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If you are a consumer or patient please visit this version. Common adverse reactions: tachycardia, palpitations, headache, insomnia, anxiety, hyperhidrosis, weight loss, decreased appetite, dry mouth, nausea, and abdominal pain 6. CNS stimulants, including methylphenidate hydrochloride tablets, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.
Assess the risk of abuse prior to prescribing, and monitor for s of abuse and dependence while on therapy [see Warnings and Precautions 5. Prior to treating pediatric patients and adults with central nervous system CNS stimulants, including methylphenidate hydrochloride tablets, assess for the presence of cardiac disease i. Assess the risk of abuse prior to prescribing, and monitor for s of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for s of abuse and overdose, and periodically reevaluate the need for methylphenidate hydrochloride tablets use [see Boxed Warning, Warnings and Precautions 5.
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 mg weekly. 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 day should take the last dose before 6 p.
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. 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.
CNS stimulants, including methylphenidate hydrochloride, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for s of abuse and dependence while on therapy [see Boxed Warning, Drug Abuse and Dependence 9. Sudden death, stroke, and myocardial infarction have been reported in adults with CNS stimulant treatment 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. CNS stimulants cause an increase in blood pressure mean increase approximately 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. CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode e. CNS stimulants, at recommended doses, may cause psychotic or manic symptoms e. If such symptoms occur, consider discontinuing methylphenidate hydrochloride. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.
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 some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal drug holidays or during discontinuation.
Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention. s and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation e. 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.
Closely monitor growth weight and height in pediatric patients treated with CNS stimulants, including methylphenidate hydrochloride. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
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.
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.
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.
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. The list below shows adverse reactions not listed for methylphenidate hydrochloride that have been reported with other methylphenidate-containing products.
Immune System Disorders: hypersensitivity reactions, such as auricular swelling, bullous conditions, eruptions, exanthemas. Psychiatric Disorders: affect lability, mania, disorientation, and libido changes. Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole. Respiratory, Thoracic, and Mediastinal Disorders: pharyngolaryngeal pain, dyspnea. Skin and Subcutaneous Tissue Disorders: angioneurotic edema, erythema, fixed drug eruption. Musculoskeletal, Connective Tissue, and Bone Disorders: myalgia, muscle twitching.
Table 1 presents clinically important drug interactions with methylphenidate hydrochloride tablets. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications 4 ]. Methylphenidate hydrochloride may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions 5. Monitor blood pressure and adjust the dosage of the antihypertensive drug as needed.
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. Concomitant use of halogenated anesthetics and methylphenidate hydrochloride may increase the risk of sudden blood pressure and heart rate increase during surgery. Avoid use of methylphenidate hydrochloride in patients being treated with anesthetics on the day of surgery.
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. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride tablets, during pregnancy.
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.
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. CNS stimulants, such as methylphenidate hydrochloride tablets, can cause vasoconstriction and thereby decrease placental perfusion. Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.
There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. The safety and effectiveness of methylphenidate hydrochloride for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of methylphenidate hydrochloride in pediatric patients less than 6 years have not been established.
The long-term efficacy of methylphenidate hydrochloride in pediatric patients has not been established. Growth should be monitored during treatment with stimulants, including methylphenidate hydrochloride. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions 5. Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only.
The clinical ificance of the long-term behavioral effects observed in rats is unknown. Methylphenidate hydrochloride tablets contain methylphenidate hydrochloride, a Schedule II controlled substance.Methylphenidate 5 mg
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