Relexxii

What Is Relexxii

Relexxii (generic name: methylphenidate HCI ER) is a once-daily, extended-release, central nervous system (CNS) stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults up to the age of 65 and pediatric patients six years of age and older. The safety and effectiveness of Relexxii for pediatric patients under age six are unknown.

According to the U.S. Food and Drug Administration (FDA), Relexxii is a federally controlled substance. “Schedule II Stimulants” are believed to have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction.

What Ingredients Are in Relexxii?

Relexxii contains methylphenidate hydrochloride salt, the same active ingredient as ADHD medications, such as Ritalin, Daytrana, Concerta, and Aptensio XR. Relexxii contains the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, phosphoric acid, polyethylene glycol, polyethylene oxide, sodium chloride, succinic acid, titanium dioxide, and triacetin.

How Does Relexxii Work?

Relexxii uses osmotic delivery technology, releasing the medication at a controlled rate throughout the day. Relexxii comes in tablet form and has a semipermeable membrane with an immediate-release drug overcoat, an osmotically active bilayer core containing the drug and excipients, and a push layer containing osmotically active components. The immediate-release drug overcoat dissolves within one hour, providing an initial dose of medication. The push layer in the tablet’s core expands and pushes the drug through a laser-drilled orifice at a controlled release rate throughout the day for 6 to 7 hours. The Relexxii tablet releases medication without dissolving its outer shell. The outer shell passes through the digestive tract and out of the body without being digested.

How Do You Use Relexxii?

Relexxii tablets should be taken orally once daily in the morning, with or without food, and must be swallowed whole with a full glass of water or another liquid. Never cut, crush, or chew the tablets because this would destroy the time-release mechanism.

What Is the Typical Dosage for Relexxii?

Relexxii is available in flexible dosing options that support targeted titration and eliminate the need for multiple pills. Daily dosages above 54 mg in pediatric patients 6 to 12 years and above 72 mg in pediatric patients 13 to 17 years have not been studied and are not recommended. Daily dosages above 72 mg are not recommended in adults.

The optimal dosage varies from patient to patient. Your doctor may adjust your daily dosage by small increments until you or your child experiences the greatest improvement in symptoms without side effects.

For updated information about dosages, interactions, and precautions, see the Relexxii drug monograph on WebMD.

Relexxii vs. Concerta

Relexxii and Concerta are both brand names for methylphenidate HCI. Relexxii and Concerta both use osmotic delivery technology, which releases the medication at a controlled rate throughout the day. In a study of 60 healthy volunteers, a once-daily dose of Relexxii 72-mg demonstrated bioequivalence to a twice-daily dose of Concerta (methylphenidate HCI) 36-mg tablets. ¹, ²

On June 23, 2022, the FDA approved Vertical Pharmaceuticals’ Relexxii for ADHD in adults (up to 65 years old) and pediatric patients six years of age and older.

Concerta received FDA approval for treating ADHD on August 1, 2000.

What Side Effects Are Associated with Relexxii?

As with all ADHD medications, follow your Relexxii prescription instructions exactly. Taking Relexxii late in the day can disrupt sleep.
The most common side effects of Relexxii reported by adults include:

• decreased appetite
• headache
• dry mouth
• nausea
• insomnia
• anxiety
• dizziness
• weight loss
• irritability
• increased sweating

Less common side effects of Relexxii include:

• priapism (an erection that does not subside)
• circulation problems in fingers and toes, including Raynaud’s Phenomenon
• eyesight changes or blurred visions

The most common side effect reported in pediatric patients taking Relexxii was upper abdominal pain. There has been some concern that stimulants may cause a slowing of growth in children and adolescents. However, research findings revealed mixed results. Some studies show no impact on growth at all ³, while others find what is considered a “negligible” slowing of growth. ⁴ Talk to your doctor if you find evidence of suppressed growth or weight in your child.

If side effects are bothersome or do not disappear, talk to your doctor. Most people taking this medication do not experience any of these side effects. See the full list of possible Relexxii side effects here.

What Precautions Are Associated with Relexxii?

Patients with known structural cardiac abnormalities, cardiomyopathy, severe heart rhythm abnormalities, coronary artery disease, and other serious heart problems should avoid using Relexxii. Patients should monitor their heart rate and blood pressure regularly while taking Relexxii, as increases may occur. Patients with a personal or family history of high blood pressure, heart problems, or heart defects should share this with their HCP.

Relexxii may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder or induce a manic or mixed episode in patients with bipolar disorder. Before initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depression, a family history of suicide, and bipolar disorder). If new psychotic or manic symptoms occur, consider discontinuing Relexxii.

Before initiating Relexxii, healthcare providers should assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. They should also regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate.

Because the Relexxii tablet is nondeformable and does not appreciably change in shape in the GI tract, Relexxii should not be administered to patients with preexisting severe gastrointestinal narrowing (e.g., esophageal motility disorders, small bowel inflammatory disease, “short gut” syndrome due to adhesions or decreased transit time, peritonitis, cystic fibrosis, chronic intestinal pseudo-obstruction, or Meckel’s diverticulum).

An ophthalmologist should evaluate any Relexxii-treated patients at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia).

The effects of Relexxii on an unborn child are not yet clear. Tell your doctor if you plan to become pregnant, are pregnant, or are breastfeeding before taking Relexxii. Women exposed to Relexxii during pregnancy or breastfeeding may participate in the National Pregnancy Registry for Psychiatric Medications to improve existing safety information.

What Interactions Are Associated with Relexxii

You should not take Relexxii if you have any of the following conditions:

• allergy or hypersensitivity to methylphenidate HCI or any of the ingredients in methylphenidate medications
• anxiety/agitation
• glaucoma
• tics or history of Tourette’s syndrome
• circulation problems
• esophagus, stomach, or intestine problems
• if you are taking monoamine oxidase inhibitors (MAOIs) or within 14 days after discontinuing MAOI treatment
• if you are taking risperidone.

Share a list of all vitamin or herbal supplements and prescription and non-prescription medications you take with the pharmacist when you fill your prescription. Inform all doctors and physicians that you are taking Relexxii before surgery or laboratory tests. Relexxii can have a dangerous interaction with certain anesthetics.

For a complete list of all possible drug interactions, refer to Relexxii’s drug label information for consumers and healthcare professionals.

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