Videx PediatricGeneric Name: didanosine (Oral route)
Oral routeCapsule, Delayed ReleasePowder for Solution
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. 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 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 .
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 Pediatric
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.
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 Pediatric
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
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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 or—May cause side effects to become worse.
Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
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 Pediatric. 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 with your doctor first.
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 solution 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 solution 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.
Children and infants over 8 months old—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 solution in the refrigerator. Throw away any unused medicine after 30 days.
Precautions While Using Videx Pediatric
It is very important that your doctor check your 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 are also using allopurinol (Zyloprim®) or ribavirin (Copegus®, Rebetol®). Using these medicines together may cause serious side effects.
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 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.
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 Pediatric 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 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
