Medication Series # 2
DISCLAIMER: This blog serves an educational purpose to those parents wanting accurate data around typically prescribed medication. It forms part of a series on medication. Please note that I am personally not a proponent of medication. Please also note that I am not a medical doctor and thus am writing this to allow parents to make informed decisions when faced by having to make a choice to medicate or not. The information contained in these blogs are derived from the FDA Medication Published Guidelines*.
This is not an opinion piece.
See my post on "An alternative approach"
A General Description:
Ritalin is a Schedule 7 medication often prescribed for children diagnosed with ADHD. Typically a diagnosis of ADHD is made accordingly to the diagnostic criteria in the DSM-5. Ritalin is the trade name for methylphenidate hydrochloride USP and is manufactured in a quick release tablets of 5, 10, and 20 mg for oral administration and Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration.
Generally classified as a stimulant, Ritalin can best be described as a Central Nervous System (CNS) stimulant. The mode of action in man is not completely understood, but Ritalin presumably activates the brain stem arousal system and cortex to produce its stimulant effect. There is neither specific evidence which clearly establishes the mechanism whereby Ritalin produces its mental and behavioural effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Accordingly to the Medication Guideline Ritalin is indicated for individuals with (Attention Deficit Hyperactivity Disorder) ADHD and Narcolepsy.
Ritalin is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilising effect in children with a behavioural syndrome characterised by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Non-localising (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
It is very interesting that the Medication Guideline also includes the following statements:
Specific etiology (cause) of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.
The effectiveness of Ritalin LA for long-term use, i.e., for more than 2 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Ritalin LA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Marked anxiety, tension, and agitation are contraindications to Ritalin, since the drug may aggravate these symptoms. Ritalin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.
Ritalin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
Hypersensitivity to Methylphenidate
Monoamine Oxidase Inhibitors
Need for Comprehensive Treatment Program:
Ritalin LA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the child’s symptoms.
The FDA has issued the following warnings on Ritalin:
Serious Cardiovascular Events (Sudden death and pre-existing structural cardiac abnormalities or other Serious Heart Problems)
Psychiatric Adverse Events
Emerging of new psychotic or manic symptoms
Long-Term suppressions of growth
Use in children under six years of age
It is also important to take note of the Black Box Warning as well:
Ritalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Patients with an element of agitation may react adversely; discontinue therapy if necessary.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of this behavioural syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Ritalin should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioural characteristics.
When these symptoms are associated with acute stress reactions, treatment with Ritalin is usually not indicated.
Ritalin should not be used in children under six years of age.
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; aggressive behaviour; a few instances of scalp Page 9 hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
Methylphenidate hydrochloride, the active ingredient in Ritalin LA® (methylphenidate hydrochloride) extended-release capsules, is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known.
Methylphenidate is thought to block the re-uptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extra-neuronal space.
Ritalin LA® (methylphenidate hydrochloride) extended-release capsules was evaluated in a randomised, double-blind, placebo-controlled, parallel group clinical study in which 134 children, ages 6 to 12, with DSM-IV diagnoses of Attention Deficit Hyperactivity Disorder (ADHD) received a single morning dose of Ritalin LA in the range of 10-40 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 Ritalin LA showed a statistically significant improvement in symptom scores from baseline over patients who received placebo. This demonstrates that a single morning dose of Ritalin LA exerts a treatment effect in ADHD.
Before Ritalin LA Treatment:
It is very important that ADHD be accurately diagnosed and that the need for medication be carefully assessed. It is important to remember that Ritalin is only part of the overall management of ADHD. Parents, teachers, physicians and other professionals are part of a team that must work together.
Before Ritalin treatment, your doctor should be made aware of any current or past physical or mental problems. Tell your doctor if there is a history of drug or alcohol abuse, depression, bipolar disorder, psychosis, epilepsy or seizure disorders, high blood pressure, heart defects, irregular heart rhythms, other heart problems, glaucoma, and facial tics (involuntary movements). Also tell your doctor if there is a family history of sudden death, irregular heart rhythm, suicide, bipolar disorder, depression or Tourette’s syndrome.
Both your doctor and your pharmacist should also be informed of all medicines that you are taking, even if these drugs are not taken on a regular basis and are available without prescription. Your doctor will decide whether you can take Ritalin with other medicines. Methylphenidate is known to interact with a number of other drugs. These include medicines to treat depression, such as monoamine oxidase inhibitors; to control seizures; and to thin blood. Sometimes these interactions may require a change in dosage, or occasionally stopping one of the drugs involved.
What are the possible side effects of Ritalin LA?
The most common side effects of Ritalin LA are:
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Information obtained from:
* Novartis. T2006-56. http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/010187s66s67,018029s37s38,021284s6s8lbl.pdf