Mydayis

Mydayis is a prescription medication used to treat ADHD (Attention Deficit Hyperactivity Disorder) in adults and adolescents.

It is a single product containing 2 medications: amphetamine and dextroamphetamine.

Mydayis belongs to a group of drugs called centrally acting sympathomimetics. These work by changing the amounts of certain natural substances in the brain.  

This medication comes in extended-release capsule form and is taken typically once daily in the morning, with or without food. Swallow the extended-release Mydayis capsules whole; do not chew or crush them.

Common side effects of Mydayis include loss of appetite, decreased weight, and trouble sleeping. 

Mydayis is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 13 years of age and older. 

• Mydayis is not for use in children 12 years of age and younger.
• Mydayis is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Mydayis in a safe place to protect it from theft. Never give Mydayis to anyone else, because it may cause death or harm them. Selling or giving away Mydayis may harm others and is against the law.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

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Serious side effects have been reported with Mydayis. See the “Mydayis Precautions” section.

Common side effects of Mydayis include the following:

• Trouble sleeping
• Decreased appetite
• Dry mouth
• Increased heart rate
• Irritability
• Weight loss
• Anxiety
• Nausea

This is not a complete list of Mydayis side effects. Ask your doctor or pharmacist for more information.

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

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 
• 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)
• 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)
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)

This is not a complete list of Mydayis drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Mydayis including the following:

• Abuse and dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.
• Serious Heart Problems. Inform your doctor if you have any heart problems. Stroke, heart attack, and sudden death have been reported in patients with serious structural heart and rhythm problems. 
• Increased blood pressure and increased heart rate. Your doctor should monitor blood pressure and heart rate when on Mydayis. 
• Psychosis. Tell your healthcare provider right away if you have some or all of the following symptoms of psychosis:
  • Thoughts and speech are unorganized
  • Experience beliefs that are not based on reality 
  • Hear, see, or feel things that are not there
• Slowing of growth (height and weight) in children. Your healthcare provider will monitor your child's height and weight when on Mydayis.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include :
  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you have or your child has any pain, numbness, skin color change, or sensitivity to temperature in the fingers or toes.

• Seizures. Your healthcare provider will stop treatment with Mydayis if you or child has a seizure.
• Serotonin syndrome. This can may happen when this medication is taken with certain other medicines and may be life-threatening. Medications that may increase risk may include medications that increase serotonin (e.g., monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs)). Call your healthcare provider or go to the nearest hospital emergency room if you notice any of the following symptoms:
  • Agitation or restlessness
  • Confusion
  • Rapid heart rate and high blood pressure
  • Loss of muscle coordination or twitching muscles
  • Heavy sweating

Mydayis is not for use in children 12 years of age and younger.

Do not take Mydayis if you

• are allergic to Mydayis or to any of its ingredients
• are allergic to other stimulant medications such as benzphetamine (Didrex), lisdexamfetamine (Vyvanse), or methamphetamine (Desoxyn)
• are taking, or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)
• have advanced heart disease
• have been told that you have moderate to severe high blood pressure 
• have a history of drug abuse

Fruit juices may interact with Mydayis by lowering its absorption. Discuss the consumption of fruit juices with your doctor.

Large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking over-the-counter products that contain caffeine can increase the side effects of this medication. Discuss consumption of caffeine-containing products with your doctor.

Before taking Mydayis, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have heart problems, heart defects or high blood pressure 
• have mental problems including psychosis, mania, bipolar illness or depression, or have a family history of suicide
• have circulation problems in fingers and toes
• have or have had seizures
• have kidney problems. You should not take Mydayis if you have end-stage renal disease (ESRD). 
• are pregnant or plan to become pregnant. It is not known if Mydayis will harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Mydayis. 
• are breastfeeding or plan to breastfeed. Mydayis passes into breast milk. You should not breastfeed during treatment with Mydayis.

Tell your doctor about all the medicines that you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Mydayis may affect the way other medicines work and other medicines may affect how Mydayis works. Taking Mydayis with other medicines can cause serious side effects.

Do not start any new medicine during treatment with Mydayis without talking to your or your child's healthcare provider first.

Tell your doctor if you are pregnant or plan to become pregnant. 

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Mydayis has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Mydayis, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Mydayis exactly as prescribed.

Mydayis comes in extended-release (long-acting) capsule form to take by mouth.

The extended-release capsule is usually taken once daily in the morning with or without food.

Do not chew, divide, or break Mydayis capsules. Swallow capsules whole.

If Mydayis capsules cannot be swallowed whole, the capsules may be opened and sprinkled over a spoonful of applesauce. Swallow all of the applesauce and medicine mixture right away. Do not chew the applesauce and medicine mixture. Do not store the sprinkled applesauce.

If you miss a dose of Mydayis, do not take your dose later in the day or double your dose to make up for a missed dose. Take your Mydayis dose the next morning at your regularly scheduled time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose of Mydayis depends on individual patient response and patient's age. It is usually started at a low dose and gradually increased until an optimal response is seen. Because the effects of Mydayis may last up to 16 hours and it might cause insomnia, Mydayis should be taken on awakening.

In adults, the recommended starting dose of Mydayis is 12.5 mg once daily in the morning upon awakening. Initial doses of 25 mg once daily may be considered for some patients. Dosage may be adjusted by 12.5 mg no sooner than weekly, up to a maximum dose of 50 mg once daily.

In adolescents, the recommended starting dose is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted by 12.5 mg no sooner than weekly, up to a recommended maximum dose of 25 mg once daily. Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients.

If you take too much Mydayis, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Mydayis is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Mydayis in a tight, light-resistant container.
• Keep this and all medicines out of the reach of children.
• Store Mydayis at room temperature, 15ºC to 30ºC (59ºF to 86ºF).

Warning: abuse and dependence.

CNS stimulants, including Mydayis, have a high potential for abuse and dependence. 

Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

• Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs.
• Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.