Artemether and lumefantrine

You should not use this medication if you are allergic to artemether or lumefantrine.

Some medicines can interact with artemether and lumefantrine and should not be used at the same time. Your doctor may need to change your treatment plan if you use any of the following drugs:

• rifampin;

• St. John's wort; or

• seizure medicine--carbamazepine, phenytoin.

To make sure artemether and lumefantrine is safe for you, tell your doctor if you have:

• heart disease;

• a personal or family history of long QT syndrome;

• liver or kidney disease;

• low levels of potassium or magnesium in your blood.

Tell your doctor about all other anti-malaria medications you have used recently.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

It is not known whether artemether and lumefantrine passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Artemether and lumefantrine should not be given to a child who weighs less than 11 pounds.

Usual Adult Dose for Malaria:

Less than 35 kg: Usual pediatric dose

35 kg or more: 4 tablets as single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days (total course: 24 tablets)

Usual Pediatric Dose for Malaria:

5 kg to less than 15 kg: 1 tablet as single initial dose, followed by 1 tablet after 8 hours, and then 1 tablet twice a day (morning and evening) for the following 2 days (total course: 6 tablets)

15 kg to less than 25 kg: 2 tablets as single initial dose, followed by 2 tablets after 8 hours, and then 2 tablets twice a day (morning and evening) for the following 2 days (total course: 12 tablets)

25 kg to less than 35 kg: 3 tablets as single initial dose, followed by 3 tablets after 8 hours, and then 3 tablets twice a day (morning and evening) for the following 2 days (total course: 18 tablets)

35 kg or more: 4 tablets as single initial dose, followed by 4 tablets after 8 hours, and then 4 tablets twice a day (morning and evening) for the following 2 days (total course: 24 tablets)

Antimalarial; fixed combination containing artemether (artemisinin-derivative antimalarial)1 161 and lumefantrine (aryl aminoalcohol antimalarial).161

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, artemether and lumefantrine is not used to prevent malaria or to treat severe or complicated malaria.

artemether and lumefantrine is available only with your doctor's prescription.

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 artemether and lumefantrine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to artemether and lumefantrine 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.

Pediatric

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).

Geriatric

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

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.

Interactions with 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 artemether and lumefantrine, 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 artemether and lumefantrine 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.

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

Using artemether and lumefantrine 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.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Amoxapine
• Amprenavir
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Blinatumomab
• Boceprevir
• Buserelin
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Degarelix
• Delamanid
• Delavirdine
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Droperidol
• Efavirenz
• Erythromycin
• Escitalopram
• Etravirine
• Fingolimod
• Flecainide
• Fluoxetine
• Fosamprenavir
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Golimumab
• Gonadorelin
• Goserelin
• Granisetron
• Guselkumab
• Halofantrine
• Haloperidol
• Histrelin
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Idelalisib
• Iloperidone
• Imipramine
• Indinavir
• Ivabradine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lopinavir
• Methadone
• Metronidazole
• Mifepristone
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nevirapine
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ondansetron
• Paliperidone
• Panobinostat
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pitolisant
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Ritonavir
• Salmeterol
• Secukinumab
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tipranavir
• Tizanidine
• Toremifene
• Trazodone
• Trifluoperazine
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Vinflunine
• Voriconazole
• Zuclopenthixol

Using artemether and lumefantrine 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

Interactions with Food/Tobacco/Alcohol

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 artemether and lumefantrine 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 artemether and lumefantrine, 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 artemether and lumefantrine. 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 (e.g., 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.

Take artemether and lumefantrine 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.

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

artemether and lumefantrine 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 artemether and lumefantrine 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 artemether and lumefantrine 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 artemether and lumefantrine. 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 older than 16 years of age weighing 35 kilograms (kg) (77 pounds [lbs]) of body weight 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 weighing 25 kg (55 lbs) to less than 35 kg (77 lbs) of body weight—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 weighing 15 kg (33 lbs) to less than 25 kg (55 lbs) of body weight—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 weighing 5 kg (11 lbs) to less than 15 kg (33 lbs) of body weight—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 weighing less than 5 kg of body weight—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of artemether and lumefantrine, 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 artemether and lumefantrine, 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.

• Tell all of your health care providers that you take artemether and lumefantrine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• You may need to have an ECG checked before starting artemether and lumefantrine and while taking it. Talk with your doctor.
• Avoid grapefruit and grapefruit juice.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this medicine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using artemether and lumefantrine while you are pregnant.
• This medicine has been shown to cause birth defects in animals. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• Coartem

Hypersensitivity to artemether, lumefantrine, or any component of the formulation; concurrent use with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St John’s wort)

Artemether-lumefantrine should be taken with food.

Artemether-lumefantrine tablets may be crushed and mixed with 1 to 2 teaspoons of water in a clean container for administration immediately prior to use. The patient can then rinse the container with more water and swallow the contents. This crushed tablet preparation should be followed by food/drink.

A repeat dose should be taken if the patient vomits within 1 to 2 hours of administration. If the repeat dose is vomited, an alternative antimalarial treatment is recommended.