CONCERTA 36 mg/1

Methylphenidate hydrochloride · TABLET, EXTENDED RELEASE · Janssen Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

CONCERTA is a tablet, extended release containing methylphenidate hydrochloride at 36 mg/1, taken oral. Manufactured by Janssen Pharmaceuticals, Inc..

Key Facts

Brand Name: CONCERTA
Generic Name: Methylphenidate hydrochloride
NDC Code (Product): 50458-586
Manufacturer: Janssen Pharmaceuticals, Inc.
Strength: 36 mg/1
Dosage Form: TABLET, EXTENDED RELEASE
Route: ORAL
Marketing Status
DEA Schedule: Schedule II (Controlled)
Application #: NDA021121
Marketing Start: 08/01/2000

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. ( 1 ) Limitations of Use The use of CONCERTA 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 Prior to initiating CONCERTA treatment assess for ( 2.1 ): the presence of cardiac disease for family history of tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. ( 2.2 ) Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is18 mg once daily. May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients ( 2.3 ): 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily. May be increased weekly in 18 mg increments, up to 72 mg once daily. ( 2.3 ) Patients currently using immediate-release methylphenidate: starting CONCERTA dosage is based on current dosage regimen. ( 2.4 ) 2.1 Pretreatment Screening Prior to treating patients with CONCERTA, assess: For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical…

Contraindications

4 CONTRAINDICATIONS CONCERTA is contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of CONCERTA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6) ] . Receiving concomitant monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with a MAO inhibitor because of the risk of a hypertensive crisis [see Drug Interactions (7) ] . Known hypersensitivity to methylphenidate or other components of CONCERTA ( 4 ) Receiving concomitant monoamine oxidase inhibitors and within 14 days following discontinuation of treatment with a MAO inhibitor ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 6 describes clinically significant drug interactions with CONCERTA. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including CONCERTA, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [ see Contraindications (4) ]. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including CONCERTA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Antihypertensive Drugs Prevention or Management Increase monitoring for blood pressure and adjust the dosage of the antihypertensive drug, as needed. Mechanism and Clinical Effect(s) CONCERTA may decrease effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5.3 ]. Halogenated Anesthetics Prevention or Management Avoid use of CONCERTA in patients being treated with anesthetics on the day of surgery. Mechanism and Clinical Effect(s) Concomitant use of halogenated anesthetics and CONCERTA may increase the risk of sudde…

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) ] Hypersensitivity Reactions [see Contraindications (4) ] Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] 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) ] Risks of Gastrointestinal Obstruction in Patients with Gastrointestinal Narrowing [see Warnings and Precautions (5.8) ] Acute Angle Closure Glaucoma [see Warnings and Precautions (5.9) ] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions (5.10) ] Motor and Verbal Tics, and Worsening of Tourette's Syndrome [see Warnings and Precautions (5.11) ] The most common…

Frequently Asked Questions

What is CONCERTA used for?

CONCERTA contains Methylphenidate hydrochloride. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is CONCERTA a controlled substance?

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

What is the generic name for CONCERTA?

The generic name for CONCERTA is Methylphenidate hydrochloride. There are 12 other brand versions of Methylphenidate hydrochloride.

What is the NDC code for CONCERTA 36 mg/1?

The NDC (National Drug Code) for CONCERTA 36 mg/1 is 50458-586, listed by Janssen Pharmaceuticals, Inc..

Product NDC

50458-586

Package NDC

50458-586-01

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

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