Didanosine Oral Solution

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Belly pain.
• Upset stomach or throwing up.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Didanosine for Oral Solution  is white to almost white, crystalline powder and is supplied in 2 g/bottle per carton and 4 g/bottle per carton.

Pregnancy

Teratogenic Effects

Pregnancy Category B
 
Reproduction studies have been performed in rats and rabbits at doses up to 12 and 14.2 times the estimated human exposure (based upon plasma levels), respectively, and have revealed no evidence of impaired fertility or harm to the fetus due to didanosine. At approximately 12 times the estimated human exposure, didanosine was slightly toxic to female rats and their pups during mid and late lactation. These rats showed reduced food intake and body weight gains but the physical and functional development of the offspring was not impaired and there were no major changes in the F2 generation. A study in rats showed that didanosine and/or its metabolites are transferred to the fetus through the placenta. Animal reproduction studies are not always predictive of human response.
 
There are no adequate and well-controlled studies of didanosine in pregnant women. Didanosine should be used during pregnancy only if the potential benefit justifies the potential risk.
 
Fatal lactic acidosis has been reported in pregnant women who received the combination of didanosine and stavudine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in nonpregnant individuals receiving nucleoside analogues [see Warnings and Precautions (5.2)]. 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. Healthcare providers caring for HIV-infected pregnant women receiving didanosine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome.

Antiretroviral Pregnancy Registry
 
To monitor maternal-fetal outcomes of pregnant women exposed to didanosine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV. A study in rats showed that following oral administration, didanosine and/or its metabolites were excreted into the milk of lactating rats. It is not known if didanosine is excreted in human milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving didanosine.

Pediatric Use

Use of didanosine in pediatric patients from 2 weeks of age through adolescence is supported by evidence from adequate and well-controlled studies of didanosine in adult and pediatric patients [see Dosage and Administration (2), Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

Geriatric Use

In an Expanded Access Program for patients with advanced HIV infection, patients aged 65 years and older had a higher frequency of pancreatitis (10%) than younger patients (5%) [see Warnings and Precautions (5.1)]. Clinical studies of didanosine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects. Didanosine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection. In addition, renal function should be monitored and dosage adjustments should be made accordingly [see Dosage and Administration (2.2)].

Renal Impairment

Patients with renal impairment (creatinine clearance of less than 60 mL/min) may be at greater risk of toxicity from didanosine due to decreased drug clearance [see Clinical Pharmacology (12.3)]. A dose reduction is recommended for these patients [see Dosage and Administration (2)].

Didanosine for Oral Solution, USP is white to almost white, crystalline powder and is supplied as follows:
 
      2 g/bottle per carton             NDC 65862-109-02
      4 g/bottle per carton             NDC 65862-110-04
 
Prior to dispensing, the pharmacist must reconstitute dry powder with Purified Water, USP, to an initial concentration of 20 mg/mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg/mL as follows:
 
20 mg/mL Initial Solution 
 
Reconstitute the product to 20 mg/mL by adding 100 mL or 200 mL of Purified Water, USP, to the 2 g or 4 g of didanosine powder, respectively, in the product bottle. 
 
10 mg/mL Final Admixture
 

1. Immediately mix one part of the 20 mg/mL initial solution with one part of Maximum Strength Mylanta® Liquid for a final dispensing concentration of 10 mg didanosine per mL. For patient home use, the admixture should be dispensed in appropriately sized, flint-glass or plastic (HDPE, PET, or PETG) bottles with child-resistant closures.
2. Instruct the patient to shake the admixture thoroughly prior to use and to store the tightly closed container in the refrigerator.

Storage
 
Storedry powder at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F) [ see USP Controlled Room Temperature] .
 
The didanosine admixture may be stored up to 30 days in a refrigerator, 36° to 46°F (2° to 8°C). Discard any unused portion after 30 days.
 
Mylanta® is a registered trademark of Johnson & Johnson-Merck Consumer Pharmaceuticals Company.

Didanosine for Oral Solution, USP  

(didanosine, also known as ddI)
 
Read this Medication Guide before you start taking didanosine for oral solution and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. You and your healthcare provider should talk about your treatment with didanosine for oral solution before you start taking it and at regular check-ups. You should stay under your healthcare provider's care when taking didanosine for oral solution.

What is the most important information I should know about didanosine for oral solution?

Didanosine for oral solution may cause serious side effects, including:
 
1. Swelling of your pancreas (pancreatitis) that may cause death. Pancreatitis can happen at any time during your treatment with didanosine for oral solution. Before you start taking didanosine for oral solution, tell your healthcare provider if you:
 

• have had pancreatitis
• have advanced HIV (human immunodeficiency virus) infection
• have kidney problems
• drink alcoholic beverages
• take a medicine called ZERIT® (stavudine)

It is important to call your healthcare provider right away if you have:

• stomach pain
• swelling of your stomach
• nausea and vomiting
• fever

2.  Build-up of acid in your blood (lactic acidosis). Lactic acidosis must be treated in the hospital as it may cause death. The risk for lactic acidosis may be higher if you:
  

• have liver problems
• are pregnant. There have been deaths reported in pregnant women who get lactic acidosis after taking didanosine for oral solution and ZERIT (stavudine).
• are overweight
• have been treated for a long time with other medicines to treat HIV 

It is important to call your health care provider right away if you:

• feel weak or tired
• have unusual (not normal) muscle pain
• have trouble breathing
• have stomach pain with nausea and vomiting
• feel cold, especially in your arms and legs
• feel dizzy or light-headed
• have a fast or irregular heartbeat  

3.  Liver problems. Some people (including pregnant women) who have taken didanosine for oral solution have had serious liver problems. These problems include liver enlargement (hepatomegaly), fat in the liver (steatosis), liver failure, and high blood pressure in the large vein of the liver (portal hypertension). Severe liver problems can lead to liver transplantation or death in some people taking didanosine for oral solution. Your healthcare provider should check your liver function while you are taking didanosine for oral solution. You should be especially careful if you have a history of heavy alcohol use or liver problems.

It is important to call your healthcare provider right away if you have:
 

• yellowing of your skin or the white of your eyes (jaundice)
• dark urine
• pain on the right side of your stomach
• swelling of your stomach
• easy bruising or bleeding
• loss of appetite
• nausea or vomiting
• vomiting blood or dark colored stools (bowel movements)

What is didanosine for oral solution?
 
Didanosine for oral solution is a prescription medicine used with other antiretroviral medicines to treat human immunodeficiency virus (HIV) infection in children and adults. Didanosine for oral solution belongs to a class of drugs called nucleoside analogues. 

Didanosine for oral solution will not cure your HIV infection. At present there is no cure for HIV infection. Even while taking didanosine for oral solution, you may continue to have HIV-related illnesses, including infections with other disease-producing organisms. Continue to see your healthcare provider regularly and report any medical problems that occur.

Who should not take didanosine for oral solution?
 
Do not take didanosine for oral solution if you take:
 

• ZYLOPRIM®, LOPURIN®, ALOPRIM® (allopurinol)
• COPEGUS®, REBETOL®, RIBASPHERE®, RIBAVIRIN®, VIRAZOLE® (ribavirin) 

What should I tell my healthcare provider before taking didanosine for oral solution?
 
Before you take didanosine for oral solution, tell your healthcare provider if you: 
 

• have or had kidney problems
• have or had liver problems (such as hepatitis)
• have or had persistent numbness, tingling, or pain in the hands or feet (neuropathy)
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if didanosine for oral solution will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking didanosine for oral solution. You and your healthcare provider will decide if you should take didanosine for oral solution while you are pregnant.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. Talk to your doctor about how you can take part in this registry.

• are breastfeeding or plan to breastfeed. Do not breastfeed. It is not known if didanosine can be passed to your baby in your breast milk and whether it could harm your baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the baby in the breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Didanosine for oral solution may affect the way other medicines work, and other medicines may affect how didanosine for oral solution works.
 
Especially tell your healthcare provider if you take: 
 

• VIREAD® (tenofovir disoproxil fumarate)
• DROXIA®, HYDREA® (hydroxyurea)
• RESCRIPTOR® (delavirdine mesylate)
• CYTOVENE®, VALCYTE® (ganciclovir)
• CRIXIVAN® (indinavir)
• DOLOPHINE® HYDROCHLORIDE, METHADOSE® (methadone)
• VIRACEPT® (nelfinavir)
• antacids
• antifungal medicines such as NIZORAL® (ketoconazole) or SPORANOX® (itraconazole)
• quinolone antibiotics such as CIPRO®, PROQUIN® XR (ciprofloxacin)
• tetracycline antibiotics such as BRISTACYCLINE®, SUMYCIN® (tetracycline)
• alcoholic beverages

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
 
Ask your healthcare provider if you are not sure if you take one of the medicines listed above.

How should I take didanosine for oral solution? 
 

• Take didanosine for oral solution exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much didanosine for oral solution to take and when to take it.
• Your healthcare provider may change your dose. Do not change your dose of didanosine for oral solution without talking to your healthcare provider.
• Do not take didanosine for oral solution with food. Take didanosine for oral solution on an empty stomach at least 30 minutes before or 2 hours after you eat.
• Try not to miss a dose, but if you do, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.
• Some medicines should not be taken at the same time of day that you take didanosine for oral solution. Check with your healthcare provider.
• If your kidneys are not working well, your healthcare provider will need to do regular blood and urine tests to check how they are working while you take didanosine for oral solution. Your healthcare provider may also lower your dosage of didanosine for oral solution if your kidneys are not working well.
• If you take too much didanosine for oral solution, contact a poison control center or emergency room right away.

What should I avoid while taking didanosine for oral solution?
 

• Alcohol. Do not drink alcohol while you take didanosine for oral solution. Alcohol may increase your risk of getting pain and swelling of your pancreas (pancreatitis) or may damage your liver.

What are the possible side effects of didanosine for oral solution?
 
Didanosine for oral solution can cause pancreatitis, lactic acidosis, and liver problems. See “What is the most important information I should know about didanosine for oral solution?” at the beginning of this Medication Guide.
 

• Vision changes. You should have regular eye exams while you take didanosine for oral solution.
• Peripheral neuropathy. Symptoms include: numbness, tingling, or pain in your hands or feet. This condition is more likely to happen in people who have had it before, in patients taking medicines that affect the nerves, and in people with advanced HIV disease. A child may not notice these symptoms. Ask your child's healthcare provider for the signs and symptoms of peripheral neuropathy in children.
• Changes in your immune system (immune reconstitution syndrome). Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider if you start having new or worse symptoms of infection after you start taking HIV medicine.
• Changes in body fat (fat redistribution). Changes in body fat have been seen in people who take antiretroviral medicines. These changes may include:

• more fat in or around your 

         -   upper back and neck (buffalo hump)
         -   breasts or chest
         -   trunk 

• less fat in your 

      -   legs
      -   arms
      -   face
 
Tell your healthcare provider if you have any of the symptoms listed above.
 
The most common side effects of didanosine for oral solution include:
 

• diarrhea
• stomach pain
• nausea
• vomiting
• headache
• rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of didanosine for oral solution. For more information, ask your healthcare provider or pharmacist. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at l-800-FDA-1088.
 
How should I store didanosine for oral solution? 
 
Store the didanosine for oral solution mixture in a tightly closed container in the refrigerator between 36° to 46°F (2° to 8°C) for up to 30 days.
 

• Safely throw away any unused didanosine for oral solution after 30 days.

Keep didanosine for oral solution and all medicines out of the reach of children and pets.
 
General information about the safe and effective use of didanosine for oral solution 
 
Avoid doing things that can spread HIV-1 infection to others.
 

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom or other barrier method to lower the chance of sexual contact with semen, vaginal secretions, or blood.
  

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use didanosine for oral solution for a condition for which it was not prescribed. Do not give didanosine for oral solution to other people, even if they have the same symptoms as you have. It may harm them. Do not keep medicine that is out of date or that you no longer need. Dispose of unused medicines through community take-back disposal programs when available or place didanosine for oral solution in an unrecognizable closed container in the household trash. 
 
This Medication Guide summarizes the most important information about didanosine for oral solution. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about didanosine for oral solution that is written for health professionals. For more information, call 1-866-850-2876.
 
What are the ingredients in didanosine for oral solution? 
 
Active Ingredient: didanosine 

Inactive Ingredients: 
 
Pediatric Oral Solution: Maximum Strength Mylanta® Liquid. 

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.
 
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
 
Revised: 02/2012
 
This Medication Guide has been approved by the U.S. Food and Drug Administration.

NDC 65862-109-02
Didanosine for Oral Solution, USP 
2 g
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
Rx only
AUROBINDO

NDC 65862-110-04
Didanosine for Oral Solution, USP
4 g
PHARMACIST: Dispense the Medication
Guide provided separately to each patient.
Rx only
AUROBINDO

NDC 65862-110-04
Didanosine for Oral Solution, USP
4 g
PHARMACIST: Dispense the Medication Guide
provided separately to each patient.
Rx only
AUROBINDO

DIDANOSINE  didanosine powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-109 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDANOSINE (DIDANOSINE) DIDANOSINE 10 mg  in 1 mL

Product Characteristics Color WHITE (White to almost white) Score      Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:65862-109-02 1 BOTTLE in 1 CARTON 1 200 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078112 03/08/2007

DIDANOSINE  didanosine powder, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:65862-110 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIDANOSINE (DIDANOSINE) DIDANOSINE 10 mg  in 1 mL

Product Characteristics Color WHITE (White to almost white) Score      Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:65862-110-04 1 BOTTLE in 1 CARTON 1 400 mL in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078112 03/08/2007

Labeler - Aurobindo Pharma Limited (650082092)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		918917642	ANALYSIS(65862-109, 65862-110), MANUFACTURE(65862-109, 65862-110)

Establishment
Name	Address	ID/FEI	Operations
Aurobindo Pharma Limited		918917662	API MANUFACTURE(65862-109, 65862-110)

Revised: 03/2013   Aurobindo Pharma Limited

Didanosine is an oral drug used to treat human immunodeficiency virus (HIV) infection. It’s always taken with other antiretroviral drugs.

The adult dose ranges from 200 mg to 400 mg, taken twice per day. Your dosage is calculated according to your body weight.

Rare but serious side effects can include pancreatitis and liver toxicity. Tell your doctor if you have stomach bloating, pain, severe nausea, vomiting, or yellowing of the whites of your eyes or skin.

Didanosine can cause vision changes. You may need eye exams while taking it.

Some people experience tingling fingers and toes while taking didanosine. Call your doctor if you experience these effects.

IMPORTANT INFORMATION

• FDA warning See Details

• May cause immune reconstitution syndrome See Details

What is didanosine?

This drug is a prescription drug. It is available in these forms: oral delayed-release capsule, oral solution.

This drug is used as part of a combination therapy. That means you will need to take it in combination with other drugs.

This drug is available in its generic form. Generic drugs may cost less but don’t always come in the same strengths or forms as brand name drugs. Talk to your healthcare provider to see if the generic will work for you.

Why it's used

This drug is used in combination with other antiretroviral drugs to treat human immunodeficiency virus (HIV) infection. It doesn’t cure HIV, but it may help to control it.

How it works

This drug works by acting on an enzyme called reverse transcriptase, which human immunodeficiency virus (HIV) needs to make copies of itself.

More Details