Generic Name: Didanosine Brand Name(s): Didanosine.

Uses

What is Didanosine used for?

Didanosine is commonly used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Didanosine belongs to a class of drugs known as nucleoside reverse transcriptase inhibitors-NRTI.

Didanosine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How should I take Didanosine?

Take this medication by mouth usually once daily on an empty stomach, at least 1 and 1/2 hours before or 2 hours after a meal, or as directed by your doctor. Swallow the capsules whole. Do not crush, chew, or open the capsules. Doing so may decrease their effectiveness.

The dosage is based on your weight, medical condition, and response to treatment.

It is very important to continue taking this medication (and other HIV medications) exactly as prescribed by your doctor. Do not skip any doses. Do not increase your dose, take this drug more often than prescribed, or stop taking it (or other HIV medicines) even for a short time unless directed to do so by your doctor. Skipping or changing your dose without approval from your doctor may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same time(s) each day.

How do I store Didanosine?

Store the tablets or capsules at room temperature in a tightly closed container, away from moisture and heat.

Store the liquid form of didanosine in the refrigerator. Throw away any leftover didanosine liquid that is more than 30 days old.

Precautions & warnings

What should I know before using Didanosine?

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 benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease such as high blood pressure, diabetes, or high cholesterol levels.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, caution is advised when using this drug in older adults because they may be more sensitive to the effects of the drug, especially the increased risk of pancreatitis.

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and didanosine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Didanosine during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Didanosine. This Didanosine is pregnancy risk category B according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Didanosine?

Headache or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).

This medication can cause severe nerve problems in the hands/feet/legs (peripheral neuropathy). Symptoms may include numbness/tingling/pain in the palms of the hand or soles of the feet. If you experience any of these symptoms, contact your doctor right away so that you can be monitored closely. Your doctor may decide to reduce or stop your dose of didanosine.

Tell your doctor right away if any of these rare but very serious side effects occur: vision problems (such as blurred vision, difficulty seeing colors), vomiting up blood, belly/abdominal swelling, easy bruising or bleeding.

Changes in body fat may occur while you are taking HIV medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of therapy with your doctor, as well as the possible role of exercise to reduce this side effect.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Didanosine?

Some products that may interact with this drug include: orlistat, ribavirin, methadone, allopurinol, drugs that are known to cause nerve problems (such as isoniazid, vincristine), drugs known to cause pancreatitis (such as pentamidine, ganciclovir, co-trimoxazole), stavudine.

Didanosine may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Didanosine?

Didanosine may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Didanosine?

Didanosine may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Didanosine.

What is the dose of Didanosine for an adult?

Usual Adult Dose for HIV Infection

Delayed-release Capsules:

-Less than 60 kg: 250 mg orally once a day

-At least 60 kg: 400 mg orally once a day

Oral Solution:

Preferred dosing:

-Less than 60 kg: 125 mg orally twice a day

-At least 60 kg: 200 mg orally twice a day

For patients requiring once-daily dosing:

-Less than 60 kg: 250 mg orally once a day

-At least 60 kg: 400 mg orally once a day

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Renal Dose Adjustments

Adult Patients:

Delayed-release capsules:

CrCl 30 to 59 mL/min:

-Less than 60 kg: 125 mg orally once a day

-At least 60 kg: 200 mg orally once a day

CrCl 10 to 29 mL/min:

-Less than 60 kg: 125 mg orally once a day

-At least 60 kg: 125 mg orally once a day

CrCl less than 10 mL/min:

-Less than 60 kg: Not recommended; an alternate formulation should be used.

-At least 60 kg: 125 mg orally once a day

Oral solution:

CrCl 30 to 59 mL/min:

-Less than 60 kg: 150 mg orally once a day OR 75 mg orally twice a day

-At least 60 kg: 200 mg orally once a day OR 100 mg orally twice a day

CrCl 10 to 29 mL/min:

-Less than 60 kg: 100 mg orally once a day

-At least 60 kg: 150 mg orally once a day

CrCl less than 10 mL/min:

-Less than 60 kg: 75 mg orally once a day

-At least 60 kg: 100 mg orally once a day

Comments:

-Coadministration with tenofovir DF: The appropriate dose of this drug has not been established in adults with CrCl less than 60 mL/min.

Liver Dose Adjustments

No adjustment recommended.

Dose Adjustments

Coadministration of either formulation with tenofovir DF:

Adult patients (CrCl at least 60 mL/min):

-Less than 60 kg: 200 mg orally once a day

-At least 60 kg: 250 mg orally once a day

Pediatric patients: Data not available

Comments:

-Delayed-release capsules: Should be taken together with tenofovir DF and a light meal (up to 400 kcal, up to 20% fat) or in the fasted state

-Oral solution: May be taken together with tenofovir DF in the fasted state; alternatively, if tenofovir DF is taken with food, this formulation should be taken on an empty stomach.

-Patients should be monitored closely for didanosine-related side effects.

-According to some experts, this combination is not generally recommended.

Dialysis

Hemodialysis or CAPD:

Adult Patients:

Delayed-release capsules:

-Less than 60 kg: Not recommended; an alternate formulation should be used.

-At least 60 kg: 125 mg orally once a day

Oral solution:

-Less than 60 kg: 75 mg orally once a day

-At least 60 kg: 100 mg orally once a day

Comments:

-No supplemental dose required after hemodialysis.

Other Comments

Administration advice:

-Administer each formulation on an empty stomach; administer the oral solution at least 30 minutes before or 2 hours after a meal.

-Delayed-release capsules: Swallow whole; do not break, chew, crush, dissolve, or open.

-For patients unable to reliably swallow a capsule, use the pediatric powder for oral solution.

-Oral solution: Shake well before each use; discard any unused portion after 30 days.

Storage requirements:

-Capsules: Store in tightly-closed bottle at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

-Pediatric powder for oral solution: Store the bottles of powder at 15C to 30C (59F to 86F); may store the reconstituted solution (final admixture) in the refrigerator at 2C to 8C (36F to 46F) for up to 30 days

Reconstitution/preparation techniques:

-Pediatric powder for oral solution: The manufacturer product information should be consulted.

Monitoring:

-General: Ultrasonography

-Hematologic: For early signs of portal hypertension, such as thrombocytopenia and splenomegaly (during routine medical visits); albumin, complete blood count, INR

-Hepatic: Liver enzymes, serum bilirubin; liver function in patients with preexisting liver dysfunction (according to standard practice)

-Ocular: Retinal examinations (periodically during therapy)

-Renal: Renal function in elderly patients (during therapy)

Patient advice:

-Read the US FDA-approved patient labeling (Medication Guide).

-Get regular eye examinations while using this drug.

What is the dose of Didanosine for a child?

Usual Pediatric Dose for HIV Infection

Delayed-release capsules:

20 to less than 25 kg: 200 mg orally once a day

25 to less than 60 kg: 250 mg orally once a day

At least 60 kg: 400 mg orally once a day

Oral solution:

2 weeks to 8 months: 100 mg/m2 orally twice a day

Older than 8 months: 120 mg/m2 orally twice a day

-Maximum dose:

—Less than 60 kg: 125 mg/dose

—At least 60 kg: 200 mg/dose

Comments:

-Oral solution: The adult dose should not be exceeded.

Use: In combination with other antiretroviral agents, for the treatment of HIV-1 infection

Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV Recommendations:

Delayed-release capsules:

6 years or older:

20 to less than 25 kg: 200 mg orally once a day

25 to less than 60 kg: 250 mg orally once a day

At least 60 kg: 400 mg orally once a day

Oral solution:

2 weeks to less than 3 months: 50 mg/m2 orally every 12 hours

3 to 8 months: 100 mg/m2 orally every 12 hours

Older than 8 months: 120 mg/m2 (dose range: 90 to 150 mg/m2) orally every 12 hours

-Maximum dose:

—Less than 60 kg: 250 mg/day

—At least 60 kg: 400 mg/day

Comments:

-This drug is not recommended due to significant toxicity and availability of safer agents.

-Viral suppression has been effective in therapy-naive patients (3 years or older) administered 240 mg/m2 orally once a day (either formulation).

-BSA-based dosing should not exceed maximum adult dose.

-Combination therapy with tenofovir disoproxil fumarate (DF) is not recommended.

-Current guidelines should be consulted for additional information.

How is Didanosine available?

Didanosine is available in the following dosage forms and strengths:

  • Oral powder for reconstitution
  • Oral tablet, chewable
  • Oral delayed release capsule

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Didanosine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

 

Review Date: January 22, 2018 | Last Modified: January 22, 2018

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