Monograph Details
|
|
Central Nervous System
> ADHD/narcolepsy
|
|
FOCALIN XR |
| Manufacturer |
|
Novartis Pharmaceuticals Corp |
| Legal Classification |
|
CII |
| Pharmacological Class |
|
Stimulant. |
| Generic Name |
|
Dexmethylphenidate HCl (single-isomer methylphenidate) 5mg, 10mg, 15mg, 20mg; ext-rel caps (contains immediate-release + e-c del-rel beads). |
| Also |
|
• FOCALIN
|
| Indications |
|
Attention deficit hyperactivity disorder. |
| Adults and Children |
|
Take once daily in the AM. Swallow whole or sprinkle contents onto applesauce (swallow immediately); do not crush, chew or divide beads. Children: <6yrs: not recommended. ≥6yrs: initially 5mg/day; may increase by 5mg weekly. Adults: Initially 10mg/day; may increase by 10mg weekly. Both: max 20mg/day. Switching from racemic methylphenidate: give ½ of total daily racemic methylphenidate dose. Switching from immediate-release dexmethylphenidate: give same total daily dose. |
| 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 |
|
|
|
|
