1300074  Artem 20mg+Lumef120mg disp tab/6/PAC-30

02 PHARMACEUTICALS
06 Anti-infective drugs
70 Antimalarial drugs

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General Description
Artemether 20mg + Lumefantrine 120mg fixed dose combination dispersible
tablets, blister strip of 6 tablets, pack of 30

Technical specifications
Each dispersible tablet contains Artemether 20mg Ph. Int. and
Lumefantrine 120mg

Therapeutic class
Artemether is a sesquiterpine lactone derived from artemesinin.
Lumefantrine is a synthetic racemic fluorene mixture
(dichlorobenzylidine derivative)

Standard shelf life
2 years (24 months)

Other available formulations
Artemether 20mg + Lumefantrine 120mg dispersible tablets, 6s
Artemether 20mg + Lumefantrine 120mg tablets, 6s, 12s, 18s, 24s
Artemether injection 20mg/ml, 40mg/ml, 80mg/ml, 100mg/ml
Artemotil 50mg/ml, 75mg/ml, 150mg/ml
Artemether 40mg+Lumefantrine 240mg tablets 6s, 12s (Not yet available
from UNICEF)
Artemether 80mg+Lumefantrine 480mg tablets 6s (Not yet available from
UNICEF)
Artesunate injection 60mg (Not yet available from UNICEF)
Artemether 15mg/5ml+Lumefantrine 90mg/5ml oral suspension (Not yet
available from UNICEF)

Indications
Treatment of acute uncomplicated malaria caused by P. falciparum alone
or with other Plasmodium spp. In areas with significant drug resistance.
By Mouth (PO)

Dosage
Suggested dosing is based on the WHO guidelines for the treatment of
Malaria: www.who.int/malaria/publications/atoz/9241546948/en/index.html

Temperature considerations
Do not store above 30 °C (86 °F)

Storage
Store in tightly closed original container
Keep out of reach and sight of children

Dispensing instructions
Dispense in original container. Do not repack

Advice patient to disperse each tablet: The dispersible tablet(s)
composing 1 dose should be completely dispersed in a small amount of
water (approximately 10ml or less). The dispensing device should be
rinsed with an additional small amount of water and be given to the
patient to ensure full dosage administration.

Lumefantrine absorption is enhanced by co-administration with fat.
Patients with acute malaria are often averse to food, therefore, they
should be encouraged to resume intake as soon as they can tolerate food
to improve absorption. Advice patients or carers of the need to take AL
with milk or fat-containing food, particularly on the second (2nd) and
third (3rd) day of treatment.

Advice patient to repeat dose if vomiting occurs within one hour of
taking the last dose.

Guidelines for use
For more details, please see
World Health Organisation (WHO), Guidelines for the treatment of
Malaria: (www.who.int/malaria/en/)
WHO, Model Lists of Essential Medicines for adults and/or children
respectively:
(www.who.int/medicines/publications/essentialmedicines/en/index.html)
WHO Model Formulary: (apps.who.int/emlib/Default.aspx?Language=EN)
or your regional and/or national guidelines.

Regulatory status
For latest updates check the list of Prequalified Medicines on the WHO
website Prequalification Programme. apps.who.int/prequal/

For latest updates check the list of USFDA approved and tentatively
approved items on the USFDA website. www.fda.gov/default.htm,
www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/

Component of kits
9906622 IEHK2006,kit,basic unit,malaria

Emergency item
This material is part of the Emergency Supply List for Nutrition


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