An Overview of Videx (Didanosine, ddI)

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Brand Name: Videx EC, Videx
Other Names: ddI, ddl EC, delayed-release didanosine, enteric-coated didanosine
Drug Class: Nucleoside Reverse Transcriptase Inhibitors
Approved Use: Treatment of HIV Infection

What is didanosine?

Didanosine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children. Didanosine is always used in combination with other anti-HIV medicines.

Didanosine is a type of anti-HIV medicine called a nucleoside reverse transcriptase inhibitor (NRTI). NRTIs work by blocking HIV reverse transcriptase, an HIV enzyme. This prevents HIV from replicating and lowers the amount of HIV in the blood.

Didanosine does not cure HIV/AIDS. It is not known if didanosine reduces the risk of passing HIV to other people.

What should I tell my health care provider before taking didanosine?

Before taking didanosine, tell your health care provider:

• If you are allergic to didanosine or any other medicines.
• If you have or have ever had kidney problems.
• If you have or have ever had liver problems, including hepatitis.
• If you have or have ever had peripheral neuropathy (numbness, tingling, burning, or pain sensation in your hands or feet or decreased ability to feel temperature or touch in your hands or feet).
• If you have any other medical conditions.
• If you are pregnant or plan to become pregnant. Whether didanosine can harm an unborn baby is unknown.
• If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking didanosine.
• About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Didanosine may affect the way other medicines or products work, and other medicines or products may affect how didanosine works. Taking didanosine together with certain medicines or products may cause serious and/or life-threatening side effects.

How should I take didanosine?

Didanosine comes in capsule form for use in adults and children 6 years of age or older who can safely swallow capsules and weigh at least 20 kg. The capsules come in 4 strengths:

• 125-mg, 200-mg, 250-mg, and 400-mg delayed-release capsules, containing enteric-coated beadlets (brand name: Videx EC).

Didanosine also comes in a pediatric powder to mix with water (brand name: Videx). The pediatric powder can be used in children 2 weeks of age and older. The pediatric powder comes in two strengths:

• 4-ounce glass bottle containing 2 g of didanosine.
• 8-ounce glass bottle containing 4 g of didanosine.

Take didanosine according to your health care provider's instructions.

Both didanosine capsules and didanosine powder should be taken on an empty stomach. Do not take didanosine with food. Swallow the didanosine capsule whole; do not open it.

Always take didanosine in combination with other anti-HIV medicines.

If you take too much didanosine, contact your local poison control center (1-800-222-1222) or go to the nearest hospital emergency room right away.

For more information on how to take didanosine, see the FDA drug labels for didanosine capsules (brand name: Videx EC) and didanosine pediatric powder for oral solution (brand name: Videx), from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

What side effects can didanosine cause?

Didanosine can cause serious, life-threatening side effects that can be life threatening. These include pancreatitis (inflammation of the pancreas), lactic acidosis (buildup of acid in the blood), and liver problems. (See the WARNING above.)

Other possible side effects of didanosine include:

• Changes in body fat (lipodystrophy).
• Changes to the nerve layer at the back of the eye (retina) or inflammation of the optic nerve.
• Damage to the nerves outside the brain and spinal cord (peripheral neuropathy).
• Changes in the immune system (immune reconstitution inflammatory syndrome).

Tell your health care provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of didanosine. Ask your health care provider or pharmacist for more information on possible side effects of didanosine.

How should didanosine be stored?

• Store didanosine capsules in a tightly closed container at 59°F to 86°F (15°C to 30°C), away from heat.
• Store bottles of didanosine powder at 59°F to 86°F (15°C to 30°C). Once the didanosine powder is mixed with water, the solution may be stored up to 30 days in a refrigerator at 36°F to 46°F (2°C to 8°C). Any solution left after 30 days should be thrown away.
• Safely throw away didanosine that is no longer needed or expired (out of date).
• Keep didanosine and all medicines out of reach of children.

Where can I find more information about didanosine?

More information about didanosine is available:

• The FDA drug labels for didanosine capsules (brand name: Videx EC) and didanosine pediatric powder for oral solution (brand name: Videx), from DailyMed. The Patient Counseling Information section of the labels includes information for people taking didanosine.
• Didanosine-related research studies, from the AIDSinfo database of ClinicalTrials.gov study summaries.
• A list of FDA-approved generics for anti-HIV medicines, from FDA.

Manufacturer Information

Bristol-Myers Squibb
800-332-2056