Once-daily
Biphentin
®
with
MLR
®
Bead
Technology
1
Recommended first-line ADHD treatment
in children, adolescents and adults.
2
*
Biphentin
®
is indicated for treatment of Attention
Deficit Hyperactivity Disorder (ADHD) in children 6–11,
adolescents 12–18 and adults >18 years of age.
Refer to the page in the bottom-right icon for additional safety information
and a web link to the Product Monograph discussing:
• Contraindications in patients with anxiety, tension, agitation,
thyrotoxicosis, advanced arteriosclerosis, symptomatic cardiovascular
disease, moderate to severe hypertension or glaucoma. 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.
• The most serious warning and precaution regarding drug dependence/
tolerance. Careful supervision is required during drug withdrawal.
• Other relevant warnings and precautions regarding risk of sudden
cardiac death in patients who are involved in strenuous exercise or
activities or have a family history of sudden cardiac death, sudden death,
screening for cardiovascular and cerebral vascular conditions, monitor
blood pressure, long-term suppression of growth, 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, 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; caution when
driving or operating machinery.
• Conditions of clinical use, adverse reactions, drug interaction and
dosing instructions in the Product Monograph.
*Recommended first-line foruncomplicatedADHD in children, adolescents and adultsbyCADDRA (CanadianAttentionDeficitHyperactivityDisorderResourceAlliance).
2
†
Rapidly and extensively absorbedwithpeakblood levels obtained in1 to3hours. The initialpeakplasma concentration at1.7hourspost-dosewas similar to
1.8hours for the immediate-release formulationwhenfasting.
2
‡
IOWA-CRatingScale andConners’ParentRatingScaleperformed at approximately10 and12hours, respectively,post-morningdose in two separate randomized,
double-blind crossover studies vs. IRmethylphenidate andplacebo and vs. IRmethylphenidate in children and adolescents≥6 years of age.
1
CR= controlled release; IR= immediate release;MPH=methylphenidate.
References:
1.
Biphentin
®
ProductMonograph,PurduePharma, June10,2016 or such laterdate asposted
atwww.purdue.ca.
2.
CanadianAttentionDeficitHyperactivity
DisorderResourceAlliance (CADDRA):CanadianADHDPracticeGuidelines, ThirdEdition, TorontoON;CADDRA,2011
.http://www.caddra.ca/pdfs/caddraGuidelines2011.pdf.AccessedOctober18,2016.
Biphentin
®
andMLR
®
are registered trademarks ofPurduePharma.
©2017PurduePharma.All rights reserved.
IN CHILDREN AND ADOLESCENTS:
EFFICACY SHOWN TO LAST
10–12 HOURS
1‡
IN ADULTS:
FAST ONSET
—SIMILAR TO IR METHYLPHENIDATE
1†
See additional safety information on page
xxx