Pronunciation:

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

Brand Names:

• Coartem

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antimalarial

Uses of This Medicine:

Artemether and lumefantrine combination is used to treat acute, uncomplicated malaria in patients 2 months of age and older who weigh at least 5 kilograms (kg). It may be used to treat malaria infections in areas or regions where it is known that other medicines (eg, 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 2 months of age and older weighing 5 kilograms (kg) or more. However, safety and efficacy have not been established in children younger than 2 months of age weighing less than 5 kg.

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.

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.

• Aurothioglucose
• Bepridil
• Carbamazepine
• Cisapride
• Dexamethasone
• Dronedarone
• Enzalutamide
• Fluconazole
• Fosphenytoin
• Ketoconazole
• Levoketoconazole
• Mesoridazine
• Nelfinavir
• Phenytoin
• Pimozide
• Piperaquine
• Posaconazole
• Rifabutin
• Rifampin
• Rifapentine
• Saquinavir
• Sparfloxacin
• St John's Wort
• Terfenadine
• Thioridazine
• Ziprasidone

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.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Boceprevir
• Buprenorphine
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Desogestrel
• Deutetrabenazine
• Dexmedetomidine
• Dienogest
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Drospirenone
• Efavirenz
• Encorafenib
• Entrectinib
• Erythromycin
• Escitalopram
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Etravirine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Formoterol
• Fosamprenavir
• Foscarnet
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gestodene
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Indinavir
• Inotuzumab Ozogamicin
• Ivabradine
• Ivosidenib
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levonorgestrel
• Lofexidine
• Lopinavir
• Macimorelin
• Medroxyprogesterone
• Mestranol
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nevirapine
• Nilotinib
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pitolisant
• Ponesimod
• Primidone
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Ritonavir
• Segesterone
• Selpercatinib
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Toremifene
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimipramine
• Triptorelin
• Ulipristal
• Vandetanib
• Vardenafil
• Vemurafenib
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Zuclopenthixol

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.

• Mefloquine

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.

• Grapefruit Juice

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:

• Bradycardia (slow heartbeat), severe or
• Heart attack, recent or
• Heart disease, severe or
• Heart rhythm problems (eg, prolonged QT interval, congenital long QT interval), or a history of or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood)—Use is not recommended. May increase the risk of severe heart rhythm problems.

• Decreased food intake during treatment—May increase the chance for this infection to return.

• Kidney disease, severe or
• Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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 (eg, 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.

• For oral dosage form (tablets):
  • For the treatment of malaria:
    • Adults and children 2 months of age and older weighing 35 kilograms or more—At first, 4 tablets as a single dose, then one dose (4 tablets) after 8 hours. On days 2 and 3, take one dose (4 tablets) two times a day. This 3-day treatment schedule should have a total of 24 tablets in six doses.
    • Children 2 months of age and older weighing 25 kg to less than 35 kg—At first, 3 tablets as a single dose, then one dose (3 tablets) after 8 hours. On days 2 and 3, take one dose (3 tablets) two times a day. This 3-day treatment schedule should have a total of 18 tablets in six doses.
    • Children 2 months of age and older weighing 15 kg to less than 25 kg—At first, 2 tablets as a single dose, then one dose (2 tablets) after 8 hours. On days 2 and 3, take one dose (2 tablets) two times a day. This 3-day treatment schedule should have a total of 12 tablets in six doses.
    • Children 2 months of age and older weighing 5 kg to less than 15 kg—At first, 1 tablet as a single dose, then one dose (1 tablet) after 8 hours. On days 2 and 3, take one dose (1 tablet) two times a day. This 3-day treatment schedule should have a total of 6 tablets in six doses.
    • Children younger than 2 months of age weighing less than 5 kg—Use and dose must be determined by your doctor.

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—

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.

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

Store the medicine in the original package with the container tightly closed.

Precautions While Using This Medicine:

It is important that your doctor check your or your child's 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 or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Tell your doctor if you or your child 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 or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you or your child 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 or your child 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:

• If possible, avoid going out between dusk and dawn because it is at these times that mosquitoes most commonly bite.
• Wear long-sleeved shirts and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply insect repellant, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• If possible, sleep in a screened or air-conditioned room or under mosquito netting sprayed with insecticide to avoid being bitten by malaria-carrying mosquitoes.
• Use mosquito coils or sprays to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

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 (eg, 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 or your child are 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

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 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

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.