Mean Baseline (SD)          
 37.7 (7.75)
 37.6 (8.13)
 37.0 (7.65)
LS Mean Change from Baseline (SE)          
 -15.9 (0.96)
 -20.3 (0.97)
 -21.2 (0.97)
LS Mean Difference from Placebo (95% CI)  
 --  -4.5 (-7.5, -1.4) b
 -5.3 (-8.3, -2.3) b
 
  (6 – 12 years)
4  
Mean Baseline (SD)  

 42.9 (6.21)
 41.7 (6.39)
 41.6 (6.66)
LS Mean Change from Baseline (SE)  
 -10.6 (1.20)
 -20.0 (1.23)
 -20.4 (1.19)
LS Mean Difference from Placebo (95% CI)
 --  -9.4 (-12.8, -6.0) b
 -9.8 (-13.1, -6.4) b
LS Mean: least-square mean; SD: standard deviation; SE: standard error; 95% CI (unadjusted) Treatment was given in combination with a psychostimulant. Doses were shown to be statistically significantly superior to placebo.
a
b
16 HOW SUPPLIED/STORAGE AND HANDLING
NDC:64725-0515-1 in a CONTAINER of 30 TABLET, EXTENDED RELEASES
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (PATIENT INFORMATION)
Dosing and Administration
Instruct patients to swallow INTUNIV whole with water, milk or other liquid. Patients should not take INTUNIV together with a high-fat meal, since this can raise blood levels of INTUNIV .  Instruct the parent or caregiver to supervise the child or adolescent taking INTUNIV and to keep the bottle of tablets out of reach of children. ®Tablets should not be crushed, chewed or broken prior to administration because this may increase the rate of release of the active drug .®®®
Instruct patients on how to properly taper the medication, if the physician decides to discontinue treatment. [ ]. SEE DOSAGE AND ADMINISTRATION (2.5)
Adverse Reactions
Advise patients that sedation can occur, particularly early in treatment or with dose increases. Caution against operating heavy equipment or driving until they know how they respond to treatment with INTUNIV Headache and abdominal pain can also occur. If any of these symptoms persist, or other symptoms occur, the patient should be advised to discuss the symptoms with the physician. ®[ ]. SEE WARNINGS AND PRECAUTIONS (5.2)
Advise patients to avoid becoming dehydrated or overheated, which may potentially increase the risks of hypotension and syncope Advise patients  to avoid use with alcohol. [ ]. SEE WARNINGS AND PRECAUTIONS (5.1)
PATIENT PACKAGE INSERT
Patient Information   INTUNIV