Drugplain

RELEXXII 72 mg/1

methylphenidate hydrochloride · TABLET, EXTENDED RELEASE · Vertical Pharmaceuticals, LLC

No Recall HistoryCurrently in Shortage
Plain English

RELEXXII is a tablet, extended release containing methylphenidate hydrochloride at 72 mg/1, taken oral. Manufactured by Vertical Pharmaceuticals, LLC.

Key Facts

Brand Name
RELEXXII
Generic Name
methylphenidate hydrochloride
NDC Code (Product)
68025-084
Manufacturer
Vertical Pharmaceuticals, LLC
Strength
72 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
NDA216117
Marketing Start
06/23/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,000 reports
headache385 reports
fatigue345 reports
anxiety343 reports
off label use328 reports
nausea316 reports
toxicity to various agents316 reports
product substitution issue277 reports
drug abuse274 reports
somnolence263 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE RELEXXII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older [ see Clinical Studies ( 14 )] . Limitations of Use The use of RELEXXII 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 )] . RELEXXII ® is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults (up to the age of 65 years) and pediatric patients 6 years of age and older ( 1 ). Limitations of Use The use of RELEXXII 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 once daily in the morning with or without food. ( 2.2 ) Swallow whole with liquid. Do not chew, divide, or crush. ( 2.2 ) Recommended dosage for patients new to methylphenidate ( 2.3 ): Pediatric patients 6 to 17 years Starting dosage is 18 mg once daily. Dosage may be increased by 18 mg once per day at weekly intervals. Maximum dosage for pediatric patients 6 to 12 years: 54 mg once daily. Maximum dosage for pediatric patients 13 to 17 years: 72 mg once daily. Adults (up to 65 years) Starting dosage is 18 mg or 36 mg once daily. Dosage may be increased by 18 mg once daily at weekly intervals. Maximum dosage: 72 mg once daily. 2.1 Pretreatment Screening Prior to treating patients with RELEXXII, 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 RELEXXII [see Warnings and Precautions ( 5.11 )]. 2.2 General Administration Information Administer RELEXXII orally once daily in the morning w…

Contraindications

4 CONTRAINDICATIONS RELEXXII is contraindicated in patients: with a known hypersensitivity to methylphenidate or other components of RELEXXII. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions ( 6.2 )] . receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis [see Drug Interactions ( 7.1 )] . Known hypersensitivity to methylphenidate or other components of RELEXXII ( 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 Table 6 presents clinically important drug interactions with RELEXXII. Table 6: Drugs Having Clinically Important Interactions with RELEXXII Monoamine Oxidase Inhibitors (MAOI) Clinical Impact: Concomitant use of MAOIs 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 )] . Intervention: Do not administer RELEXXII concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Antihypertensive Drugs Clinical Impact: RELEXXII 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 RELEXXII may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervent…

Adverse Reactions

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Box Warning, Warnings and Precautions ( 5.1 ), and Drug Abuse and Dependence ( 9.2 , 9.3 )] Known hypersensitivity to methylphenidate or other ingredients [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 )] Potential for Gastrointestinal Obstruction [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 To…

Frequently Asked Questions

What is RELEXXII used for?

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

Is RELEXXII a controlled substance?

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

What is the generic name for RELEXXII?

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

What is the NDC code for RELEXXII 72 mg/1?

The NDC (National Drug Code) for RELEXXII 72 mg/1 is 68025-084, listed by Vertical Pharmaceuticals, LLC.

Product NDC

68025-084

Package NDC

68025-084-30

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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