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

SIMPLIFY THE MATH FOR YOUR ADHD PATIENTS

The first and only 72-mg methylphenidate ER tablet for appropriate patients ages 13-651,2

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

SIMPLIFY THE MATH FOR YOUR ADHD PATIENTS

The first and only 72-mg methylphenidate ER tablet for appropriate patients ages 13-651,2

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.

 

Key Features

Methylphenidate ER 72-mg (methylphenidate HCl) extended-release tablets are generic for branded methylphenidate HCl extended-release tablets.2 Consider these features:

  • 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

Do you have similar ADHD patients in your practice?

Diagnosis: ADHD

Current Medications: (2x36-mg) methylphenidate ER tablets daily

Situation: Patient and parents may prefer the convenience of taking one 72-mg tablet daily vs two 36-mg tablets daily.

Diagnosis: ADHD

Current Medications: (2x36-mg) methylphenidate ER tablets daily

Situation: The patient’s prescription plan imposes a monthly quantity limit of 30 tablets of methylphenidate, incurring higher out-of-pocket costs.

Diagnosis: ADHD and generalized anxiety disorder

Current Medications: (2x36-mg) methylphenidate ER tablets daily and medications for anxiety

Situation: Patient switched from branded methylphenidate HCl extended-release tablets to a generic methylphenidate extended-release product to reduce out-of-pocket costs. She is now concerned about receiving tablets that vary in shape, size, and color from fill to fill. She prefers a consistent-looking product produced from the same manufacturer with each fill.

Diagnosis: ADHD

Current Medications: Patient started on 18-mg of methylphenidate ER 6 months ago and has recently titrated in weekly 18-mg increments to 54-mg daily

Situation: ADHD symptoms have improved, but a dose adjustment may provide better control. Patient requires titration to 72-mg daily but is resistant to taking a second tablet.

Not actual patients. Fictionalized for illustrative purposes.

Osmodex® – Drug delivery system

Osmotic Delivery Technology similar to branded methylphenidate HCl extended-release tablets1,2

tablets for Parkinson’s disease | extrapyramidal disease drugs | OSMOLEX ER

Osmotic pressure delivers methylphenidate at a controlled release rate throughout the day1,2

  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
 

The only product to demonstrate bioequivalence to two 36-mg branded methylphenidate HCl extended-release tablets2

Pharmacokinetic study of mean methylphenidate plasma concentration over time — Administration of one Methylphenidate ER 72-mg tablet vs two 36-mg branded methylphenidate HCl extended-release tablets2

Per revised FDA guidance in 2014,

additional bioequivalence metrics are required to ensure that a new methylphenidate ER alternative is therapeutically equivalent to branded methylphenidate HCl extended-release tablets.3

Metrics

Cmax

AUC(0-∞)

AUC(0-3)

AUC(3-7)

AUC(7-12)

Meets FDA Bioequivalence Criteria

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√

√

√

√

A single-dose, two-treatment, four-period, two-sequence, fully replicated crossover study was conducted in 60 healthy volunteers to compare one Methylphenidate ER 72-mg tablet to two 36-mg branded methylphenidate HCl extended-release tablets.2

Indication and Important Safety Information

The 72-mg methylphenidate hydrochloride extended-release tablet USP is a CNS stimulant 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.

Indication and Important Safety Information

The 72-mg methylphenidate hydrochloride extended-release tablet USP is a CNS stimulant 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.


WARNING: DRUG DEPENDENCE

See full prescribing information for complete boxed warning.

Methylphenidate hydrochloride extended-release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abuse can lead to marked tolerance and psychological dependence, with varying degrees of abnormal behavior.


  • Methylphenidate hydrochloride extended-release tablets should not be used in patients with known hypersensitivity to the product; marked anxiety, tension, or agitation; glaucoma; tics or a family history or diagnosis of Tourette’s syndrome; or in patients currently using or within 2 weeks of using an MAO inhibitor
  • Methylphenidate is a stimulant. Stimulants should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems. Stimulants should be used with caution in patients with a history of high blood pressure or increased heart rate. Patients with a history of high blood pressure and for whom methylphenidate is deemed an appropriate therapy should be monitored for changes in heart rate and blood pressure
  • Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior psychiatric history. Stimulants may also exacerbate psychiatric symptoms in patients with preexisting psychiatric illness
  • Stimulants may lower the convulsive threshold in patients with epilepsy, potentially leading to seizures. Stimulants should not be taken in the presence of seizures
  • Immediate medical attention should be sought if signs or symptoms of prolonged penile erections (priapism) are observed
  • Careful observation for peripheral vasculopathy in extremities, including but not limited to Raynaud’s phenomenon, is necessary during treatment with ADHD stimulants
  • Pediatric patients should be monitored for height and weight at age-appropriate intervals for potential long-term suppression of growth
  • Difficulties with accommodation and blurring of vision have been reported with stimulant treatment. Patients with a history of glaucoma should not take stimulants
  • This extended-release tablet is nondeformable and does not appreciably change in shape in the GI tract; therefore, gastrointestinal obstruction may potentially occur in patients with prior history of GI narrowing
  • Periodic complete blood count (CBC) with differential and platelet counts are advised during prolonged therapy
  • The most common adverse reaction in double-blind clinical trials (>5%) in children and adolescents was upper abdominal pain. The most common adverse reactions in double-blind clinical trials (>5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decrease, irritability, and hyperhidrosis

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


References

  1. Methylphenidate hydrochloride extended-release tablets [package insert]. Trigen Laboratories, LLC; 2017.
  2. Data on file, Osmotica Pharmaceutical US LLC.
  3. US Food and Drug Administration. Draft Guidance on Methylphenidate Hydrochloride. Revised November 2014. Accessed July 2018.