Drug Catalog - Product Detail
Dexmethylphenidate HCl Tab 5 MG 100 EA
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00781-5689-01 | SANDOZ | 100 | 5MG | TABLET |
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Description
11 DESCRIPTION Dexmethylphenidate hydrochloride is the d-threo -enantiomer of racemic methylphenidate hydrochloride, which is a 50/50 mixture of the d-threo and l-threo -enantiomers. Dexmethylphenidate hydrochloride tablets are a central nervous system (CNS) stimulant, available in 3 tablet strengths. Each tablet contains dexmethylphenidate hydrochloride 2.5 mg, 5 mg, or 10 mg for oral administration. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its empirical formula is C 14 H 19 NO 2 •HCl. Its molecular weight is 269.77g/mol and its structural formula is: Note: * = asymmetric carbon centers Dexmethylphenidate hydrochloride 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. Dexmethylphenidate hydrochloride tablets also contain the following inert ingredients: pregelatinized starch, lactose monohydrate, sodium starch glycolate, microcrystalline cellulose, magnesium stearate, and FD&C Blue No.1 #5516 aluminum lake (2.5 mg tablets), D&C Yellow Lake #10 (5 mg tablets); the 10 mg tablet contains no dye. dexmethylphenidate hydrochloride structural formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Dexmethylphenidate hydrochloride tablets (D-shaped, embossed “D” on upper convex face and dosage strength on lower convex face) are available as follows: • 2.5 mg Tablets – blue Bottles of 100………………………………………………….NDC 0781-5676-01 • 5 mg Tablets – yellow Bottles of 100………………………………………………….NDC 0781-5689-01 • 10 mg Tablets – white Bottles of 100………………………………………………….NDC 0781-5691-01 Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drug disposal of CNS stimulants. Dispose of remaining, unused, or expired dexmethylphenidate hydrochloride by a medicine takeback program or by an authorized collector registered with the Drug Enforcement Administration. If no take-back program or authorized collector is available, mix dexmethylphenidate hydrochloride with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and discard dexmethylphenidate hydrochloride in the household trash. T2019-34 October 2019
Indications & Usage
1 INDICATIONS AND USAGE Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Dexmethylphenidate hydrochloride is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Administer orally twice daily, 4 hours apart with or without food ( 2 ) • For patients new to methylphenidate: Recommend starting dose of 5 mg once daily (2.5 mg twice daily ( 2.1 )) • For patients currently taking methylphenidate: Initiate dexmethylphenidate hydrochloride therapy with half (1/2) the current total daily dose of methylphenidate ( 2.3 ) • Titrate weekly in increments of 2.5 to 5 mg to a maximum of 20 mg/day (10 mg twice daily) ( 2.1 ) 2.1 Pre-Treatment Screening Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including dexmethylphenidate hydrochloride, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions 5.2 ]. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for dexmethylphenidate hydrochloride use [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9 )]. 2.2 Pediatric Patients with ADHD Patients New to Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride for pediatric patients who are not currently taking racemic methylphenidate, or for patients who are on stimulants other than methylphenidate, is 5 mg daily (2.5 mg twice daily) with or without food. Patients Currently on Methylphenidate The recommended starting dose of dexmethylphenidate hydrochloride for pediatric patients currently using methylphenidate is half the total daily dose of racemic methylphenidate. Titration Schedule The dose may be titrated weekly in increments of 2.5 to 5 mg to a maximum of 20 mg daily (10 mg twice daily). The dose should be individualized according to the needs and response of the patient. Maintenance/Extended Treatment Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of dexmethylphenidate hydrochloride and adjust dosage as needed. 2.3 Administration Instructions Dexmethylphenidate hydrochloride is administered orally twice daily, at least 4 hours apart. 2.4 Dose Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or if necessary, discontinued dexmethylphenidate hydrochloride. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.