| Customization: | Available |
|---|---|
| Application: | Internal Medicine |
| Usage Mode: | For oral administration |
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ARTEMETHER+LUMEFANTRINE TABLET 80+480mg
Indications:
This medication is used to treat malaria in adults and children. The two ingredients in this medication belong to a class of drugs known as antimalarials. Malaria is an infection caused by mosquito bites received while traveling or living in regions of the world where malaria is common. Malaria parasites enter the body, and live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in the liver. Both treatments may be needed for a complete cure and to avoid the return of infection (relapse). This product is not used to prevent malaria.
Dosage and Administration:
Take this medication by mouth, with food, exactly as prescribed by your doctor. This medication is usually taken twice a day with a meal for 3 days (6 doses) or as directed by your doctor. On your first day of treatment, take your first dose with food, followed by your second dose 8 hours later. Then each day for the next 2 days, take one dose in the morning and one dose in the evening.
Precautions & Warning:
Before taking artemether/lumefantrine, tell your doctor or pharmacist if you are allergic to artemether or lumefantrine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent use (within the past month) of any medication to prevent or treat malaria (such as halofantrine, quinine, or quinidine), kidney problems, liver problems.
Artemether/lumefantrine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Contra-indications:
Hypersensitivity to Artemether, Lumefantrine or any of the excipients in the finished product.
Drug interactions:
CYP3A4 Inhibitors: Use cautiously due to potential for QT prolongation.
Mefloquine: If used immediately before treatment, monitor for decreased effcacy of Coartem Tablets and encourage food consumption
Hormonal Contraceptives: Effectiveness may be reduced; use an additional method of birth control
Anti-Retrovirals: Usc cautiously due to potential for QT prolongation, loss of anti-viral effcacy, or loss of antimalarial effcacy of Coartem Tablets.
CYP2D6 Substrates: Monitor for adverse reactions and potential QT prolongation
Storage instructions:
Do not store above 30°C.
| Testing terms | Standards | Results |
| Characters | yellowish tablets | yellowish tablets |
| Uniformity of weight | ±7.5% | 2.8% |
| friability | No fractures, cracks or shredded pieces were detected, and the weight loss did not exceed 1% |
0.32% |
| Dissolution | Artemether 1h Limit:Min 30% 3h Limit:Min 50% Benfluorenol Limit: Min 50% |
1h:58.11% 3h:65.66% 81.01% |
| Microbial Limit | Test Passed | Test Passed |
| Assay | Ci6H26O5 Limit: 90~110% C30H32Cl3NO Limit: 90~110% |
102.90% 97.55% |
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