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artemether and lumefantrine
Coartem Pharmaceutical company:
Novartis
www.novartis.com

Pharmacologic classification: schizontocide
Therapeutic classification:
antimalarial agent
Pregnancy risk category:
C


AVAILABLE FORMS
Tablets: artemether 20 mg and lumefantrine 120 mg

INDICATIONS AND DOSAGES
Uncomplicated malaria caused by Plasmodium falciparum
Adults and children who weigh 35 kg or more: Initially, 4 tablets P.O., followed by 4 tablets P.O. in 8 hours, and then 4 tablets P.O. b.i.d. for the next 2 days. Total course, 24 tablets.
Children who weigh 25 to 34 kg: Initially, 3 tablets P.O., followed by 3 tablets P.O. in 8 hours, and then 3 tablets b.i.d. on each of the next 2 days. Total course, 18 tablets.
Children who weigh 15 to 24 kg: Initially, 2 tablets P.O., followed by 2 tablets in 8 hours, and then 2 tablets b.i.d. on each of the next 2 days. Total course, 12 tablets.
Children who weigh 5 kg to 14 kg: Initially, 1 tablet P.O, followed by 1 tablet in 8 hours, and then 1 tablet b.i.d. on each of the next 2 days. Total course, 6 tablets.

CONTRAINDICATIONS AND CAUTIONS
Contraindicated in patients hypersensitive to the drug or its components. Avoid use in patients with prolonged QT syndrome, in patients with hypokalemia or hypomagnesemia, and in those taking other drugs that prolong the QT interval.
   Use cautiously in patients with severe hepatic or renal impairment.

INTERACTIONS
Drug-drug. Antiretrovirals, quinidine, procainamide, disopyramide, amiodarone, sotalol, ziprasidone, antidepressants, halofantrine, pimozide, terfenadine, astemizole, cisapride, quinine, CYP2D6 substrates (flecainide, imipramine, amitriptyline, clomipramine), CYP3A4 inhibitors (ketoconazole, macrolides, antidepressants, other imidazole antifungals), fluoroquinolones: May further prolong QT interval. Avoid using together.
Hormonal contraceptives: May reduce contraceptive effect. Recommend alternative or additional contraception.
Mefloquine: May decrease drug's effectiveness. Administer drug with food to increase absorption.
Drug-food. Grapefruit juice: Drug level may increase. Advise patient to avoid drinking grapefruit juice.

ADVERSE REACTIONS
CNS: agitation, asthenia, ataxia, clonus, dizziness, fatigue, fever, fine motor delay, gait disturbance, headache, hyperreflexia, hypoesthesia, insomnia, malaise, mood swings, nystagmus, sleep disorder, tremor.
CV: palpitations.
EENT: conjunctivitis, ear infection, nasopharyngitis, oral herpes, rhinitis, tinnitus, vertigo.
GI: abdominal pain, anorexia, constipation, diarrhea, dyspepsia, dysphagia, gastroenteritis, nausea, peptic ulcer, vomiting.
GU: hematuria, proteinuria, urinary tract infection.
Hematologic: anemia.
Hepatic: hepatomegaly.
Musculoskeletal: arthralgia, back pain, myalgia.
Respiratory: asthma, bronchitis, cough, pharyngolaryngeal pain, pneumonia, respiratory infection.
Skin: acrodermatitis, impetigo, pruritus, rash, subcutaneous abscess, urticaria.
Other: abscess, acrodermatitis, chills, helminthic infection, hookworm infection, influenza, malaria, Plasmodium falciparum infection, splenomegaly.

Reactions may be common, uncommon, life-threatening, or
COMMON AND LIFE-THREATENING.

     
   

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