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Clinical Use:
Biphentin® is indicated as an integral part of a total
treatment program for ADHD that may include other
measures (psychological, educational, and social)
for patients with this syndrome. Drug treatment may
not be indicated for all patients with this syndrome.
Effectiveness for more than 4 weeks has not been
systematically evaluated in placebo-controlled trials.
Physicians electing to use Biphentin® for extended
periods should periodically re-evaluate the long-
term usefulness of the drug for the individual patient.
Should not be taken by children under 6 years of age.
No data is available for patients >65 years of age.
Contraindications:
• Anxiety, tension, agitation, thyrotoxicosis, advanced
arteriosclerosis, symptomatic cardiovascular
disease, moderate to severe hypertension or
glaucoma
• Patients who are hypersensitive to methylphenidate
hydrochloride or to any other ingredient in the
formulation or component of the container
• Motor tics or with family history or diagnosis of
Tourette’s syndrome
• Concomitant use of an MAO inhibitor or within a
minimum of 14 days following discontinuation of an
MAO inhibitor
Most Serious Warning and Precaution:
• Drug dependence/tolerance. Careful supervision is
required during drug withdrawal
Other Relevant Warnings and Precautions:
• The risk of sudden cardiac death should be
considered although incremental risk of adverse
cardiac events has not been confirmed
• Patients who are involved in strenuous exercise or
activities; are using other stimulants or medications
for ADHD; or have a family history of sudden cardiac
death
• Cardiovascular—sudden death and pre-existing
structural cardiac abnormalities or other serious
heart problems
• Screen for cardiovascular and cerebral vascular
conditions before initiating treatment and monitor
for new conditions during treatment
• Monitor blood pressure at appropriate intervals
especially in patients with pre-existing conditions
that may result in hypertension
• Long-term suppression of growth: Carefully monitor
patients requiring long-term therapy. Interrupt
treatment in patients not growing or gaining weight
as expected
• Psychiatric effects: Not for treatment of depression;
not for use in treatment or prevention of normal
fatigue states; may exacerbate psychosis symptoms
in patients with pre-existing psychotic disorder;
screen for risk of bipolar disorder in patients with
comorbid depressive symptoms; monitor patients
for signs of suicide-related behaviour; monitor
patients for new psychotic or manic episodes and
aggressive behaviour
• Neurologic effects: Discontinue if seizure frequency
rises
• Ophthalmologic effects
• Priapism
• Associated with peripheral vasculopathy, including
Raynaud’s phenomenon
• Not for use in pregnant women unless the potential
benefit outweighs the risk to the fetus. A risk to the
suckling child cannot be excluded
• Patients with an element of agitation may react
adversely; discontinue therapy if necessary
• Patients should be cautious when driving or
operating machinery
• Drug interactions
For more information:
Please consult the product monograph at http://www.
for important
information relating to adverse reactions, drug
interactions, and dosing information which have not
been discussed in this piece. The Product Monograph
is also available by calling Purdue Pharma
at 1-800-387-5349.