution for additional information.

The chemical name for didanosine is 2',3'-dideoxyinosine. The structural formula is:

VIDEX EC (didanosine, USP) Structural Formula Illustration

Didanosine is a white crystalline powder with the molecular formula C10H12N4O3 and a molecular weight of 236.2. The aqueous solubility of didanosine at 25° C and pH of approximately 6 is 27.3 mg/mL. Didanosine is unstable in acidic solutions. For example, at pH less than 3 and 37° C, 10% of didanosine decomposes to hypoxanthine in less than 2 minutes. In VIDEX EC, an enteric coating is used to protect didanosine from degradation by stomach acid.

What are the possible side effects of didanosine (Videx, Videx EC)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using didanosine and call your doctor at once if you have any of these serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea...

Read All Potential Side Effects and See Pictures of Videx EC »

What are the precautions when taking didanosine delayed-release capsules - enteric-coated beadlets (Videx EC)?

Before taking didanosine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, kidney problems, liver problems (such as hepatitis, cirrhosis), nerve problems (such as peripheral neuropathy), alcohol use, high fat levels in the blood (triglycerides), gall bladder problems (such as gall stones), gout.

Avoid alcoholic beverages because they may increase your risk for liver problems and pancreatitis.

Didanosine may increase your risk of a heart attack. Discuss the risks and...

Read All Potential Precautions of Videx EC »


Videx EC Consumer (continued)

SIDE EFFECTS: See also Warning section.

Headache or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain in the palms of the hand or soles of the feet. If you experience any of these symptoms, contact your doctor immediately so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of didanosine.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision problems (such as blurred vision, difficulty seeing colors), vomiting up blood, belly/abdominal swelling, easy bruising or bleeding.

Changes in body fat may occur while you are taking HIV medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking didanosine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: pancreatitis, kidney problems, liver problems (such as hepatitis, cirrhosis), nerve problems (such as peripheral neuropathy), alcohol use, high fat levels in the blood (triglycerides), gall bladder problems (such as gall stones), gout.

Avoid alcoholic beverages because they may increase your risk for liver problems and pancreatitis.

Didanosine may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease such as high blood pressure, diabetes, or high cholesterol levels.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To decrease your risk of spreading HIV disease to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially the increased risk of pancreatitis.

During pregnancy, this medication should be used only when clearly needed. However, it is now normal to prescribe HIV medicines for pregnant women with HIV. This has been shown to decrease the risk of giving HIV to the baby. Didanosine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.


Videx EC Patient Information Including Side Effects

Brand Names: Videx, Videx EC

Generic Name: didanosine (Pronunciation: dye DAN oh seen)

  • What is didanosine (Videx EC)?
  • What are the possible side effects of didanosine (Videx EC)?
  • What is the most important information I should know about didanosine (Videx EC)?
  • What should I discuss with my healthcare provider before taking didanosine (Videx EC)?
  • How should I take didanosine (Videx EC)?
  • What happens if I miss a dose (Videx EC)?
  • What happens if I overdose (Videx EC)?
  • What should I avoid while taking didanosine (Videx EC)?
  • What other drugs will affect didanosine (Videx EC)?
  • Where can I get more information?

What is didanosine (Videx EC)?

Didanosine is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Didanosine is used to treat HIV, which causes the acquired immunodeficiency syndrome (AIDS). Didanosine is not a cure for HIV or AIDS.

Didanosine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of didanosine (Videx EC)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using didanosine and call your doctor at once if you have any of these serious side effects:

  • liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • lactic acidosis - muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, nausea with vomiting, and fast or uneven heart rate;
  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • peripheral neuropathy - numbness, tingling, or pain in your hands or feet;
  • problems with vision, increased sensitivity to light;
  • fever, chills, body aches, flu symptoms; or
  • any other signs of new infection.

Less serious side effects may include:

  • mild stomach pain, diarrhea;
  • headache;
  • weak feeling; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Didanosine can cause life-threatening effects on your liver or pancreas. Call your doctor at once if you have any of these symptoms: severe pain in your upper stomach spreading to your back, fast heart rate, nausea and vomiting, diarrhea, loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not take didanosine without telling your doctor if you are pregnant. Didanosine may be harmful to an unborn baby, and may also be more likely to cause pancreatitis in a pregnant woman.

Didanosine may also cause a build up of lactic acid in the body. Symptoms include unusual muscle pain and weakness, trouble breathing, fast or uneven heart rate, nausea, vomiting, stomach pain, and numbness or cold feeling in your arms or legs. Contact your doctor at once if you have any of these symptoms, even if they are only mild.

There are many other medicines that can interact with didanosine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

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