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Aptensio XR extended-release capsules
Generic Name: methylphenidate (METH-il-FEN-i-date)
Brand Name: Examples include Aptensio XR and Ritalin LA
Use Aptensio XR extended-release capsules with caution if you have a history of mental or mood problems, or alcohol or substance abuse or dependence. Abuse of Aptensio XR extended-release capsules may cause it to not work as well. Abuse may also lead to addiction and mental or mood changes. Do not suddenly stop using Aptensio XR extended-release capsules. Depression and other mental problems may occur. Your doctor should slowly lower your dose over a period of time if you need to stop using it.
Aptensio XR extended-release capsules are used for:
Treating attention deficit hyperactivity disorder (ADHD). It may also be used for other conditions as determined by your doctor.
Aptensio XR extended-release capsules are a central nervous system stimulant. Exactly how it works is not known.
Do NOT use Aptensio XR extended-release capsules if:
- you are allergic to any ingredient in Aptensio XR extended-release capsules
- you have severe anxiety, agitation, or tension
- you have glaucoma
- you have motor tics (involuntary movements), Tourette syndrome, or a family history of Tourette syndrome
- you have serious heart problems (eg, heart defect, irregular heartbeat)
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Aptensio XR extended-release capsules:
Some medical conditions may interact with Aptensio XR extended-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have had an allergic reaction to dexmethylphenidate
- if you have a history of high blood pressure, heart problems (eg, heart failure, heart defects, fast or irregular heartbeat), blood vessel problems, or heart attack, or if a family member has a history of any of these problems or sudden death
- if you have a history of seizures or abnormal electroencephalograms (EEGs)
- if you have a history of an overactive thyroid, chronic fatigue, cystic fibrosis, or stomach or bowel problems (eg, blockage, inflammation, narrowing)
- if you have a history of mood or mental problems (eg, agitation, anxiety, bipolar disorder, depression, psychosis, tension), abnormal thoughts, hallucinations, suicidal thoughts or attempts, or alcohol or other substance abuse or dependence, or if a family member has a history of any of these problems
- if you have circulation problems in your hands or feet (eg, Raynaud phenomenon, thromboangiitis obliterans)
Some MEDICINES MAY INTERACT with Aptensio XR extended-release capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- MAOIs (eg, phenelzine) because severe high blood pressure may occur
- Anticoagulants (eg, warfarin), certain anticonvulsants (eg, phenobarbital, phenytoin, primidone), phenylbutazone, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or tricyclic antidepressants (eg, imipramine) because the risk of their side effects may be increased by Aptensio XR extended-release capsules
- Medicines for high blood pressure (eg, guanethidine, metoprolol) because their effectiveness may be decreased by Aptensio XR extended-release capsules
This may not be a complete list of all interactions that may occur. Ask your health care provider if Aptensio XR extended-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Aptensio XR extended-release capsules:
Use Aptensio XR extended-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Aptensio XR extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Aptensio XR extended-release capsules refilled.
- Take Aptensio XR extended-release capsules by mouth in the morning. Talk with your doctor about how you should take Aptensio XR extended-release capsules with regard to food.
- Swallow Aptensio XR extended-release capsules whole. Do not break, crush, chew, or divide before swallowing.
- If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. The applesauce should NOT be warm. Mix the medicine with the applesauce and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use.
- If you take an antacid, H2 antagonist (eg, ranitidine) or proton pump inhibitor (eg, omeprazole), ask your doctor or pharmacist how to take it with Aptensio XR extended-release capsules.
- If you miss a dose of Aptensio XR extended-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Aptensio XR extended-release capsules.
Important safety information:
- Tell your doctor or dentist that you take Aptensio XR extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
- Aptensio XR extended-release capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Aptensio XR extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are using Aptensio XR extended-release capsules.
- Do NOT take more than the recommended dose without checking with your doctor.
- Aptensio XR extended-release capsules should be used as a part of an ADHD treatment program that includes a variety of treatment measures (eg, psychological, educational, social).
- If your condition does not get better within 1 month or if it gets worse, check with your doctor.
- Heart attack, stroke, and sudden death have occurred in adults taking stimulant medicines. Sudden deaths have also occurred in children with heart defects or other serious heart problems. If you have a heart defect or another serious problem, talk with your doctor about other therapies to treat your condition.
- Aptensio XR extended-release capsules may cause a prolonged (more than 4 hours) or painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
- Aptensio XR extended-release capsules may cause circulation problems in the hands and feet. Tell your doctor if you have any numbness, pain, tingling, cold feeling, or skin color change (eg, from pale to blue or red) in your hands or feet. Call your doctor right away if you have any unexplained sores or wounds on your fingers or toes.
- Before you start any new medicine, check the label to see if it has a decongestant in it. If it does or if you are not sure, check with your doctor or pharmacist.
- Lab tests, including blood pressure, heart function, complete blood cell counts, and platelet counts, may be performed while you use Aptensio XR extended-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Aptensio XR extended-release capsules may affect growth rate and weight gain in CHILDREN and teenagers in some cases. They may need regular growth and weight checks while they take Aptensio XR extended-release capsules.
- Caution is advised when using Aptensio XR extended-release capsules in CHILDREN; they may be more sensitive to its effects, especially loss of appetite, stomach pain, weight loss, trouble sleeping, and fast heartbeat.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Aptensio XR extended-release capsules while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Aptensio XR extended-release capsules, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, Aptensio XR extended-release capsules may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Aptensio XR extended-release capsules stops working well. Do not take more than prescribed.
Some people who use Aptensio XR extended-release capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. Do not suddenly stop taking Aptensio XR extended-release capsules. If you do, you may have WITHDRAWAL symptoms. These may include depression or other mental problems. If you need to stop Aptensio XR extended-release capsules, your doctor will lower your dose over time.
Possible side effects of Aptensio XR extended-release capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth; headache; indigestion; loss of appetite; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping; vomiting; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; joint pain; purple or brownish red spots on the skin; unusual hoarseness); blurred vision or other vision problems; chest, jaw, or arm pain; confusion; dark urine; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; muscle pain or weakness; new or worsening mental, mood, or behavior changes (eg, abnormal thoughts, aggression, agitation, anxiety, depression, hostility, irritability, panic attacks, persistent crying, restlessness, unusual sadness); one-sided weakness; seizures; severe or persistent dizziness or headache; shortness of breath; slurred speech; sudden, severe nausea or vomiting; suicidal thoughts or attempts; tremor; uncontrolled speech or muscle movements; unusual sweating; unusual tiredness or weakness; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Aptensio XR extended-release capsules:
Store Aptensio XR extended-release capsules at room temperature. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Aptensio XR extended-release capsules out of the reach of children and away from pets.
- If you have any questions about Aptensio XR extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
- Aptensio XR extended-release capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Aptensio XR extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aptensio XR extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Aptensio XR extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Aptensio XR extended-release capsules.