Methylphenidate Hydrochloride (CD)

METHYLPHENIDATE HYDROCHLORIDE (CD)- methylphenidate hydrochloride capsule, extended release
Teva Pharmaceuticals USA, Inc.

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including methylphenidate hydrochloride extended-release capsules (CD), 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 Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)].

1 INDICATIONS AND USAGE

Methylphenidate hydrochloride extended-release capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age.

2 DOSAGE AND ADMINISTRATION

2.1 Pretreatment Screening

Prior to initiating treatment with methylphenidate hydrochloride extended-release capsules (CD), assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [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 capsule (CD) use [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2 Dosage Recommendations

The recommended starting dose of methylphenidate hydrochloride extended-release capsules (CD) is 20 mg once daily. Dosage may be adjusted in weekly 10 mg to 20 mg increments to the maximum recommended dose of 60 mg per day.

Dosage should be individualized according to the needs and responses of the patient.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of methylphenidate hydrochloride extended-release capsules (CD), and adjust the dosage as needed.

2.3 Administration Instructions

Administer methylphenidate hydrochloride extended-release capsules (CD) orally once daily in the morning, before breakfast.

Swallow the capsule whole with the aid of liquids. Alternatively, open the capsule and sprinkle the contents onto a small amount (tablespoon) of applesauce and administer immediately. Do not store for future use. Drink fluids following the intake of the sprinkled capsule contents with applesauce. The capsules and the capsule contents must not be crushed or chewed.

2.4 Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue methylphenidate hydrochloride extended-release capsules (CD). If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue methylphenidate hydrochloride extended-release capsules (CD).

3 DOSAGE FORMS AND STRENGTHS

Methylphenidate hydrochloride extended-release capsules (CD) are available in the following dosage strengths (see Table 1):

Table 1: Strengths and Identifying Characteristics of Methylphenidate Hydrochloride Extended-Release Capsules (CD)

Strength

Capsule Color

Imprinting on Capsule Cap

10 mg

light green opaque cap/white opaque body

“93” over “5295”

20 mg

light turquoise blue opaque cap /white opaque body

“93” over “5296”

30 mg

light brown opaque cap/white opaque body

“93” over “5297”

40 mg

light brown opaque cap/white opaque body

“93” over “5298”

50 mg

light blue opaque cap/white opaque body

“93” over “5292”

60 mg

white opaque cap/white opaque body

“93” over “5293”

4 CONTRAINDICATIONS

Methylphenidate hydrochloride extended-release capsules (CD) are contraindicated in patients with:

  • known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules (CD). Angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules (CD). Anaphylactic reactions have been reported in patients treated with other methylphenidate products [see Adverse Reactions (6)].
  • Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis [see Drug Interactions (7)].
  • Methylphenidate hydrochloride extended-release capsules (CD) contain sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Abuse and Dependence

CNS stimulants, including methylphenidate hydrochloride extended-release capsules (CD), 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 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 rhythm abnormalities, 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 capsule (CD) treatment.

5.3 Blood Pressure and Heart Rate Increases

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

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