COARTEM (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Coartem (artemether/lumefantrine) Tablets

20 mg/120 mg Tablets — yellow, round flat tablets with beveled edges and scored on one side. Tablets are imprinted with “N/C” on one side and “CG” on the other.

Bottle of 24 NDC 0078-0568-45

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature ].

Dispense in tight container (USP).

17 PATIENT COUNSELING INFORMATION

Advise patients to read the FDA-Approved Patient Labeling (Patient Information).

Administration Instructions

Instruct patients to take Coartem Tablets with food. Patients who do not have an adequate intake of food are at risk for recrudescence of malaria [see Dosage and Administration (2.1)].

Hypersensitivity

Patients with known hypersensitivity to artemether, lumefantrine, or to any of the excipients should not receive Coartem Tablets [see Contraindications (4)].

Prolongation of the QT Interval

  • Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia [see Warnings and Precautions (5.1)].
  • Instruct patients to inform their physician if they are taking any other medications that prolong the QT interval, such as Class IA (quinidine, procainamide, disopyramide), or Class III (amiodarone, sotalol) antiarrhythmic agents; antipsychotics (pimozide, ziprasidone); antidepressants; certain antibiotics (macrolide antibiotics, fluoroquinolone antibiotics, imidazole, and triazole antifungal agents) [see Warnings and Precautions (5.1)].
  • Instruct patients to notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness [see Warnings and Precautions (5.1)].

Drug Interactions With CYP2D6

Instruct patients to avoid medications that are metabolized by the cytochrome enzyme CYP2D6 while receiving Coartem Tablets since these drugs also have cardiac effects (e.g., flecainide, imipramine, amitriptyline, clomipramine) [see Warnings and Precautions (5.4)].

Contraception

Advise patients that use of Coartem may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptive to use an alternative non-hormonal contraceptive method or add a barrier method of contraception during treatment with Coartem [see Drug Interactions (7.5) and Use in Specific Populations (8.3)].

Use of QT Prolonging Drugs and Other Antimalarials

Halofantrine and Coartem Tablets should not be administered within 1 month of each other due to potential additive effects on the QT interval. Antimalarials should not be given concomitantly with Coartem Tablets, unless there is no other treatment option, due to limited safety data [see Warnings and Precautions (5.2)].

Sequential Use of Quinine

QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets due to the long elimination half-life of lumefantrine and the potential for additive effects on the QT interval. ECG monitoring is advised if use of drugs that prolong the QT interval is medically required [see Drug Interactions (7.7)].

Prior Use of Mefloquine

Closely monitor food intake in patients who received mefloquine immediately prior to treatment with Coartem Tablets [see Drug Interactions (7.4)].

Drug Interactions With CYP3A4

Use Coartem Tablets cautiously in patients receiving other drugs that are substrates, inhibitors or inducers of CYP3A4, including grapefruit juice, especially those that prolong the QT interval or are antiretroviral drugs. Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort is contraindicated with Coartem Tablets [see Warnings and Precautions (5.3)].

Hypersensitivity Reactions

Inform patients that Coartem Tablets can cause hypersensitivity reactions. Instruct patients to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction [see Contraindications (4)].

T2019-88

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: August 2019
Patient Information Coartem® (co-AR-tem) (artemether and lumefantrine)tablets, for oral use

Read this Patient Information leaflet before you start taking Coartem. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Coartem? Coartem is a prescription medicine used to treat uncomplicated malaria caused by the parasite Plasmodium falciparum (P. falciparum) in people 2 months of age and older who weigh at least 11 pounds (5 kg).

Coartem is not approved to:

  • Treat severe or complicated P. falciparum malaria
  • Prevent malaria

It is not known if Coartem is safe and effective in children who weigh less than 11 pounds (5 kg).

Who should not take Coartem? Do not take Coartem if you:
  • are allergic to artemether, lumefantrine, or any of the ingredients in Coartem. See the end of this Patient Information leaflet for a complete list of ingredients in Coartem. Symptoms of a serious allergic reaction with Coartem can include: rash, hives, fast heartbeat, trouble swallowing or breathing, swelling of lips, tongue, face, tightness of the throat, or trouble speaking. If you have any of these symptoms of a serious allergic reaction while taking Coartem, stop taking Coartem and get emergency medical help right away.
  • are taking rifampin (medicine used to treat leprosy or tuberculosis), carbamazepine or phenytoin (medicines used to treat epilepsy), or St. John’s wort (Hypericum perforatum , a medicinal plant or extract of this medicinal plant).
What should I tell my healthcare provider before taking Coartem? Before taking Coartem, tell your healthcare provider about all of your medical conditions, including if you:
  • have heart disease or a family history of heart problems or heart disease.
  • have liver or kidney problems.
  • have recently taken other medicines used to treat malaria.
  • are pregnant or plan to become pregnant. Treatment of malaria is important because it can be a serious disease for a pregnant woman and her unborn baby.
  • are taking hormonal contraceptives (such as birth control pills). Coartem may affect how well hormonal contraceptives work and may cause them to not work as well. Females who are able to become pregnant should use another effective non-hormonal form of birth control or an additional barrier method of birth control (such as male condoms) during treatment with Coartem. Talk with your healthcare provider if you have questions about birth control methods that may be right for you during this time.
  • are breastfeeding or plan to breastfeed. It is not known if Coartem passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Coartem.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Coartem and other medicines may affect each other causing side effects. Coartem may affect the way other medicines work and other medicines may affect how Coartem works.

Especially tell your healthcare provider if you take:

  • any other medicines to treat or prevent malaria
  • medicines for your heart
  • antipsychotic medicines
  • antidepressants
  • medicines for seizures or trigeminal neuralgia (facial nerve pain)
  • antibiotics (including medicines to treat tuberculosis)
  • antifungal medicines (such as itraconazole, ketoconazole, and fluconazole)
  • medicines to treat HIV-infection
  • hormonal methods of birth control. See “What should I tell my healthcare provider before taking Coartem?

Ask your healthcare provider if you are not sure if your medicine is listed above. Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Coartem?

  • Take Coartem exactly as prescribed.
  • If you weigh 77 pounds (35 kg) or more , 1 dose of Coartem is 4 tablets. A full course of treatment is 6 doses (24 tablets) of Coartem taken over 3 days:
    • Day 1: take 1 dose, then 8 hours later take 1 dose
    • Day 2: take 1 dose in the morning, 1 dose in the evening
    • Day 3: take 1 dose in the morning, 1 dose in the eveningImportant: Take the full course of treatment with Coartem for all 3 days even if you are feeling better.
  • If you weigh less than 77 pounds (35 kg) , your healthcare provider will tell you how many tablets to take for each dose.
  • Each dose of Coartem should be taken with food or drink , such as milk, infant formula, pudding, porridge, or broth. It is important for you to eat as soon as you can so that your malaria will go away and not get worse.
  • Do not drink grapefruit juice while you take Coartem. Drinking grapefruit juice during treatment with Coartem can cause you to have too much medicine in your blood.
  • If you are not able to swallow Coartem tablets, Coartem may be crushed and mixed with 1 to 2 teaspoons of water in a clean container. If any medicine remains, you can add more water to the container and drink right away.
  • If you vomit within 1 to 2 hours after taking Coartem, you should take another dose of Coartem. If you vomit the second dose, tell your healthcare provider. A different medicine may need to be prescribed for you.

Tell your healthcare provider right away if:

  • your malaria does not get better or you get flu-like symptoms such as chills, fever, muscle pains, or headaches again after you finish treatment with Coartem
  • you vomit any doses of Coartem
  • you are not able to eat
  • you have any change in the way your heart beats or a loss of consciousness (fainting)
What are the possible side effects of Coartem? Coartem can cause serious side effects, including:
  • A heart problem called QT prolongation that can cause an abnormal heartbeat can happen in people who take Coartem. The chance of this happening is higher in people with a family history of prolonged QT interval, low potassium (hypokalemia) or low magnesium (hypomagnesemia), and in people who take certain medicines including medicine to control heartbeats.
The most common side effects of Coartem in adults include:
  • headache
  • not wanting to eat
  • dizziness
  • fever
  • weakness or lack of energy
  • joint pain
  • muscle pain, tenderness and weakness
The most common side effects of Coartem in children include:
  • fever
  • cough
  • vomiting
  • not wanting to eat
  • headache

These are not all the possible side effects of Coartem. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Coartem?
  • Store Coartem at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store Coartem in the original container and keep the container tightly closed.
Keep Coartem and all medicines out of the reach of children.
General information about the safe and effective use of Coartem. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Coartem for a condition for which it was not prescribed. Do not give Coartem to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information leaflet summarizes the most important information about Coartem. If you would like more information about Coartem talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Coartem that is written for health professionals.
What are the ingredients in Coartem? Active ingredients: artemether, lumefantrine Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2019-89 For more information about Coartem, call 1-855-262-7836 or go to http://www.coartem.us.com

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