Ritalin LA

What Is Ritalin LA?

Ritalin LA (methylphenidate hydrochloride) is a central nervous system stimulant used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy. Ritalin LA is available in generic form.

What Are Side Effects of Ritalin LA?

Common side effects of Ritalin LA include:

• headache,
• stomach pain,
• loss of appetite,
• trouble sleeping (insomnia),
• dizziness,
• nausea,
• vomiting,
• weight loss,
• lightheadedness,
• irritability,
• nervousness,
• blurred vision or other vision problems,
• dry mouth,
• constipation,
• sweating,
• skin rash,
• numbness/tingling/cold feeling in your hands or feet,
• blue fingers/toes,
• elevated blood pressure, or
• (rarely) drowsiness.

Dosage for Ritalin LA

The recommended starting dose of Ritalin LA is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and effectiveness.

What Drugs, Substances, or Supplements Interact with Ritalin LA?

Ritalin LA may interact with MAO inhibitors, blood thinners, clonidine, dobutamine, epinephrine, isoproterenol, phenylbutazonie, cold/allergy medicine containing phenylephrine, potassium citrate, sodium acetate, sodium bicarbonate, citric acid (Vitamin C), potassium citrate, sodium citrate, medications to treat high or low blood pressure, stimulants, diet pills, seizure medicine, or antidepressants. Tell your doctor all medications and supplements you use.

Ritalin LA During Pregnancy and Breastfeeding

Ritalin LA should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding. Do not stop taking Ritalin LA suddenly or you may have withdrawal symptoms.

Additional Information

Our Ritalin LA (methylphenidate hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Ritalin LA Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or
• penis erection that is painful or lasts 4 hours or longer (rare).

Methylphenidate can affect growth in children. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

• excessive sweating;
• mood changes, feeling nervous or irritable, sleep problems (insomnia);
• fast heart rate, pounding heartbeats or fluttering in your chest, increased blood pressure;
• loss of appetite, weight loss;
• dry mouth, nausea, stomach pain; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ritalin LA (Methylphenidate Hydrochloride Extended-Release Capsules)

 

Ritalin LA Professional Information

SIDE EFFECTS

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

• Abuse and Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
• Known hypersensitivity to methylphenidate or other ingredients of Ritalin LA [see CONTRAINDICATIONS]
• Hypertensive crisis when used concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS, DRUG INTERACTIONS]
• Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
• Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
• Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Priapism [see WARNINGS AND PRECAUTIONS]
• Peripheral Vasculopathy, Including Raynaud’s Phenomenon [see WARNINGS AND PRECAUTIONS]
• Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because 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 Ritalin 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 Ritalin LA in doses of 10 to 40 mg per day. Safety of Ritalin 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 Ritalin LA in children with ADHD aged 6 to 12 years. All subjects received Ritalin 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 Ritalin 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 Ritalin 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 Ritalin 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% Ritalin LA-Treated Subjects in the 2-Week Double-Blind Phase

Preferred Term	Ritalin 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 Treatment

In the 2-week double-blind treatment phase of a placebo-controlled parallel-group study in children with ADHD, one Ritalin 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 Ritalin 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.

Postmarketing Experience

The following adverse reactions have been identified during the post approval use of methylphenidate products. 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 Ritalin, Ritalin-SR, And Ritalin LA

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 children

Psychiatric Disorders: insomnia, anxiety, restlessness, agitation, psychosis (sometimes with visual and tactile hallucinations), depressed mood

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

Investigations: weight loss (adult ADHD patients)

Adverse Reactions Reported With Other Methylphenidate-Containing Products

The list below shows adverse reactions not listed with Ritalin, Ritalin-SR, or Ritalin LA formulations 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, 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

DRUG INTERACTIONS

Clinically Important Drug Interactions With Ritalin LA

Table 3 presents clinically important drug interactions with Ritalin LA.

Table 3: Clinically Important Drug Interactions With Ritalin LA

Monoamine Oxidase Inhibitors (MAOI)
Clinical Impact	Concomitant use of MAOIs and CNS stimulants, including Ritalin LA, can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see CONTRAINDICATIONS].
Intervention	Concomitant use of Ritalin LA with MAOIs or within 14 days after discontinuing MAOI treatment is contraindicated.
Examples	selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue
Antihypertensive Drugs
Clinical Impact	Ritalin LA may decrease the effectiveness of drugs used to treat hypertension [see WARNINGS AND PRECAUTIONS].
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 Ritalin LA may increase the risk of sudden blood pressure and heart rate increase during surgery.
Intervention	Avoid use of Ritalin LA 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

Drug Abuse And Dependence

Controlled Substance

Ritalin LA contains methylphenidate hydrochloride, a Schedule II controlled substance.

Abuse

CNS stimulants, including Ritalin 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 [see OVERDOSE].

To reduce the abuse of CNS stimulants, including Ritalin 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 [see HOW SUPPLIED], monitor for signs of abuse while on therapy, and reevaluate the need for Ritalin and Ritalin-SR use.

Dependence

Tolerance

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 Ritalin LA.

Dependence

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 Ritalin and Ritalin SR. 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.

Read the entire FDA prescribing information for Ritalin LA (Methylphenidate Hydrochloride Extended-Release Capsules)