DESCRIPTION
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
			
			
Dose Range
		
		
			
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
		
	
 
HOW SUPPLIED
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.
 
SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
	
Drug Dependence
	
Hypersensitivity to Methylphenidate
	
Agitation
	
Glaucoma
	
Serious Cardiovascular Events
	
Psychiatric Adverse Events
	
Seizures
	
Priapism
	
Long-Term Suppression of Growth
	
Visual Disturbance
	
Potential for Gastrointestinal Obstruction
	
Hematologic Monitoring