What Is This Medicine
and What Is It Used For?
Concerta (methylphenidate HCl 18 mg) is a once-daily
extended-release formulation of methylphenidate, a central nervous system
stimulant indicated for the treatment of Attention-Deficit/Hyperactivity
Disorder (ADHD) in children (6 years and older), adolescents, and adults.
Concerta uses the OROS (Osmotic Controlled-Release Oral delivery System)
technology, which delivers approximately 22% of the dose immediately and the
remaining 78% over the following 8–10 hours
This provides a smooth, sustained plasma
concentrations throughout the school or working day while minimising the peaks
and troughs associated with immediate-release formulations.
Methylphenidate acts as a CNS stimulant by blocking the
reuptake of dopamine and norepinephrine into presynaptic neurons, thereby
increasing their concentrations in the synaptic cleft, particularly in the
prefrontal cortex.
The 18 mg dose is the starting dose for Concerta, with
titration based on clinical response. Concerta tablets must be swallowed whole,
crushing, chewing, or splitting destroys the controlled-release mechanism and
delivers the full dose immediately, which is both less effective and
potentially dangerous.
How to Take This
Medicine
Concerta is taken orally once daily in the morning, with or
without food. The tablet must be swallowed whole, do not crush, chew, split, or
dissolve. The tablet shell does not dissolve and may appear in the stool; this
is normal.
Children (6–12 years) and Adolescents (13–17 years), Not
Previously on Methylphenidate
• Start: 18 mg once daily in
the morning.
• Titration: Increase in 18
mg increments at weekly intervals based on response and tolerability.
• Maximum dose: 54 mg/day in
children 6–12 years; 72 mg/day in adolescents 13–18 years.
Adults, Not Previously on Methylphenidate
• Start: 18–36 mg once daily
in the morning.
• Titration: Increase in 18
mg increments at weekly intervals.
• Maximum dose: 72 mg/day in
adults.
Switching from Immediate-Release Methylphenidate
• Patients on 5 mg 2–3 times
daily → Concerta 18 mg once daily.
• Patients on 10 mg 2–3
times daily → Concerta 36 mg once daily.
• Patients on 15 mg 2–3
times daily → Concerta 54 mg once daily.
Clinical Notes
• If no benefit is seen
after 1 month at an appropriate dose, discontinue and reassess the diagnosis.
• Periodic treatment-free
trials may be considered to assess continued need.
• Monitor height and weight
in children at every follow-up, stimulants may temporarily suppress growth.
Side Effects
Side effects vary in frequency and severity. Not every
patient will experience all listed effects. Seek immediate medical attention
for any serious or unexpected reactions.
|
Category |
Side Effects |
|
Common |
Decreased appetite (most common, often
self-limiting after the first few weeks); Insomnia (especially if dose is
taken late in the day); Headache; Abdominal pain and nausea; Irritability or
mood changes; Increased heart rate and blood pressure; Weight loss; Dizziness |
|
Serious |
Cardiovascular events: Sudden
unexplained death in patients with pre-existing structural cardiac anomalies
or cardiomyopathy has been reported. Screen all patients before starting.;
Psychiatric effects: New-onset or worsening psychosis, mania, or aggressive
behaviour.; Growth suppression in children with prolonged use.; Suicidal
ideation: Monitor during initiation and dose changes. |
|
Rare / Severe |
Priapism (prolonged erection);
Peripheral vasculopathy including Raynaud's phenomenon; Tourette's syndrome
exacerbation; Serious hypersensitivity reactions |
Contraindications
|
⚠ CONTRAINDICATIONS |
|
• Known hypersensitivity to methylphenidate or any
excipient |
|
• Current or within 14 days of MAOI therapy, risk of
hypertensive crisis |
|
• Significant pre-existing cardiovascular disease,
structural cardiac abnormalities, serious arrhythmias |
|
• Moderate to severe hypertension |
|
• Hyperthyroidism |
|
• Anxiety disorder, tension, or agitation (stimulants
can worsen these) |
|
• Personal or family history of motor tics or Tourette
syndrome (relative, assess risk/benefit) |
|
• History of drug abuse or dependence |
|
• Glaucoma |
Safety Warnings and
Special Precautions
• Cardiovascular risk:
Screen for personal and family history of sudden death, cardiac disease, or
arrhythmias before initiating. Monitor heart rate and blood pressure at
baseline and during treatment.
• Abuse and dependence:
Methylphenidate is a Schedule II/IV controlled substance. High abuse potential.
Prescriptions should be for short periods; monitor for signs of misuse or
diversion.
• Psychiatric effects: May
cause or worsen psychosis, mania, or aggression. Assess for psychiatric
comorbidities before starting.
• Growth: Long-term
stimulant use may reduce growth velocity in children. Monitor height and weight
regularly. Consider drug holidays during growth periods.
• Seizure threshold: Use
with caution in patients with epilepsy. Although Concerta rarely lowers seizure
threshold, monitor for any change in seizure frequency.
• MAOIs: Concurrent use is
absolutely contraindicated; allow 14 days after stopping an MAOI before
starting methylphenidate.
Drug Interactions
The following interactions are clinically significant. Always
inform your healthcare provider of ALL medicines, supplements, and herbal
products you are taking.
• MAO inhibitors:
Contraindicated, risk of hypertensive crisis and serotonin syndrome.
• Antihypertensive agents:
Methylphenidate may reduce the effect of antihypertensive drugs.
• Vasopressor agents: May
potentiate pressor effects.
• Coumarin anticoagulants
(warfarin): Methylphenidate may inhibit warfarin metabolism; monitor INR.
• Anticonvulsants
(phenobarbitone, phenytoin, primidone): Methylphenidate may inhibit their
metabolism; monitor plasma levels.
Storage Instructions
Store at 25°C; excursions permitted to 15–30°C. Store in the
original, child-resistant container. Keep away from heat, moisture, and light.
This is a controlled substance, store in a secure, locked location.
Prescription Status in
Kenya
|
💊 PRESCRIPTION ONLY MEDICINE (POM), CONTROLLED
SUBSTANCE under the Pharmacy and Poisons Act, Kenya. Methylphenidate requires
dispensing against a valid prescription. Prescription quantities should be
limited. Document dispensing in the controlled drugs register. Pharmacists
should be alert to signs of prescription forgery or misuse. |
Patient Guidance
|
ℹ PATIENT GUIDANCE |
|
• Swallow Concerta whole in the morning. Never crush,
chew, or break the tablet, this can deliver too much medicine at once and is
dangerous. |
|
• Take it at the same time each morning for consistent
effect throughout the day. |
|
• It is normal to have less appetite at lunchtime, try
to eat a nutritious breakfast and evening meal. |
|
• If it is causing sleep problems, speak to your
doctor, the dose timing may need adjusting. |
|
• Do not give this medicine to anyone else. It is a
controlled substance and is personal to you. |
|
• Tell your doctor immediately if you or your child
notices unusual thoughts, hallucinations, mood swings, or chest pain. |
|
• Attend all follow-up appointments, weight, height,
heart rate, and blood pressure need monitoring. |
Pharmacist / Prescriber
Notes
Concerta 18 mg is a Schedule IV controlled substance. At
dispensing, counsel caregivers and patients that the tablet must be swallowed
whole without alteration to the OROS shell. Verify that a pre-treatment cardiac
evaluation has been documented. Screen for concurrent MAOIs (absolute
contraindication). Monitor for signs of diversion or misuse, particularly in
adolescent and adult patients. Growth parameters (height, weight) should be
recorded at each dispensing encounter for paediatric patients. Pharmacists
should note that the tablet shell may be found intact in the stool, this is
normal and does not mean the drug was not absorbed.
Frequently Asked
Questions (FAQs)
Q1: Why must the Concerta tablet be
swallowed whole?
A: Concerta uses a special technology
that releases the medicine slowly over 10–12 hours. Crushing or splitting the
tablet destroys this mechanism and releases the full dose at once, which can
cause harmful effects and the medicine will not last the whole day.
Q2: How soon will Concerta start working?
A: The effect begins within 1–2 hours of
the morning dose and lasts approximately 10–12 hours, covering the school or
work day. Unlike atomoxetine, methylphenidate works the same day.
Q3: My child does not want to eat lunch
since starting Concerta, is this dangerous?
A: Appetite suppression is the most
common side effect of methylphenidate and typically affects lunchtime appetite
when the drug is at peak effect. Encourage a good breakfast before the dose and
a nutritious dinner. If weight loss is significant, consult your doctor who may
adjust the dose or timing.
Q4: Is Concerta addictive?
A: Methylphenidate has abuse potential,
particularly when misused (crushed and inhaled, or taken in higher doses). When
used as prescribed by a doctor, the oral extended-release form has low
addiction risk. However, it must be kept securely and not shared.
Q5: Will my child always need ADHD
medication?
A: Not necessarily. Some children grow
out of ADHD symptoms by adolescence, while others continue to need support into
adulthood. Periodic evaluation of continued need (including drug holidays) is
recommended to assess whether ongoing treatment is still necessary.
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