Health Guide
Drug Guide

Artemether and lumefantrine (Oral route)

Pronunciation:

ar-TEM-e-ther, loo-me-FAN-treen

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Antimalarial

Uses of This Medicine:

Artemether and lumefantrine combination is used to treat acute, uncomplicated malaria in patients who weigh at least 5 kilograms (11 pounds). It may be used to treat malaria infections in areas or regions where it is known that other medicines (e.g., chloroquine) may not work.

Artemether and lumefantrine combination belongs to a group of medicines known as antimalarials. It treats malaria, a red blood cell infection transmitted by the bite of a mosquito. However, this medicine is not used to prevent malaria or to treat severe or complicated malaria.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of artemether and lumefantrine combination in children. However, safety and efficacy have not been established in children weighing less than 5 kilograms (11 pounds).

Older adults

Appropriate studies on the relationship of age to the effects of artemether and lumefantrine combination have not been performed in the geriatric population. However, geriatric-specific problems that would limit the usefulness of this medication in the elderly are not expected.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk with your doctor if you have any questions.

This medicine should be taken with food or drinks (e.g., milk, infant formula, pudding, porridge, or broth). This will help your body absorb the medicine.

If you or your child are unable to swallow the tablet, it may be crushed and mixed with one or two teaspoons of water in a clean container.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you or your child vomit within 1 to 2 hours of taking this medicine, take another dose. If you vomit the second dose, tell your doctor right away. You may need to use a different medicine to treat your condition.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is important that your doctor check your progress after treatment. This is to make sure that the infection is cleared up completely, and to allow your doctor to check for any unwanted effects.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you have used other medicines to treat your malaria infection. Using this medicine together with halofantrine (Halfan®), mefloquine (Lariam®), or quinine may increase the chance for more serious side effects.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you have flu-like symptoms (such as chills, fever, headache, or muscle pains) again after treatment with this medicine.

This medicine may cause serious allergic reactions. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble with breathing, trouble with swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in or will be traveling to an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

This medicine may decrease the effects of birth control pills or transdermal patches. To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills or patches (e.g., condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.

Grapefruits and grapefruit juice may increase the effects of artemether and lumefantrine combination by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you taking this medicine.

Do not take other medicines, including prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements, unless they have been discussed with your doctor. Artemether and lumefantrine combination should not be taken with certain other medicines, including carbamazepine (Tegretol®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), or St. John's wort.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Abdominal or stomach pain
chills
cough
fast, irregular, pounding, or racing heartbeat or pulse
fever
headache
muscle aches
pale skin
right upper abdominal or stomach pain and fullness
sore throat
stuffy or runny nose
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Less common
Accumulation of pus
acid or sour stomach
belching
black, tarry stools
bladder pain
blood in the urine
bloody or cloudy urine
body aches or pain
change in hearing
chest pain
cloudy urine
convulsions
cough producing mucus
decreased urine
diarrhea
difficult, burning, or painful urination
difficulty with breathing
difficulty with swallowing
dizziness
dry mouth
ear congestion
ear drainage
earache or pain in the ear
frequent urge to urinate
general feeling of discomfort or illness
heartburn
increased thirst
indigestion
joint pain
loss of appetite
loss of voice
lower back or side pain
mood changes
muscle pain or cramps
nasal congestion
nausea or vomiting
noisy breathing
numbness or tingling in the hands, feet, or lips
red rash with watery, yellow-colored, or pus filled blisters
shivering
shortness of breath
sneezing
sores, ulcers, or white spots on the lips or in the mouth
stomach discomfort, upset, or pain
sweating
swollen glands
swollen, red, tender area of infection
thick yellow to honey-colored crusts
tightness in the chest
troubled with sleeping
Incidence not known
Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Difficulty with moving
lack or loss of strength
muscle aching or cramping
muscle pain or stiffness
sleeplessness
unable to sleep
weight loss
Less common
Back pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning, dry, or itching eyes
continuing ringing or buzzing or other unexplained noise in the ears
difficulty having a bowel movement (stool)
discharge or excessive tearing
dizziness or lightheadedness
feeling of constant movement of self or surroundings
hearing loss
hives or welts
redness of the skin
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
sensation of spinning
shakiness and unsteady walk
shakiness in the legs, arms, hands, or feet
trembling or shaking of the hands or feet
uncontrolled eye movements
unsteadiness, trembling, or other problems with muscle control or coordination

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 9/15/2016

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