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artemether and lumefantrine

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Overview

What is COARTEM?

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 artemether is (3,5a,6,8a,9,10,12,12a)-10-methoxy-3,6,9-trimethyldecahydro-3,12-epoxypyrano[4,3-]-1,2-benzodioxepine. Artemether is a white, crystalline powder that is freely soluble in acetone, soluble in methanol and ethanol, and practically insoluble in water. It has the empirical formula CHO with a molecular weight of 298.4, and the following structural formula:

The chemical name of lumefantrine is (1)-2-(dibutylamino)-1-{(9Z)-2,7-dichloro-9-[(4-chlorophenyl)methylene]-9-fluorene-4-yl}ethanol. Lumefantrine is a yellow, crystalline powder that is freely soluble in N,N-dimethylformamide, chloroform, and ethyl acetate; soluble in dichloromethane; slightly soluble in ethanol and methanol; and insoluble in water. It has the empirical formula CHClNO with a molecular weight of 528.9, and the following structural formula:

     

Coartem Tablets are for oral administration. Each Coartem Tablet contains 20 mg of artemether and 120 mg lumefantrine. The inactive ingredients are colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and polysorbate 80.



What does COARTEM look like?



What are the available doses of COARTEM?

Tablets are scored and contain 20 mg artemether and 120 mg lumefantrine. ()

What should I talk to my health care provider before I take COARTEM?

How should I use COARTEM?

Coartem (artemether/lumefantrine) Tablets are indicated for treatment of acute, uncomplicated malaria infections due to in patients of 5 kg bodyweight and aboveCoartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [].

Limitations of Use

:

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 can be tolerated since this improves absorption of artemether and lumefantrine.

For patients who are unable to swallow the tablets such as infants and children, Coartem Tablets may be crushed and mixed with a small amount of water (1 to 2 teaspoons) in a clean container for administration immediately prior to use. The container can be rinsed with more water and the contents swallowed by the patient. The crushed tablet preparation should be followed whenever possible by food/drink (e.g., milk, formula, pudding, broth, and porridge).

In the event of vomiting within 1 to 2 hours of administration, a repeat dose should be taken. If the repeat dose is vomited, the patient should be given an alternative antimalarial for treatment.


What interacts with COARTEM?

Sorry No Records found


What are the warnings of COARTEM?

Sorry No Records found


What are the precautions of COARTEM?

Sorry No Records found


What are the side effects of COARTEM?

Sorry No records found


What should I look out for while using COARTEM?

Hypersensitivity

Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets .

Strong CYP3A4 Inducers

Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy .


What might happen if I take too much COARTEM?

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 blood electrolyte monitoring, should be given as appropriate.


How should I store and handle COARTEM?

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F). Coartem (artemether/lumefantrine) Tablets20 mg/120 mg Tablets - Bottle of 24                         NDC 0078-0568-45Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [].Dispense in tight container (USP).Coartem (artemether/lumefantrine) Tablets20 mg/120 mg Tablets - Bottle of 24                         NDC 0078-0568-45Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [].Dispense in tight container (USP).Coartem (artemether/lumefantrine) Tablets20 mg/120 mg Tablets - Bottle of 24                         NDC 0078-0568-45Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [].Dispense in tight container (USP).Coartem (artemether/lumefantrine) Tablets20 mg/120 mg Tablets - Bottle of 24                         NDC 0078-0568-45Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [].Dispense in tight container (USP).Coartem (artemether/lumefantrine) Tablets20 mg/120 mg Tablets - Bottle of 24                         NDC 0078-0568-45Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [].Dispense in tight container (USP).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Coartem Tablets, a fixed dose combination of artemether and lumefantrine in the ratio of 1:6, is an antimalarial agent .

Non-Clinical Toxicology
Hypersensitivity

Known hypersensitivity to artemether, lumefantrine, or to any of the excipients of Coartem Tablets .

Strong CYP3A4 Inducers

Coadministration of strong inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. John’s wort with Coartem Tablets can result in decreased concentrations of artemether and/or lumefantrine and loss of antimalarial efficacy .

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed ).

Caution should also be taken in concurrent or serial use of other amino-glycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral neomycin sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

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

Coartem Tablets should be avoided in patients:

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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