Drug ID: 1d00000133
Drug Name: Atomoxetine
Generic Names: Tomoxetin (40 mg) | Axepta -25 | Attentrol (18 mg) | Tomoxetin (10 mg) | Tomoxetin (25 mg) | Attentrol (25 mg) | Attentrol | Axepta | Axepta (40 mg) | Axepta (10 mg) | Tomoxetin (18 mg) | Strattera
Category: CNS Agents
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Dosing of children and adolescents up to 70 kg body weight
Initial: The recommended dose is 0.5 mg/kg and increased after a minimum of 3 days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg.
Dosing of children and adolescents over 70 kg body weight and adults Initial:
The recommended dose is 40 mg and increased after a minimum of 3 days to a target total daily dose of approximately 80 mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening.
Recommended In: This medication is a selective norepinephrine reuptake inhibitor (SNRI), prescribed for Attention deficit hyperactivity disorder (ADHD). It increases the level of norepinephrine in the brain, which is needed to control behavior.
Directions For Use: It comes as a capsule and tablet to take by mouth, with or without food.
Storage: Store it at controlled room temperature (25°C).
Dosage Forms: Tablet | Capsule
Side Effects: Child and Adolescent:
Gastrointestinal - Liver disease, abdominal pain, vomiting and nausea.
General- Fatigue, irritability and unexpected therapeutic response.
Metabolism- Loss of appetite and decreased weight.
Central Nervous System- Headache, drowsiness and dizziness.
Gastrointestinal- Abdominal pain, vomiting, nausea and constipation.
Psychiatric- Mood changes.
Gastrointestinal- Dry mouth, nausea, constipation, abdominal pain, indigestion and vomiting.
General- Fatigue, chills, unexpected therapeutic response and stress.
Metabolic- Decreased appetite and weight.
Central Nervous System- Dizziness, drowsiness, tingling, sinus, headache and tremor.
Psychiatric- Sleeplessness, decreased libido and sleep disorder.
Urinary- Urinary hesitation and/or urinary retention and painful urination.
Genitourinary- Impotence, painful menstrual periods, delayed ejaculation and irregular periods.
Skin- Excessive sweating and rash.
Vascular- Hot flushes.
In Case of Overdose: In some cases of overdose involving Atomoxetine, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of Atomoxetine were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations.
Consult with a Certified Poison Control Center for up to date guidance and advice. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.
Avoid If: Contraindicated in patients with narrow-angle glaucoma, severe cardiovascular disease, co-administered with MAOIs or within 14 days of treatment with MAOIs and hypersensitivity.
Caution should be exercised in patients with history of depression or bipolar disorder, suicidal thoughts, high or low blood pressure, seizures, liver diseases, heart problems, stroke, blood or bleeding problems, seizures, trouble urinating, Raynaud syndrome, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
It may cause dizziness, drowsiness, lightheadedness or fainting, do not drive a car or operate machinery and sit up or stand slowly from bed while taking this medication.
Avoid alcohol consumption.
Monitor blood pressure and heart rate regularly while taking this medication.
Avoid excess dosage.
Children and teenagers may develop with increased risk of suicidal thoughts, watch them carefully.
Rarely this medication may cause prolonged, painful erection. If it so consult with your doctor.
Monitor heart rate, blood pressure and liver function while taking this medication.
Drug Interaction: Monoamine Oxidase Inhibitors
With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity.
Antihypertensive Drugs and Pressor Agents
Because of possible effects on blood pressure, STRATTERA should be used cautiously with antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure.
STRATTERA should be administered with caution to patients being treated with systemically-administered (oral or intravenous) albuterol (or other beta2 agonists) because the action of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure.