Videx EC (Didanosine Delayed-Release Capsules - Enteric-Coated Beadlets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Videx EC

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Videx EC

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VIDEX EC
(didanosine, USP)

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 [see WARNINGS AND PRECAUTIONS].

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 [see WARNINGS AND PRECAUTIONS].

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 »

Last reviewed on RxList: 12/5/2011
This monograph has been modified to include the generic and brand name in many instances.