What is the most important information I should know about Videx?

• Serious, even fatal, cases of pancreatitis (inflammation of the pancreas) have been reported with the use of Videx. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.
• Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.
• Avoid alcohol while taking Videx. Alcohol may increase the risk of damage the pancreas and/ or liver.
• Take Videx on an empty stomach at least 30 minutes before or 2 hours after a meal.

What is Videx?

• Videx is an antiviral medication. It is in a category of HIV medicines called reverse transcriptase inhibitors. Videx inhibits the reproduction of HIV in the body.
• Videx is used to treat the human immunodeficiency virus (HIV), which causes the acquired immunodeficiency syndrome (AIDS). Videx is not a cure for HIV or AIDS.
• Videx may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Videx?

• Before taking Videx, tell your doctor if you
  • have liver disease;
  • have kidney disease;
  • have a history of pancreatitis;
  • have numbness or tingling in your hands or feet (peripheral neuropathy);
  • have gout; or
  • consume alcohol.
• You may not be able to take Videx, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• The chewable and dispersible buffered-tablet forms of Videx contain phenylalanine. Individuals with phenylketonuria (PKU) need to monitor intake of this additive. The buffered tablets also contain sodium, which must be monitored by patients on sodium-restricted diets.
• Videx is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take Videx without first talking to your doctor if you are pregnant or could become pregnant. It is very important to treat HIV/ AIDS during pregnancy to reduce the risk of infecting the baby. Talk to your doctor about treatment options.
• It is not known whether Videx passes into breast milk. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed. Do not take Videx without first talking to your doctor if you are breast-feeding a baby.

How should I take Videx?

• Take Videx exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Take Videx on an empty stomach at least 30 minutes before or 2 hours after a meal.
• Chew or crush and swallow the chewable tablets. Alternatively, the chewable tablets can be dissolved in at least 1 ounce of water (for every two tablets). The crushed-tablet suspension is stable at room temperature for up to 1 hour but should be consumed as soon as possible after mixing. If additional flavor is desired, 1 ounce of clear apple juice can be added to this mixture, which should then be consumed immediately.
• Mix the buffered powder with at least 4 ounces of water for each packet of powder. This powder must be mixed only with water. Do not add juice or any other liquid. The suspension is good at room temperature for up to 4 hours. However, it should be consumed as soon as possible after mixing.
• To ensure that you measure a correct dose, measure the pediatric liquid form of Videx with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Shake the liquid well before measuring a dose.
• Do not crush, chew, or open the Videx EC capsules. Swallow them whole. They have a special coating that must not be broken until it dissolves in the small intestine.
• Treatment of HIV/ AIDS almost always requires the use of two or more drugs. If you need to stop taking one of the medicines you are taking for HIV, you should stop all of them until you can talk to your doctor.
• Store the Videx tablets and powder at room temperature away from moisture and heat.
• Store the pediatric suspension in the refrigerator for up to 30 days then throw away any unused liquid.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication.

What happens if I overdose?

• Seek emergency medical attention.
• Symptoms of a Videx overdose include inflammation of the pancreas (abdominal pain, nausea, vomiting); liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue); numbness or tingling in the hands or feet; diarrhea; and painful joints.

What should I avoid while taking Videx?

• Avoid alcohol while taking Videx. Alcohol may increase the risk of damage the pancreas and/ or liver.
• Videx is not a cure for HIV or AIDS, and the virus can still be transmitted to others during with the medication. Follow your doctor's instructions with respect to high-risk activities such as unprotected sex and the sharing of needles.

What are the possible side effects of Videx?

• Serious, even fatal, cases of pancreatitis (inflammation of the pancreas) have been reported with the use of Videx. Notify your doctor immediately if you develop symptoms of pancreatitis including nausea, vomiting, diarrhea, abdominal pain.
• Lactic acidosis and severe liver problems, including fatal cases, have been reported with the use of reverse transcriptase inhibitors, alone or in combination. Contact your doctor immediately if you experience nausea, vomiting, or unusual or unexpected stomach discomfort; weakness and tiredness; shortness of breath; weakness in the arms and legs; yellowing of the skin or eyes; or pain in the upper stomach area. These may be early symptoms of lactic acidosis or liver problems.
• If you experience any of the following serious side effects, stop taking Videx and seek emergency medical attention or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • peripheral neuropathy (nerve damage) which may cause numbness, tingling, or pain in the hands or feet;
  • liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue);
  • a suddenly slow or irregular heartbeat;
  • fever or chills; or
  • visual changes (decreased vision or blindness, or changes in your eye color).
• Other, less serious side effects may be more likely to occur. Continue to take Videx and talk to your doctor if you experience
  • headache;
  • mild nausea, vomiting, upset stomach, diarrhea, or decreased appetite;
  • dryness of the mouth or eyes;
  • a rash; or
  • redistribution of body fat (loss of fat from the arms, legs, and face and increased fat around the neck, breast, and trunk).
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Videx?

• Do not take Videx at the same time as any of the following drugs:
  • tetracycline (Sumycin, Terramycin, Achromycin, others), doxycycline (Doryx, Vibramycin, others), or minocycline (Minocin);
  • ciprofloxacin (Cipro), enoxacin (Penetrex), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), ofloxacin (Floxin), sparfloxacin (Zagam), trovafloxacin (Trovan), or norfloxacin (Noroxin);
  • indinavir (Crixivan);
  • delavirdine (Rescriptor);
  • nelfinavir (Viracept);
  • ritonavir (Norvir);
  • tenofovir (Viread);
  • ketoconazole (Nizoral) or itraconazole (Sporanox); or
  • ribavirin (Rebetol, Rebetron).
• You may not be able to take Videx or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.
• Many drugs other than those listed here may also interact with Videx. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.