ProCentra

Dextroamphetamine is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.

Dextroamphetamine is used to treat narcolepsy and attention deficit hyperactivity disorder (ADHD).

Dextroamphetamine may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Dextroamphetamine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

Dextroamphetamine is sometimes taken 2 or 3 times per day. Extended-release dextroamphetamine is taken only once per day. Follow your doctor's dosing instructions very carefully.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

While using this medicine, your doctor will need to check your progress at regular visits. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture, heat, and light.

Keep track of your medicine. Dextroamphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

Many drugs can interact with dextroamphetamine. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

• an antacid;

• an antidepressant;

• blood pressure medication; or

• seizure medicine.

This list is not complete and many other drugs can interact with dextroamphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Dextroamphetamine is used to treat attention-deficit hyperactivity disorder (ADHD) and narcolepsy (uncontrollable desire for sleep or a sudden attack of deep sleep). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Dextroamphetamine 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. Prescriptions cannot be refilled. A new prescription must be obtained from your doctor each time you or your child needs this medicine.

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 dextroamphetamine tablets to treat attention-deficit hyperactivity disorder in children younger than 3 years of age. Safety and efficacy have not been established.

Dextroamphetamine sustained-release capsule is not recommended to treat attention-deficit hyperactivity disorder in children younger than 6 years of age.

Geriatric

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

Pregnancy

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.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• 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.

• Abiraterone
• Acetazolamide
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benzthiazide
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cinacalcet
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Milnacipran
• Mirabegron
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Piritramide
• Polythiazide
• Protriptyline
• Quinidine
• Quinine
• Remifentanil
• Rizatriptan
• Rolapitant
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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
• Anxiety, severe or
• Arteriosclerosis (hardening of the arteries), severe or
• Coronary artery disease or
• Drug abuse, history of or
• Glaucoma or
• Heart attack, recent or
• Heart failure or
• Heart or blood vessel disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, ventricular arrhythmia) or
• Hypertension (high blood pressure), moderate to severe or
• Hyperthyroidism (overactive thyroid) or
• Stroke, history of or
• Tension, severe—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
• Mania, history of or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Thyroid problems or
• Tourette's syndrome, or family history of—Use with caution. May make these conditions worse. .

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

Take this medicine only as directed by your doctor. Do not take more or less 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 or your child feel that the medicine is not working properly after you have taken 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 these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If you or your child use the tablet form of this medicine, and you take it 2 or 3 times a day. Take the first dose in the morning. The other doses may be taken during the day with 4 to 6 hours between doses.

It is best to take the sustained-release capsule in the morning. Taking this medicine in the afternoon or evening could make it harder for you to fall asleep.

Swallow the sustained-release capsule whole. Do not crush, break, or chew it.

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 attention-deficit hyperactivity disorder (ADHD):
  • For oral dosage form (sustained-release capsules):
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may adjust your dose if needed.
    • Children younger than 6 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults and children 6 years of age and older—At first, 5 milligrams (mg) 1 or 2 times a day. Your doctor may adjust your dose if needed.
    • Children 3 to 5 years of age—At first, 2.5 mg once a day. Your doctor may adjust your dose if needed.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.
• For narcolepsy:
  • For oral dosage forms (sustained-release capsules or tablets):
    • Adults and children 12 years of age and older—At first, 10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
    • Children 6 to 12 years of age—At first, 5 mg once a day. Your doctor may adjust your dose if needed.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

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.

Use ProCentra as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine early in the day to prevent sleep problems.
• Take with or without food.
• Avoid taking ProCentra with fruit juice.
• Take this medicine at the same time of day.
• To gain the most benefit, do not miss doses.
• Measure liquid doses carefully. Use the measuring device that comes with ProCentra. If there is none, ask the pharmacist for a device to measure this medicine.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

ProCentra® (dextroamphetamine sulfate) Oral Solution is indicated in:

Narcolepsy

Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotionally lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.

Fatigue and depression usually follow the central stimulation.

Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually proceeded by convulsions and coma.

Treatment

Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford Laboratories) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.

Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.