Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Hydrochloride Tablets, USP 5 mg tablets: Round, pale yellow to yellow uncoated tablet, debossed with "A62" on one side and plain on other side, may have mottled appearance. NDC 67877-616-01 Bottles of 100 Tablets NDC 67877-616-33 Carton of 10 Tablets (1 X 10 Unit-Dose) 10 mg tablets: Round, light blue to blue uncoated tablet, debossed with "A63" on one side and functionally scored on other side, may have mottled appearance. NDC 67877-617-01 Bottles of 100 Tablets NDC 67877-617-33 Carton of 10 Tablets (1 X 10 Unit-Dose) 20 mg tablets: Round, pale yellow to yellow uncoated tablet, debossed with "A64" on one side and functionally scored on other side, may have mottled appearance. NDC 67877-618-01 Bottles of 100 Tablets NDC 67877-618-33 Carton of 10 Tablets (1 X 10 Unit-Dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drugdisposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tabletsby a medicine takeback program or by an authorized collector registered with the Drug EnforcementAdministration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard methylphenidate hydrochloride tablets in the householdtrash.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 67877-616-01 Methylphenidate Hydrochloride Tablets, USP 5 mg Rx only 100 Tablets NDC 67877-616-33 Methylphenidate Hydrochloride Tablets, USP 5 mg Rx only 10 Tablets NDC 67877-617-01 Methylphenidate Hydrochloride Tablets, USP 10 mg Rx only 100 Tablets NDC 67877-617-33 Methylphenidate Hydrochloride Tablets, USP 10 mg Rx only 10 Tablets NDC 67877-618-01 Methylphenidate Hydrochloride Tablets, USP 20 mg Rx only 100 Tablets NDC 67877-618-33 Methylphenidate Hydrochloride Tablets, USP 20 mg Rx only 10 Tablets methylphenidate-5mg-100s-1.jpg methylphenidate-5mg-10s-1.jpg methylphenidate-10mg-100s-1.jpg methylphenidate-10mg-10s-1.jpg methylphenidate-20mg-100s-1.jpg methylphenidate-20mg-10s-1.jpg
- 16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Hydrochloride Tablets, USP 5 mg tablets: Round, pale yellow to yellow uncoated tablet, debossed with "A62" on one side and plain on other side, may have mottled appearance. NDC 67877-616-01 Bottles of 100 Tablets NDC 67877-616-33 Carton of 10 Tablets (1 X 10 Unit-Dose) 10 mg tablets: Round, light blue to blue uncoated tablet, debossed with "A63" on one side and functionally scored on other side, may have mottled appearance. NDC 67877-617-01 Bottles of 100 Tablets NDC 67877-617-33 Carton of 10 Tablets (1 X 10 Unit-Dose) 20 mg tablets: Round, pale yellow to yellow uncoated tablet, debossed with "A64" on one side and functionally scored on other side, may have mottled appearance. NDC 67877-618-01 Bottles of 100 Tablets NDC 67877-618-33 Carton of 10 Tablets (1 X 10 Unit-Dose) Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP). Disposal Comply with local laws and regulations on drugdisposal of CNS stimulants. Dispose of remaining, unused, or expired methylphenidate hydrochloride tabletsby a medicine takeback program or by an authorized collector registered with the Drug EnforcementAdministration. If no take-back program or authorized collector is available, mix methylphenidate hydrochloride tablets with an undesirable, nontoxic substance to make it less appealing to children and pets. Place the mixture in a container, such as a sealed plastic bag and discard methylphenidate hydrochloride tablets in the householdtrash.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 67877-616-01 Methylphenidate Hydrochloride Tablets, USP 5 mg Rx only 100 Tablets NDC 67877-616-33 Methylphenidate Hydrochloride Tablets, USP 5 mg Rx only 10 Tablets NDC 67877-617-01 Methylphenidate Hydrochloride Tablets, USP 10 mg Rx only 100 Tablets NDC 67877-617-33 Methylphenidate Hydrochloride Tablets, USP 10 mg Rx only 10 Tablets NDC 67877-618-01 Methylphenidate Hydrochloride Tablets, USP 20 mg Rx only 100 Tablets NDC 67877-618-33 Methylphenidate Hydrochloride Tablets, USP 20 mg Rx only 10 Tablets methylphenidate-5mg-100s-1.jpg methylphenidate-5mg-10s-1.jpg methylphenidate-10mg-100s-1.jpg methylphenidate-10mg-10s-1.jpg methylphenidate-20mg-100s-1.jpg methylphenidate-20mg-10s-1.jpg
Overview
Methylphenidate hydrochloride tablets USP contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5mg, 10mg, and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablets USP contains the following inactive ingredients: Colloidal Silicon Dioxide, D&C Yellow #10 Aluminium lake, FD&C Blue #1/Brilliant Blue FCF Aluminium lake (10-mg tablets), Lactose Monohydrate, Magnesium Stearate, Polyethylene glycol, Pregelatinized starch (5-mg and 20-mg tablets), Sucrose. Methylphenidate-structure
Indications & Usage
Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride is a centralnervoussystem(CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders(ADHD) and Narcolepsy(1).
Dosage & Administration
Methylphenidate Hydrochloride Tablets ( 2.2 ): Pediatric Patients 6 Years and Older:Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10- mg increments. Dosages above 60 mg/dayare not recommended. Adults: Average daily dosage is 20 mg to 30 mg,administered 2 or 3 times daily,preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. 2.1 Pretreatment Screening Prior to treatingpediatricpatientsandadultswithcentral nervous system(CNS)stimulants,including methylphenidate hydrochloride tablets,assessforthepresenceofcardiacdisease(i.e.,perform a carefulhistory,includingfamilyhistory of suddendeathorventriculararrhythmia, and physicalexamination) [seeWarningsandPrecautions( 5.2 )] . Assesstheriskofabusepriortoprescribing,and monitorforsignsofabuseanddependencewhileontherapy.Maintaincarefulprescriptionrecords,educatepatientsaboutabuse,monitorforsigns of abuseandoverdose, and periodicallyreevaluate the needformethylphenidate hydrochloride tablets use [seeBoxedWarning,WarningsandPrecautions( 5.1 ),DrugAbuseandDependence( 9 .2, 9.3)]. 2.2 General Dosing Information Methylphenidate Hydrochloride Tablets Pediatric Patients 6 years and Older: Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5- to 10-mgweekly.Daily dosage above 60 mg is not recommended. Adults: Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg.Patients who are unable to sleep if medication is taken late in the dayshould take the last dose before 6 p.m. Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets, and adjust dosage as needed. 2.3 Dose Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage,or, if necessary,discontinue methylphenidate hydrochloride tablets.Ifimprovement is notobservedafterappropriatedosageadjustmentover a one-monthperiod, the drugshouldbediscontinued.
Warnings & Precautions
Serious CardiovascularEvents :Sudden death has been reported in association with CNS-stimulant treatment at usual doses in pediatric patients with structural cardiac abnormalities or other serious heart problems.In adults, sudden death, stroke, and myocardialinfarction have been reported. Avoid use in patients with known structuralcardiacabnormalities,cardiomyopathy, serious heart rhythm arrhythmias, or coronary artery disease ( 5.2 ). Blood Pressure and Heart RateIncreases :Monitorblood pressure and pulse. Consider the benefits and risk in patients for whom an increase in blood pressure or heartrate would be problematic( 5.3 ). Psychiatric Adverse Reactions : Use of stimulantsmay cause psychotic or manicsymptoms in patients with no prior history or exacerbation of symptoms in patients with preexisting psychiatric illness. Evaluate for preexistingpsychotic or bipolar disorder prior to methylphenidate hydrochloride use( 5.4 ). Priapism :Cases of painful and prolonged penile erections, and priapism have been reported with methylphenidateproducts.Immediatemedical attention should be sought if signs or symptoms of prolonged penile erections or priapism areobserved( 5.5 ). Peripheral Vasculopathy, I ncluding Raynaud’s Phenomenon :Stimulants used to treat ADHD are associated with peripheralvasculopathy,includingRaynaud’sphenomenon.Carefulobservation for digital changes is necessaryduringtreatment with ADHD stimulants( 5.6 ). Long-Term Suppression of Growth : Monitor height and weight at appropriateintervals in pediatric patients ( 5.7 ). 5.1 Potential for Abuse and Dependence CNS stimulants,including methylphenidate hydrochloride tablets, other methylphenidate-containingproducts, 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 [seeBoxed Warning, 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 stimulanttreatment 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 serious 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 treatment. 5.3 Blood Pressure and Heart Rate Increases CNS stimulants cause an increase in blood pressure (mean increaseapproximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia. 5.4 Psychiatric Adverse Reactions Exacerbation of Preexisting Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychoticdisorder. Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixedmood 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. In a pooled analysis of multipleshort-term, placebo-controlled studies of CNS stimulants,psychotic or manicsymptoms occurred in approximately 0.1% of CNSstimulant-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 sometime on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or duringdiscontinuation).Patients who developabnormally sustained or frequent and painful erections should seek immediate medical attention. 5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon CNS stimulants, including methylphenidate hydrochloride, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usuallyintermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughoutthe course of treatment. Signs and symptomsgenerallyimprove after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. 5.7 Long-Term Suppression of Growth CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughoutthe year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth reboundduringthis period of development. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including methylphenidate hydrochloride. Patients who are not growing or gainingheight or weight as expected may need to have their treatment interrupted.
Boxed Warning
ABUSE AND DEPENDENCE CNSstimulants,including methylphenidate hydrochloride tablets, other methylphenidate-containing products, and amphetamines, have a highpotentialforabuseanddependence.Assesstherisk 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 )] . WARNING: ABUSE AND DEPENDENCE See full prescribing informationforcomplete boxed warning. CNS stimulants, including methylphenidate hydrochloride tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence ( 5.1 , 9.2 , 9.3 ). Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy( 5.1 , 9.2 ).
Contraindications
Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylacticreactions, have been reported in patients treated with methylphenidate [seeAdverse Reactions (6.1)]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 daysfollowingdiscontinuation of treatment with an MAOI, because of the risk of hypertensive crises [see Drug Interactions ( 7.1 )]. Known hypersensitivity to methylphenidate or other product components of methylphenidate hydrochloride tablets ( 4 ). Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days ( 4 ).
Adverse Reactions
The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warningsand Precautions ( 5.1 ), Drug Abuse and Dependence ( 9.2 , 9.3 ) ] Knownhypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications( 4 )] Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [seeContraindications ( 4 ), Drug Interactions ( 7.1 )] Serious Cardiovascular Reactions [see Warningsand Precautions ( 5.2 )] Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.3 )] Psychiatric Adverse Reactions [seeWarningsandPrecautions( 5.4 )] Priapism [seeWarningsand Precautions ( 5.5 )] Peripheral Vasculopathy, IncludingRaynaud’sPhenomenon [seeWarningsand Precautions ( 5.6 )] Long-Term Suppression of Growth [see Warnings and Precautions ( 5.7 )] The following adverse reactions associated with the use of methylphenidate hydrochloride tablets, and othermethylphenidate products were identified in clinical trials,spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Adverse Reactions Reported With methylphenidate hydrochloride Infections andInfestations: nasopharyngitis Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia,anemia Immune System Disorders: hypersensitivity reactions, includingangioedema, and anaphylaxis Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolongeduse in pediatric patients Psychiatric Disorders: insomnia,anxiety, restlessness, agitation, psychosis(sometimes with visual and tactile hallucinations), depressed mood Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoatheetoid movements, drowsiness, convulsions, cerebrovascular disorders (including vasculitis, cerebral hemorrhages and cerebrovascular accidents), serotonin syndrome in combination with serotonergic drugs Eye Disorders: blurred vision, difficulties in visual accommodation Cardiac Disorders: tachycardia,palpitations, increased blood pressure, arrhythmias, angina pectoris Respiratory, Thoracic, and Mediastinal Disorders: cough Gastrointestinal Disorders: dry mouth, nausea, vomiting,abdominal pain, dyspepsia Hepatobiliary Disorders: abnormal liver function, ranging from transaminase elevation to severe hepatic injury Skin andSubcutaneousTissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythemamultiforme rash, thrombocytopenic purpura Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis Investigations: weight loss (adult ADHD patients) Additional Adverse Reactions Reported with Other Methylphenidate-ContainingProducts The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets that have been reported with other methylphenidate-containingproducts. Blood and Lymphatic Disorders: pancytopenia Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas Psychiatric Disorders: affect lability, mania,disorientation, and libido changes Nervous System Disorders: migraine Eye Disorders: diplopia, mydriasis Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole Vascular Disorders: peripheral coldness, Raynaud'sphenomenon Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea Gastrointestinal Disorders: diarrhea, constipation Skin andSubcutaneousTissue Disorders: angioneuroticedema,erythema, fixed drug eruption Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia,muscle twitching Renal and Urinary Disorders: hematuria Reproductive System and Breast Disorders: gynecomastia General Disorders: fatigue, hyperpyrexia Urogenital Disorders : priapism Commonadverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Antihypertensive D rugs: Monitorbloodpressure.Adjust dosage of antihypertensive drug as needed ( 7 .1). Halogenated Anesthetics: Avoid use of methylphenidate hydrochloride on the day of surgery if halogenated anesthetics will be used ( 7 .1). 7.1 Clinically Important Drug Interactions With methylphenidate hydrochloride Table 1 presents clinically important drug interactions with methylphenidate hydrochloride. Table 1: Clinically ImportantDrugInteractionswith methylphenidate hydrochloride Monoamine Oxidase Inhibitors (MAOI) Clinical Impact Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )] . Intervention Concomitant use of methylphenidate hydrochloride with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive Drugs Clinical Impact Methylphenidate hydrochloride may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions( 5.3 )] . Intervention Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed. Examples Potassium-sparing and thiazide diuretics, calcium channel blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta blockers, centrally acting alpha-2 receptor agonists Halogenated Anesthetics Clinical Impact Concomitant use of halogenated anesthetics and methylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Intervention Avoid use of methylphenidate hydrochloride in patients being treated with anesthetics on the day of surgery. Examples halothane, isoflurane, enflurane, desflurane, sevoflurane Risperidone Clinical Impact Combined use of methylphenidate with risperidone when there is a change, whether an increase or decrease, in dosage of either or both medications, may increase the risk of extrapyramidal symptoms (EPS) Intervention Monitor for signs of EPS
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