Monograph Details

Central Nervous System > ADHD/narcolepsy
FOCALIN
Manufacturer
Novartis Pharmaceuticals Corp
Legal Classification
CII
Pharmacological Class
Stimulant.
Generic Name
Dexmethylphenidate HCl (single-isomer methylphenidate) 2.5mg, 5mg, 10mg+; tabs; +dye-free.
Also
FOCALIN XR
Indications
Attention deficit hyperactivity disorder.
Adults and Children
<6 years: not recommended. ≥6 years: initially 2.5mg twice daily. Switching from racemic methylphenidate (eg, Ritalin): ½ of racemic methylphenidate dose. Allow at least 4 hours between doses. May increase at 1 week intervals; max 20mg/day.
Contraindications
Marked anxiety, tension, agitation. Glaucoma. History of tics or Tourette's syndrome in patient or family. During or within 14 days of MAOIs.
Precautions
Discontinue if seizures or agitation occur. Reduce dose or discontinue if paradoxical worsening of symptoms occurs. Reassess periodically. Reevaluate therapy at puberty. Hypertension. Heart failure. Hyperthyroidism. Recent MI. Psychosis. Seizures. Not for treating depression or normal fatigue states. Emotionally unstable (eg, drug or alcohol abusers). May worsen behavior disturbances, thought disorders. Monitor growth, blood pressure, CBC, differential, platelet counts. Pregnancy (Cat.C). Nursing mothers.
Interactions
See Contraindications. Caution with anticonvulsants, pressor agents, central α-agonists (eg, clonidine). May increase levels of anticonvulsants, oral anticoagulants, tricyclics, SSRIs, phenylbutazone. Antagonizes guanethidine, other antihypertensives. Caps: may be affected by drugs that affect pH.
Adverse Reactions
Abdominal pain, nausea, anorexia, fever, insomnia, CNS overstimulation, anxiety, weight loss, dizziness, headache, dyskinesias, hypertension, tachycardia, arrhythmias, Tourette's syndrome, toxic psychosis, seizures, blood dyscrasias, rash, visual disturbances, tics.
How Supplied
Caps, tabs—100
Additional Resources
Related Prescribing Note