WARNING

Adzenys ER (Extended Release) is a medication used to treat ADHD and contains amphetamine. Here are some potential risks and side effects:

• Cardiovascular Issues: Can increase blood pressure and heart rate, potentially leading to cardiovascular problems.
• Mental Health Effects: May cause or worsen anxiety, agitation, or manic symptoms.
• Dependence and Abuse: There’s a risk of misuse or dependency, as amphetamines are stimulants.
• Appetite Suppression: Can lead to weight loss and poor appetite.
• Insomnia: May cause difficulty sleeping.

It’s important to use it under medical supervision and report any concerning symptoms to your doctor.

Why is this medication prescribed?

Adzenys ER, which is a brand name for an extended-release formulation of generic amphetamine, is primarily prescribed to treat Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. Amphetamine is a central nervous system stimulant that affects chemicals in the brain and nerves contributing to hyperactivity and impulse control.

• Improves Focus and Attention: Adzenys ER helps individuals with ADHD by increasing attention, staying focused on tasks, and controlling behavior problems.
• Reduces Impulsiveness and Hyperactivity: It helps in managing the symptoms of hyperactivity and impulsiveness, which are common in ADHD patients.
• Extended-Release Formula: The extended-release formulation allows for a once-daily dose, which provides symptom control throughout the day without the need for multiple doses.

How should this medicine be used?

Adzenys ER (generic name: amphetamine) is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) in patients aged 6 and older. It is an extended-release liquid suspension designed to provide a steady release of medication throughout the day.

Instructions for Use:

• Dosage: Follow the exact dosage prescribed by your healthcare provider. The dosage is usually individualized based on the patient’s needs and response to the medication.
• Administration: Shake the bottle well before each dose to ensure the medication is evenly mixed. Measure the dose carefully using the provided dosing cup or an oral syringe. Do not use a household spoon. The medication can be taken with or without food.
• Timing: Take the medication in the morning. Since Adzenys ER is a stimulant, taking it later in the day may cause difficulty sleeping (insomnia).
• Missed Dose: If you miss a dose, take it as soon as you remember, but if it’s late in the day, skip the missed dose and take the next dose at the regular time the following morning. Do not double up to make up for a missed dose.
• Storage: Store Adzenys ER at room temperature, away from light and moisture. Keep the bottle tightly closed when not in use. Keep out of reach of children to prevent accidental overdose.
• Precautions: Do not take more than the prescribed dose. Inform your doctor of any other medications or supplements you are taking, as Adzenys ER can interact with other drugs. Avoid alcohol while taking this medication, as it can increase the risk of side effects.
• Possible Side Effects: Common side effects include insomnia, loss of appetite, dry mouth, nervousness, dizziness, and stomach pain. Serious side effects may include heart problems, mental/mood changes (such as agitation, hallucinations, and depression), and uncontrolled movements.
• Regular Monitoring: Your doctor may periodically check your blood pressure, heart rate, and growth in children while you are using this medication.

Always follow your healthcare provider’s guidance and read the medication guide provided with the prescription. If you have any questions or concerns, consult your doctor or pharmacist.

Other uses for this medicine

• Narcolepsy: In some cases, it may be used to manage symptoms of narcolepsy, a sleep disorder characterized by excessive daytime sleepiness.
• Depression: Occasionally, it might be prescribed in combination with other medications to treat certain cases of depression that have not responded to standard treatments.

What special precautions should I follow?

Special Precautions for Adzenys ER:

• Medical History: Inform your doctor if you have any history of heart problems (e.g., heart defects, heart rhythm problems, coronary artery disease), high blood pressure, or mental/mood disorders (e.g., bipolar disorder, psychosis). Disclose any history of substance use disorder (e.g., overuse of or addiction to drugs/alcohol).
• Risk of Abuse and Dependence: Adzenys ER has a high potential for abuse and dependence. It should be used exactly as prescribed by your healthcare provider. Misuse of amphetamines can cause serious (possibly fatal) heart and blood pressure problems.
• Heart Health: Before starting Adzenys ER, your doctor may evaluate you for heart conditions through physical examination and potentially an EKG, especially if you have a history of heart problems. Monitor your blood pressure and heart rate regularly while on this medication.
• Mental Health: Adzenys ER can exacerbate certain mental health conditions, such as anxiety, agitation, or mania. Be sure to inform your doctor of any mental health history. Report any new or worsening symptoms of mental health conditions immediately.
• Growth in Children: Stimulants like Adzenys ER can slow growth in children. Your doctor will monitor your child’s growth (height and weight) regularly during treatment.
• Pregnancy and Breastfeeding: Amphetamines can harm an unborn baby. If you are pregnant or planning to become pregnant, discuss this with your doctor. Amphetamines pass into breast milk and may affect a nursing infant. If you are breastfeeding, talk to your doctor about the potential risks.
• Interactions: Adzenys ER can interact with certain medications, including monoamine oxidase inhibitors (MAOIs), antidepressants, and medications for blood pressure. Provide your doctor with a full list of all medications and supplements you are taking. Avoid drinking alcohol, as it can increase certain side effects.
• Operating Machinery or Driving: Adzenys ER may impair your ability to perform tasks that require alertness, such as driving or operating machinery. Be cautious until you know how the medication affects you.
• Regular Monitoring: Regular follow-ups with your healthcare provider are essential to monitor for effectiveness and side effects. This may include blood pressure checks, heart rate monitoring, and assessment of mental health.
• Allergic Reactions: Inform your healthcare provider if you have a known allergy to amphetamines or other ingredients in Adzenys ER. Seek immediate medical attention if you experience signs of an allergic reaction, such as rash, itching/swelling, severe dizziness, or difficulty breathing.

Following these precautions can help minimize the risks associated with Adzenys ER and ensure its safe and effective use. Always consult your healthcare provider with any concerns or questions.

What special dietary instructions should I follow?

• Food Intake: Adzenys ER can be taken with or without food. However, if you experience stomach upset, you may take it with food to help minimize discomfort.
• Avoid Caffeine: Limit the intake of caffeine-containing beverages or foods (e.g., coffee, tea, cola, chocolate) because caffeine can increase the side effects of Adzenys ER.
• Alcohol: Avoid alcohol while taking Adzenys ER, as it can increase the risk of side effects such as dizziness and may worsen the effects of the medication.

What should I do if I forget a dose?

• If you miss a dose, take it as soon as you remember. However, if it is late in the day, skip the missed dose to avoid potential insomnia.
• Do not take a double dose to make up for the missed dose. Simply take your next dose at the regular scheduled time the following morning.

What side effects can this medication cause?

Adzenys ER (Generic Amphetamine) can cause a range of side effects. Some may be mild and temporary, while others can be more serious. Here are some common and less common side effects:

Common Side Effects:

• Insomnia: Difficulty sleeping, especially if taken later in the day.
• Decreased Appetite: Reduced hunger, which can lead to weight loss.
• Dry Mouth: A feeling of dryness in the mouth.
• Headache: General or tension headaches.
• Nausea: Feeling queasy or having an upset stomach.
• Nervousness: Feeling anxious or jittery.
• Dizziness: Lightheadedness or feeling unsteady.

Serious Side Effects:

• Cardiovascular Issues: Increased heart rate, elevated blood pressure, or chest pain. Seek medical attention if you experience these symptoms.
• Mental Health Changes: New or worsening symptoms of mood disorders, such as depression, mania, aggression, hallucinations, or paranoia.
• Severe Allergic Reactions: Rash, itching, swelling, severe dizziness, or trouble breathing.
• Growth Issues: Slowed growth in children, including delayed weight gain or height increase.
• Circulation Problems: Symptoms such as fingers or toes feeling cold or turning blue, which could indicate peripheral vasculopathy.
• Severe Abdominal Pain: Pain that could indicate a serious condition like pancreatitis.
• Skin Changes: Unusual skin reactions, such as severe rashes or ulcers.

If you experience any severe or concerning symptoms, it’s important to contact your healthcare provider immediately. They can help determine whether the side effects are manageable or if an alternative treatment is needed.

What should I know about storage and disposal of this medication?

Storage and Disposal of Adzenys ER:

Storage:

• Room Temperature: Store Adzenys ER at room temperature, typically between 68°F and 77°F (20°C to 25°C). Avoid exposing the medication to excessive heat, moisture, or direct light.
• Keep Secure: Store the medication in a safe place, out of reach of children and pets. Because Adzenys ER is a controlled substance with a high potential for abuse, it should be stored securely to prevent misuse or theft.
• Keep the Bottle Closed: Ensure the bottle is tightly closed when not in use to maintain the medication’s effectiveness.

Disposal:

• Do Not Flush: Do not flush Adzenys ER down the toilet or pour it down a drain unless specifically instructed to do so.
• Follow Local Guidelines: Dispose of unused or expired medication through a drug take-back program if available. If a take-back program is not accessible, mix the medication with an undesirable substance (e.g., dirt, cat litter, or used coffee grounds), place it in a sealed plastic bag, and dispose of it in the household trash.
• Consult Your Pharmacist: If you are unsure how to dispose of Adzenys ER, ask your pharmacist for guidance.

In case of emergency/overdose

• Call Emergency Services: If you suspect an overdose, call 911 or your local emergency number immediately.
• Poison Control: You can also contact the Poison Control Center at 1-800-222-1222 for guidance if you’re in the United States.
• Provide Information: Be prepared to provide information such as the dosage taken, the time of overdose, and any symptoms observed. If possible, have the medication bottle with you.

An overdose of Adzenys ER can be life-threatening. Symptoms may include:

• • Restlessness or tremor
  • Rapid breathing
  • Confusion, aggression, or hallucinations
  • Panic
  • Fever
  • Seizures (convulsions)
  • Unconsciousness or coma
  • Extreme fatigue, depression, or fainting
  • Nausea, vomiting, diarrhea, or stomach cramps
  • Irregular heartbeats or high blood pressure

What other information should I know?

• Medication Guide: Always read the medication guide provided with Adzenys ER each time you fill your prescription. This guide contains essential information about the medication, its use, and potential side effects.
• Regular Monitoring: Attend all scheduled appointments with your healthcare provider. Regular monitoring of your blood pressure, heart rate, and mental health is essential while on this medication.
• Medication Sharing: Never share Adzenys ER with anyone, even if they have similar symptoms. It is a prescription medication that should only be used by the person for whom it was prescribed.
• Inform Healthcare Providers: Ensure that all your healthcare providers, including dentists, know you are taking Adzenys ER, as it can interact with other medications or treatments.
• Avoid Abrupt Discontinuation: Do not suddenly stop taking Adzenys ER without consulting your doctor, as this can cause withdrawal symptoms or worsen your condition.
• Traveling with Medication: If you are traveling, especially by air, carry your medication in its original labeled container and bring a copy of your prescription. Be aware of the laws regarding controlled substances in the areas where you are traveling.
• Medication Interaction: Be aware that Adzenys ER can interact with other medications, including over-the-counter drugs, vitamins, and herbal supplements. Always consult your healthcare provider before starting any new medication.

By following these guidelines and staying informed, you can use Adzenys ER safely and effectively. Always reach out to your healthcare provider with any questions or concerns.