Methylphenidate Hydrochloride Prescribing Information
| Strength | Color | Tablet Description |
| 27 mg | Gray | capsule shaped, imprinted with “M” in a box and “27” on one side in black ink |
| 36 mg | White | capsule shaped, imprinted with “M” in a box and “36” on one side in black ink |
| 54 mg | Red | capsule shaped, imprinted with “M” in a box and “54” on one side in black ink |
The following are discussed in more detail in other sections of the labeling:
Abuse, Misuse, and Addiction
[see Boxed Warning, Warnings and Precautions ]- Hypersensitivity to Methylphenidate[see Contraindications ]
- Monoamine Oxidase Inhibitors[see Contraindications and Drug Interactions ]
- Risks to Patients with Serious Cardiac Disease[see Warnings and Precautions ]
- Increased Blood Pressure and Heart Rate[see Warnings and Precautions ]
- Psychiatric Adverse Reactions[see Warnings and Precautions ]
- Seizures[see Warnings and Precautions ]
- Priapism[see Warnings and Precautions ]
- Peripheral Vasculopathy, including Raynaud’s Phenomenon[see Warnings and Precautions ]
- Long-Term Suppression of Growth in Pediatric Patients[see Warnings and Precautions ]
- Potential for Gastrointestinal Obstruction[see Warnings and Precautions ]
- Hematologic Monitoring[see Warnings and Precautions ]
- Acute Angle Closure Glaucoma[see Warnings and Precautions ]
- Increased Intraocular Pressure and Glaucoma[see Warnings and Precautions ]
- Motor and Verbal Tics, and Worsening of Tourette’s Syndrome[see Warnings and Precautions ]
The most common adverse reaction in double-blind clinical trials (>5%) in pediatric patients (children and adolescents) was abdominal pain upper. 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 decreased, irritability, and hyperhidrosis
The most common adverse reactions associated with discontinuation (≥1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased
The development program for methylphenidate hydrochloride extended-release tablets included exposures in a total of 3906 participants in clinical trials. Children, adolescents, and adults with ADHD were evaluated in 6 controlled clinical studies and 11 open-label clinical studies (see Table 3). Safety was assessed by collecting adverse events, vital signs, weights, and ECGs, and by performing physical examinations and laboratory analyses.
| Patient Population | N | Dose Range |
| Children | 2216 | 18 to 54 mg once daily |
| Adolescents | 502 | 18 to 72 mg once daily |
| Adults | 1188 | 18 to 108 mg once daily |
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using their own terminology. Consequently, to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Throughout this section, adverse reactions are reported. Adverse reactions are adverse events that were considered to be reasonably associated with the use of methylphenidate hydrochloride extended-release tablets based on the comprehensive assessment of the available adverse event information. A causal association for methylphenidate hydrochloride extended-release tablets often cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in clinical practice.
The majority of adverse reactions were mild to moderate in severity.
Methylphenidate Hydrochloride Extended-Release Tablets USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride.
Its structural formula is:
Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone.
Methylphenidate hydrochloride extended-release tablets also contain the following inert ingredients: silicified microcrystalline cellulose, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, medium-chain triglycerides, oleic acid, polyethylene glycol, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, triacetin, shellac.
Each tablet also contains the following additional inert ingredients:
Methylphenidate hydrochloride extended-release tablets were demonstrated to be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in 4 randomized, double-blind, placebo-controlled studies in children and adolescents and 2 double-blind placebo-controlled studies in adults who met the Diagnostic and Statistical Manual 4th edition (DSM-IV) criteria for ADHD.