Adhansia XR

Adhansia XR (methylphenidate hydrochloride) is a prescription medication used to treat ADHD (attention deficit hyperactivity disorder) in patients aged 6 and older. Adhansia XR belongs to a group of drugs called stimulants. These work by increasing specific chemicals in the brain that can lessen ADHD symptoms.

This medication is available as an extended release capsule. Adhansia XR may be taken whole or the capsule may be opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. 

Common side effects include decreased appetite, insomnia and weight loss.

Adhansia XR is a prescription medicine used to treat ADHD (attention deficit hyperactivity disorder) in patients 6 and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Adhansia XR. See the “Adhansia XR Precautions” section.

Common side effects of Adhansia XR include the following:

• Insomnia
• Dry mouth
• Decreased appetite
• Weight loss

This is not a complete list of Adhansia XR side effects. Ask your doctor or pharmacist for more information. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including ones that you may only be taking for a short time, such as antibiotics.  Especially tell your doctor if you are taking:

• Anti-depressants or other drugs that act as MAOIs (selegiline, linezolid, phenelzine, methylene blue) 
• Stomach acid reducers (omprzaole, pantoprazole, famotidine)

This is not a complete list of Adhansia XR drug interactions.  Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Adhansia XR including:

• Abuse and dependence. Adhansia XR, other methylphenidate containing medicines, and amphetamines have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Adhansia XR. 
• Heart-related problems, including:

• sudden death, stroke, and heart attack in adults
• sudden death in children who have heart problems or heart defects
• increased blood pressure and heart rate

Your healthcare provider should check you or your child carefully for heart problems before starting treatment with Adhansia XR. Tell your healthcare provider if you or your child have any heart problems, heart defects, high blood pressure, or have a family history of these problems.

Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with Adhansia XR. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Adhansia XR.

• Mental (psychiatric) problems, including:
  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with Adhansia XR, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.

• Priapism (prolonged and painful erections) in men. Seek medical attention for an erection lasting longer than 4 hours.
• Peripheral vasculopathy, including Raynaud's phenomenon
  • Tingling in hands or feet
  • Discoloration of fingers or toes
  • Numbness in hands or feet
  • Coldness of extremities 
• Slowing of growth (height and weight) in children. Children should have their height and weight checked often while taking Adhansia XR. Adhansia XR treatment may be stopped if your child is not growing or gaining weight.
• FD&C Yellow No. 5. Adhansia XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin.

Do not take Adhansia XR if you:

• are allergic to any of its ingredients, including FD&C yellow dye #5
• are taking or have taken MAOIs recently
• have heart structure irregularities, cardiomyopathy, serious heart rhythm abnormalities, or coronary artery disease (CAD)
• have pre-existing psychiatric illness

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Adhansia XR, there are no specific foods that you must exclude from your diet when receiving this medication.

It is advised not to drink alcohol while taking Ahansia XR. Alcohol may cause a rapid release of the drug in your body system.

Before you take Adhansia XR tell your doctor about all your medical conditions. Especially tell your doctor if you:

• are allergic to Adhansia XR or to any of its ingredients, including yellow dye #5
• have heart problems
• have a history of psychiatric conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Available data from observational studies of pregnant women taking Adhansia XR is not yet sufficient to determine a link between use of this medication and an increased risk for major birth defects or miscarraige.

There is a pregnancy registry that monitors outcomes of fetal exposure to Adhansia XR. The purpose of the registry is to collect information about the health of females exposed to Adhansia XR and their baby. If you or your child becomes pregnant during treatment with Adhansia XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Tell your doctor if you are breastfeeding or if you plan to breastfeed.

Adhansia XR has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Adhansia XR, a choice should be made whether to stop nursing or stop using this medication. The importance of the drug to the mother should be considered.

• Take Adhansia XR exactly as prescribed by your healthcare provider. 
• Your healthcare provider may change the dose if needed.
• Take Adhansia XR by mouth 1 time each day in the morning. 
• Adhansia XR can be taken with or without food, but take it the same way each time.
  • Swallow Adhansia XR capsules whole. If Adhansia XR capsules cannot be swallowed whole, the capsules may be opened and sprinkled onto a tablespoonful of applesauce or yogurt. Make sure to sprinkle all the medicine onto the applesauce or yogurt. The Adhansia XR dose should not be divided.
    • swallow all the applesauce or yogurt and medicine mixture without chewing right away or within 10 minutes
    • do not chew the applesauce or yogurt
    • do not store applesauce or yogurt and medicine mixture
• Your healthcare provider may sometimes stop Adhansia XR treatment for a while to check ADHD symptoms.
• If a dose of Adhansia XR is missed do not take the dose later in the day or take an extra dose to make up for the missed dose, wait until the next morning to take the next scheduled dose.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Adhansia XR comes in an extended release capsule taken by mouth once daily in the morning. It can be taken with or without food. The recommended starting dose is 25 mg. Adhansia XR dose can be titrated up every 5 days until optimal dose acheived. Doses above 100 mg for adults and 85 mg for adolescents have not been studied and are not advised.

If you take too much Adhansia XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep Adhansia XR at room temperature 20° to 25°C (68° to 77°F).
• Keep this and all medicines out of the reach of children.
• This medication has a risk for abuse and dependence.
• Protect from light and moisture.
• Dispose of any unused medication through proper channels.

• CNS stimulants, including ADHANSIA XR, other methylphenidatecontaining products, and amphetamines, have a high potential for abuse and dependence. 
• Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.