Lariact Tablets 20/120

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Artemether , Lumefantrine

Available from:

S Kant Healthcare Limited, INDIA

ATC code:

Antimalarials

INN (International Name):

Artemether + Lumefantrine

Dosage:

20/120

Pharmaceutical form:

Tablets

Manufactured by:

S Kant Healthcare Limited, INDIA

Product summary:

Physical description: Yellow coloured, circular, uncoated flat beveled edges tablets, having break line on one side and plain on other side; Local technical representative: Abacus Pharma Africa Limited (8473)

Authorization status:

Registered/Compliant

Authorization date:

2022-04-11

Summary of Product characteristics

PRESCRIBING INFORMATION (SUMMARY OF PRODUCT CHARACTERISTICS)
1. NAME OF THE MEDICINAL PRODUCT
PRODUCT NAME: Artemether 20 mg + Lumefantrine 120 mg Tablets
BRAND NAME: LARIACT
STRENGTH:
Each uncoated tablet contains:
Artemether…………………….20 mg
Lumefantrine………………….120 mg
Excipients……. q. s
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Artemether 20 mg and Lumefantrine 120 mg Tablets
_For full list of excipients, see section 6.1 _
3. PHARMACEUTICAL FORM:
Solid Oral Dosage Form - Uncoated Tablets
DESCRIPTION:
Yellow colored circular, uncoated flat beveled edges tablet, having
break line on one side and
another side plain.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION:
LARIACT is indicated for the treatment of acute uncomplicated
_Plasmodium falciparum _malaria
in adult, children and infants of 5 kg and above._ _
Consideration should be given to official guidance regarding the
appropriate use of antimalarial
agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION:
Tablets for oral administration.
To increase absorption, LARIACT should be taken with food or a milky
drink. If patients are
unable to tolerate food, LARIACT should be administered, but the
systemic exposure may be
reduced. Patients who vomit within 1 hour of taking the medication
should repeat the dose.
For administration to small children and infants, the tablet/s may be
crushed.
ADULTS AND CHILDREN WEIGHING 35 KG AND ABOVE
For patients 12 years of age and above and 35 kg body weight and
above, a course of
treatment comprises six doses of four tablets i.e. total of 24
tablets, given over a period of 60
hours as follows: the first dose of four tablets, given at the time of
initial diagnosis, should be
followed by five further doses of four tablets given at 8, 24, 36, 48
and 60 hours thereafter.
CHILDREN AND INFANTS WEIGHING 5 KG TO LESS THAN 35 KG
A six-dose regimen is recommended with 1 to 3 tablets per dose,
depending on body weight:
5 to less than 15 kg body weight: the first dose of one tablet, given
at the time of initial
d