Molecule
Dexmethylphenidate is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is available as extended-release capsules and tablets for oral use. MedsAcross supplies Dexmethylphenidate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Focalin is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Source: US FDA prescribing information
Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.
Source: US FDA prescribing information
• Administer orally twice daily, 4 hours apart with or without food. • For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily). • For patients currently taking methylphenidate: Initiate Focalin therapy with half (1/2) the current total daily dose of methylphenidate. • Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily).
Source: US FDA prescribing information
• Hypersensitivity to methylphenidate or other components of Focalin. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate. • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises. • Known hypersensitivity to methylphenidate or other components of Focalin. • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
Source: US FDA prescribing information
Boxed warning (abuse, misuse, and addiction): Focalin has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Focalin, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. • Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease. • Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. • Psychiatric Adverse Reactions: Prior to initiating Focalin, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Focalin.
Source: US FDA prescribing information
The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction • Known hypersensitivity to methylphenidate or other ingredients of Focalin • Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors • Risks to Patients with Serious Cardiac Disease • Increased Blood Pressure and Heart Rate • Psychiatric Adverse Reactions • Priapism • Peripheral Vasculopathy, Including Raynaud’s phenomenon • Long-Term Suppression of Growth in Pediatric Patients • Acute Angle Closure Glaucoma • Increased Intraocular Pressure and Glaucoma • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome The most common adverse reactions (greater than or equal to 5% and twice the rate of placebo) in pediatric patients 6 to 17 years were abdominal pain, fever, nausea, and anorexia.
Source: US FDA prescribing information
• Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed. Clinically Important Drug Interactions with Focalin Table 2 presents clinically important drug interactions with Focalin. Table 2: Clinically Important Drug Interactions with Focalin Monoamine Oxidase Inhibitors (MAOIs) Clinical impact Concomitant use of MAOIs and CNS stimulants, including Focalin, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Intervention Concomitant use of Focalin with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Focalin may decrease the effectiveness of drugs used to treat hypertension.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
22 presentations of Dexmethylphenidate, sorted by availability.
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 13 November 2001 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Dexmethylphenidate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 22 presentations of Dexmethylphenidate and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Dexmethylphenidate, including Focalin, Focalin XR.
Yes. The US FDA first approved Dexmethylphenidate on 13 November 2001, according to Drugs@FDA.
No listed presentation of Dexmethylphenidate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Dexmethylphenidate is classified under ATC code N06BA11 (Dexmethylphenidate).
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