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Isason Artemether & Lumefantrine 20/120 Tablets

NAFDAC Reg. No. C4-1399 · Drug

Registered with NAFDAC. Registration activeAs of 28 October 2026 · synced automatically from official sources.
Product
Isason Artemether & Lumefantrine 20/120 Tablets
NAFDAC number
C4-1399
Active ingredient
Artemether; Lumefantrine
Strength
20 mg; 120 mg
Form
Tablet
Manufacturer
Not listed
Applicant (holder)
Isason Pharmaceuticals (Nig) Ltd
Approved
21 Dec 2020
Status
Inactive View on NAFDAC ↗
Registration valid to
20 Dec 2025
WHO alerts
None found
Community reports
None
Times checked
0
Commonly used to treat malaria. General information only — confirm the correct course with a healthcare provider, especially for children or pregnant women.

What we found

  • Isason Artemether & Lumefantrine 20/120 Tablets is on the NAFDAC register with an active registration (C4-1399). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. This is not medical advice. Always follow your doctor or pharmacist.

What Isason Artemether & Lumefantrine 20/120 Tablets is used for

From the official U.S. FDA label for artemether, the active ingredient registered with NAFDAC.

What it is used for

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 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets are not approved for patients with severe or complicated P. falciparum malaria. Coartem Tablets are not approved for the prevention of malaria. …

Possible side effects

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Hypersensitivity Reactions [see Contraindications (4)] Prolongation of the QT Interval [see Warnings and Precautions (5.1)] Use of QT Prolonging Drugs and Other Antimalarials [see Warnings and Precautions (5.2)] Drug Interactions with CYP3A4 [see Warnings and Precautions (5.3)] Drug Interactions with CYP2D6 [see Warnings and Precautions (5.4)] The most common adverse reactions in adults (greater than 30%) are headache, anorexia, dizziness, asthenia, arthralgia, and myalgia. …

Do not use if

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 inducers of CYP3A4 such as rifampin, carbamazepine, phenytoin, and St. …

Warnings

Avoid use in patients with known QT prolongation, those with hypokalemia or hypomagnesemia, and those taking other drugs that prolong the QT interval. ( 5.1 , 12.6 ) Halofantrine and Coartem Tablets should not be administered within one month of each other due to potential additive effects on the QT interval. ( 5.1 , 5.2 , 12.3 ) Antimalarials should not be given concomitantly, unless there is no other treatment option, due to limited safety data. ( 5.2 ) QT prolonging drugs, including quinine and quinidine, should be used cautiously following Coartem Tablets. …

Pregnancy & breastfeeding

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, or adverse maternal or fetal outcomes (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. …

General information only, not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of Isason Artemether & Lumefantrine 20/120 Tablets

Add the expiry date on your pack for a full Trust Score.

3 free checks left today Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About Isason Artemether & Lumefantrine 20/120 Tablets

What is in Isason Artemether & Lumefantrine 20/120 Tablets?

Isason Artemether & Lumefantrine 20/120 Tablets contains Artemether; Lumefantrine (20 mg; 120 mg), as tablet, according to its NAFDAC registration record.

Is Isason Artemether & Lumefantrine 20/120 Tablets registered with NAFDAC?

Yes. Isason Artemether & Lumefantrine 20/120 Tablets is listed on the NAFDAC register under registration number C4-1399, and its registration is active as of 28 October 2026.

Has Isason Artemether & Lumefantrine 20/120 Tablets been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches Isason Artemether & Lumefantrine 20/120 Tablets in our automatically synced alert list.

How can I check that my pack of Isason Artemether & Lumefantrine 20/120 Tablets is genuine?

Run a free authenticity scan with the NAFDAC number C4-1399, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is Isason Artemether & Lumefantrine 20/120 Tablets used for?

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 kg and above. Coartem Tablets have been shown to be effective in geographical regions where resistance to chloroquine has been reported [see Clinical Studies (14.1)] . Limitations of Use : Coartem Tablets ar (Summarised from the official U.S. FDA label for artemether. Always follow your doctor or pharmacist.)

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