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Dyanavel XR (Oral)

Generic Name: amphetamine (Oral route)

am-FET-a-meen

Oral route(Suspension, Extended Release;Tablet, Extended Release, Disintegrating)

CNS stimulants, including amphetamine extended-release oral formulations, other amphetamine-containing products, and methylphenidate, 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 .

Oral route(Tablet)

Abuse potential is high with the use of amphetamines. Using amphetamines for a prolonged period of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of patients obtaining amphetamines for distribution to others or for nontherapeutic use. Prescribe and dispense amphetamines sparingly. Sudden death and serious cardiovascular adverse events may occur with misuse of amphetamines .

Commonly used brand name(s)

In the U.S.

  • Adzenys XR ODT
  • Dyanavel XR
  • Evekeo

Available Dosage Forms:

  • Tablet, Extended Release, Disintegrating
  • Suspension, Extended Release
  • Tablet

Therapeutic Class: Central Nervous System Agent

Chemical Class: Amphetamine (class)

Uses For Dyanavel XR

Amphetamine is used to treat narcolepsy (sleep disorder). It is also used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Amphetamine is also used for weight reduction in obese patients.

Amphetamine 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. 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 a doctor's prescription.

Before Using Dyanavel XR

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine tablets in children with obesity who are younger than 12 years of age, in children with narcolepsy who are younger than 6 years of age, and in children with ADHD who are younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in children with ADHD who are younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of amphetamine tablets in geriatric patients.

Appropriate studies have not been performed on the relationship of age to the effects of amphetamine extended-release oral suspension and extended-release oral disintegrating tablets in the geriatric population. Safety and efficacy have not been established.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Sibutramine
  • Toloxatone
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acetazolamide
  • Benzthiazide
  • Chlorothiazide
  • Chlorpromazine
  • Diazoxide
  • Donepezil
  • Furazolidone
  • Hydrochlorothiazide
  • Hydroflumethiazide
  • Hydroxytryptophan
  • Polythiazide
  • Safinamide
  • Sodium Bicarbonate
  • Trichlormethiazide
  • Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Guanethidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Agitation, severe or
  • Arteriosclerosis (hardening of the arteries), severe or
  • Drug abuse, history of or
  • Heart attack, recent or
  • Heart failure or
  • Heart or blood vessel disease (eg, cardiomyopathy, coronary artery disease) or
  • Heart rhythm problems (eg, arrhythmia, ventricular arrhythmia) or
  • Hypertension (high blood pressure), moderate to severe or
  • Hyperthyroidism (overactive thyroid) or
  • Stroke, history of—Should not be used in patients with these conditions.
  • Bipolar disorder (manic-depressive illness), or a family history of or
  • Blood vessel problems (eg, Raynaud disease) or
  • Depression, or a family history of or
  • Hypertension (high blood pressure), mild or
  • Psychosis (mental illness), history of or
  • Seizures, history of or
  • Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

Proper Use of amphetamine

This section provides information on the proper use of a number of products that contain amphetamine. It may not be specific to Dyanavel XR. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you feel that the medicine is not working properly after taking it for several weeks, check with your doctor first and do not increase the dose.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Amphetamine is used for different conditions and comes in different forms. Make sure you understand how to take your prescribed brand.

It is best to take this medicine when you wake up in the morning. You may take this medicine with or without food.

Measure the extended-release oral suspension with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Shake the bottle before each use.

If you are using the extended-release oral disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release suspension):
    • For ADHD:
      • Adults and children 6 years of age and older—At first, 2.5 or 5 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (extended release oral disintegrating tablets):
    • For ADHD:
      • Adults—12.5 milligrams (mg) once a day, in the morning.
      • Children 13 to 17 years of age and older—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 12.5 mg per day.
      • Children 6 to 12 years of age—At first, 6.3 mg once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 18.8 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For ADHD:
      • Adults and children 6 years of age and older—At first, 5 milligrams (mg) once or two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day.
      • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may increase your dose as needed.
      • Children younger than 3 years of age—Use is not recommended.
    • For narcolepsy:
      • Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 to 11 years of age—At first, 5 mg once a day, in the morning. Your doctor may increase your dose as needed.
      • Children younger than 6 years of age—Use and dose must be determined by your doctor.
    • For weight loss:
      • Adults and children 12 years of age and older—5 to 10 milligrams (mg) per day, taken 30 to 60 minutes before each meal. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mg per day.
      • Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Dyanavel XR

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly. Blood and blood pressure tests may be needed to check for unwanted effects. Your doctor may occasionally stop treatment to check symptoms of ADHD.

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

This medicine may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, fast or uneven heartbeat, trouble breathing, or fainting while taking 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, or irritability. 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 your child's height and weight.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine may cause Raynaud phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Avoid drinking alcohol while taking this medicine.

Use with medications that increase stomach or urine alkalinity, such as sodium bicarbonate, acetazolamide, and some thiazide diuretics should be avoided. .

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Dyanavel XR Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Seeing, hearing, or feeling things that are not there
  • severe mental changes
Incidence not known
  • Blurred vision
  • dizziness
  • false or unusual sense of well-being
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • restlessness
  • shakiness in the legs, arms, hands, or feet
  • slow or fast heartbeat
  • trouble sleeping
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Abdominal or stomach cramps
  • confusion
  • dark-colored urine
  • diarrhea
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fever
  • muscle cramps or spasms
  • muscle pain or stiffness
  • nausea
  • seizures
  • sweating
  • unusual tiredness or weakness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Decreased interest in sexual intercourse
  • difficulty having a bowel movement (stool)
  • dry mouth
  • hives or welts, itching, or skin rash
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • loss of appetite
  • redness of the skin
  • unpleasant taste
  • weight loss

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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