methylphenidate hydrochloride CD

methylphenidate hydrochloride CD is an FDA-registered drug product whose active ingredient is METHYLPHENIDATE HYDROCHLORIDE. It is labelled by Lannett Company, LLC taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 0527-4579, application NDA021259, label effective 20260731. It is one of 27 FDA drug label records sharing the active ingredient METHYLPHENIDATE HYDROCHLORIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METHYLPHENIDATE HYDROCHLORIDE are most often described in connection with: methylphenidate hcl, extended-release capsules, pediatric patients, years age, treatment attention, deficit hyperactivity, disorder adhd, higher incidence. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Methylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD 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 )] . Methylphenidate HCl Extended-Release Capsules CD is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. ( 1 ) Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD is not recommended in pediatric patients younger than 6 years of age because they had higher 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 )

2 DOSAGE AND ADMINISTRATION Prior to initiating Methylphenidate HCl Extended-Release Capsules CD treatment, assess each patient’s risk for ( 2.1 ): Abuse, misuse, and addiction ( 5.1 ) Presence of cardiac disease ( 5.2 ) Developing a manic episode ( 5.4 ) A family history of tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette syndrome ( 5.10 ) Take orally once daily in the morning, before breakfast. Swallow whole with the aid of liquids, or sprinkle contents onto a small amount of applesauce and give immediately. Do not crush or chew the capsule or capsule contents ( 2.1 ) Recommended starting dose is 20 mg once daily. Dosage may be increased 10-20 mg at weekly intervals; do not exceed 60 mg per day ( 2.2 ) 2.1 Pretreatment Screening Prior to treating patients with Methylphenidate HCl Extended-Release Capsules CD, assess: The risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.1 )] . For the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions ( 5.2 )] . The risk for developing a manic episode (e.g., history of depressive symptoms or a family history of suicide, bipolar disorder, or depression) [see Warnings and Precautions ( 5.4 )] . For a family history for tics or Tourette syndrome and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see Warnings and Precautions ( 5.10 )] . 2.2 Dosage Recommendations The recommended starting dose of Methylphenidate HCl 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. 2.3 Administration Instructions Administer Methylphenidate HCl 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 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue Methylphenidate HCl Extended-Release Capsules CD. If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue Methylphenidate HCl Extended-Release Capsules CD. 2.5 Switching from a Monoamine Oxidase Inhibitor Must wait at least 14 days after stopping a monoamine oxidase (MAO) inhibitor before starting Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 ) and Drug Interactions ( 7 )] .

4 CONTRAINDICATIONS Methylphenidate HCl Extended-Release Capsules CD is contraindicated in patients with: Known hypersensitivity to methylphenidate or other component of Methylphenidate HCl Extended-Release Capsules CD. Angioedema has been reported in patients treated with Methylphenidate HCl 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 HCl Extended-Release Capsules CD contains sucrose. Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received a methylphenidate product. Methylphenidate HCl Extended-Release Capsules CD is contraindicated in: Known hypersensitivity to methylphenidate or other components of Methylphenidate HCl Extended-Release Capsules CD ( 4 ) Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ) Use in patients with patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency ( 4 ) Patients with pheochromocytoma or a history of pheochromocytoma ( 4 )

6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 )] Hypersensitivity to Methylphenidate and Other Component of Methylphenidate HCl Extended-Release Capsules CD [see Contraindications ( 4 )] Hypertensive Crisis when Used Concomitantly with MAOIs [see Contraindications (4) and 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 Precautions ( 5.7 )] Acute Angle Closure Glaucoma [see Warnings and Precautions ( 5.8 )] Increased Intraocular Pressure and Glaucoma [see Warnings and Precautions ( 5.9 )] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see Warnings and Precautions ( 5.10 )] The most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical trials experience with Methylphenidate HCl Extended-Release Capsules CD included 188 pediatric patients 6 to 15 years old with ADHD exposed to Methylphenidate HCl Extended-Release Capsules CD. Patients received Methylphenidate HCl Extended-Release Capsules CD 20 mg, 40 mg, and/or 60 mg per day. The 188 patients were evaluated in the following studies: Study 1, a 3-week placebo-controlled clinical study consisting of a total of 314 pediatric patients (ages 6 to 15 years; Methylphenidate HCl Extended-Release Capsules CD n=155); Study 2, a placebo-controlled, crossover clinical study consisting of 25 pediatric patients (ages 7 to 12 years); and Study 3, an uncontrolled clinical study consisting of 8 pediatric patients (ages 6 to 10 years). Adverse Reactions Leading to Discontinuation of Treatment In the 3-week placebo-controlled, parallel-group trial, two Methylphenidate HCl Extended-Release Capsules CD-treated patients (1%) and no placebo-treated patients discontinued due to an adverse reaction (rash and pruritus; and headache, abdominal pain, and dizziness, respectively). Most Common Adverse Reactions The most common adverse reactions that occurred in 5% or more of patients treated with Methylphenidate HCl Extended-Release Capsules CD in a pool of Studies 1, 2 and 3 (ages 6 to 15 years) where the incidence in patients treated with Methylphenidate HCl Extended-Release Capsules CD was at least twice the incidence in placebo-treated patients were anorexia and insomnia. Adverse reactions that occurred in ≥5% of patients treated with Methylphenidate HCl Extended-Release Capsules CD and greater than placebo in pooled Studies, 1, 2, and 3 are presented in Table 2: Table 2: Adverse Reactions (≥5% and Greater than Placebo) in Pediatric Patients Ages 6 to 15 Years Receiving Methylphenidate HCl Extended-Release Capsules CD in Pooled Three to Four Week Trials Body System Preferred Term Methylphenidate HCl Extended-Release Capsules CD (n=188) % Placebo (n=190) % General Headache 12 8 Abdominal Pain (stomachache) 7 4 Digestive System Anorexia 9 2 Nervous System Insomnia 5 2 6.2 Postmarketing Experience The following adverse reactions have been identified during postmarketing use of Methylphenidate HCl Extended-Release Capsules CD and other methylphenidate HCl products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse Reactions with Methylphenidate HCl Extended-Release Capsules CD Blood and the lymphatic system disorders: thrombocytopenia Cardiac disorders: cardiac arrest, sudden death Immune system disorders: angioedema Musculoskeletal and connective tissue disorders: rhabdomyolysis Psychiatric disorders: abnormal behavior, aggression, anxiety, irritability, obsessive-compulsive disorder, suicidal behavior (including completed suicide), libido changes, serotonin syndrome in combination with serotonergic drugs Nervous System Disorder: migraine, reversible ischemic neurological deficit, bruxism Skin and subcutaneous tissue disorders: fixed drug eruption Vascular disorders: peripheral coldness, Raynaud’s phenomenon Adverse Reactions with Other Methylphenidate HCl Products Blood and the lymphatic system disorders: leukopenia, anemia, pancytopenia Cardiac disorders: palpitations; increased blood pressure, tachycardia, angina pectoris, cardiac arrhythmia, myocardial infarction, bradycardia, extrasystole Eye disorders: blurred vision, difficulties in visual accommodation, diplopia, increased intraocular pressure, mydriasis Gastrointestinal disorders: nausea, abdominal pain, dry mouth, vomiting, dyspepsia, diarrhea, constipation General Disorders: fatigue, hyperpyrexia Hepatobiliary disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Immune system disorders: hypersensitivity, including anaphylaxis, auricular swelling, bullous conditions, eruptions, exanthemas Infections and infestations: nasopharyngitis Metabolism and nutrition disorders: decreased appetite, reduced weight gain and suppression of growth during prolonged use in pediatric patients Musculoskeletal and connective tissue disorders: arthralgia, muscle cramps, myalgia, muscle twitching Nervous System Disorder: nervousness, dizziness, headache, dyskinesia, including choreoatheetoid movements, drowsiness, tremor, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs, motor and verbal tics Psychiatric disorders: depressed mood, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), affect liability, mania, disorientation Renal and urinary disorders: hematuria Reproductive system and breast disorders: gynecomastia Respiratory, thoracic and mediastinal disorders: pharyngolaryngeal pain, dyspnea, cough Skin and subcutaneous tissue disorders: scalp hair loss, hyperhidrosis, angioneurotic edema, erythema, exfoliative dermatitis, thrombocytopenic purpura, urticaria, erythema multiforme rash Urogenital disorders: priapism Vascular disorders: isolated cases of cerebral arteritis and/or occlusion

FDA lists 27 drug label records with METHYLPHENIDATE HYDROCHLORIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is methylphenidate hydrochloride CD used for?
1 INDICATIONS AND USAGE Methylphenidate HCl Extended-Release Capsules CD is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use The use of Methylphenidate HCl Extended-Release Capsules CD is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a …

Who makes methylphenidate hydrochloride CD?
Lannett Company, LLC is the labeler of record for methylphenidate hydrochloride CD. 27 FDA label records share the active ingredient METHYLPHENIDATE HYDROCHLORIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does methylphenidate hydrochloride CD come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is methylphenidate hydrochloride CD prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing METHYLPHENIDATE HYDROCHLORIDE?
Yes. 27 FDA drug label records list METHYLPHENIDATE HYDROCHLORIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has methylphenidate hydrochloride CD been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.