Adzenys XR ODT

Name: Adzenys XR ODT

What Is Adzenys XR-ODT?

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

Amphetamine is used to treat attention deficit hyperactivity disorder (ADHD).

The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments.

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

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine may be habit-forming. Never share amphetamine 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.

Using this medicine improperly can cause death or serious side effects on the heart.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

  • moderate to severe high blood pressure;
  • heart disease or coronary artery disease (hardened arteries);
  • overactive thyroid;
  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or
  • a history of drug or alcohol addiction.

Some stimulants have caused sudden death in certain people. Tell your doctor if you have:

  • heart problems or a congenital heart defect;
  • high blood pressure; or
  • a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

  • depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
  • motor tics (muscle twitches) or Tourette's syndrome;
  • kidney disease;
  • a thyroid disorder;
  • seizures or epilepsy;
  • an abnormal brain wave test (EEG); or
  • blood circulation problems in the hands or feet.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Amphetamine is not approved for use by anyone younger than 6 years old.

Adzenys XR-ODT Dosage

Using this medicine improperly can cause death or serious side effects on the heart.

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

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Amphetamine may be habit-forming. Never share amphetamine 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.

You may take amphetamine with or without food. It is best to take this medicine first thing in the morning.

If your doctor changes your brand, strength, or type of stimulant medicine, your dosage needs may change. Use only the brand of this medicine your doctor has prescribed.

Shake the oral suspension (liquid) well just before you measure a dose. 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.

To take the null (Adzenys XR-ODT):

  • Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil. Do not push a tablet through the foil or you may damage the tablet.
  • Use dry hands to remove the tablet and place it in your mouth.
  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. If desired, you may drink liquid to help swallow the dissolved tablet.

While using this medicine, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.

Amphetamine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of the amount of medicine used from each new bottle. Amphetamine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Throw away unused or expired amphetamine in a sealed container or bag. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, fainting, seizure (convulsions), or coma.

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

Adzenys XR-ODT Interactions

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

  • Acidifying agents such guanethidine, reserpine, glutamic acid HCl, ascorbic acid, and fruit juices 
  • Urinary acidifying agents such as ammonium chloride and sodium acid phosphate 
  • Adrenergic blockers
  • Gastrointestinal alkalizing agents such as sodium carbonate and urinary alkalizing agents such as acetazolamide
  • Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
  • Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
  • Antihistamines
  • Antihypertensives
  • Chlorpromazine
  • Haloperidol
  • Ethosuximide
  • Lithium
  • Methenamine
  • Norepinephrine
  • Phenobarbital
  • Phenytoin
  • Propoxyphene
  • Medications that reduce the acid level in your stomach such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
  • Veratrum alkaloids

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

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)

Before Using Adzenys XR ODT

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.

  • 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
  • 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
  • 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

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.

Precautions While Using Adzenys XR ODT

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.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

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 (eg, St. John's wort) or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

What is the most important information I should know about Adzenys XR-ODT (amphetamine)?

Amphetamine may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems--unexplained wounds on your fingers or toes.

What happens if I miss a dose?

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.

What other drugs will affect Adzenys XR-ODT (amphetamine)?

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs amphetamine, and may increase side effects.

Many drugs can interact with amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Indications and usage

Adzenys XR-ODT is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].

Description

Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablet) contains a 3 to 1 ratio of d- to l-amphetamine, a central nervous system stimulant.

The labeled strengths reflect the amount of amphetamine base in Adzenys XR-ODT whereas the strengths of the (mixed salts of a single-entity amphetamine) products are in terms of the amount of amphetamine salts. Table 1 in Section 2.5 details the equivalent amounts of active ingredient in these products.

Structural Formula:

C9H13N    MW  135.21

Adzenys XR-ODT is an extended-release orally disintegrating tablet containing 50% immediate-release and 50% delayed-release amphetamine for once daily dosing.

Adzenys XR-ODT also contains the following inactive ingredients: Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol.

PRINCIPAL DISPLAY PANEL - 18.8 mg Tablet Blister Pack Carton

NDC 70165-030-30

Contains:
30 Tablets (5 x 6-count blister cards)
Travel Case

Rx Only

Adzenys XR-ODT™CII
Amphetamine Extended-Release
Orally Disintegrating Tablets

Do not crush or chew tablets

Each tablet contains 18.8 mg of amphetamine
(equivalent to that in a 30 mg strength mixed salts
of a single-entity amphetamine product)

18.8 mg

NEOS™
Therapeutics

PHARMACIST: Dispense the enclosed Medication Guide to each patient.

Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-005
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 3.1 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE (orange to light orange mottled) Score no score
Shape ROUND Size 3mm
Flavor ORANGE Imprint Code A1
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-005-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-010
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 6.3 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 4mm
Flavor ORANGE Imprint Code A2
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-010-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-015
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 9.4 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 5mm
Flavor ORANGE Imprint Code A3
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-015-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-020
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 12.5 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 5mm
Flavor ORANGE Imprint Code A4
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-020-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-025
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 15.7 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor ORANGE Imprint Code A5
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-025-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Adzenys XR-ODT 
amphetamine tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70165-030
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amphetamine (Amphetamine) Amphetamine 18.8 mg
Inactive Ingredients
Ingredient Name Strength
Mannitol  
Crospovidone (15 MPA.S AT 5%)  
MICROCRYSTALLINE CELLULOSE  
Methacrylic Acid  
Sodium Polystyrene Sulfonate  
Citric Acid Monohydrate  
Fructose  
Silicon Dioxide  
Triethyl Citrate  
Sucralose  
Magnesium Stearate  
Polyethylene Glycol, Unspecified  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor ORANGE Imprint Code A6
Contains     
Packaging
# Item Code Package Description
1 NDC:70165-030-30 30 BLISTER PACK in 1 CARTON
1 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA204326 02/16/2016
Labeler - Neos Therapeutics, LP (836126052)
Establishment
Name Address ID/FEI Operations
Neos Therapeutics, LP 836126052 MANUFACTURE(70165-005, 70165-010, 70165-015, 70165-020, 70165-025, 70165-030), PACK(70165-005, 70165-010, 70165-015, 70165-020, 70165-025, 70165-030), LABEL(70165-005, 70165-010, 70165-015, 70165-020, 70165-025, 70165-030), ANALYSIS(70165-005, 70165-010, 70165-015, 70165-020, 70165-025, 70165-030)
Revised: 10/2016   Neos Therapeutics, LP

Pharmacology

Mechanism of Action

Noncatecholamine, sympathomimetic amine that elicits CNS stimulant activity

Peripheral actions include increased systolic and diastolic blood pressures, and weak bronchodilator and respiratory stimulant action

Amphetamine Pregnancy Warnings

The limited published data in human pregnancy is insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. In animal studies, no effects on morphological development were seen but long-term neurochemical and behavioral effects (e.g., learning and memory deficits, altered locomotor activity, changes in sexual function) have been reported at clinically relevant doses. Fetal malformations and death as well as severe maternal toxicity were observed in animals following parenteral administration of d-amphetamine doses approximately 6 times the MRHD or greater. Animal studies with d- to l-amphetamine ratio of 3.2 to 1 did not reveal any effects on fertility or early embryonic development at doses of approximately 5 times the MRHD. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is recommended only if the benefit justifies the risk to the fetus. US FDA pregnancy category: C (immediate-release oral tablet) US FDA pregnancy category: Not Assigned (extended-release oral suspension) Comments: -Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight; these infants should be monitored for feeding difficulties, irritability, agitation, excessive drowsiness and other withdrawal symptoms. -This drug and others within the amphetamine class may cause vasoconstriction of placental blood vessels and increase the risk for intrauterine growth restriction.

Amphetamine Identification

Substance Name

Amphetamine

CAS Registry Number

300-62-9

Drug Class

Adrenergic Agents

Central Nervous System Stimulants

Dopamine Agents

Sympathomimetics

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