Artemether 20 mg & Lumefantrine 120 mg Tablets (Uncoated)

What is Artemether 20 mg & Lumefantrine 120 mg Tablets (Uncoated)?

Artemether 20 mg & Lumefantrine 120 mg Tablets are an oral antimalarial combination containing artemether and lumefantrine. Each tablet provides 20 mg of artemether and 120 mg of lumefantrine and is used for the treatment of uncomplicated malaria caused by susceptible Plasmodium species, including Plasmodium falciparum, according to approved indications.

Uses / Indications

Artemether 20 mg & Lumefantrine 120 mg Tablets may be indicated for:

• Treatment of uncomplicated malaria caused by susceptible Plasmodium falciparum
• Treatment of uncomplicated malaria in areas where artemisinin-based combination therapy is recommended
• Management of uncomplicated malaria where the combination is approved and clinically appropriate

This formulation is not intended for the treatment of severe or complicated malaria, for which urgent medical assessment and appropriate parenteral or other recommended therapy may be required.

Benefits

• Combines two antimalarial agents with complementary mechanisms of action.
• Provides oral antimalarial therapy for appropriate cases of uncomplicated malaria.
• Artemether provides rapid antimalarial activity against susceptible malaria parasites.
• Lumefantrine has a longer duration of antimalarial activity and helps eliminate remaining susceptible parasites.
• Available as a fixed-dose combination containing 20 mg of artemether and 120 mg of lumefantrine per tablet.

Side Effects

Common Side Effects

Possible adverse effects may include:

• Headache
• Dizziness
• Weakness or fatigue
• Nausea
• Vomiting
• Abdominal pain
• Diarrhoea
• Loss of appetite
• Muscle or joint discomfort

Less Common or Serious Side Effects

Clinically important reactions may include:

• Palpitations or changes in heart rhythm
• Fainting or significant dizziness
• Severe allergic or hypersensitivity reactions
• Severe skin reactions
• Significant vomiting or diarrhoea that may interfere with treatment
• Abnormal liver function or other clinically significant reactions

Medical attention should be sought if severe allergic symptoms, fainting, significant heart-related symptoms, or other serious reactions occur.

How Does It Work?

Artemether

Artemether is an artemisinin derivative that is rapidly converted to its active metabolite, dihydroartemisinin. It acts against malaria parasites and contributes to rapid reduction of the parasite burden during treatment.

Lumefantrine

Lumefantrine is an antimalarial agent that acts against susceptible malaria parasites through mechanisms involving interference with parasite haemoglobin metabolism. Its longer persistence helps eliminate remaining parasites following the rapid action of the artemisinin component.

Combination Action

The two active ingredients provide complementary antimalarial activity. Artemether contributes rapid parasite clearance, while lumefantrine provides longer-lasting activity against susceptible parasites, helping reduce the risk of treatment failure when the combination is used according to the approved regimen.

Dosage Guidelines

The dosage regimen depends on factors such as the patient’s age, body weight, clinical condition and the approved treatment protocol.

The exact dose and treatment duration should follow the approved product information and the recommendation of a qualified healthcare professional.

For oral tablets:

• Take exactly as prescribed.
• Follow the complete prescribed treatment schedule.
• Swallow the tablets with sufficient water unless otherwise directed.
• Treatment should not be stopped early unless advised by a healthcare professional.
• If vomiting occurs shortly after a dose, follow the instructions in the approved product information or seek professional medical advice regarding whether the dose should be repeated.

The product is intended for uncomplicated malaria and should not be used as a substitute for urgent treatment of severe malaria.

When Not to Use

Artemether and lumefantrine should generally not be used in patients with:

• Known hypersensitivity to artemether, lumefantrine, related compounds, or any component of the formulation
• Severe or complicated malaria requiring a different treatment approach
• Concomitant use with medicines that are contraindicated because of clinically important interactions, particularly medicines that may significantly increase the risk of QT interval prolongation

Particular medical assessment may be required in patients with significant cardiac, hepatic or other underlying conditions.

Drug / Product Interactions

Clinically important interactions may occur with medicines that affect cardiac rhythm or alter the metabolism of artemether and lumefantrine.

Particular caution may be required with:

• Medicines known to prolong the QT interval
• Strong CYP3A4 inhibitors or inducers
• Certain antimalarial medicines
• Some anticonvulsants and other medicines that may induce hepatic drug-metabolising enzymes
• Medicines that may significantly affect electrolyte balance

Patients should inform their healthcare professional about all prescription medicines, over-the-counter medicines and herbal products being used before treatment.

Safety Advice

Overdose

If an overdose is suspected, seek immediate medical attention or contact an appropriate poison-control or emergency medical service.

Overdose may increase the risk of adverse effects, including cardiac rhythm disturbances.

Missed Dose

Take a missed dose as soon as remembered according to the approved treatment schedule. If it is close to the next scheduled dose, follow the product instructions or seek professional advice. Do not double a dose unless specifically instructed by a healthcare professional.

Driving

Dizziness, weakness or other adverse effects may occur. Patients should exercise caution with driving or operating machinery if they experience symptoms that could impair alertness.

Alcohol

Alcohol may worsen certain adverse effects such as dizziness or gastrointestinal discomfort. Patients should discuss alcohol consumption with a healthcare professional during treatment.

Pregnancy

Use during pregnancy should be based on appropriate medical assessment. The potential benefits and risks should be considered by a qualified healthcare professional, particularly according to the stage of pregnancy and the severity of malaria.

Breastfeeding

Artemether and lumefantrine may be used during breastfeeding only according to appropriate medical advice and the approved product information.

Children

Paediatric use should be based on body weight, age and the approved dosing recommendations. The appropriate regimen should be determined by a qualified healthcare professional.

Elderly Patients

Treatment in elderly patients should take into account overall health, concomitant medicines and relevant hepatic, cardiac or other underlying conditions.

Hepatic Impairment

Patients with significant hepatic impairment may require particular medical assessment because hepatic metabolism contributes to the elimination of the active ingredients.

Cardiac Conditions

Patients with known cardiac rhythm disorders, clinically significant electrolyte disturbances or medicines that prolong the QT interval should receive appropriate medical assessment before treatment.

General Instructions

• Take the medicine exactly according to the prescribed treatment schedule.
• Swallow the tablets with sufficient water unless otherwise directed.
• Complete the recommended treatment course.
• Do not alter the dosage without professional advice.
• Inform the healthcare professional about other medicines being taken.
• Seek medical attention if symptoms worsen or if severe malaria is suspected.
• Keep the medicine in its original packaging where appropriate.
• Do not share prescription medicines with other people.

Special Dietary / Lifestyle Tips

Artemether and lumefantrine absorption can be affected by food intake. The tablets should therefore be taken according to the administration instructions in the approved product information, which may recommend administration with food or a suitable drink containing fat.

Adequate fluid intake is also important during malaria illness unless fluid restriction has been advised by a healthcare professional.

Comparison with Other Treatments

Artemether and lumefantrine is an artemisinin-based combination therapy containing a rapidly acting artemisinin derivative together with a longer-acting partner antimalarial.

Other antimalarial treatments may contain different active ingredients, combinations, routes of administration or treatment schedules. The appropriate therapy depends on factors including the malaria species, geographic resistance patterns, disease severity, patient characteristics, previous treatment and applicable treatment guidelines.

Severe malaria requires a different treatment approach and urgent medical care rather than routine oral therapy for uncomplicated malaria.

Precautions & Warnings

• Confirm any history of hypersensitivity to either active ingredient or formulation components.
• Use only for malaria indications for which the product is approved.
• Severe or complicated malaria requires urgent medical treatment.
• Use caution in patients with cardiac rhythm disorders or clinically significant electrolyte abnormalities.
• Review concomitant medicines for potential QT-prolonging or metabolic interactions.
• Patients with significant hepatic impairment may require medical assessment before treatment.
• Follow the complete prescribed treatment regimen.
• Seek medical attention if vomiting prevents adequate treatment or if symptoms worsen.
• Use during pregnancy and breastfeeding should follow appropriate professional assessment.
• Do not use the product for self-treatment of an undiagnosed febrile illness without appropriate medical evaluation.

Can I Use It With Other Medicines?

Generally Compatible With

Artemether/lumefantrine can be used with other medicines when clinically appropriate and after consideration of the patient’s complete medication profile.

Use With Caution / Avoid

Professional advice is particularly important when the product is used with:

• QT-prolonging medicines
• Strong CYP3A4 inhibitors or inducers
• Certain anticonvulsants
• Other antimalarial medicines
• Medicines that can significantly affect electrolyte levels or cardiac rhythm

Patients should not start, stop or change other medicines without appropriate medical advice.

Storage

Store according to the storage conditions stated on the approved product label and package insert.

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• Protect from inappropriate light exposure where relevant.
• Keep out of reach of children.
• Do not use after the expiry date.
• Keep in the original packaging where appropriate.

Frequently Asked Questions

1. What is Artemether 20 mg & Lumefantrine 120 mg Tablets used for?

Artemether 20 mg & Lumefantrine 120 mg Tablets are used for the treatment of uncomplicated malaria caused by susceptible malaria parasites, particularly Plasmodium falciparum, when the combination is clinically and locally appropriate.

2. What are the active ingredients in these tablets?

Each tablet contains artemether 20 mg and lumefantrine 120 mg.

3. How does Artemether and Lumefantrine work?

Artemether provides rapid antimalarial activity and reduces the parasite burden, while lumefantrine provides longer-lasting activity against susceptible malaria parasites.

4. How should Artemether 20 mg & Lumefantrine 120 mg Tablets be taken?

The tablets should be taken according to the approved treatment schedule and the recommendation of a qualified healthcare professional. Administration should follow the product instructions regarding food.

5. Can this medicine be used for severe malaria?

This oral combination is intended for uncomplicated malaria. Severe or complicated malaria requires urgent medical assessment and an appropriate treatment regimen.

6. Can Artemether and Lumefantrine be taken with other medicines?

Some medicines can interact with artemether/lumefantrine, particularly medicines affecting cardiac rhythm or CYP3A4 metabolism. Patients should provide their healthcare professional with a complete list of current medicines.

7. Can Artemether and Lumefantrine be used during pregnancy?

Use during pregnancy should be determined by a qualified healthcare professional after considering the clinical circumstances and approved product information.

8. How should Artemether 20 mg & Lumefantrine Tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert. Keep it properly closed, protected from moisture and out of reach of children.