Methylphenidate Hydrochloride

METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride capsule, extended release
Rhodes Pharmaceuticals

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Methylphenidate Hydrochloride Extended-Release Capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy [see Warning and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

Methylphenidate Hydrochloride Extended-Release Capsules is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older [see Clinical Studies (14)].

Limitations of Use

Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss [see Use in Specific Populations (8.4)].

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to treating pediatric patients and adults with CNS stimulants including Methylphenidate Hydrochloride Extended-Release Capsules, 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].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for Methylphenidate Hydrochloride Extended-Release Capsules use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

2.2 General Dosing Information

The recommended starting dose of Methylphenidate Hydrochloride Extended-Release Capsules for patients 6 years and older is 10 mg once daily in the morning with or without food. Advise patients to establish a routine pattern with regard to meals. The dose should be individualized according to the needs and response of the patient.

The dose may be titrated weekly in increments of 10 mg. Daily doses above 60 mg have not been studied and are not recommended.

Methylphenidate Hydrochloride Extended-Release Capsules may be taken whole or the capsule may be opened and the entire contents sprinkled onto applesauce. If the patient is using the sprinkled administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Pharmacological treatment of ADHD may be needed for extended periods. Healthcare providers should periodically re-evaluate the long-term use of Methylphenidate Hydrochloride Extended-Release Capsules, and adjust dosage as needed.

2.3 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

3 DOSAGE FORMS AND STRENGTHS

  • 10 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body & light turquoise blue opaque cap containing white spherical beads. Body Imprinting: 910. Cap imprinting: RP
  • 15 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and orange cap containing white spherical beads. Body imprinting: 915. Cap imprinting: RP
  • 20 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and yellow opaque cap containing white spherical beads. Body imprinting: 920. Cap imprinting: RP
  • 30 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and blue violet cap containing white spherical beads. Body imprinting: 930. Cap imprinting: RP
  • 40 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and pink opaque cap containing white spherical beads. Body imprinting: 940. Cap imprinting: RP
  • 50 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and green opaque cap containing white spherical beads. Body imprinting: 950. Cap Imprinting: RP
  • 60 mg Extended-Release Capsules Hard Gelatin Capsules, white opaque body and gray opaque cap containing white spherical beads. Body imprinting: 960. Cap imprinting: RP

4 CONTRAINDICATIONS

  • Hypersensitivity to methylphenidate or other components of the product. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with methylphenidate products [see Adverse Reactions (6.1)].
  • Concomitant treatment with monoamine oxidase inhibitors, and also within 14 days following discontinuation of treatment with a monoamine oxidase inhibitor, because of the risk of hypertensive crisis [see Drug Interactions (7.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including Methylphenidate Hydrochloride Extended-Release Capsules, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy [see Boxed Warning and Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Methylphenidate Hydrochloride Extended-Release Capsules treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

5.4 Psychiatric Adverse Reactions

Exacerbation of Pre-Existing Psychosis

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

New Psychotic or Manic Symptoms

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Methylphenidate Hydrochloride Extended-Release Capsules. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0 in placebo-treated patients.

5.5 Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products, in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

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