COARTEM Tablet (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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1. Indications and Usage

Coartem Tablets are indicated for treatment of acute, uncomplicated malaria infections due to Plasmodium falciparum (P. falciparum) in patients 2 months of age and older with a bodyweight of 5 ...

2. Dosage and Administration

2.1 Administration Instructions Coartem Tablets should be taken with food. Patients with acute malaria are frequently averse to food. Patients should be encouraged to resume normal eating as soon as food ...

3. Dosage Forms and Strengths

Coartem Tablets contain 20 mg of artemether and 120 mg of lumefantrine. Coartem Tablets are supplied as yellow, round, flat tablets with beveled edges and scored on one side. Tablets are imprinted with ...

4. Contraindications

Hypersensitivity Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets [see Adverse Reactions (6.2)]. Strong CYP3A4 Inducers Coadministration of strong ...

5. Warnings and Precautions

5.1 Prolongation of the QT Interval Some antimalarials (e.g., halofantrine, quinine, quinidine) including Coartem Tablets have been associated with prolongation of the QT interval on the electrocardiogram ...

6. Adverse Reactions

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Coartem Tablets. Because these events are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Rifampin Oral administration of rifampin, a strong CYP3A4 inducer, with Coartem Tablets resulted in significant decreases in exposure to artemether, DHA (metabolite of artemether), and lumefantrine ...

8. Use in Specific Populations

8.6 Hepatic and Renal Impairment No specific pharmacokinetic studies have been performed in patients with either hepatic or renal impairment. Coartem Tablets have not been studied for efficacy and safety ...

8.1. Pregnancy

Risk Summary Published data from clinical studies and pharmacovigilance data have not established an association with artemether/lumefantrine use during pregnancy and major birth defects, miscarriage, ...

8.2. Lactation

Risk Summary There are no data on the presence of artemether or lumefantrine in human milk, the effects on the breastfed infant or the effects on milk production. Artemether and lumefantrine are transferred ...

8.3. Females and Males of Reproductive Potential

Contraception Use of Coartem may reduce the efficacy of hormonal contraceptives. Advise patients using hormonal contraceptives to use an alternative non-hormonal contraceptive method or add a barrier method ...

8.4. Pediatric Use

The safety and effectiveness of Coartem Tablets have been established in pediatric patients aged 2 months and older with a bodyweight of 5 kg and above for the treatment of acute, uncomplicated malaria ...

8.5. Geriatric Use

Clinical studies of Coartem Tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. In general, the greater frequency ...

10. Overdosage

There is no information on overdoses of Coartem Tablets higher than the doses recommended for treatment. In cases of suspected overdosage, symptomatic and supportive therapy, which would include ECG and ...

11. Description

Coartem Tablets contain a fixed combination of 2 antimalarial active ingredients, artemether, an artemisinin derivative, and lumefantrine. Both components are blood schizontocides. The chemical name of ...

12. Clinical Pharmacology

12.6 Effects on the Electrocardiogram In a healthy adult volunteer parallel-group study including a placebo and moxifloxacin control-group (n=42 per group), the administration of the 6-dose regimen of ...

12.1. Mechanism of Action

Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent [see Microbiology (12.4)].

12.3. Pharmacokinetics

Absorption Following administration of Coartem Tablets to healthy volunteers and patients with malaria, artemether is absorbed with peak plasma concentrations reached about 2 hours after dosing. Absorption ...

12.4. Microbiology

Mechanism of Action Coartem Tablets, a fixed ratio of 1:6 parts of artemether and lumefantrine, respectively, is an antimalarial agent. Artemether is rapidly metabolized into an active metabolite DHA. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Carcinogenicity studies were not conducted. Mutagenesis No evidence of mutagenicity was detected. The artemether-lumefantrine combination was evaluated using the Salmonella and ...

13.2. Animal Toxicology and/or Pharmacology

Neonatal rats (7 to 21 days old) were more sensitive to the toxic effects of artemether (a component of Coartem Tablets) than older juvenile rats or adults. Mortality and severe clinical signs were observed ...

14. Clinical Studies

14.1 Treatment of Acute, Uncomplicated P. falciparum Malaria The efficacy of Coartem Tablets was evaluated for the treatment of acute, uncomplicated malaria caused by P. falciparum in HIV negative ...

16.1. How Supplied

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. ...

16.2. Storage and Handling

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 ...