Ritalin LA 10 mg/1

methylphenidate hydrochloride · CAPSULE, EXTENDED RELEASE · Novartis Pharmaceuticals Corporation

No Recall HistoryCurrently in Shortage

Plain English

Ritalin LA is a capsule, extended release containing methylphenidate hydrochloride at 10 mg/1, taken oral. Manufactured by Novartis Pharmaceuticals Corporation.

Key Facts

Brand Name: Ritalin LA
Generic Name: methylphenidate hydrochloride
NDC Code (Product): 0078-0424
Manufacturer: Novartis Pharmaceuticals Corporation
Strength: 10 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA021284
Marketing Start: 06/05/2002

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective2,587 reports

fatigue1,784 reports

nausea1,525 reports

headache1,487 reports

anxiety1,433 reports

depression1,245 reports

somnolence1,044 reports

insomnia981 reports

feeling abnormal959 reports

off label use946 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Ritalin LA ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age [see Clinical Studies ( 14 )] . Limitations of Use The use of Ritalin LA 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 )]. Ritalin LA is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 12 years of age ( 1 ). Limitations of Use The use of Ritalin LA 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 • Administer orally once daily in the morning ( 2.2 ). • Capsules may be swallowed whole or opened and the entire contents sprinkled on applesauce ( 2.2 ). • Should not be crushed, chewed, or divided ( 2.2 ). • Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended ( 2.3 ). • For patients currently using Ritalin: Dosage is based on current dose regimen ( 2.4 ). • If switching from other methylphenidate products, discontinue treatment and titrate with Ritalin LA ( 2.4 ). 2.1 Pretreatment Screening Prior to treating patients with Ritalin LA, 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 Ritalin LA [see Warnings and Precautions ( 5.10 )] . 2.2 General Dosing Information The recommended starting dose for Ritalin LA is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dos…

Contraindications

4 CONTRAINDICATIONS • Hypersensitivity to methylphenidate or other components of Ritalin LA. 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 product components ( 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 and heart. Adjust dosage of antihypertensive drug as needed ( 7.1 ). 7.1 Clinically Important Drug Interactions with Ritalin LA Table 3 presents clinically important drug interactions with Ritalin LA. Table 3: Clinically Important Drug Interactions with Ritalin LA Monoamine Oxidase Inhibitors (MAOI) Clinical impact Concomitant use of MAOIs and CNS stimulants, including Ritalin LA, 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 Ritalin LA with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Antihypertensive Drugs Clinical impact Ritalin LA 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 Ritalin LA may increase the risk of sudden blood pre…

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 Ritalin LA [see Contraindications ( 4 )] • Hypertensive crisis when used concomitantly with 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 (…

Frequently Asked Questions

What is Ritalin LA used for?

Ritalin LA contains methylphenidate hydrochloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Ritalin LA a controlled substance?

Yes, Ritalin LA is classified as CII under the DEA Controlled Substances Act.

What is the generic name for Ritalin LA?

The generic name for Ritalin LA is methylphenidate hydrochloride. There are 12 other brand versions of methylphenidate hydrochloride.

What is the NDC code for Ritalin LA 10 mg/1?

The NDC (National Drug Code) for Ritalin LA 10 mg/1 is 0078-0424, listed by Novartis Pharmaceuticals Corporation.

Product NDC

0078-0424

Package NDC

0078-0424-05

Other Methylphenidate Brands

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

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