Videx Pediatric

Generic name: Didanosine
Drug class: Nucleoside reverse transcriptase inhibitors (NRTIs)

Usage of 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.

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

stomach pain

tingling, burning, numbness, and pain in the hands or feet

vomiting

Rare

Chills

fever

itching, skin rash

seizures

sore throat

swelling of the feet or lower legs

unusual bleeding and bruising

unusual tiredness and weakness

yellow skin and eyes

Incidence not known

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

confusion

constipation

cool, pale skin

cough

dark urine

decreased appetite

decreased vision

depression

diarrhea

difficulty with moving

difficulty with swallowing

dizziness

dry eyes or 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

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 or stomach pain and fullness

shakiness

sleepiness

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

stomach ache or discomfort

sweating

swollen glands or joints

tightness in the chest

troubled breathing with exertion

unexplained weight loss

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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

Belching

excess air or gas in the stomach or bowels

feeling of fullness

hair loss or thinning of the hair

heartburn

indigestion

lack or loss of strength

passing gas

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.

Before taking 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 2 weeks of age and older.

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.

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

Oxypurinol

Ribavirin

Stavudine

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.

Atazanavir

Cabotegravir

Darunavir

Hydroxyurea

Orlistat

Tacrolimus

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.

Atevirdine

Ciprofloxacin

Delavirdine

Enoxacin

Ganciclovir

Indinavir

Itraconazole

Ketoconazole

Lomefloxacin

Methadone

Metoclopramide

Moxifloxacin

Nelfinavir

Nirmatrelvir

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.

Relate drugs

How to use Videx Pediatric

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 Medication Guide. Read and follow these instructions 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 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) or more—Dose is based on body weight and must be determined by your doctor. The usual dose is 200 milligrams (mg) 2 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 2 times a day or 250 mg once a day.

Children older than 8 months of age—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)) 2 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) 2 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.

Warnings

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®), ribavirin (Copegus®, Rebetol®), or stavudine (Zerit®). Using these medicines together may cause serious side effects.

This medicine may cause a life-threatening condition called pancreatitis. 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 breathing, vomiting, or yellow eyes or skin.

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.

Your immune system may get stronger when you start taking HIV medicines. Sometimes the immune system will start to fight infections that were hidden in your body, such as pneumonia or tuberculosis, or may result in a flare-up of a hidden autoimmune disorder such as Graves' disease, polymyositis, or Guillain-Barré syndrome. Tell your doctor right away if you notice any changes in your health.

This medicine may cause you or your child to lose fat from your legs, arms, or face. Talk to your doctor if you have any concerns.

Check with your doctor right away if you or your child start to see unusual colors or have blurred vision. Your doctor may want you to have your eyes checked regularly by an eye doctor (ophthalmologist).

Do not drink alcohol while you are using this medicine.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

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.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.