Adzenys XR ODT

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using amphetamine and call your doctor at once if you have:

• chest pain, trouble breathing, feeling like you might pass out;
• fast heartbeats, rapid breathing;
• confusion, unusual thoughts, paranoia, hallucinations (seeing or hearing things that are not real);
• new behavior problems, aggression, anger, feeling irritable;
• numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
• changes in your vision; or
• unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).

Amphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• stomach pain, nausea, vomiting, loss of appetite;
• diarrhea, constipation;
• weight loss;
• mood changes, feeling restless or nervous, sleep problems (insomnia);
• dry mouth, unusual or unpleasant taste in the mouth;
• runny nose, nosebleeds;
• increased heart rate;
• headache, dizziness;
• itching; or
• impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Serious side effects have been reported with Adzenys XR-ODT including the following:

Potential for abuse and dependence. Medications similar to Adzenys XR-ODT have a high potential for abuse and dependence. Consult with your physician prior to beginning therapy with Adzenys XR-ODT if you have a history of medication abuse and/or dependence.

Serious heart problems. Sudden death, stroke, and heart attacks have been reported in adults using medications similar to Adzenys XR-ODT at normal doses. Sudden death has also been reported in pediatric patients taking medications similar to Adzenys XR-ODT. If you have heart problems or any heart diseases, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Increases in blood pressure and/or heart rate. Medications similar to Adzenys XR-ODT can cause an increase in both blood pressure and heart rate. If you have high blood pressure or heart rate abnormalities, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Psychiatric side effects. Medications similar to Adzenys XR-ODT may worsen pre-existing psychiatric disorders including bipolar disorder, depression, and/or psychotic disorders. If you have or have ever had any psychiatric disorders, consult with your physician prior to beginning therapy with Adzenys XR-ODT.

Slowed growth in children. Medications similar to Adzenys XR-ODT have been known to cause weight loss and slowed growth rate in children. Your child's pediatrician will monitor their growth rate during therapy with Adzenys XR-ODT.

Blood vessel problems. Medications similar to Adzenys XR-ODT have been known to cause blood vessel problems including peripheral vasculopathy and Raynaud's Phenomenon. Your physician will monitor you for the development of these types of problems during the course of your therapy as well as instruct you on how to be aware of the development of symptoms of these types of problems.

Do not take Adzenys XR-ODT if you:

• are allergic to Adzenys XR-ODT or to any of its ingredients
• currently take or have taken an monoamine oxidase inhibitor medication (MAOI) within 14 days

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Adzenys XR-ODT, there are no specific foods that you must exclude from your diet when receiving this medication.

• Store at 20°C to 25º C (68°F to 77º F)
• Store this and all medications away from children

Warning: Abuse and Dependence

• Central nervous system stimulants, including Adzenys XR-ODT, 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 

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;

• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;

• a seizure (convulsions);

• muscle twitches (tics); or

• changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea, constipation;

• loss of appetite, weight loss;

• mood changes, feeling restless or nervous, sleep problems (insomnia);

• dry mouth, unusual or unpleasant taste in the mouth;

• runny nose, nosebleeds;

• increased heart rate;

• headache, dizziness;

• itching; or

• impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Dry mouth.
• Not hungry.
• Not able to sleep.
• Hard stools (constipation).
• Headache.
• Weight loss.
• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Bad taste in your mouth.
• Feeling nervous and excitable.
• Restlessness.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Frequency Not Defined

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure; isolated reports of cardiomyopathy associated with chronic use

Central nervous system: Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome

Gastrointestinal: Dry mouth, unpleasant taste, diarrhea, constipation; anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect

Allergic: Urticaria

Endocrine: Impotence, changes in libido, and frequent or prolonged erections

Postmarketing reports

Musculoskeletal: Rhabdomyolysis

Serotonin syndrome

Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet extended release disintegrating

Along with its needed effects, amphetamine (the active ingredient contained in Adzenys XR-ODT) 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 while taking amphetamine:

• Seeing, hearing, or feeling things that are not there
• severe mental changes

• Agitation
• blurred vision
• confusion
• diarrhea
• dizziness
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• headache
• nervousness
• overactive reflexes
• pounding in the ears
• restlessness
• shakiness in the legs, arms, hands, or feet
• shivering
• slow or fast heartbeat
• sweating
• talking or acting with excitement you cannot control
• 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 while taking amphetamine:

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

Some side effects of amphetamine 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:

• 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

Breastfeeding is not recommending during treatment. Excreted into human milk: Yes Comments: -The effect of amphetamine in milk on the neurological development of the breastfed infant has not been well studied. -Large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established.

-The urinary excretion in a breastfed infant whose mother took amphetamine 35 mg daily and exclusively breastfed for 6 months ranged from 1.9% to 2.1% of the mother's excretion; this infant experienced no adverse reactions and grew normally, and the mother experienced no adverse effect on milk production. -The urinary excretion in a breastfed infant whose mother took racemic amphetamine 5 mg four times daily ranged from 0.1% to 0.3% of the mother's excretion; this infant showed no signs of abnormal development during the first 2 years of life. -In a study of 20 postpartum women, dextroamphetamine reduced serum prolactin by 25% to 32% (7.5 mg IV dose) and 30% to 37% (15 mg IV dose). Another study showed a 20 mg oral dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.