Clinical Use:

FOQUEST^® is indicated as an integral part of a total treatment program for ADHD that may include other measures (i.e., psychological, educational and/or social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis.

Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use. FOQUEST^® should not be used in children under 6 years of age. No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use in patients under 6 years of age.

The effectiveness of FOQUEST^® has not been evaluated for more than 4 weeks in placebo-controlled clinical trials. If electing to use FOQUEST^® for extended periods, the long-term usefulness of the drug for the individual patient should be periodically re-evaluated.

Contraindications:

• Known hypersensitivity or idiosyncrasy to sympathomimetic amines
• Thyrotoxicosis
• Advanced arteriosclerosis
• Symptomatic cardiovascular disease
• Moderate to severe hypertension
• Glaucoma
• Patients with a history of drug abuse
• During or within 14-days following the administration of monoamine oxidase inhibitors
  (hypertensive crises may result)

Most Serious Warning and Precaution:

Drug dependence: Like other stimulants, FOQUEST^® has the potential to be abused, leading to dependence and tolerance.

Other Relevant Warnings and Precautions:

• The safety of FOQUEST^® has been studied in a 6-month open-label trial. Long-term effects of FOQUEST^® have not been well established beyond 6 months in adolescents (12-17 years of age) and 7 weeks in children (6-11 years of age)
• Caution in patients who: are involved in strenuous exercise or activities, use other stimulants, or have a family history of sudden/cardiac death
• Sudden death, stroke, and myocardial infarction
• CNS stimulants should be used with caution in patients with a condition of the cardiovascular or cerebrovascular system
• Hypertension
• Misuse may cause serious cardiovascular adverse events and sudden death
• Alcohol should not be taken with FOQUEST^®
• Long-term suppression of growth: Carefully monitor patients requiring long-term therapy. Interrupt treatment in patients not growing or gaining weight as expected
• Increase in seizure frequency
• Onset or exacerbation of motor and verbal tics
• Impairment in ability to operate machinery or vehicles
• Visual disturbances
• 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, aggressive behaviour, marked anxiety, or agitation
• Serotonin syndrome has been reported with methylphenidate, including FOQUEST^®, with concomitant use of serotonergic or dopaminergic drugs; if concomitant treatment with FOQUEST^® and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases
• Priapism
• Peripheral vasculopathy, including Raynaud’s phenomenon
• Not to be given to pregnant women unless the potential benefit outweighs the risk to the fetus
• Either abstain from breastfeeding or abstain from FOQUEST^® therapy, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the woman
• Periodic laboratory tests are advised during prolonged therapy
• FOQUEST^® has the potential for misuse and dependence

For More Information:

Please consult the product monograph at https://elvium.ca/wp-content/uploads/FOQUEST-PM-EN.pdf for important information relating to adverse reactions, drug interactions (particularly with co-administration of clonidine), and dosing information which have not been discussed in this piece. The product monograph is also available by calling us at
1-833-744-0005.