Methylphenidate Hydrochloride
Generic Name: methylphenidate hydrochloride
Brand Names:
Concerta
11 DESCRIPTION CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four strengths. Each extended-release tablet for oral administration contains 18, 27, 36, or 54 mg of methylphenidate hydrochloride, USP. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, its empirical formula is C 14 H 19 NO 2 ∙HCl, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder.
Overview
11 DESCRIPTION CONCERTA ® is a central nervous system (CNS) stimulant. CONCERTA is available in four strengths. Each extended-release tablet for oral administration contains 18, 27, 36, or 54 mg of methylphenidate hydrochloride, USP. Chemically, methylphenidate hydrochloride is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride, its empirical formula is C 14 H 19 NO 2 ∙HCl, and its structural formula is: Methylphenidate hydrochloride, USP is a white, odorless crystalline powder.
Uses
1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.
Dosage
2 DOSAGE AND ADMINISTRATION Prior to initiating CONCERTA treatment assess for ( 2.1 ): the presence of cardiac disease for family history of tics or Tourette' syndrome and clinically evaluate patients for motor or verbal tics or Tourette's syndrome Administer once daily in the morning with or without food. Swallow whole with liquids; do not chew, divide, or crush. ( 2.2 ) Recommended dosage in pediatric patients 6 to 17 years of age new to methylphenidate: starting dosage is18 mg once daily. May be increased weekly in 18 mg increments. Maximum dosage for pediatric patients ( 2.3 ): 6 to 12 years: 54 mg once daily 13 to 17 years: 72 mg once daily Recommended dosage in adults (up to 65 years of age) new to methylphenidate: starting dosage is 18 mg or 36 mg once daily.
Side Effects
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] Hypersensitivity Reactions [see Contraindications (4) ] Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] 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 Prec...
Interactions
7 DRUG INTERACTIONS Table 6 describes clinically significant drug interactions with CONCERTA. Table 6: Clinically Significant Drug Interactions Monoamine Oxidase Inhibitors Prevention or Management Concomitant use of CNS stimulants, including CONCERTA, with MAOIs or within 14 days after discontinuing an MAOI is contraindicated [ see Contraindications (4) ]. Mechanism and Clinical Effect(s) Concomitant use of MAOIs and CNS stimulants, including CONCERTA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.
Warnings
WARNING: ABUSE, MISUSE, AND ADDICTION CONCERTA 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 CONCERTA, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing CONCERTA, assess each patient's risk for abuse, misuse, and addiction. 5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions : Prior to initiating CONCERTA, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing CONCERTA. 4 CONTRAINDICATIONS CONCERTA is contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of CONCERTA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6) ] .
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ .
Storage
Storage and Handling Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) [see USP Controlled Room Temperature] . Protect from humidity.
Frequently Asked Questions
What is Methylphenidate Hydrochloride used for?▼
1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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) and Use in Specific Populations (8.4) ]. CONCERTA is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old.
What are the side effects of Methylphenidate Hydrochloride?▼
6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] Hypersensitivity Reactions [see Contraindications (4) ] Monoamine Oxidase Inhibitors [see Contraindications (4) , Drug Interactions (7) ] 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 Prec...
Can I take Methylphenidate Hydrochloride during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including CONCERTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/ .
What are the important warnings for Methylphenidate Hydrochloride?▼
WARNING: ABUSE, MISUSE, AND ADDICTION CONCERTA 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 CONCERTA, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with a higher dosage or unapproved methods of administration, such as snorting or injection. Before prescribing CONCERTA, assess each patient's risk for abuse, misuse, and addiction. 5 WARNINGS AND PRECAUTIONS Risks to Patients with Serious Cardiac Disease : Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease ( 5.2 ). Increased Blood Pressure and Heart Rate : Monitor blood pressure and pulse ( 5.3 ). Psychiatric Adverse Reactions : Prior to initiating CONCERTA, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing CONCERTA. 4 CONTRAINDICATIONS CONCERTA is contraindicated in patients: Known to be hypersensitive to methylphenidate or other components of CONCERTA. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with CONCERTA. [see Adverse Reactions (6) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.