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Videx EC

Generic Name: didanosine (Oral route)

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Oral route(Capsule, Delayed Release;Powder for Solution)

Fatal and nonfatal pancreatitis has occurred during therapy with didanosine. Didanosine 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. 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 .

Commonly used brand name(s)

In the U.S.

  • Videx
  • Videx EC
  • Videx Pediatric

Available Dosage Forms:

  • Powder for Suspension
  • Tablet, Chewable
  • Powder for Solution
  • Capsule, Delayed Release

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For Videx EC

Didanosine is used in combination with other medicines for the treatment of human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Didanosine will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease. Didanosine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have the problems usually related to AIDS or HIV disease.

Slideshow: Flashback: FDA Drug Approvals 2013

This medicine is available only with your doctor's prescription.

The buffered tablets that are to be chewed, crushed or mixed with water are no longer available in the United States. This product was voluntarily discontinued, and it was not due to safety concerns. Didanosine delayed-release capsules (Videx® EC) and pediatric powder for oral solution are still available.

Before Using Videx EC

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of didanosine in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of didanosine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving didanosine.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Allopurinol
  • Ribavirin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Hydroxyurea
  • Stavudine
  • Tenofovir Disoproxil Fumarate
  • Zalcitabine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atazanavir
  • Atevirdine
  • Ciprofloxacin
  • Delavirdine
  • Enoxacin
  • Ganciclovir
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Lomefloxacin
  • Methadone
  • Metoclopramide
  • Moxifloxacin
  • Nelfinavir
  • Norfloxacin
  • Ofloxacin
  • Ranitidine
  • Rifabutin
  • Ritonavir
  • Sulfamethoxazole
  • Trimethoprim
  • Trovafloxacin Mesylate
  • Valganciclovir

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Alcohol use, active or history of or
  • Liver disease (including hepatitis) or
  • Obesity (overweight) or
  • Pancreatitis (inflammation of the pancreas), history of or
  • Peripheral neuropathy (nerve disorder), history of—Use with caution. May cause side effects to become worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Portal hypertension (high blood pressure in the portal vein of the liver)—Use with caution. May make this condition worse.

Proper Use of didanosine

This section provides information on the proper use of a number of products that contain didanosine. It may not be specific to Videx EC. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Keep taking didanosine for the full time of treatment, even if you begin to feel better. Only take medicine that your doctor has prescribed specifically for you. Do not share your medicine with other people.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. If you need help in planning the best times to take your medicine, check with your doctor.

Didanosine should be taken on an empty stomach since food may keep it from working properly. Didanosine oral liquid should be taken at least 30 minutes before or 2 hours after you eat.

Swallow the delayed-release capsule whole. Do not break, crush, chew, or open it.

Shake the oral liquid before use. Measure each dose with a specially marked measuring spoon or measuring cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For HIV infection:
    • For oral dosage form (delayed-release capsules):
      • Adults, teenagers, and children who can swallow capsules—Dose is based on body weight and must be determined by your doctor.
        • For patients weighing 60 kilograms (kg) or more—400 milligrams (mg) once a day.
        • For patients weighing 25 kg to less than 60 kg—250 mg once a day.
        • For patients weighing 20 kg to less than 25 kg—200 mg once a day.
      • Children weighing less than 20 kg—The oral capsules are not given to small children.
    • For oral dosage form (solution):
      • Adults weighing 60 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The usual dose is 200 milligrams (mg) two times a day or 400 mg once a day.
      • Adults weighing less than 60 kg—Dose is based on body weight and must be determined by your doctor. The usual dose is 125 mg two times a day or 250 mg once a day.
      • Teenagers, children, and infants 8 months of age and older—Dose is based on body size and must be determined by your doctor. The usual dose is 120 milligrams per square meter (mg/m(2)) two times a day.
      • Infants 2 weeks to 8 months old—Dose is based on body size and must be determined by your doctor. The usual dose is 100 mg/m(2) two times a day.
      • Infants younger than 2 weeks old—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the delayed-release capsules in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the oral liquid in the refrigerator. Throw away any unused medicine after 30 days.

Precautions While Using Videx EC

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use didanosine if you or your child are also using allopurinol (Zyloprim®) or ribavirin (Copegus®, Rebetol®). Using these medicines together may cause serious side effects.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking a anti-viral medicine.

HIV may be acquired from or spread to other people through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent transmission of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

This medicine may cause a life-threatening condition called pancreatitis. Stop using this medicine and check with your doctor right away if you or your child have more than one of these symptoms: bloating; chills; constipation; darkened urine; a fast heartbeat; fever; indigestion; loss of appetite; nausea; pains in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have more than one of these symptoms: abdominal or stomach discomfort or cramping; dark urine; decreased appetite; diarrhea; a general feeling of discomfort; light-colored stools; muscle cramping or pain; nausea; unusual tiredness or weakness; trouble with breathing; vomiting; or yellow eyes or skin.

Stop using this medicine and check with your doctor right away if you or your child have abdominal or stomach pain; black, tarry stools; bleeding gums; blood in the urine or stools; pinpoint red spots on the skin; or unusual bleeding or bruising. These may be symptoms of a condition called non-cirrhotic portal hypertension.

Tell your doctor right away if you or your child start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

When you or your child start taking HIV medicines, your immune system may get stronger. If you have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine may cause you or your child to have excess body fat. Tell your doctor right away if you notice changes in your body shape, including an increased amount of body fat in the neck or upper back, face, around the chest, or stomach area. You might also lose fat from your legs, arms, or face.

This medicine may cause changes in vision. Check with your doctor right away if you or your child start to see unusual colors or have blurred vision.

Do not drink alcohol while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Videx EC Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Nausea and vomiting
  • stomach pain
  • tingling, burning, numbness, and pain in the hands or feet
Rare
  • Convulsions (seizures)
  • fever and chills
  • shortness of breath
  • skin rash and itching
  • sore throat
  • swelling of the feet or lower legs
  • unusual bleeding and bruising
  • unusual tiredness and weakness
  • yellow skin and eyes
Incidence not known
  • Abdominal or stomach discomfort
  • anxiety
  • black, tarry stools
  • bleeding gums
  • blindness
  • bloating
  • blood in the urine or stools
  • blue-yellow color blindness
  • blurred vision
  • change in the color of the eye
  • chest pain
  • clay colored stools
  • cold sweats
  • coma
  • confusion
  • constipation
  • cool, pale skin
  • cough
  • dark urine
  • decreased appetite
  • decreased vision
  • depression
  • diarrhea
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • dry eyes
  • dry mouth
  • eye pain
  • fast heartbeat
  • fast, shallow breathing
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of discomfort
  • headache
  • hives
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • joint pain
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle aching, cramping, or pain
  • nervousness
  • nightmares
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • right upper abdominal pain and fullness
  • shakiness
  • sleepiness
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomachache
  • sweating
  • swollen glands
  • swollen joints
  • tightness in the chest
  • troubled breathing with exertion
  • unexplained weight loss
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty with sleeping
  • irritability
  • restlessness
Incidence not known
  • Acid or sour stomach
  • belching
  • excess air or gas in the stomach or intestines
  • full feeling
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • lack or loss of strength
  • passing gas
  • redistribution or accumulation of body fat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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