RELEXXII

RELEXXII- methylphenidate hydrochloride tablet, extended release
Vertical Pharmaceuticals, LLC

WARNING: ABUSE, MISUSE, AND ADDICTION

RELEXXII has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including RELEXXII, can result in overdose and death [see Overdosage (10)] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing RELEXXII, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout RELEXXII treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.2)].

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)].

2 DOSAGE AND ADMINISTRATION

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 with or without food.

Swallow RELEXXII whole with liquid. Do not chew, divide, or crush [see Warnings and Precautions (5.8)].

2.3 Dosage Recommendations for Patients New to Methylphenidate

Table 1 includes the starting dosage and dosage recommendations for RELEXXII in pediatric patients 6 to 17 years and adults who are not currently taking methylphenidate or other stimulants.

Table 1: Dosage Recommendations for RELEXXII in Pediatric Patients 6 to 17 years and Adults

Patient Population

RELEXXII Recommended Starting Dosage

RELEXXII Dosage Range

Pediatric patients

6 to 12 years

18 mg once daily

18 mg to 54 mg once daily

13 to 17 years

18 mg once daily

18 mg to 72 mg once daily

(not to exceed 2 mg/kg/day)

Adults

18 (up to 65 years)

18 mg or 36 mg once daily

18 mg to 72 mg once daily

2.4 Dosage Recommendations for Patients Currently Using Methylphenidate

The recommended starting dosage of RELEXXII for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 mg to 60 mg daily is provided in Table 2.

Table 2. Recommended Starting Dosage when Converting from Methylphenidate Regimens to RELEXXII

Current Methylphenidate Daily Dosage

Recommended Starting Dosage of RELEXXII

5 mg methylphenidate twice daily or three times daily

18 mg once daily in the morning

10 mg methylphenidate twice daily or three times daily

36 mg once daily in the morning

15 mg methylphenidate twice daily or three times daily

54 mg once daily in the morning

20 mg methylphenidate twice daily or three times daily

72 mg once daily in the morning

2.5 Dose Titration

Doses may be increased in 18 mg increments at weekly intervals for patients who have not achieved clinical response at a lower dose. Daily dosages above 54 mg in pediatric patients 6 to 12 years and above 72 mg in pediatric patients 13 to 17 years have not been studied and are not recommended. Daily dosages above 72 mg are not recommended in adults.

Dosage strengths of 27 mg, 45 mg, and 63 mg are available for additional titration options based on clinical response.

2.6 Dosage Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reaction occur, reduce the dosage, or, if necessary, discontinue RELEXXII.

If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue RELEXXII.

3 DOSAGE FORMS AND STRENGTHS

RELEXXII (methylphenidate hydrochloride extended-release tablets) are available in the following strengths:

  • 18 mg: yellow with “TL706” imprinted in black ink
  • 27 mg: gray with “TL707” imprinted in black ink
  • 36 mg: white with “TL708” imprinted in black ink
  • 45 mg: pink with “TL711” imprinted in black ink
  • 54 mg: pink with “TL709” imprinted in black ink
  • 63 mg: orange with “TL700” imprinted in black ink and
  • 72 mg: blue with “TL710” imprinted in black ink.

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)].

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