Azstarys dosage, forms, and strengths

Azstarys is a brand-name prescription treatment for attention deficit hyperactivity disorder (ADHD). It’s a long-acting form of methylphenidate, a CNS stimulant widely used to improve focus and impulse control. Azstarys combines two variations of methylphenidate. The first, dexmethylphenidate, is twice as potent as methylphenidate and begins to work immediately. The effects wear off in about three hours. The second, serdexmethylphenidate, is slowly converted by the body into dexmethylphenidate and improves ADHD symptoms for as long as 13 hours. That means children and adults with ADHD need only take one dose daily in the morning rather than five doses every five hours.

Azstarys forms and strengths

Azstarys is available only as capsules in three dosage strengths: 

• 26.1 mg/5.2 mg (serdexmethylphenidate/dexmethylphenidate) 

• 39.2 mg/7.8 mg (serdexmethylphenidate/dexmethylphenidate) 

• 52.3 mg / 10.4 mg (serdexmethylphenidate/dexmethylphenidate) 

The dosage strengths of these capsules may confuse people who are more accustomed to other methylphenidate products. 

The larger number (dose) in the Azstarys dosage strength is the long-acting version of dexmethylphenidate, while the smaller dose is the fast-acting dexmethylphenidate. The smaller dose begins working right away, while the larger dose is gradually converted to its active form over the course of the day.

It's important to note that the total dose in an Azstarys capsule is not equivalent to the same milligram amount of other methylphenidate products. For this reason, patients and caregivers cannot substitute another methylphenidate drug for Azstarys. To switch between Azstarys and other methylphenidate medications, a new prescription from a healthcare provider will be required. 

Azstarys dosage for adults

The Food and Drug Administration (FDA) has approved Azstarys to treat symptoms of ADHD in adults and children 6 years of age and older. Doses are taken once daily in the morning, with or without food. 

Azstarys is generally safe. However, people who have had an allergic reaction to serdexmethylphenidate or methylphenidate should not take it. People with heart disease should be aware that there’s a risk they may experience serious heart problems, including death, when taking Azstarys.

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Azstarys dosage for children

Azstarys is FDA-approved to treat pediatric patients 6 years of age and older who have been diagnosed with ADHD. The recommended dosage is the same for adults, but younger children (6–12 years of age) may have the dose reduced to the smallest possible dose of 26.1 mg/5.2 mg daily. There are no children’s formulations of Azsartys, such as chewable tablets or liquid.

• Standard Azstarys dosage for children ages 6–12 years of age: 26.1 mg/5.2 mg–52.3 mg/10.4 mg capsule taken once daily in the morning

• Standard Azstarys dosage for children ages 13 years of age and older: 39.2 mg/7.8 mg–52.3 mg/10.4 mg capsule taken once daily in the morning

• Maximum Azstarys dosage for children ages 6 and older: 52.3 mg/10.4 mg daily

Azstarys dosage restrictions

No dosage reductions are necessary for people with kidney, liver, or other medical conditions. 

How to take Azstarys

Taking Azstarys is relatively simple. Only one dose is required each morning. The most important thing to know is to take the dose as early as possible in the morning. If a dose is missed, don’t take it too late in the day. It will keep you or your child awake at night. 

• Like all medicines, follow all the healthcare provider’s instructions when taking or administering Azstarys. The dose may need to be changed at the start of treatment.

• Please read the Medication Guide that comes with this medicine.

• Take only one capsule daily by mouth.

• Take the capsule in the morning.

• Doses can be taken with or without food.

• Swallow the capsule whole with a drink of water or other liquid.

• If swallowing a capsule is difficult, open the capsule and sprinkle the ingredients on two tablespoons of applesauce or ¼ cup of water (50 mL). Swallow the mixture right away. Do not keep the mixture for later.

• Do not substitute other methylphenidate drugs for Azstarys until talking to the healthcare provider.

• Store Azstarys capsules in a child-proof container at room temperature.

Azstarys dosage FAQs

How long does it take Azstarys to work?

Azstarys starts working about 30 minutes after a capsule is swallowed. Its strongest (peak) effects last about one hour after the drug is taken.

How long does Azstarys stay in your system?

Azstarys is a long-acting drug that provides its therapeutic effects for about 13 hours. Since Azstarys contains two active components, serdexmethylphenidate, and dexmethylphenidate, each component has different half-lives. However, during clinical studies, it was shown that it took about 60 hours for the body to completely clear a dose. 

What happens if I miss a dose of Azstarys?

Ask the healthcare provider what to do if a dose of Azstarys is missed. Doses should be taken in the morning. When taken later in the day, the drug could interfere with sleep. Never take two doses or double doses to make up for a missed dose.

How long can you take Azstarys?

Azstarys treatment is intended for long-term or even lifelong use. Clinical studies did not find side effects specifically due to long-term use. 

How do I stop taking Azstarys?

Because Azstarys may cause dependency, it is important to talk to the healthcare provider before stopping this drug. It normally does not require a gradual dose reduction (tapered dosing), but a healthcare provider may decide to prescribe another drug to prevent any symptoms of ADHD.

Your healthcare professional may continue to prescribe Azstarys as long as it works and doesn’t cause problems such as allergic reactions or intolerable side effects. When it’s time to stop it, the healthcare provider may prescribe other treatment options, including other methylphenidate drugs, amphetamines, and non-stimulants such as Strattera (atomoxetine), Kapvay (clonidine ER), Intuniv (guanfacine hydrochloride ER), and Qelbree (viloxazine ER).

What is the maximum dosage for Azstarys?

The maximum dosage for Azstaryis is 52.3 mg/10.4 mg daily.

Can you overdose on Azstarys?

Yes, an overdose of Azstarys can be very serious, particularly if taken with other drugs. An overdose could cause life-threatening issues such as heart attack, high fever, or muscle damage, depending on the nature of the overdose. 

If an overdose is suspected, immediately contact a poison control helpline, call 911, or get emergency medical help. 

There may be no symptoms. When there are, those symptoms can include racing heartbeats (tachycardia), high blood pressure, low blood pressure, agitation, hallucinations, seizures, fever, and muscle pain.

What interacts with Azstarys?

To avoid possible drug interactions, make sure your healthcare provider knows about all the prescription drugs, including over-the-counter (OTC) drugs, vitamins, and supplements that you or your child use.

Azstarys can never be taken with drugs called monoamine oxidase inhibitors (MAOIs). MAOIs are primarily used to treat depression. Find a complete list of MAOIs here. Any MAOI must be stopped at least 14 days before starting Azstarys.

While no other drugs are strictly prohibited, some can cause problems or interact when combined with Azstarys. These include: 

• Other CNS stimulants (e.g., ADHD medications)

• Antidepressants

• Drugs that treat seizures

• Blood pressure medications (antihypertensives)

• Drugs that narrow blood vessels (vasopressors)

• The antipsychotic drug risperidone

• The blood thinner warfarin

Certain types of anesthetics may cause serious adverse reactions in people taking Azstarys. Before any surgery or medical procedure involving anesthesia, make sure the healthcare provider knows about Azstarys treatment. It may be necessary to stop taking Azstarys several days before the procedure.

What happens when you mix Azstarys and alcohol?

There are no known interactions between Azstarys and alcohol. Even so, get medical advice from the healthcare provider about drinking alcohol when taking Azstarys or any other ADHD medication. Research has shown that alcohol use and ADHD can cause a variety of problems, such as alcohol abuse and increased disinhibition, that have nothing to do with the medications being used.

Is it safe to take Azstarys during pregnancy?

Ask your healthcare provider for medical advice about taking Azstarys during pregnancy. There are theoretical risks to both the fetus and the pregnancy, but none have been reported for women taking methylphenidate. There is a pregnancy registry for women who take ADHD medications, including Azstarys, during pregnancy. This registry helps collect information about the mother and baby's health. If you or your child becomes pregnant while using Azstarys, talk to your healthcare provider about joining the National Pregnancy Registry for Psychostimulants by calling 1-866-961-2388.

Is it safe to take Azstarys while breastfeeding?

There are no studies on Azstarys in women who are breastfeeding, so it is unclear how much of the drug may pass into breast milk or whether it affects the nursing infant. There is currently no evidence that it causes problems. Studies on methylphenidate (a similar ADHD medication) show that it can pass into breast milk, but no side effects were observed in breastfed infants. If taking Azstarys while breastfeeding, mothers and doctors should watch for possible side effects in the baby, such as fussiness, decreased appetite, and weight gain. Always talk to a healthcare provider before using Azstarys while breastfeeding.

What are the possible side effects of Azstarys?

The most common side effects of Azstarys are trouble sleeping, appetite loss, weight loss, nausea, vomiting, stomach upset, abdominal pain, dizziness, irritability, mood swings, fast heart rate, and elevated blood pressure (hypertension).

What are the serious side effects of Azstarys?

Though not common, Azstarys can cause serious adverse reactions, including:

• Psychotic or manic symptoms

• Painful or long-lasting erections (priapism)

• Worsening of tics ( Tourette’s syndrome)

• Circulation problems in the fingers and toes (Raynaud’s phenomenon)

• Increased pressure in the eye and glaucoma

• Suppression of growth in children

There may be other side effects of Azstarys that are not listed here. If you experience any unusual symptoms, contact your healthcare provider for advice.

What should I know before starting Azstarys?

The most important thing to know about Azstarys is that it is a CNS stimulant and a controlled substance that has a high potential to cause dependency, abuse, and addiction. Because of this, the FDA issued a boxed warning on the drug label warning patients or their caregivers about this risk. Misusing this drug or combining it with other illicit drugs can be deadly. It is illegal and dangerous to give or sell this drug to other people.

Patients or their caregivers should also know that Azstarys may cause serious heart problems, including sudden death in people with existing heart disease. These patients should immediately contact the healthcare provider if they notice symptoms of heart problems such as chest pain, fainting, or shortness of breath.

Azstarys can worsen the symptoms of many mental health conditions, such as bipolar disorder, psychosis, Tourette’s syndrome, or depression. Make sure the healthcare provider is aware of these conditions before starting Azstarys.

Sources

• Azstarys, Corium

• Azstarys HCP, Corium

• Azstarys dosing and administration information, Corium (2021)

• Azstarys in Ora-Blend single dose, U.S. Pharmacist

• Azstarys serdexmethylphenidate and dexmethylphenidate capsule prescribing information, DailyMed (NIH National Library of Medicine)

• The Clinically Meaningful Link Between Alcohol Use and Attention Deficit Hyperactivity Disorder, PubMed Central (2002)

• Dexmethylphenidate, Drugs and Lactation Database

• Methylphenidate, StatPearls

• Similar bioavailability of dexmethylphenidate extended (bimodal) release, dexmethylphenidate immediate release and racemic methylphenidate extended (bimodal) release formulations in man, International Journal of Clinical Pharmacology and Therapeutics

• Methylphenidate use in pregnancy and lactation: a systematic review of evidence. British journal of clinical pharmacology (2013)