Malex
Generic Name
Artemether + Lumefantrine
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| malex 500 mg tablet | ৳ 4.10 | ৳ 24.60 |
Description
Overview of the medicine
Malex (Artemether and Lumefantrine) is an antimalarial drug combination used for the treatment of uncomplicated Plasmodium falciparum malaria. It is an Artemisinin-based Combination Therapy (ACT), recommended by the WHO.
Uses & Indications
Dosage
Adults
A typical 3-day course involves 6 doses. For 20 mg/120 mg tablets: 4 tablets initially, then 4 tablets after 8 hours, followed by 4 tablets twice daily for the next 2 days (total 6 doses).
Elderly
No specific dose adjustment needed based on age; follow adult dosage.
Renal_impairment
No specific dose adjustment required for mild to moderate renal impairment; use with caution in severe cases.
How to Take
Take orally with food or a fatty drink (e.g., milk) to enhance absorption. If vomiting occurs within 1-2 hours of a dose, repeat the dose.
Mechanism of Action
Artemether is rapidly metabolized to dihydroartemisinin, both of which are potent schizonticides that inhibit parasite growth by interfering with essential parasitic processes. Lumefantrine is a slow-acting blood schizonticide that interferes with heme detoxification and forms a toxic complex that damages the parasite.
Pharmacokinetics
Onset
Rapid onset (within hours for artemether component).
Excretion
Mainly fecal for lumefantrine, renal and fecal for artemether metabolites.
Half life
Artemether: ~2-3 hours (for dihydroartemisinin). Lumefantrine: ~3-6 days.
Absorption
Artemether is rapidly absorbed and metabolized. Lumefantrine is slowly and erratically absorbed; absorption is enhanced by food, especially fatty meals.
Metabolism
Both are extensively metabolized in the liver by CYP450 enzymes (mainly CYP3A4 for artemether, CYP2D6 and CYP3A4 for lumefantrine).
Side Effects
Contraindications
- Hypersensitivity to artemether, lumefantrine, or any excipients
- Patients with a family history of sudden death, or congenital prolongation of the QTc interval
- Concurrent use with drugs known to prolong the QTc interval
Drug Interactions
Grapefruit juice
May inhibit CYP3A4, potentially altering drug levels.
CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)
May increase lumefantrine levels.
Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin)
May decrease levels of artemether and lumefantrine, reducing efficacy.
QTc prolonging drugs (e.g., Amiodarone, Sotalol, some antipsychotics)
Increased risk of cardiac arrhythmias.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
No specific antidote. Symptomatic and supportive treatment should be given. Monitor cardiac function (ECG) and potassium levels due to QTc prolongation risk.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the risk to the fetus. Not recommended during the first trimester. Use with caution during lactation; advise mothers to temporarily discontinue breastfeeding during treatment.
Side Effects
Contraindications
- Hypersensitivity to artemether, lumefantrine, or any excipients
- Patients with a family history of sudden death, or congenital prolongation of the QTc interval
- Concurrent use with drugs known to prolong the QTc interval
Drug Interactions
Grapefruit juice
May inhibit CYP3A4, potentially altering drug levels.
CYP2D6 inhibitors (e.g., Fluoxetine, Paroxetine)
May increase lumefantrine levels.
Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin)
May decrease levels of artemether and lumefantrine, reducing efficacy.
QTc prolonging drugs (e.g., Amiodarone, Sotalol, some antipsychotics)
Increased risk of cardiac arrhythmias.
Storage
Store below 30°C in a dry place, away from direct sunlight. Keep out of reach of children.
Overdose
No specific antidote. Symptomatic and supportive treatment should be given. Monitor cardiac function (ECG) and potassium levels due to QTc prolongation risk.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit outweighs the risk to the fetus. Not recommended during the first trimester. Use with caution during lactation; advise mothers to temporarily discontinue breastfeeding during treatment.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, hospitals, clinics
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of Artemether-Lumefantrine in treating uncomplicated P. falciparum malaria, including in multi-drug resistant regions. Studies consistently show high cure rates.
Lab Monitoring
- Baseline and periodic ECG monitoring (especially in patients with risk factors for QTc prolongation)
- Electrolyte monitoring (potassium, magnesium)
- Liver function tests (LFTs) if prolonged treatment or symptoms of hepatotoxicity occur
Doctor Notes
- Emphasize the importance of taking the medication with food for optimal absorption.
- Be aware of potential QTc prolongation, especially with concomitant medications.
- Counsel patients on the importance of completing the full 6-dose regimen.
Patient Guidelines
- Complete the entire course of medication, even if you feel better.
- Take with food or a fatty drink.
- Report any severe side effects immediately to your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it's almost time for the next dose. Do not double the dose.
Driving Precautions
May cause dizziness or fatigue; avoid driving or operating heavy machinery if affected.
Lifestyle Advice
- Maintain good hydration.
- Avoid grapefruit juice during treatment.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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