Aptensio XR

1 What is Aptensio XR?

Brand: Aptensio XR, Concerta, Metadate CD, Metadate ER, Methylin, Methylin ER, QuilliChew ER, Quillivant XR, Ritalin, Ritalin LA, Ritalin-SR

Generic: Methylphenidate

Aptensio XR belongs to the group of medicines called central nervous system (CNS) stimulants. It is widely used to treat the attention deficit hyperkinetic disorder (ADHD).

This drug is also used to treat narcolepsy. Narcolepsy is an uncontrollable desire for sleep or a sudden attack of deep sleep.

Aptensio XR works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive.

As a result, behavior and learning ability are improved in children. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

  • Capsule, Extended Release
  • Tablet, Extended Release Chewable
  • Tablet, Extended Release
  • Powder for Suspension, Extended Release
  • Solution
  • Tablet, Chewable
  • Tablet

2 What to Know Before Using

Before using Aptensio XR, you must know all about the risks and complications associated with it. The suitable drug therapy is usually chosen by a doctor with the active participation of the patient.

There are some important factors such as drug interactions, the presence of any metabolic impairment, history of hypersensitivity reaction, pregnancy, lactation etc. which may alter the desired therapeutic effects of a medicine.

Sometimes the presence of other health disorders affects the beneficial effects of this medicine and even may cause serious toxic effects. If you have had any allergic reactions to any medicine then you must tell your doctor about that. The use of methylphenidate is contraindicated in those who are hypersensitive to this drug or any of the ingredients of the formulation.

Make sure you inform your doctor if you have any other medical problems, especially:

Because of drug-drug interactions, certain medicines should not be used along with this medicine. It is always recommended to consult with your doctor if you are in need of some other medications or even any over-the-counter medicine for another health problem in order to avoid unwanted toxic effects.

The following drug interactions should be kept in mind:

  • May reduce effects of antihypertensive drugs.
  • Possible severe hypertension and tachycardia with sibutramine.
  • Increased risk of hypertensive crisis with MAO inhibitors.
  • Severe toxic reactions with clonidine.
  • CNS depression with alcohol.
  • Increased serum levels or effects with CYP2D6 inhibitors such as chlorpromazine, delavirdine, fluoxetine, miconazole, paroxetine, pergolide, quinidine, quinine, ritonavir, ropinirole, etc.
  • Reduced serum level with carbamazepine.
  • May increase serum levels of phenytoin and TCAs.

Animal reproduction studies have shown an adverse effect, and there are no adequate and well-controlled studies in pregnant women. Thus, this drug should be used during pregnancy only if clearly needed.

Besides, caution should be exercised when used in lactating women because there are no adequate studies in women for determining infant risk when using this medication during breastfeeding.

3 Proper Usage

To use Aptensio XR properly, you must follow all instructions given by your doctor. The dosage schedule and the duration of drug therapy should be individualized and determined based on the physician’s advice.

The therapeutic dose may also vary with the patient’s condition or requirement and the strength of the medicine as well. This medicine comes with patient information.

You should read and follow the instructions carefully before using this medicine; however, the treatment schedule of different dosage forms for different indications are listed below:

For treatment of attention deficit hyperactivity disorder (ADHD):

  • For short-acting oral dosage forms (chewable tablets or solution):
    • Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. The average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children 6 years and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 6 years—Use and dose must be determined by the doctor.
  • For short-acting oral dosage form (tablets):
    • Adults—5 to 20 milligrams (mg) 2 or 3 times a day, taken 30 to 45 minutes before meals.
    • Children 6 years and older—At first, 5 mg two times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 6 years—Use and dose must be determined by the doctor.
  • For long-acting oral dosage form (extended-release capsules):
    • Patients who have not been treated with methylphenidate:
      • Adults and children 6 years and older—At first, 10 to 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years—Use and dose must be determined by the doctor.
    • Patients who are already taking methylphenidate:
      • Adults and children 6 years and older—10 to 60 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years—Use and dose must be determined by the doctor.
  • For long-acting oral dosage form (extended-release suspension):
    • Adults and children 6 years and older—At first, 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 6 years—Use and dose must be determined by the doctor.
  • For long-acting oral dosage form (extended-release tablets):
    • For patients who have not been treated with Concerta®:
      • Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
      • Children 6 years and older—At first, 18 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
      • Children younger than 6 years—Use and dose must be determined by your doctor.
    • For patients already using Concerta®:
      • Adults and children 6 years and older—At first, 18 to 72 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
      • Children younger than 6 years—Use and dose must be determined by your doctor.

For treatment of narcolepsy:

  • For short-acting oral dosage forms (chewable tablets or solution):
    • Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. The average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children 6 years and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 6 years—Use and dose must be determined by the doctor.
  • For short-acting oral dosage form (tablets):
    • Adults—5 to 20 milligrams (mg) 2 or 3 times a day, taken 30 to 45 minutes before meals.
    • Children 6 years and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
    • Children younger than 6 years—Use and dose must be determined by your doctor.

You should use this medicine following the directions were given by your doctor. If you miss a dose of this medicine, take it as soon as possible. But, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Do not use this drug in larger amounts, more often, or for a longer time than your doctor ordered. Further, it is advised to store the medicine in a closed container at room temperature away from heat, moisture, and direct light.

All kinds of medicines should be kept out of the reach of children. However, outdated medicines should be disposed of by an appropriate way.

4 Precautions to Take

Before using Aptensio XR, there are some precautions you must take. Firstly, regular visits to your doctor are recommended to check that this medicine is working properly or not.

Additionally, the following guidelines should be followed to prevent unwanted complications as well as for the better prognosis of the patients:

Blood pressure and heart rate should be measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine should not be used if you have used a drug for depression called a MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, in the past 14 days.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

In addition, this drug may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child has chest pain, shortness of breath, fainting, or a fast, irregular heartbeat while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of his height and weight to make sure that he is growing properly.

Methylphenidate may cause a condition called Raynaud phenomenon. Check with your doctor right away if you or your child has tingling or pain in the fingers or toes when exposed to cold, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Make sure any doctor or dentist who treats you knows that you are using Metadate CD®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while taking the Attention XR™, Metadate CD®, or Ritalin LA® extended-release capsules.

If you experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Do not use any prescription or nonprescription medicine, herbal preparation, or dietary supplement without checking with your doctor.

5 Potential Side Effects

Make sure you meet with your doctor in using Aptensio XR to avoid unwanted potential side effects. Along with the beneficial effects, this medicine may cause some unwanted effects that may not need any medical attention.

These side effects usually go away during the treatment episode as your body adjusts to the medicine. Your healthcare professional may advise you about the ways how to prevent or reduce those unwanted side effects.

Sometimes you may need to consult with the doctor if you notice any of the following toxic effects:

More common:

  • Abdominal discomfort
  • Anorexia
  • Bowel upset
  • Fast heartbeat
  • Headache
  • Insomnia
  • Nervousness

Less common:

Rare:

  • Black, tarry stools
  • Blood in the urine or stools
  • Blurred vision or other changes in vision
  • Confusion
  • Convulsions
  • Depression
  • Muscle cramps
  • Pinpoint red spots on the skin
  • Scaling, severe redness, soreness, or swelling of the skin
  • Uncontrolled and repeated body movements
  • Unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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