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Methylphenidate Hydrochloride is a brand name for Methylphenidate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release capsules are 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 hydrochloride extended-release capsules is not recommended in…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION 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.
1) Recommended starting dose is 20 mg once daily. Dosage may be increased 10 mg to 20 mg at weekly intervals; do not exceed 60 mg per day. 10) ] . 10) ] . 2 Dosage Recommendations The recommended starting dose of methylphenidate hydrochloride extended-release capsules 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. 3 Administration Instructions Administer methylphenidate hydrochloride extended-release capsules 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. 4 Dosage Reduction and Discontinuation If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or, if necessary, discontinue methylphenidate hydrochloride extended-release capsules.
If improvement is not observed after appropriate dosage adjustment over a one-month period, discontinue methylphenidate hydrochloride extended-release capsules.
10) ] The most common adverse reactions (≥ 5% and twice the rate of placebo) were anorexia and insomnia. gov/medwatch. 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 hydrochloride extended-release included 188 pediatric patients 6 to 15 years old with ADHD exposed to methylphenidate hydrochloride extended-release. Patients received methylphenidate hydrochloride extended-release 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 hydrochloride extended-release 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 hydrochloride extended-release-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 hydrochloride extended-release in a pool of Studies 1, 2 and 3 (ages 6 to 15 years) where the incidence in patients treated with methylphenidate hydrochloride extended-release was at least twice the incidence in placebo-treated patients were anorexia and insomnia.
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.
2) Increased Blood Pressure and Heart Rate: Monitor blood pressure and pulse. 3) Psychiatric Adverse Reactions: Prior to initiating methylphenidate hydrochloride extended-release, screen patients for risk factors for developing a manic episode.
If new psychotic or manic symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release. 4) Priapism: If abnormally sustained or frequent and painful erections occur, patients should seek immediate medical attention.
5) Peripheral Vasculopathy, including Raynaud’s Phenomenon: Careful observation for digital changes is necessary during methylphenidate hydrochloride extended-release treatment. , rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
6) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients. Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 8) Increased Intraocular Pressure (IOP) and Glaucoma: Prescribe methylphenidate hydrochloride extended-release to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor patients with a history of increased IOP or open angle glaucoma. 9) Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating methylphenidate hydrochloride extended-release, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
4 CONTRAINDICATIONS Methylphenidate hydrochloride extended-release capsules are contraindicated in patients with: known hypersensitivity to methylphenidate or other component of methylphenidate hydrochloride extended-release capsules.
Angioedema has been reported in patients treated with methylphenidate hydrochloride extended-release capsules. 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 contain sucrose.
Therefore, patients with hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Known hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules.
( 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 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Post-marketing Experience The following adverse reactions have been identified during post-marketing use of methylphenidate hydrochloride extended-release and other methylphenidate hydrochloride 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 Hydrochloride Extended-Release 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 Hydrochloride 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
Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate. 1 Abuse, Misuse, and Addiction Methylphenidate hydrochloride extended-release has a high potential for abuse and misuse.
The use of methylphenidate hydrochloride extended-release exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. 2) ] . Misuse and abuse of CNS stimulants, including methylphenidate hydrochloride extended-release, 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 methylphenidate hydrochloride extended-release, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store methylphenidate hydrochloride extended-release in a safe place, preferably locked, and instruct patients to not give methylphenidate hydrochloride extended-release to anyone else.
Throughout methylphenidate hydrochloride extended-release treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended dosage.
Avoid methylphenidate hydrochloride extended-release use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac problems. 3 Increased Blood Pressure and Heart Rate 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).
Some patients may have larger increases. Monitor all methylphenidate hydrochloride extended-release-treated patients for hypertension and tachycardia. 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. , comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients, compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing methylphenidate hydrochloride extended-release.
5 Priapism Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use in both adult and pediatric male patients. Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate, often subsequent to an increase in dosage.
Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation). Methylphenidate hydrochloride extended-release-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
6 Peripheral Vasculopathy, including Raynaud’s Phenomenon CNS stimulants, including methylphenidate hydrochloride extended-release, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at the therapeutic dosages of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction in or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during methylphenidate hydrochloride extended-release treatment. , rheumatology referral) may be appropriate for methylphenidate hydrochloride extended-release-treated patients who develop signs of symptoms of peripheral vasculopathy.
4) ] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. 7 kg less growth in weight over 3 years), without evidence of growth rebound during this development period. Closely monitor growth (weight and height) in methylphenidate hydrochloride extended-release-treated pediatric patients.
Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. 8 Acute Angle Closure Glaucoma There have been reports of angle closure glaucoma associated with methylphenidate treatment.
, patients with significant hyperopia) should be evaluated by an ophthalmologist. 2) ] . Prescribe methylphenidate hydrochloride extended-release to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.
Closely monitor methylphenidate hydrochloride extended-release-treated patients with a history of abnormally increased IOP or open angle glaucoma. 10 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics.
2) ] . Before initiating methylphenidate hydrochloride extended-release, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor methylphenidate hydrochloride extended-release -treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.