Support Services for Extrapyramidal Drugs & Parkinson’s Disease Treatment | OSMOLEX ER

Methylphenidate ER 72-mg (methylphenidate HCl) extended-release tablets

The first and only 72-mg methylphenidate ER tablet for appropriate patients ages 13-65

Learn about Methylphenidate ER 72-mg, which is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13 years of age and older, and adults up to the age of 65.

Support Services for Extrapyramidal Drugs & Parkinson’s Disease Treatment | OSMOLEX ER

Methylphenidate ER 72-mg (methylphenidate HCl) extended-release tablets

The first and only 72-mg methylphenidate ER tablet for appropriate patients ages 13-65

Learn about Methylphenidate ER 72-mg, which is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13 years of age and older, and adults up to the age of 65.

 

Methylphenidate ER 72-mg (methylphenidate HCl) extended-release tablets are a generic formulation of branded methylphenidate HCl extended-release tablets

  • CONVENIENT – one 72-mg tablet daily vs two 36-mg tablets daily
  • FEWER TABLETS (30 vs 60) – may reduce out-of-pocket costs when prescription plans impose a monthly quantity limit of 30 tablets of methylphenidate
  • CONSISTENT – each fill has a consistent appearance from the same manufacturer
  • GENERIC – may enhance access and affordability

Did you know?

  • Some brand-name drugs have multiple generic competitors. As a result, the tablets may vary in appearance each time you fill your prescription. Methylphenidate ER 72-mg tablets are produced by only one manufacturer. This means you will receive the same light blue, round tablet every time you fill your prescription. In addition, Methylphenidate ER 72-mg was launched as a generic to help gain favorable coverage from insurance plans.
  • Generic drugs go through a demanding review process to receive approval from the US Food and Drug Administration (FDA). The FDA ensures a generic medication provides equivalent safety and efficacy as the brand-name medicine.
  • In 2014, the FDA revised its guidelines for all methylphenidate ER generics. Methylphenidate ER 72-mg tablets met these stricter guidelines to demonstrate equivalence to branded methylphenidate HCl extended-release tablets.

The osmotic delivery system in the Methylphenidate ER 72-mg tablets is designed to release methylphenidate at a controlled release rate throughout the day

Osmodex® – Drug delivery system

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Inside each blue tablet is an osmotic (water pressure) drug-delivery system that works similarly to branded methylphenidate HCl extended-release tablets:

  1. The immediate-release drug layer dissolves within one hour of administration
  2. The rate-controlling semipermeable membrane controls the rate at which water enters the tablet core
  3. The push layer in the tablet core expands and pushes drug through the laser-drilled orifice at a controlled release rate throughout the day
 

Indication and Important Safety Information

The 72-mg methylphenidate hydrochloride extended-release tablet is a prescription medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13 years of age and older, and adults up to the age of 65.

Indication and Important Safety Information

The 72-mg methylphenidate hydrochloride extended-release tablet is a prescription medication approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents 13 years of age and older, and adults up to the age of 65.


WARNING: DRUG DEPENDENCE

See full prescribing information for complete boxed warning.

Abuse of methylphenidate may lead to dependence. Tell your healthcare professional if you or your child has had prior issues of abuse or dependence with alcohol or drugs. Keep Methylphenidate ER 72-mg tablets in a safe place to prevent misuse and abuse by others.


Who should not take Methylphenidate ER 72-mg?

Methylphenidate ER 72-mg should not be taken by patients who have:

  • allergies to methylphenidate or other ingredients in Methylphenidate ER 72-mg
  • significant anxiety, tension, or agitation
  • glaucoma
  • tics, Tourette’s syndrome, or family history of Tourette’s syndrome
  • current or past use of monoamine oxidase inhibitor (MAOI)
  • esophagus, stomach, or intestinal narrowing

Children under 13 years of age should not take 72-mg Methylphenidate ER tablets.


Tell your healthcare professional if you or your child has had:

  • any heart problems, heart defects, high blood pressure, or a family history of these problems
  • has had depression, abnormal thoughts or visions, bipolar disorder, or seizures
  • numbness, pain, skin color change, or sensitivity to temperature in fingers or toes

Contact your healthcare professional immediately if you or your child:

  • develops abnormal thinking or hallucinations, abnormal or extreme moods, and/or excessive activity
  • if aggressive behavior or hostility develops or worsens while taking Methylphenidate ER 72-mg

Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for permanent damage, priapism should be evaluated by a doctor immediately.

Your child’s healthcare professional should check height and weight often and may interrupt Methylphenidate ER 72-mg treatment if your child is not growing or gaining weight as expected.

Stimulants may impair the ability of a patient to operate potentially hazardous machinery or vehicles. Caution should be used accordingly until you are reasonably certain that Methylphenidate ER 72-mg tablets do not adversely affect your or your child’s ability to engage in such activities.


The most common adverse reactions in double-blind clinical trials (>5%) reported:

  • in children and adolescents, upper abdominal pain
  • in adult patients, decreased appetite, headache, dry mouth, nausea, trouble sleeping, anxiety, dizziness, weight decrease, irritability, and increased sweating

Please click here for full Prescribing Information, including Boxed Warning.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.