Methylphenidate Hydrochloride (Page 2 of 5)

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 pediatric patients who received methylphenidate for 7 days per week throughout the year had 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 development period.

Closely monitor growth (weight and height) in methylphenidate hydrochloride tablets-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

5.8 Acute Angle Closure Glaucoma

There have been reports of angle closure glaucoma associated with methylphenidate treatment.

Although the mechanism is not clear, methylphenidate hydrochloride tablets-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

5.9 Increased Intraocular Pressure and Glaucoma

There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment [see Adverse Reactions (6.2)].

Prescribe methylphenidate hydrochloride tablets and methylphenidate hydrochloride sustained-release tablets 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 tablets-treated patients with a history of abnormally increased IOP or open angle glaucoma.

5.10 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. Worsening of Tourette’s syndrome has also been reported [see Adverse Reactions (6)].

Before initiating methylphenidate hydrochloride tablets, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor methylphenidate hydrochloride tablets-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

6 ADVERSE REACTIONS

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 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, trismus

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 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

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

Table 1 presents clinically important drug interactions with methylphenidate hydrochloride tablets

Table 1: Clinically Important Drug Interactions with Methylphenidate Hydrochloride Tablets

Monoamine Oxidase Inhibitors (MAOI)

Clinical Impact

Concomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride 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 with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.

Antihypertensive Drugs

Clinical Impact

Methylphenidate hydrochloride 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.

Halogenated Anesthetics

Clinical Impact

Concomitant use of halogenated anesthetics and methylphenidate hydrochloride tablets may increase the risk of sudden blood pressure and heart rate increase during surgery.

Intervention

Avoid use of methylphenidate hydrochloride tablets in patients being treated with anesthetics on the day of surgery.

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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