Didanosine

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Rarely, didanosine has caused a severe (sometimes fatal) pancreas problem (pancreatitis) when used alone or with other HIV medicines. Immediately tell your doctor if you develop symptoms of pancreatitis (such as nausea/vomiting that doesn't stop, stomach/abdominal/back pain).

Rarely, didanosine has caused a severe (sometimes fatal) liver and blood problem (lactic acidosis). These problems may be more likely in females or people who are overweight (obese). Immediately tell your doctor if you develop symptoms of liver problems (such as nausea that doesn't stop, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, muscle aches, severe weakness). Didanosine should not be used with a certain HIV medicine, stavudine, due to increased risk of these serious side effects.

Read the Medication Guide provided by your pharmacist before you start using didanosine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach (at least 1 and 1/2 hours before or 2 hours after a meal) as directed by your doctor, usually once daily. 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 keep 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.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

See also Warning section.

Headache or diarrhea may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

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 you have any serious side effects, including: vision problems (such as blurred vision, difficulty seeing colors), vomiting up blood, belly/abdominal swelling, easy bruising or bleeding.

Loss of body fat (such as in the face, arms, and legs) may occur while you are taking this medication. This effect may be permanent. Tell your doctor right away if you notice any changes in body fat.

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

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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).

Older adults may be at greater risk for pancreatitis while using this drug.

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 unknown if this medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

See also Warning section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as eye exams, kidney/liver function, complete blood count with platelets, viral load, T-cell counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.