Artemether 40 mg & Lumefantrine 240 mg Tablets (Uncoated)

What is Artemether 40 mg & Lumefantrine 240 mg Tablets (Uncoated)?

Artemether 40 mg & Lumefantrine 240 mg Tablets are an oral fixed-dose antimalarial combination containing artemether and lumefantrine. Each tablet contains 40 mg of artemether and 240 mg of lumefantrine. The formulation is used for the treatment of uncomplicated malaria caused by susceptible Plasmodium species, according to approved indications.

Uses / Indications

Artemether 40 mg & Lumefantrine 240 mg Tablets may be indicated for:

• Treatment of uncomplicated malaria caused by susceptible Plasmodium falciparum
• Management of uncomplicated malaria where artemisinin-based combination therapy is recommended
• Treatment of uncomplicated malaria when this artemether/lumefantrine combination is approved and clinically appropriate

This oral formulation is not intended for the treatment of severe or complicated malaria, which requires urgent medical assessment and an appropriate treatment regimen.

Benefits

• Combines two antimalarial agents with complementary pharmacological activity.
• Provides oral therapy for appropriate cases of uncomplicated malaria.
• Artemether contributes rapid antimalarial activity against susceptible malaria parasites.
• Lumefantrine provides longer-lasting antimalarial activity against susceptible parasites.
• Provides a fixed-dose combination containing 40 mg of artemether and 240 mg of lumefantrine per tablet.

Side Effects

Common Side Effects

Possible adverse effects may include:

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

Less Common or Serious Side Effects

Clinically important adverse reactions may include:

• Palpitations or changes in heart rhythm
• Fainting
• Significant dizziness
• Severe allergic or hypersensitivity reactions
• Severe skin reactions
• Clinically significant liver-related abnormalities
• Persistent vomiting or diarrhoea that may interfere with treatment

Medical attention should be sought if severe allergic symptoms, fainting, significant cardiac 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 exerts antimalarial activity against susceptible malaria parasites and contributes to rapid reduction of parasite levels.

Lumefantrine

Lumefantrine is a longer-acting antimalarial agent that acts against susceptible malaria parasites, including through interference with parasite haemoglobin metabolism. Its longer persistence complements the rapid activity of artemether.

Combination Action

The combination provides complementary antimalarial activity. Artemether contributes rapid parasite reduction, while lumefantrine provides sustained activity against susceptible parasites, supporting treatment of uncomplicated malaria when used according to the approved regimen.

Dosage Guidelines

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

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.
• Follow the approved instructions concerning food or other administration requirements.
• If vomiting occurs shortly after a dose, follow the approved product information or seek professional medical advice regarding further dosing.

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 tablets 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 an alternative treatment approach
• Concomitant use with medicines that are contraindicated because of clinically important interactions, particularly certain medicines associated with QT interval prolongation

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

Drug / Product Interactions

Clinically relevant 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 hepatic enzyme-inducing medicines
• Medicines that can significantly affect electrolyte balance

Patients should inform their healthcare professional about all prescription medicines, over-the-counter medicines and herbal products they are taking.

Safety Advice

Overdose

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

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

Missed Dose

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

Driving

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

Alcohol

Alcohol may aggravate certain symptoms such as dizziness or gastrointestinal discomfort. 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 according to the clinical circumstances and approved product information.

Breastfeeding

Use during breastfeeding should follow appropriate medical advice and the approved product information.

Children

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

Elderly Patients

Elderly patients may require assessment of their overall health, concomitant medicines and relevant cardiac, hepatic or other underlying conditions before treatment.

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 cardiac rhythm disorders, clinically significant electrolyte abnormalities or concomitant medicines that may 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.
• Follow the complete recommended treatment course.
• Do not alter the dosage without professional advice.
• Inform the healthcare professional about all other medicines being taken.
• Seek medical attention if symptoms worsen or 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. The tablets should therefore be administered according to the approved product information, which may specify administration with food or a suitable drink containing fat.

Adequate fluid intake may also be helpful 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 and treatment schedules. Selection depends on factors such as malaria species, local antimalarial resistance patterns, disease severity, patient characteristics, previous treatment and applicable treatment guidelines.

Severe malaria requires urgent medical care and an appropriate treatment regimen 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.
• Exercise 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 persistent vomiting prevents adequate treatment or symptoms worsen.
• Use during pregnancy and breastfeeding should be based on 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 may 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

Do 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 40 mg & Lumefantrine 240 mg Tablets used for?

Artemether 40 mg & Lumefantrine 240 mg Tablets are used for the treatment of uncomplicated malaria caused by susceptible malaria parasites, particularly Plasmodium falciparum, when clinically appropriate.

2. What are the active ingredients in these tablets?

Each tablet contains artemether 40 mg and lumefantrine 240 mg.

3. How does Artemether and Lumefantrine work?

Artemether provides rapid antimalarial activity and contributes to parasite reduction, while lumefantrine provides longer-lasting activity against susceptible malaria parasites.

4. How should Artemether 40 mg & Lumefantrine 240 mg Tablets be taken?

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

5. Can these tablets 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 inform their healthcare professional about all medicines they are taking.

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 40 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.