Drugplain

Focalin XR 5 mg/1

dexmethylphenidate hydrochloride · CAPSULE, EXTENDED RELEASE · Novartis Pharmaceuticals Corporation

No Recall History
Plain English

Focalin XR is a capsule, extended release containing dexmethylphenidate hydrochloride at 5 mg/1, taken oral. Manufactured by Novartis Pharmaceuticals Corporation.

Key Facts

Brand Name
Focalin XR
Generic Name
dexmethylphenidate hydrochloride
NDC Code (Product)
0078-0430
Manufacturer
Novartis Pharmaceuticals Corporation
Strength
5 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA021802
Marketing Start
05/31/2005

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective749 reports
nausea199 reports
anxiety191 reports
headache186 reports
fatigue169 reports
abnormal behaviour166 reports
feeling abnormal165 reports
disturbance in attention157 reports
decreased appetite153 reports
off label use148 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies ( 14 )] . Limitations of Use The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions ( 5.7 ), Use in Specific Populations ( 8.4 )]. Focalin XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) ( 1 ). Limitations of Use The use of Focalin XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.7 , 8.4 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Patients new to methylphenidate: Recommended starting dose is 5 mg once daily for pediatric patients and 10 mg once daily for adults with or without food in the morning ( 2.2 ). • Patients currently on methylphenidate: Focalin XR dosage is half (1/2) the current total daily dosage of methylphenidate ( 2.2 ). • Patients currently on Focalin (dexmethylphenidate) immediate-release tablets: Give the same daily dose of Focalin XR ( 2.2 ). • Titrate weekly in increments of 5 mg in pediatric patients and 10 mg in adult patients ( 2.2 ). • Maximum recommended daily dose: 30 mg in pediatric patients and 40 mg in adults ( 2.2 ). • Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.3 ). 2.1 Pretreatment Screening Prior to treating patients with Focalin XR, assess: • for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . • the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Focalin XR [see Warnings and Precautions ( 5.10 )] . …

Contraindications

4 CONTRAINDICATIONS • Hypersensitivity to methylphenidate or other components of Focalin XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate [see Adverse Reactions ( 6.1 )] . • Concomitant treatment with monoamine oxidase inhibitors (MAOIs) or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )] . • Known hypersensitivity to methylphenidate or other components of Focalin XR ( 4 ). • Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).

Drug Interactions

7 DRUG INTERACTIONS • Antihypertensive Drugs: Monitor blood pressure. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions With Focalin XR Table 5 presents clinically important drug interactions with Focalin XR. Table 5: Clinically Important Drug Interactions With Focalin XR Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including Focalin XR, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )]. Intervention Concomitant use of Focalin XR with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Focalin XR may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions ( 5.3 )]. Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Halogenated Anesthetics Clinical impact Concomitant use of halogenated anesthetics and Focalin XR may increase the risk of sudden blood pressure and h…

Adverse Reactions

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] • Known hypersensitivity to methylphenidate or other ingredients of Focalin XR [see Contraindications ( 4 )] • Hypertensive Crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] • Risks to Patients with Serious Cardiac Disease [see Warnings and Precautions ( 5.2 )] • Increased Blood Pressure and Heart Rate [see Warnings and Precautions ( 5.3 )] • Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Priapism [see Warnings and Precautions ( 5.5 )] • Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see Warnings and Precautions ( 5.6 )] • Long-Term Suppression of Growth in Pediatric Patients [see Warnings and Precautions ( 5.7 )] • Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] • Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] • Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10…

Frequently Asked Questions

What is Focalin XR used for?

Focalin XR contains dexmethylphenidate hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Focalin XR a controlled substance?

Yes, Focalin XR is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Focalin XR?

The generic name for Focalin XR is dexmethylphenidate hydrochloride. There are 10 other brand versions of dexmethylphenidate hydrochloride.

What is the NDC code for Focalin XR 5 mg/1?

The NDC (National Drug Code) for Focalin XR 5 mg/1 is 0078-0430, listed by Novartis Pharmaceuticals Corporation.

Product NDC

0078-0430

Package NDC

0078-0430-05

Other Dexmethylphenidate Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)