CONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. CONCERTA also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.
DOSAGE AND ADMINISTRATION
General Dosing Information
CONCERTA should be administered orally once daily in the morning with or without food. CONCERTA must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed
The recommended starting dose of CONCERTA for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults.
Table 1: CONCERTA Recommended Starting Doses and Dose Ranges
|Patient Age|| |
Recommended Starting Dose
|Children 6-12 years of age||18 mg/day||18 mg - 54 mg/day|
|Adolescents 13-17 years of age||18 mg/day|| |
18 mg - 72 mg/day not to exceed 2 mg/kg/day
|Adults 18-65 years of age||18 or 36 mg/day||18 mg - 72 mg/day|
Dosage Forms And Strengths
CONCERTA (methylphenidate HCl) Extended-Release Tablets are available in the following dosage strengths: 18 mg tablets are yellow and imprinted with “alza 18,” 27 mg tablets are gray and imprinted with “alza 27,” 36 mg tablets are white and imprinted with “alza 36,” and 54 mg tablets are brownish-red and imprinted with “alza 54.”
CONCERTA (methylphenidate HCl) Extended-release Tablets are available in 18 mg, 27 mg, 36 mg, and 54 mg dosage strengths. The 18 mg tablets are yellow and imprinted with “alza 18”. The 27 mg tablets are gray and imprinted with “alza 27”. The 36 mg tablets are white and imprinted with “alza 36”. The 54 mg tablets are brownish-red and imprinted with “alza 54”. All four dosage strengths are supplied in bottles containing 100 tablets.
The following are discussed in more detail in other sections of the labeling:
- Drug Dependence
- Hypersensitivity to Methylphenidate
- Serious Cardiovascular Events
- Psychiatric Adverse Events
- Long-Term Suppression of Growth
- Visual Disturbance
- Potential for Gastrointestinal Obstruction
- Hematologic Monitoring