Videx EC Information and Uses

Videx EC

Videx EC (generic: didanosine) is a prescription medication used to treat human immunodeficiency virus (HIV) infection. Videx EC belongs to a class of drugs called nucleoside analogues which work by decreasing the amount of HIV in the blood.

This medication comes in extended-release capsules (Videx EC) and a liquid form to be taken by mouth on an empty stomach. Videx EC capsules are usually taken once daily. The liquid is usually taken once or twice daily.

Common side effects of Videx EC include diarrhea, stomach pain, nausea, and vomiting.

Uses of Videx EC

Videx EC is a prescription medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV) infection in children and adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Videx EC

Videx EC can cause pancreatitis, lactic acidosis, and liver problems. See “Drug Precautions”.

Vision changes. You should have regular eye exams while taking Videx EC.
Peripheral neuropathy. Symptoms include: numbness, tingling, or pain in your hands or feet. This condition is more likely to happen in people who have had it before, in patients taking medicines that affect the nerves, and in people with advanced HIV disease. A child may not notice these symptoms. Ask the child’s healthcare provider for the signs and symptoms of peripheral neuropathy in children.
Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking HIV medicine.
Changes in body fat (fat redistribution). Changes in body fat have been seen in people who take antiretroviral medicines. These changes may include:
- more fat in or around your
  - upper back and neck (buffalo hump)
  - breasts or chest
  - trunk
- less fat in your
  - legs
  - arms
  - face

Tell your healthcare provider if you have any of the symptoms listed above.

The most common side effects of Videx EC include:

diarrhea
stomach pain
nausea
vomiting
headache
rash

Tell your healthcare 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 Videx EC. For more information, ask your healthcare provider or pharmacist.

Videx EC Interactions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Videx EC may affect the way other medicines work, and other medicines may affect how Videx EC works.

Especially tell your healthcare provider if you take:

Cytovene, Valcyte (ganciclovir)
Dolophine Hydrochloride, Methadose (methadone)
Viracept (nelfinavir)
Viread (tenofovir disoproxil fumarate)
alcoholic beverages

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

Videx EC Precautions

Videx EC may cause serious side effects, including:

1. Swelling of your pancreas (pancreatitis) that may cause death. Pancreatitis can happen at any time during your treatment with Videx EC. Before you start taking Videx EC, tell your healthcare provider if you:

have had pancreatitis
have advanced HIV (human immunodeficiency virus) infection
have kidney problems
drink alcoholic beverages
take a medicine called Zerit (stavudine)

It is important to call your healthcare provider right away if you have:

stomach pain
swelling of your stomach
nausea and vomiting
fever

2. Build-up of acid in your blood (lactic acidosis). Lactic acidosis must be treated in the hospital as it may cause death. Before you start taking Videx EC, tell your healthcare provider if you:

have liver problems
are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking Videx EC and Zerit (stavudine).
are overweight
have been treated for a long time with other medicines to treat HIV

It is important to call your healthcare provider right away if you:

feel weak or tired
have unusual (not normal) muscle pain
have trouble breathing
have stomach pain with nausea and vomiting
feel cold, especially in your arms and legs
feel dizzy or light-headed
have a fast or irregular heartbeat

3. Liver problems. Serious liver problems have happened in some people (including pregnant women) who take Videx EC. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and high blood pressure in the large vein of the liver (portal hypertension). Severe liver problems can lead to liver transplantation or death in some people taking Videx EC. Your healthcare provider should check your liver function while you are taking Videx EC. You should be especially careful if you have a history of heavy alcohol use or liver problems.

It is important to call your healthcare provider right away if you have:

yellowing of your skin or the white of your eyes (jaundice)
dark urine
pain on the right side of your stomach
swelling of your stomach
easy bruising or bleeding
loss of appetite
nausea or vomiting
vomiting blood or dark colored stools (bowel movements)

Do not take Videx EC if you take:

Zyloprim, Lopurin, Aloprim (allopurinol)
Copegus, Rebetol, Ribasphere, Ribavirin, Virazole (ribavirin)

Do not drink alcohol while taking Videx EC. Alcohol may increase your risk of getting pain and swelling of your pancreas (pancreatitis) or may damage your liver.

Videx EC Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Videx EC there are no specific foods that you must exclude from your diet when receiving Videx EC.

Inform MD

Before you take Videx EC, tell your healthcare provider if you:

have or had kidney problems
have or had liver problems (such as hepatitis)
have or had persistent numbness, tingling, or pain in the hands or feet (neuropathy)
have any other medical conditions
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Videx EC and Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Videx EC will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Videx EC. You and your healthcare provider will decide if you should take Videx EC while you are pregnant.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

Videx EC and Lactation

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if Videx EC can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Videx EC Usage

Take Videx EC exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much Videx EC to take and when to take it.
Your healthcare provider may change your dose. Do not change your dose of Videx EC without talking to your healthcare provider.
Do not take Videx EC with food. Take Videx EC on an empty stomach.
Take Videx EC capsules whole. Do not break, crush, dissolve, or chew Videx EC capsules before swallowing. If you cannot swallow Videx EC capsules whole, tell your healthcare provider. You may need a different medicine.
Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
Some medicines should not be taken at the same time of day that you take Videx EC. Check with your healthcare provider.
If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take Videx EC. Your healthcare provider may also lower your dosage of Videx EC if your kidneys are not working well.
If you take too much Videx EC, contact a poison control center or emergency room right away.

Videx EC Dosage

Take Videx EC exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dosage is based on body weight as follows:

20 kg to less than 25 kg - 200 mg once daily
25 kg to less than 60 kg - 250 mg once daily
at least 60 kg - 400 mg once daily.

Videx EC Overdose

If you take too much Videx EC, contact a poison control center or emergency room right away.

Forms of Videx EC

Active Ingredients: didanosine

Inactive Ingredients:

Carboxymethylcellulose sodium 12, diethyl phthalate, methacrylic acid copolymer, sodium hydroxide, sodium starch glycolate, talc, gelatin, and titanium dioxide.

Other Requirements

Store Videx EC capsules in a tightly closed container between 59° F to 86° F (15° C to 30° C)
Safely throw away any unused Videx EC

Keep Videx EC and all medicines out of the reach of children and pets.

Videx EC FDA Warning

WARNING: PANCREATITIS, LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine used alone or in combination regimens in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. Videx EC should be suspended in patients with suspected pancreatitis and discontinued in patients with confirmed pancreatitis.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including didanosine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. The combination of didanosine and stavudine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk.