Methylphenidate Hydrochloride (Page 2 of 6)

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 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.

5.6 Peripheral Vasculopathy, Including Raynaud’s Phenomenon

CNS stimulants, including methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent 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 throughout the course of treatment. Signs 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.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 throughout the 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 rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

6 ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

  • Abuse and Dependence [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 and methylphenidate hydrochloride extended-release tablets [see Contraindications ( 4)]
  • Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors [see Contraindications ( 4), Drug Interactions ( 7.1)]
  • Serious Cardiovascular Reactions [see Warnings and Precautions ( 5.2)]
  • Blood Pressure and Heart Rate Increases [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 [see Warnings and Precautions ( 5.7)]

The following adverse reactions associated with the use of methylphenidate hydrochloride tablets, methylphenidate hydrochloride extended-release 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 and Methylphenidate Hydrochloride Extended-Release 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

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 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

Investigations: weight loss (adult ADHD patients)

Additional Adverse Reactions Reported with Other Methylphenidate-Containing Products The list below shows adverse reactions not listed for methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release 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

Eye Disorders: diplopia, mydriasis

Cardiac Disorders: sudden cardiac death, myocardial infarction, bradycardia, extrasystole

Vascular Disorders: peripheral coldness, Raynaud’s phenomenon

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

7 DRUG INTERACTIONS

7.1 Clinically Important Drug Interactions with Methylphenidate Hydrochloride Tablets and Methylphenidate Hydrochloride Extended-Release Tablets

Table 1 presents clinically important drug interactions with methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets.

Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Tablets and Methylphenidate Hydrochloride Extended-Release Tablets

Monoamine Oxidase Inhibitors (MAOI)

Clinical Impact

Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets 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 tablets or methylphenidate hydrochloride extended-release tablets 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 tablets and methylphenidate hydrochloride extended-release tablets 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 tablets or methylphenidate hydrochloride extended-release tablets may increase the risk of sudden blood pressure and heart rate increase during surgery.

Intervention

Avoid use of methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets 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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