Methylphenidate

Methylphenidate Hydrochloride

10MG, 20MG, 5MG tabletÉtats-UnisCommercialiséAutorisé le 23 déc. 1977

Contenu en anglais

Ouvrir dans le registreInterroger Osler

Indications

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 tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1 ).

Contre-indications

2.3Dosage Reduction and Discontinuation

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued. 4 CONTRAINDICATIONS

Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [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 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 ).

Mises en garde et précautions d’emploi

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 ).

Indications

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 tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy ( 1 ).

Contre-indications

2.3Dosage Reduction and Discontinuation

Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride tablets. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate [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 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 ).

Grossesse et allaitement

8.1Pregnancy Risk Summary

Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (see Clinical Considerations ) . No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis at doses up to 10 and 15 times, respectively, the maximum recommended human dose (MRHD) of 60 mg/day given to adolescents on a mg/m 2 basis.

However, spina bifida was observed in rabbits at a dose 52 times the MRHD given to adolescents. A decrease in pup body weight was observed in a pre- and post-natal development study with oral administration of methylphenidate to rats throughout pregnancy and lactation at doses 6 times the MRHD given to adolescents (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions CNS stimulants, such as methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion.

No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. Data Animal Data In embryo-fetal development studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis.

Malformations (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 52 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (15 times the MRHD given to adolescents on a mg/m 2 basis). There was no evidence of morphological development effects in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (10 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), which was also maternally toxic.

The no effect level for embryo-fetal development in rats was 25 mg/kg/day (3 times the MRHD on a mg/m 2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (6 times the MRHD of 60 mg/day given to adolescents on a mg/m 2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (approximately 2 times the MRHD given to adolescents on a mg/m 2 basis).

Effets indésirables

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 , 9.3 ) ]
Known hypersensitivity to methylphenidate or other ingredients of methylphenidate hydrochloride tablets [see Contraindications ( 4 )]
Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4 ), Drug Interactions ( 7.1 )]
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 following adverse reactions associated with the use of methylphenidate hydrochloride tablets and other methylphenidate 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 Tablets Infections and Infestations: nasopharyngitis Blood and the Lymphatic System Disorders : leukopenia, thrombocytopenia, anemia Immune System Disorders: hypersensitivity reactions, including angioedema, and anaphylaxis Metabolism and Nutrition Disorders: decreased appetite, reduced weight gain, and suppression of growth during prolonged use in pediatric patients Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood, depression Nervous System Disorders: headache, dizziness, tremor, dyskinesia, including choreoathetoid 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 and Subcutaneous Tissue Disorders: hyperhidrosis, pruritus, urticaria, exfoliative dermatitis, scalp hair loss, erythema multiforme rash, thrombocytopenic purpura Musculoskeletal and Connective Tissue Disorders: arthralgia, muscle cramps, rhabdomyolysis, trismus Investigations: weight loss (adult ADHD patients) Vascular Disorders: peripheral coldness, Raynaud's phenomenon Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets that have been reported with other methylphenidate-containing products. 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, motor and verbal tics Eye Disorders: diplopia, increased intraocular pressure, mydriasis Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea Gastrointestinal Disorders: diarrhea, constipation Skin and Subcutaneous Tissue Disorders: angioneurotic edema, 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 Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Conditionnement	Code	Statut
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA209753-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA209753-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA209753-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA085799-001	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA086428-001	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA086429-001	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA213936-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA213936-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA213936-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA090710-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA090710-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA090710-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA091159-002	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA091159-003	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA091159-001	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA208737-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA208737-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA208737-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA040300-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA040300-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA040300-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA206932-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA206932-001	Prescription
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA206932-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA209276-001	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA209276-002	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA209276-003	Discontinued
METHYLPHENIDATE HYDROCHLORIDE 10MG	ANDA211779-002	Prescription
METHYLPHENIDATE HYDROCHLORIDE 20MG	ANDA211779-003	Prescription
METHYLPHENIDATE HYDROCHLORIDE 5MG	ANDA211779-001	Prescription

Methylphenidate Hydrochloride

Indications

Contre-indications

2.3Dosage Reduction and Discontinuation

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

Methylphenidate Hydrochloride

Indications

Contre-indications

2.3Dosage Reduction and Discontinuation

Mises en garde et précautions d’emploi

Deux médicaments dans une même question ?

5.1Abuse, Misuse, and Addiction

5.2Risks to Patients with Serious Cardiac Disease

5.3Increased Blood Pressure and Heart Rate

5.4Psychiatric Adverse Reactions Exacerbation of Pre-existing Psychosis

5.5Priapism Prolonged

5.6Peripheral Vasculopathy, Including Raynaud’s Phenomenon

5.7Long-Term Suppression of Growth in Pediatric Patients

Interactions

7.1Clinically Important Drug Interactions with Methylphenidate Hydrochloride Tablets Table

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

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Conditionnements

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