Methylphenidate Hydrochloride (La) Prescribing Information
CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), 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 signs of abuse and dependence while on therapy
CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving.
Signs and symptoms of CNS stimulant abuse include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed. Abusers of CNS stimulants may chew, snort, inject, or use other unapproved routes of administration which may result in overdose and death
To reduce the abuse of CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants
Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drug's desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA).
Physical dependence (which is manifested by a withdrawal syndrome produced by abrupt cessation, rapid dose reduction, or administration of an antagonist) may occur in patients treated with CNS stimulants, including methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets. Withdrawal symptoms after abrupt cessation following prolonged high-dosage administration of CNS stimulants include dysphoric mood; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.
Methylphenidate hydrochloride extended-release capsules (LA) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age
Methylphenidate hydrochloride extended-release capsules (LA) was evaluated in a randomized, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12, with DSM-IV diagnoses of ADHD received a single morning dose of methylphenidate hydrochloride extended-release capsules (LA)in the range of 10 to 40 mg/day, or placebo, for up to 2 weeks. The doses used were the optimal doses established in a previous individual dose titration phase. In that titration phase, 53 of 164 patients (32%) started on a daily dose of 10 mg and 111 of 164 patients (68%) started on a daily dose of 20 mg or higher. The patient's regular schoolteacher completed the Conners ADHD/DSM-IV Scale for Teachers (CADS-T) at baseline and the end of each week. The CADS-T assesses symptoms of hyperactivity and inattention. The change from baseline of the (CADS-T) scores during the last week of treatment was analyzed as the primary efficacy parameter. Patients treated with methylphenidate hydrochloride extended-release capsules (LA) showed a statistically significant improvement in symptom scores from baseline [Mean (final score - baseline) = -10.7 points)] over patients who received placebo [Mean (final score - baseline) = +2.8 points ]. The lower the final score on the CADS-T scale from baseline, the less severe the disease is. This demonstrates that a single morning dose of methylphenidate hydrochloride extended-release capsules (LA) exerts a treatment effect in ADHD.
Figure 2: CADS-T Total Subscale - Mean Change From Baseline* |
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- Administer orally once daily in the morning ().
2.2 General Dosing InformationThe recommended starting dose for methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.
Administer methylphenidate hydrochloride extended-release capsules (LA) orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed.
- Capsules may be swallowed whole, or opened and the entire contents sprinkled on applesauce ().
2.2 General Dosing InformationThe recommended starting dose for methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.
Administer methylphenidate hydrochloride extended-release capsules (LA) orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed.
- Should not be crushed, chewed, or divided ().
2.2 General Dosing InformationThe recommended starting dose for methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Increase dosage gradually, in increments of 10 mg weekly. Daily dosage above 60 mg is not recommended. When a lower initial dose is appropriate, patients may begin treatment with 10 mg.
Administer methylphenidate hydrochloride extended-release capsules (LA) orally once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets, and adjust dosage as needed.
- Patients new to methylphenidate: Start at 20 mg daily, titrating the dose weekly in 10-mg increments. Doses above 60 mg daily are not recommended ().
2.3 Patients Currently Using Methylphenidate Hydrochloride Tablets or Methylphenidate Hydrochloride Extended-Release TabletsThe recommended dose of methylphenidate hydrochloride extended-release capsules (LA) for patients currently taking methylphenidate hydrochloride tablets twice daily or methylphenidate hydrochloride extended-release tablets (SR) is provided below.
TABLE 1: Recommended Dose Conversion From Methylphenidate Hydrochloride Tablets or Methylphenidate Hydrochloride Extended-Release Tablets Previous Methylphenidate Hydrochloride Tablets or Methylphenidate Hydrochloride Extended-Release Tablets Dose Recommended Methylphenidate Hydrochloride Extended-Release Capsules (LA) Dose 5 mg methylphenidate hydrochloride tablets twice daily 10 mg once daily 10 mg methylphenidate hydrochloride tablets twice daily or 20 mg methylphenidate hydrochloride extended-release tablets 20 mg once daily 15 mg methylphenidate hydrochloride tablets twice daily 30 mg once daily 20 mg methylphenidate hydrochloride tablets twice daily or 40 mg of methylphenidate hydrochloride extended-release tablets 40 mg once daily 30 mg methylphenidate hydrochloride tablets twice daily or 60 mg of methylphenidate hydrochloride extended-release tablets 60 mg once daily - For patients currently using methylphenidate hydrochloride tablets or methylphenidate hydrochloride extended-release tablets: Dosage is based on current dose regimen ().
2.4 Switching From Other Methylphenidate ProductsIf switching from other methylphenidate products, discontinue that treatment, and titrate with methylphenidate hydrochloride extended-release capsules (LA) using the titration schedule.
Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles
[see Description (11), Clinical Pharmacology (12.3)].Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.
- If switching from other methylphenidate products, discontinue treatment and titrate with methylphenidate hydrochloride extended-release capsules (LA) ().
2.4 Switching From Other Methylphenidate ProductsIf switching from other methylphenidate products, discontinue that treatment, and titrate with methylphenidate hydrochloride extended-release capsules (LA) using the titration schedule.
Do not substitute for other methylphenidate products on a milligram-per-milligram basis, because different methylphenidate base compositions and differing pharmacokinetic profiles
[see Description (11), Clinical Pharmacology (12.3)].Clinical judgment should be used when selecting the starting dose. Daily dosage above 60 mg is not recommended.
- 10 mg extended-release capsules white/light green (imprinted mayne 609 on both the body and cap)
- 20 mg extended-release capsules white/white (imprinted mayne 610 on both the body and cap)
- 30 mg extended-release capsules white/light blue, (imprinted mayne 611 on both body and cap)
- 40 mg extended-release capsules white/dark blue, (imprinted mayne 612 on both body and cap)
- 60 mg extended-release capsules light yellow/dark yellow (imprinted mayne 614 on both body and cap)
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including methylphenidate hydrochloride extended-release capsules (LA) during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy registry for ADHD medications at 1-866-961-2388 or visit https://womensmentalhealth.org/adhd-medications/.
- Hypersensitivity to methylphenidate or other components of methylphenidate hydrochloride extended-release capsules (LA). Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with methylphenidate[see].
6.1 Clinical Trial ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The clinical program for methylphenidate hydrochloride extended-release capsules (LA) consisted of 6 studies: 2 controlled clinical studies conducted in children with ADHD aged 6 to 12 years and 4 clinical pharmacology studies conducted in healthy adult volunteers. These studies included a total of 256 subjects; 195 children with ADHD and 61 healthy adult volunteers. The subjects received methylphenidate hydrochloride extended-release capsules (LA) in doses of 10 to 40 mg per day. Safety of methylphenidate hydrochloride extended-release capsules (LA) was assessed by evaluating frequency and nature of adverse events, routine laboratory tests, vital signs, and body weight. A placebo-controlled, double-blind, parallel-group study was conducted to evaluate the efficacy and safety of methylphenidate hydrochloride extended-release capsules (LA) in children with ADHD aged 6 to 12 years. All subjects received methylphenidate hydrochloride extended-release capsules (LA) for up to 4 weeks, and had their dose optimally adjusted, prior to entering the double-blind phase of the trial. In the 2-week double-blind treatment phase of this study, patients received either placebo or methylphenidate hydrochloride extended-release capsules (LA) at their individually-titrated dose (range, 10 to 40 mg).
Adverse reactions with an incidence greater than 5% during the initial 4-week single-blind methylphenidate hydrochloride extended-release capsules (LA) titration period of this study were headache, insomnia, upper abdominal pain, appetite decreased, and anorexia.
Adverse reactions with an incidence greater than 2% among methylphenidate hydrochloride extended-release capsules (LA) -treated subjects, during the 2-week double-blind phase of the clinical study, are shown in Table 2:
Table 2: Adverse Reactions in Greater Than 2% Methylphenidate Hydrochloride Extended-Release Capsules (LA)-Treated Subjects in the 2-Week Double-Blind Phase Preferred Term Methylphenidate Hydrochloride Extended-Release Capsules (LA)
N = 65
N (%)Placebo N = 71
N (%)Anorexia 2 (3.1) 0 (0.0) Insomnia 2 (3.1) 0 (0.0) Adverse Events Associated with Discontinuation of TreatmentIn the 2-week double-blind treatment phase of a placebo-controlled parallel-group study in children with ADHD, one methylphenidate hydrochloride extended-release capsules (LA)-treated subject (1/65, 1.5%) discontinued due to an adverse event (depressed mood).
In the single-blind titration period of this study, subjects received methylphenidate hydrochloride extended-release capsules (LA) for up to 4 weeks. During this period a total of 6 subjects (6/161, 3.7%) discontinued due to adverse events. The adverse events leading to discontinuation were anger (2 patients), hypomania, anxiety, depressed mood, fatigue, migraine, and lethargy.
- 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].
7.1 Clinically Important Drug Interactions With Methylphenidate Hydrochloride Extended-Release Capsules (LA)Table 3 presents clinically important drug interactions with methylphenidate hydrochloride extended-release capsules (LA)
Table 3: Clinically Important Drug Interactions With Methylphenidate Hydrochloride Extended-Release Capsules (LA) Monoamine Oxidase Inhibitors (MAOI)Clinical ImpactConcomitant use of MAOIs and CNS stimulants, including methylphenidate hydrochloride extended-release capsules (LA), can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications (4)].InterventionConcomitant use of methylphenidate hydrochloride extended-release capsules (LA) with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated. Examplesselegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Antihypertensive DrugsClinical ImpactMethylphenidate hydrochloride extended-release capsules (LA) may decrease the effectiveness of drugs used to treat hypertension [see Warnings and Precautions (5.3)].InterventionMonitor blood pressure and adjust the dosage of the antihypertensive drug as needed. ExamplesPotassium-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 AnestheticsClinical ImpactConcomitant use of halogenated anesthetics and methylphenidate hydrochloride extended-release capsules (LA) may increase the risk of sudden blood pressure and heart rate increase during surgery. InterventionAvoid use of methylphenidate hydrochloride extended-release capsules (LA) in patients being treated with anesthetics on the day of surgery. Exampleshalothane, isoflurane, enflurane, desflurane, sevoflurane RisperidoneClinical ImpactCombined 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) InterventionMonitor for signs of EPS