Dexmethylphenidate Hydrochloride Prescribing Information
Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Dexmethylphenidate Hydrochloride Tablets, 2.5 mg are blue, round-shaped, convex tablets debossed with 91 on one side and plain on the other side
Dexmethylphenidate Hydrochloride Tablets, 5 mg are yellow, round-shaped, convex tablets debossed with 92 on one side and plain on the other side
Dexmethylphenidate Hydrochloride Tablets, 10 mg are white to off white, round-shaped, convex tablets debossed with 93 on one side and plain on the other side
- Hypersensitivity to methylphenidate or other components of dexmethylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ].
- 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 [see Drug Interactions ].
The following are discussed in more detail in other sections of the labeling:
- Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions , Drug Abuse and Dependence ]
- Known hypersensitivity to methylphenidate or other ingredients of dexmethylphenidate hydrochloride tablets [see Contraindications ]
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications , 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 ]
- 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 ]
- 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 ]
Dexmethylphenidate hydrochloride tablets contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the
Chemically, dexmethylphenidate hydrochloride tablet is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C14H19NO2•HCl. Its structural formula is:
Note: * = asymmetric carbon centers
Dexmethylphenidate hydrochloride tablet is a white to off-white 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. Its molecular weight is 269.77 g/mol.