Atomax
Generic Name
Atomoxetine 10 mg tablet
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
atomax 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Atomoxetine is a non-stimulant medication used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children, adolescents, and adults. It helps improve attention, concentration, and reduces impulsivity and hyperactivity by affecting norepinephrine levels in the brain.
Uses & Indications
Dosage
Adults
Initial 40 mg daily, increasing to 80 mg daily after a minimum of 3 days. Maximum 100 mg daily.
Elderly
Limited data; initiate with lower doses and titrate carefully, especially if comorbid conditions or other medications are present. Max 60 mg daily for those >65 years due to potential higher plasma concentrations.
Renal_impairment
No dosage adjustment needed for patients with end-stage renal disease (ESRD). Use with caution in patients with hepatic impairment, and dosage adjustment may be necessary for moderate to severe impairment.
How to Take
Take orally, once or twice daily, with or without food. Swallow the tablet whole; do not crush, chew, or open it as it may irritate the eyes if exposed.
Mechanism of Action
Atomoxetine selectively inhibits the presynaptic norepinephrine transporter, resulting in increased synaptic norepinephrine in the prefrontal cortex, which is thought to mediate its therapeutic effects in ADHD.
Pharmacokinetics
Onset
Therapeutic effects typically begin within 1-2 weeks, with full effect seen after 4-6 weeks.
Excretion
Excreted primarily in the urine (80%) as metabolites, and feces (17%).
Half life
Approximately 5.2 hours in extensive metabolizers and 21.6 hours in poor metabolizers (CYP2D6).
Absorption
Readily absorbed after oral administration, peak plasma concentrations reached in 1-2 hours.
Metabolism
Primarily metabolized by the cytochrome P450 2D6 (CYP2D6) enzymatic pathway to 4-hydroxyatomoxetine, which is further glucuronidated. Some minor metabolism by other CYP enzymes.
Side Effects
Contraindications
- Hypersensitivity to atomoxetine or any component.
- Use with MAOIs or within 14 days of discontinuing MAOIs.
- Narrow-angle glaucoma.
- Pheochromocytoma or other serious cardiovascular disorders.
Drug Interactions
MAO Inhibitors
May lead to serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, mental status changes, and features resembling neuroleptic malignant syndrome.
Vasopressor Agents
Use with caution due to potential additive effects on blood pressure.
Beta-agonists (e.g., salbutamol)
May potentiate cardiovascular effects of salbutamol, particularly tachycardia and blood pressure increases.
CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine)
May increase atomoxetine plasma concentrations, requiring dose adjustment.
Storage
Store at room temperature (below 30°C), protected from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose include drowsiness, agitation, hyperactivity, unusual behavior, dilated pupils, dry mouth, and mild to moderate tachycardia. Treatment is supportive and symptomatic, including gastric lavage and activated charcoal. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Atomoxetine is excreted in breast milk; a decision should be made whether to discontinue nursing or the drug, considering its importance to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Pharmacies
Approval Status
Approved
Patent Status
Off-patent (Generic available)
Clinical Trials
Extensively studied in numerous randomized, double-blind, placebo-controlled trials demonstrating efficacy in ADHD across different age groups. Post-marketing surveillance continues to monitor safety and long-term effects.
Lab Monitoring
- Monitor liver function tests (ALT, AST, bilirubin) at baseline and periodically, or if symptoms of liver injury develop.
- Monitor blood pressure and heart rate at baseline, after dose increases, and periodically during treatment.
Doctor Notes
- Assess cardiovascular history and current status before initiating therapy and monitor regularly.
- Educate patients and caregivers about the risk of suicidal ideation and the need for immediate reporting of any concerns.
- Therapeutic effect may take several weeks to establish; manage patient expectations.
Patient Guidelines
- Do not stop taking this medicine suddenly without consulting your doctor.
- Report any thoughts of self-harm or unusual behavior changes to your doctor immediately.
- Avoid crushing or opening the tablet.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or drowsiness, especially at the start of treatment. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that atomoxetine therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Maintain a regular sleep schedule.
- Engage in regular physical activity.
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Global Brand Names
International brand names for this medicine
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