Atomoxetine Hydrochloride

Indications
 Oral
Attention deficit hyperactivity disorder
Adult: Initially, 40 mg daily, may increase gradually after at least 7 days to 80 mg daily; up to 100 mg daily may be used after 2-4 wk.
Child: For adolescents and children (≥6 yr): ≤ 70 kg: Initially, 500 mcg/kg/day, may increase gradually to 1.2 mg/kg/day, up to 100 mg daily or 1.4 mg/kg/day whichever is lower; >70 kg: Initially, 40 mg daily, may increase gradually after at least 7 days to 80 mg daily, up to 100 mg daily may be used after 2-4 wk.
Hepatic impairment: Moderate impairment: Reduce dose by 50%. Severe impairment: Reduce dose by 75%.
Contraindications
 Angle-closure glaucoma. Not to be used with or within 14 days of discontinuing treatment with MAOIs.
Warnings / Precautions
 Monitor height and wt gain especially during the initial period of treatment; dose reduction or treatment interruption may be needed in children whose growth or wt gain is not satisfactory. Patients with high BP or cardiovascular conditions that may be worsened by increases in BP or heart rate. Caution when used in patients with a history of psychotic illness or bipolar disorder. May increase the risk of urinary obstruction or hesitancy. Monitor for signs of clinical worsening, suicidality or unusual behavioural changes especially during the start of treatment and during dose changes. Safety and efficacy have not been established in patients <6 yr. Not recommended for use in pregnancy.
Adverse Reactions
 GI disturbances, anorexia and wt loss, fatigue. CNS symptoms e.g. headache, insomnia, sleep disturbances, dizziness, irritability and emotional lability. Cough, sinusitis or rhinorrhoea, urinary hesitancy or retention. Reduced libido and sexual dysfunction. Skin rashes, increased sweating and hot flushes.
Overdose Reactions
 Symptoms include somnolence, agitation, hyperactivity, abnormal behaviour, mydriasis, tachycardia, dry mouth and GI symptoms. Gastric emptying and use of activated charcoal may reduce drug absorption; monitor patient and provide supportive treatment. Dialysis may not be beneficial.
Drug Interactions
 May cause additive effect when used with drugs that increase BP. May potentiate the effect of salbutamol on the CVS. Increased risk of seizures when used with drugs that are known to lower seizure threshold. May increase risk of cardiac events when used with drugs that affect cardiac conduction or electrolyte balance, or that inhibit CYP2D6 (e.g. chlorpromazine, delavirdine, fluoxetine, miconazole, pergolide, quinidine, ritonavir).
Potentially Fatal: Concurrent use with or within 2 wk of discontinuing MAOIs may cause serious toxicity (e.g. hyperthermia, rigidity, myoclonus, mental status changes, autonomic instability, neuroleptic malignant syndrome). Combined use is contraindicated.
See Below for More atomoxetine Drug Interactions
Mechanism of Actions
 Atomoxetine hydrochloride selectively inhibits the reuptake of noradrenaline. It is used in the treatment of attention deficit hyperactivity disorder in adults and children aged ≥6 yr.
Absorption: Good absorption after oral admin. Bioavailability ranges from 63-94% depending on whether the patient is an extensive or poor metaboliser.
Distribution: About 98% bound to plasma proteins.
Metabolism: Mainly metabolised by cytochrome P450 isoenzyme CYP2D6 to the active metabolite 4-hydroxyatomoxetine.
Excretion: Largely excreted in the urine mainly as glucuronide metabolites; <17% of a dose is excreted in the faeces. Elimination half-life ranges from 5.2-21.6 hr.
Administration
 May be taken with or without food. (Swallow whole, do not open cap.)
Storage Conditions
 Oral: Store at 15-30°C.
ATC Classification
 N06BA09 - atomoxetine ; Belongs to the class of centrally-acting sympathomimetics. Used as CNS stimulant.
Storage
 Oral: Store at 15-30°C.
Available As
  • Atomoxetine Hydrochloride 10 mg
  • Atomoxetine Hydrochloride 18 mg
  • Atomoxetine Hydrochloride 25 mg
  • Atomoxetine Hydrochloride 40 mg

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