What Is This Medicine
and What Is It Used For?
Strattera (atomoxetine hydrochloride 40 mg) is a selective
norepinephrine reuptake inhibitor (NRI) indicated for the treatment of
Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 years and
older, adolescents, and adults.
Atomoxetine acts by selectively inhibiting the presynaptic
norepinephrine transporter (NET), thereby increasing norepinephrine
concentrations in the prefrontal cortex, a brain region central to attention,
impulse control, and executive function. It also modestly increases dopamine in
the prefrontal cortex via secondary mechanisms.
Strattera (atomoxetine hydrochloride 40 mg) has a delayed
onset of therapeutic effect compared to stimulants; full clinical benefit may
take 4–8 weeks or longer to manifest. This is an important counselling point
for patients and caregivers. Atomoxetine is typically used as part of a
comprehensive treatment plan that includes psychological, educational, and
social support measures.
How to Take This
Medicine
Strattera capsules should be swallowed whole without opening.
They can be taken with or without food. The capsule contents are irritating and
must not come into contact with the eyes or skin.
Paediatric Patients (≥6 years, body weight ≤70 kg)
• Initial dose: 0.5
mg/kg/day for a minimum of 7 days.
• Titration: Increase to
approximately 1.2 mg/kg/day (given as a single daily dose in the morning, or
divided as two doses morning and late afternoon).
• Maximum dose: 1.4
mg/kg/day or 100 mg/day, whichever is lower.
Adults and Adolescents / Children >70 kg
• Initial dose: 40 mg/day as
a single morning dose for at least 3 days.
• After 3 days: Increase to
80 mg/day (once daily or divided into two doses).
• After a further 2–4 weeks:
May be increased to a maximum of 100 mg/day if optimal response has not been achieved.
• No data support doses
above 100 mg/day in adults.
Special Populations
• Hepatic impairment
(Child-Pugh B): Reduce dose to 50% of normal. Moderate impairment (Child-Pugh
C): Reduce to 25% of normal.
• Poor CYP2D6 metabolisers:
Begin at lower doses and titrate carefully, as drug exposure is substantially
higher in poor metabolisers.
• Concurrent CYP2D6
inhibitors (e.g., paroxetine, fluoxetine, quinidine): Start at the lowest dose and
titrate with caution.
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 |
Nausea and vomiting (particularly
early in treatment, often self-limiting); Decreased appetite and weight loss;
Abdominal discomfort; Somnolence or insomnia (dose-timing dependent);
Dizziness; Dry mouth; Constipation; In adults: urinary hesitation or
retention; sexual dysfunction (erectile problems, decreased libido); Mood
changes, irritability |
|
Serious |
Suicidal ideation: Risk is
increased in children and adolescents. Monitor closely, particularly in the
first weeks of treatment and after dose changes.; Hepatotoxicity: Rare but
serious liver injury has been reported. Discontinue if jaundice or
significant elevation of liver enzymes occurs.; Cardiovascular effects:
Modest increases in heart rate and blood pressure. Avoid in patients with
symptomatic cardiac disease.; Psychosis or mania: May unmask pre-existing
psychiatric conditions or precipitate psychosis in susceptible individuals. |
|
Rare / Severe |
Severe hypersensitivity reactions
including angioedema; Priapism (prolonged erection) |
Contraindications
|
⚠ CONTRAINDICATIONS |
|
• Known hypersensitivity to atomoxetine or any
excipient |
|
• Current or recent (within 14 days) treatment with a
monoamine oxidase inhibitor (MAOI), risk of potentially fatal hypertensive
crisis, hyperthermia, and neurotoxicity |
|
• Narrow-angle glaucoma |
|
• Severe cardiovascular disease where increased heart rate
or blood pressure is hazardous |
|
• Phaeochromocytoma |
Safety Warnings and
Special Precautions
• Suicidal ideation: A
black-box warning exists in many countries (and relevant guidance in Kenya)
regarding increased suicidal thinking in children and adolescents during the
first weeks of treatment. Families and carers must be informed to monitor for
any new or worsening mood symptoms, behavioural changes, or statements about
self-harm.
• Delayed efficacy: Unlike
stimulants, Strattera may take 4–8 weeks to show full benefit. Patients and
families should be counselled to continue therapy despite the absence of
immediate effect.
• Growth monitoring: Regular
monitoring of height and weight in paediatric patients is recommended, as
appetite suppression may temporarily impair growth trajectory.
• Hepatotoxicity: Rare;
instruct patients to report jaundice, dark urine, or right upper quadrant pain
immediately.
• Cardiac evaluation: Before initiating therapy, obtain personal and family cardiac history and conduct a physical examination. Refer for evaluation if any cardiac abnormalities are
detected.
• Tics and Tourette syndrome:
Assess for the presence of tics before starting therapy; use with caution if tics
are present.
Drug Interactions
The following interactions are clinically significant. Always
inform your healthcare provider of ALL medicines, supplements, and herbal products
you are taking.
• MAOIs: Absolutely
contraindicated; allow at least 14 days after stopping an MAOI before starting
atomoxetine.
• CYP2D6 inhibitors
(fluoxetine, paroxetine, quinidine): Markedly increase atomoxetine plasma
levels; initiate at a lower dose and titrate slowly.
• Vasopressor agents or
sympathomimetics (e.g., pseudoephedrine, salbutamol): May potentiate
cardiovascular effects; use with caution.
• Antihypertensive
medicines: Atomoxetine's blood pressure effects may be affected; monitor blood
pressure.
• CNS stimulants: No
established pharmacokinetic interaction, but the combination may increase
cardiovascular adverse effects.
Storage Instructions
Store below 25°C. Keep in original packaging. Keep out of
reach of children. Do not open the capsule, the contents are irritating to
mucous membranes.
Prescription Status in
Kenya
|
💊 PRESCRIPTION-ONLY MEDICINE (POM) in Kenya.
Atomoxetine is not classified as a controlled substance, as it has no
demonstrated abuse potential. Prescriptions require a registered medical
practitioner, ideally with experience in the management of ADHD. |
Patient Guidance
|
ℹ PATIENT GUIDANCE |
|
• Strattera is not a stimulant and has no abuse risk, it
is safe for children and adults who need long-term ADHD treatment. |
|
• It takes several weeks (4–8 weeks) before the full
benefit is felt. Do not stop it early because it "is not working
yet." |
|
• Take it every day as prescribed, missing doses
reduces effectiveness. Try to take it at the same time each day. |
|
• If your child becomes unusually sad, anxious, or
talks about hurting themselves, contact your doctor immediately. |
|
• Mild nausea at the start of treatment usually
improves within a few weeks; taking the capsule with food may help. |
|
• Never open the capsule; the powder inside can
irritate the eyes and skin. |
|
• Attend all follow-up appointments for growth
monitoring and blood pressure checks. |
Pharmacist / Prescriber
Notes
Atomoxetine is not a controlled substance and does not
require the same dispensing controls as stimulant ADHD medications. At the
point of dispensing, counsel caregivers carefully on the delayed therapeutic
onset, the importance of adherence, and the black-box warning on suicidal
ideation in children and adolescents. Verify there are no concurrent MAOIs or
strong CYP2D6 inhibitors. Growth parameters (height, weight) should be tracked
at each prescription refill. Note that generic atomoxetine is available and is
bioequivalent to Strattera; counsel on switching if cost is a concern.
Frequently Asked
Questions (FAQs)
Q1: How is Strattera different from
Ritalin or Concerta?
A: Strattera (atomoxetine) is a
non-stimulant; it does not contain amphetamine or methylphenidate, is not a
controlled substance, and does not have abuse potential. It works by increasing
norepinephrine rather than dopamine and takes weeks to work, unlike stimulants, which act the same day.
Q2: Can Strattera be taken by adults with
ADHD?
A: Yes. Atomoxetine is approved for ADHD
in both children (6 years and older) and adults. It is a good option for adults
with ADHD who prefer to avoid controlled stimulant medications or have
co-existing anxiety.
Q3: My child has been on Strattera for 3
weeks, but nothing has changed. Should we stop?
A: No. Strattera takes 4 to 8 weeks
(sometimes longer) to reach its full effect. Stopping too early means the
treatment never had a fair chance. Speak to your doctor if you have concerns,
but give it the full recommended trial period.
Q4: Will Strattera cause dependence or
addiction?
A: No. Atomoxetine has no known abuse
liability and does not cause dependence. This makes it a preferred ADHD option
in individuals with a history of substance misuse or where there are concerns
about stimulant medication access.
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