AXEPTA 18 MG 30 CAPSULES

Indications

Approved Uses

Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older, adolescents, and adults

Off-Label Uses

Off-label uses with some clinical precedent include adjunctive treatment in depression (e.g., residual fatigue/inattention) and certain anxiety-spectrum presentations; other proposed uses (e.g., enuresis, neurogenic orthostatic hypotension, 'cognitive disengagement syndrome') have limited/variable evidence and are not established guideline indications.

Dosage & Administration

Dosing by Condition

ADHD (children ≥6 years and adolescents ≤70 kg): Initial 0.5 mg/kg/day for minimum 7 days, then increase to target 1.2 mg/kg/day; max 1.4 mg/kg/day or 100 mg/day whichever is less. ADHD (adults and adolescents >70 kg): Initial 40 mg/day for minimum 7 days, then increase to target 80 mg/day; max 100 mg/day

Initial Dose

Children/adolescents ≤70 kg: 0.5 mg/kg/day; Adults and adolescents >70 kg: 40 mg/day

Maintenance Dose

Children/adolescents ≤70 kg: 1.2 mg/kg/day; Adults and adolescents >70 kg: 80 mg/day

Maximum Dose

100 mg/day (or 1.4 mg/kg/day in children/adolescents ≤70 kg, whichever is less)

Children's Dosage

Children ≥6 years and adolescents ≤70 kg: Initial 0.5 mg/kg/day once daily or divided twice daily; after ≥7 days increase to 1.2 mg/kg/day; max 1.4 mg/kg/day or 100 mg/day. Not approved for children under 6 years

Dose Adjustment Notes

Titrate no more frequently than every 7 days. With strong CYP2D6 inhibitors or known CYP2D6 poor metabolizers: use slower titration and lower effective/target doses (e.g., start 0.5 mg/kg/day in children/adolescents or 40 mg/day in adults; increase only if needed and tolerated after several weeks). Hepatic impairment: reduce dose (moderate: ~50%; severe: ~75%). Renal impairment: generally no adjustment required.

How to Take

Swallow the hard capsule whole with water; do not open, crush, or chew. May be taken with or without food. Usually given once daily in the morning; may be given as two divided doses (morning and late afternoon/early evening) if needed for tolerability or symptom control.

Side Effects

Common Side Effects

Decreased appetite, nausea, dry mouth, constipation, abdominal pain, vomiting, headache, insomnia, dizziness, fatigue/somnolence, irritability; may increase heart rate and blood pressure.

Side Effect Frequency

Very common (≥10%): decreased appetite, nausea, dry mouth, insomnia, headache, abdominal pain. Common (1-10%): vomiting, constipation, dizziness, fatigue, irritability, dyspepsia, increased heart rate, increased blood pressure, weight loss, erectile dysfunction/sexual dysfunction, urinary hesitation/retention. Uncommon (0.1-1%): suicidal ideation, aggression/hostility, psychotic or manic symptoms, syncope. Rare/very rare: severe hepatotoxicity, priapism, seizures, Raynaud’s phenomenon.

Safety & Warnings

Contraindications

Hypersensitivity to atomoxetine; concomitant use with MAO inhibitors or within 14 days of stopping an MAOI; narrow-angle glaucoma; pheochromocytoma or history of pheochromocytoma; severe cardiovascular disorders where increases in BP/HR could be clinically important.

Warnings & Precautions

Monitor for suicidality (especially early and with dose changes); assess cardiovascular history/exam and monitor BP/HR; caution in hypertension/tachycardia/cardiovascular disease; discontinue and evaluate if signs of liver injury occur; screen for bipolar disorder and monitor for psychosis/mania and aggression/hostility; monitor height/weight in children; counsel to seek urgent care for priapism.

Age Restriction

Approved for use in children 6 years of age and older (not approved for <6 years).

Drug Interactions

Drug Interactions

Contraindicated with MAOIs; strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion) increase atomoxetine exposure; caution with drugs that increase BP/HR (e.g., pressor agents, beta-agonists) and with QT-prolonging drugs in at-risk patients.

Interaction Severity

MAJOR/Contraindicated: MAO inhibitors (and within 14 days of stopping an MAOI). MODERATE: Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) requiring dose adjustment/slow titration; pressor agents/systemic beta-agonists (e.g., albuterol/salbutamol) and other agents that raise BP/HR-monitor; QT-prolonging drugs-use caution/monitor in at-risk patients.

Food Interaction

No clinically significant food restriction; can be taken with or without food (food may improve GI tolerability in some patients).

Special Populations

Pregnancy

Caution

Children

Children ≥6 years and adolescents ≤70 kg: Initial 0.5 mg/kg/day once daily or divided twice daily; after ≥7 days increase to 1.2 mg/kg/day; max 1.4 mg/kg/day or 100 mg/day. Not approved for children under 6 years

Elderly

Limited data in elderly patients; start at lower doses and titrate cautiously with cardiovascular monitoring

Kidney Impairment

No dose adjustment needed, including in end-stage renal disease.

Liver Impairment

Mild (Child-Pugh A): no adjustment; Moderate (Child-Pugh B): use 50% of usual initial/target dose; Severe (Child-Pugh C): use 25% of usual initial/target dose (i.e., 75% reduction).

Storage & Patient Advice

Stopping the Medicine

Abrupt discontinuation is generally acceptable (no taper required), but stopping should be clinician-guided and ADHD symptoms may return.

Overdose

Symptoms may include GI upset, somnolence or agitation, tachycardia, hypertension, mydriasis, dry mouth, QTc prolongation and seizures; management is supportive with airway/ventilation as needed, cardiac monitoring, and consideration of activated charcoal if early-no specific antidote and dialysis is unlikely to help.

Patient Counseling

Take exactly as prescribed, with or without food; swallow capsules whole (do not open/crush/chew). Benefit may take several weeks (often 4-8 weeks). Do not stop without prescriber advice. Report mood/behavior changes or suicidal thoughts, and symptoms of liver injury (jaundice, dark urine, RUQ pain). Expect possible appetite/GI effects and possible dizziness-use caution with driving until effects are known. Avoid/limit alcohol and inform clinicians about all medicines, especially MAOIs and CYP2D6 inhibitors.

Monitoring Requirements

Monitor blood pressure and heart rate at baseline, after dose increases, and periodically; monitor weight/height (growth) in children/adolescents; monitor for new/worsening psychiatric symptoms including suicidality; assess for liver injury and check LFTs if symptoms/signs occur.

Pharmacology

Mechanism of Action

Selective norepinephrine reuptake inhibitor (NET inhibitor) increasing synaptic norepinephrine (and indirectly dopamine in the prefrontal cortex) to improve ADHD symptoms.

Onset of Action

Some symptom improvement may be noticed within 1-2 weeks; full therapeutic benefit often requires 4-6 weeks (may take longer in some patients).

Duration of Effect

Single-dose pharmacodynamic effect lasts about 24 hours (once-daily coverage in many patients); clinical symptom control is maintained with continuous daily dosing.

Half-Life

Approximately 5 hours in extensive metabolizers; up to 24 hours in poor metabolizers.

Bioavailability

Approximately 63% in extensive metabolizers and 94% in poor metabolizers.

Metabolism

Extensive hepatic metabolism primarily via CYP2D6 to 4-hydroxyatomoxetine (then rapidly conjugated); minor contribution from other pathways (e.g., CYP2C19).

Excretion

Primarily renal excretion of metabolites (majority of dose in urine, largely as conjugated metabolites); smaller fraction excreted in feces.

Protein Binding

Approximately 98% protein bound (primarily to albumin).

Product Information

Available Dosage Forms

Capsule, hard (oral).

Composition per Dose

Each hard capsule: 18 mg atomoxetine as hydrochloride

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

ADHD Non-stimulant

Controlled Substance

No

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