Drugplain

JORNAY PM Extended-Release 60 mg/1

Methylphenidate Hydrochloride · CAPSULE · Ironshore Pharmaceuticals Inc.

No Recall HistoryCurrently in Shortage
Plain English

Jornay PM is a prescription medication containing methylphenidate, a stimulant used to treat attention-deficit/hyperactivity disorder (ADHD). This extended-release capsule is designed to be taken in the evening so that the medication becomes active the next morning.

Key Facts

Brand Name
JORNAY PM Extended-Release
Generic Name
Methylphenidate Hydrochloride
NDC Code (Product)
71376-203
Manufacturer
Ironshore Pharmaceuticals Inc.
Strength
60 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA209311
Marketing Start
06/01/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,063 reports
headache401 reports
anxiety367 reports
off label use360 reports
fatigue359 reports
nausea330 reports
toxicity to various agents318 reports
insomnia294 reports
product substitution issue280 reports
somnolence276 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE JORNAY PM is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies ( 14 )] . Limitations of Use The use of Jornay PM 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) ]. JORNAY PM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. ( 1 ) Limitations of Use The use of Jornay PM 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 JORNAY PM should be taken only in the evening. ( 2.2 ) Recommended starting dose for patients 6 years and above is 20 mg daily in the evening. ( 2.2 ) Adjust the timing of administration between 6:30 p.m. and 9:30 p.m. to optimize the tolerability and the efficacy the next morning and throughout the day. Dosage may be increased weekly in increments of 20 mg per day up to a maximum daily dose of 100 mg. ( 2.2 ) Patients are advised to take JORNAY PM consistently either with food or without food. ( 2.2 ) Capsules may be swallowed whole or opened and the entire contents sprinkled onto applesauce. ( 2.2 ) To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis. ( 2.4 ) 2.1 Pretreatment Screening Prior to treating patients with JORNAY PM, 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 [see Warnings and Precautions ( 5.10 )]. 2.2 Recommende…

Contraindications

4 CONTRAINDICATIONS JORNAY PM is contraindicated in patients: With a history of hypersensitivity to methylphenidate or other components of JORNAY PM. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions ( 6 )]. Receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of a monoamine oxidase inhibitor, because of the risk of hypertensive crisis [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. Adjust dosage of antihypertensive drug as needed ( 7.2 ) 7.1 MAO Inhibitors Do not administer JORNAY PM concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAO inhibitors and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )] . 7.2 Antihypertensive Drugs JORNAY PM may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed [see Warnings and Precautions ( 5.3 )]. 7.3 Halogenated Anesthetics Concomitant use of halogenated anesthetics and JORNAY PM may increase the risk of sudden blood pressure and heart rate increase during surgery. Monitor blood pressure and avoid use of JORNAY PM in patients being treated with anesthetics on the day of surgery. 7.4 Risperidone The combined use of methylphenidate with risperidone when there is a change in dose of either or both medications may increase the risk of…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to methylphenidate or other components of JORNAY PM [see Contraindications ( 4 )] Hypertensive crisis when used concomitantly with monoamine oxidase inhibitors [see Contraindications ( 4 ) and 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 JORNAY PM Extended-Release used for?

Jornay PM is a prescription medication containing methylphenidate, a stimulant used to treat attention-deficit/hyperactivity disorder (ADHD). This extended-release capsule is designed to be taken in the evening so that the medication becomes active the next morning.

Is JORNAY PM Extended-Release a controlled substance?

Yes, JORNAY PM Extended-Release is classified as CII under the DEA Controlled Substances Act.

What is the generic name for JORNAY PM Extended-Release?

The generic name for JORNAY PM Extended-Release is Methylphenidate Hydrochloride. There are 12 other brand versions of Methylphenidate Hydrochloride.

What is the NDC code for JORNAY PM Extended-Release 60 mg/1?

The NDC (National Drug Code) for JORNAY PM Extended-Release 60 mg/1 is 71376-203, listed by Ironshore Pharmaceuticals Inc..

Product NDC

71376-203

Package NDC

71376-203-03

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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