Artemether 20 mg & Lumefantrine 120 mg Dispersible Tablets (Uncoated Dispersible) Tablet

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

Artemether 20 mg & Lumefantrine 120 mg Dispersible Tablets is a combination antimalarial formulation containing artemether and lumefantrine. Each tablet provides 20 mg of artemether and 120 mg of lumefantrine. The dispersible dosage form is intended for use in the treatment of susceptible malaria infections according to approved product information and qualified healthcare professional guidance.

Uses / Indications

Artemether 20 mg + Lumefantrine 120 mg may be indicated for the treatment of uncomplicated malaria caused by susceptible Plasmodium species, including infections caused by Plasmodium falciparum, according to applicable treatment guidelines and approved product information.

The specific treatment regimen depends on factors such as patient age or weight, infection severity, and applicable national or regional malaria treatment guidelines.

Benefits

• Provides antimalarial activity through the complementary actions of artemether and lumefantrine.
• Artemether contributes rapid reduction of malaria parasite burden.
• Lumefantrine provides longer-lasting antimalarial activity and helps eliminate remaining susceptible parasites.
• The combination is used as an artemisinin-based combination therapy for appropriate uncomplicated malaria.
• The dispersible tablet formulation may be suitable for patients who have difficulty swallowing conventional tablets, when used according to the approved product instructions.

Side Effects

Common Side Effects

Possible adverse effects may include:

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

Less Common or Serious Side Effects

Clinically important reactions may include:

• Hypersensitivity or allergic reactions
• Significant skin reactions
• Changes in heart rhythm, including QT interval prolongation
• Palpitations or fainting
• Abnormal liver-function tests
• Neurological symptoms such as seizures, particularly in severe illness or susceptible patients

Medical attention should be sought if severe allergic reactions, fainting, significant palpitations, severe skin reactions, or other serious symptoms occur.

How Does It Work?

Artemether

Artemether is an artemisinin derivative. It is converted to an active metabolite that generates reactive intermediates within the malaria parasite. These compounds damage essential parasite components and rapidly reduce the parasite burden in the blood.

Lumefantrine

Lumefantrine is an antimalarial agent that interferes with processes involved in the parasite’s handling of haemoglobin and contributes to elimination of susceptible malaria parasites.

Combination Action

Artemether provides relatively rapid parasite clearance, while lumefantrine has a longer duration of antimalarial activity. Their complementary pharmacological profiles support their use together as an artemisinin-based combination therapy.

Dosage Guidelines

The appropriate dosage and treatment schedule depend on the patient’s age, body weight, clinical condition, malaria species, severity of infection, and applicable treatment guidelines.

For dispersible tablets:

• Use exactly according to the approved product information and prescribed schedule.
• The tablet should be dispersed according to the instructions supplied with the product before administration.
• Follow the recommended dosing schedule carefully.
• If vomiting occurs shortly after a dose, follow the approved product instructions or seek advice from a healthcare professional regarding whether another dose is required.
• Do not alter the treatment schedule without professional advice.

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

When Not to Use

This combination should generally not be used in patients with a known hypersensitivity to artemether, lumefantrine, related artemisinin compounds, or any component of the formulation.

Medical advice is particularly important for patients with:

• Significant cardiac rhythm disorders
• Conditions associated with QT prolongation
• Severe hepatic impairment
• A history of serious reactions to antimalarial medicines
• Concomitant use of medicines that may significantly prolong the QT interval

Drug / Product Interactions

Clinically important interactions may occur because lumefantrine is metabolised through hepatic enzyme pathways and because the combination may affect cardiac repolarisation.

Particular attention may be required with:

• Strong CYP3A4 inhibitors or inducers
• Medicines known to prolong the QT interval
• Certain antiarrhythmic medicines
• Other antimalarial medicines
• Medicines that can significantly alter hepatic drug metabolism

Patients should inform their healthcare professional about all prescription medicines, over-the-counter medicines, and supplements before starting 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 and neurological complications.

Missed Dose

If a dose is missed, follow the approved product instructions or seek advice from a healthcare professional. Do not take extra doses to compensate unless specifically instructed.

Pregnancy

Use during pregnancy should be based on an appropriate clinical assessment and applicable malaria treatment recommendations. Untreated malaria during pregnancy can also pose significant risks, so treatment decisions should be made by a qualified healthcare professional.

Breastfeeding

Artemether and lumefantrine can be present in breast milk. A healthcare professional should assess the appropriate use of this combination during breastfeeding.

Children

The appropriate dose in children is generally determined according to body weight and the approved dosing schedule. Use in children should follow the product information and healthcare professional’s instructions.

Elderly Patients

Older patients may require particular attention to concomitant medicines, cardiac status, hepatic function, and other factors that can influence treatment.

Hepatic Impairment

Patients with significant hepatic impairment may require careful clinical assessment because hepatic metabolism contributes to the elimination of these medicines.

General Instructions

• Use the medicine exactly according to the prescribed treatment schedule.
• Prepare the dispersible tablet according to the approved product instructions.
• Complete the recommended treatment course unless otherwise directed by a healthcare professional.
• Do not share antimalarial medicines with other people.
• Inform the healthcare professional about existing heart conditions and all medicines being taken.
• Seek medical attention if symptoms worsen, persist, or recur after treatment.
• Follow applicable malaria treatment guidelines and approved product information.

Special Dietary / Lifestyle Tips

Food can affect the absorption of lumefantrine. The approved product information should be followed regarding administration with food or a suitable drink.

Maintain adequate hydration where clinically appropriate. Patients recovering from malaria should also follow healthcare professional advice regarding rest, nutrition, and follow-up.

Comparison with Other Treatments

Artemether and lumefantrine form an artemisinin-based combination therapy with complementary antimalarial activity. Other antimalarial medicines or combinations may contain different active ingredients and have different mechanisms, parasite activity profiles, dosing schedules, contraindications, and resistance considerations.

Selection of an antimalarial regimen depends on factors including the malaria species, geographic resistance patterns, disease severity, patient age and weight, pregnancy status, previous treatment, and applicable national or international treatment guidelines.

Precautions & Warnings

• Use only for malaria infections for which this combination is an appropriate treatment option.
• Complete the recommended treatment course according to approved instructions.
• Inform the healthcare professional about any history of cardiac rhythm abnormalities.
• Use caution with medicines that can prolong the QT interval.
• Inform the healthcare professional about all medicines and supplements being taken.
• Patients with significant hepatic impairment may require additional clinical consideration.
• Seek immediate medical attention for severe allergic reactions, fainting, significant palpitations, or serious skin reactions.
• If malaria symptoms persist or recur after treatment, further medical assessment is required.

Can I Use It With Other Medicines?

Generally Compatible With

Artemether/lumefantrine can be used with other medicines when clinically appropriate and when potential interactions have been assessed by a healthcare professional.

Use With Caution / Avoid

Particular caution may be required with:

• Medicines that strongly inhibit or induce CYP3A4
• Medicines that prolong the QT interval
• Certain antiarrhythmic medicines
• Other antimalarial medicines
• Medicines that may significantly affect hepatic drug metabolism

Always provide a complete list of current medicines to the healthcare professional before treatment.

Storage

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

• Keep properly closed.
• Protect from excessive heat.
• Protect from moisture.
• 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 used for?

It is an antimalarial combination used for the treatment of appropriate uncomplicated malaria infections caused by susceptible Plasmodium species, according to approved product information and applicable treatment guidelines.

2. What are the active ingredients in this formulation?

Each tablet contains artemether 20 mg and lumefantrine 120 mg.

3. How does Artemether and Lumefantrine work?

Artemether acts rapidly against malaria parasites, while lumefantrine provides longer-lasting antimalarial activity. Their complementary actions help reduce and eliminate susceptible malaria parasites.

4. What is a dispersible tablet?

A dispersible tablet is designed to be dispersed according to the product instructions before administration. This dosage form can be useful for patients who have difficulty swallowing conventional tablets.

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

It should be taken according to the approved product information and the dosing schedule prescribed by a qualified healthcare professional. The dispersible tablet should be prepared as directed in the product instructions.

6. Can this medicine be used in children?

Yes, artemether/lumefantrine combinations are used in appropriate paediatric patients, with dosing generally determined by body weight and the approved product information. A healthcare professional should determine the appropriate regimen.

7. Can Artemether/Lumefantrine affect the heart?

This combination can affect cardiac repolarisation and may prolong the QT interval in susceptible circumstances. Patients with cardiac conditions or those taking medicines that affect cardiac rhythm should seek professional advice before use.

8. How should Artemether 20 mg & Lumefantrine 120 mg tablets be stored?

Store the product according to the conditions stated on the approved product label and package insert, and keep it out of reach of children.