Macsunate AQ Forte Tablets

Maa: Tansania

Kieli: englanti

Lähde: Tanzania Medicinces & Medical Devices Authority

Aktiivinen ainesosa:

Artesunate , amodiaquine

Saatavilla:

Macleods Pharmaceuticals Limited, INDIA

ATC-koodi:

Antimalarials, Artemisinin and derivatives, combin

INN (Kansainvälinen yleisnimi):

Artesunate and amodiaquine

Annos:

100 + 270 mg

Lääkemuoto:

Tablets

Valmistaja:

Macleods Pharmaceuticals Limited, INDIA

Tuoteyhteenveto:

Physical description: Bilayered round flat, beveled edged, uncoated tablets having plain surface on both side, one layer is yellow colored , the other is white to off colored; Local technical representative: Barnabas Maganga Shija (3292)

Valtuutuksen tilan:

Registered/Compliant

Valtuutus päivämäärä:

2022-11-07

Pakkausseloste

* if a weight-age mismatch occurs, dosing should be weight-based.
AS: artesunate
AQ: amodiaquine
Artesunate & Amodiaquine should not be taken with a high-fat meal.
The tablets should be swallowed with water.
For patients unable to swallow the tablets whole, e.g. very young
children, the
tablets can be dissolved in water before administration. The tablets
can also be
crushed and administered with water.
Should vomiting occur within half an hour after dosing, a repeated
dose of
Artesunate & Amodiaquine is to be taken. In case of further vomiting,
treatment
for severe malaria should be considered.
DRUG INTERACTIONS
Interactions with drugs used for treatment of HIV and/or tuberculosis
may occur,
though little clinical data is available. Prescriber should be
vigilant for adverse
events potentially related to such interactions, including liver
toxicity and
neutropenia.
Artesunate
&
Amodiaquine
is
not
recommended
to
be
administered
concomitantly with drugs known to inhibit the liver enzymes cytochrome
(CYP)
2A6 (e.g. methoxsalen, pilocarpine, tranylcypromine) and/or CYP2C8
(e.g.
trimethoprim,
ketoconazole,
ritonavir,
saquinavir,
lopinavir,
gemfibrozil,
montelukast,).
No pharmacokinetic interactions of artesunate with other antimalarial
drugs of
importance have been identified. However, concomitant administration
of
For the use only of a Registered Medical Practitioner or a Hospital or
a
Laboratory
MACSUNATE AQ FORTE
Artesunate and Amodiaquine Tablets 100/270 mg
COMPOSITION
Each Bilayered tablet contains:
Artesunate ……………...............................……100mg
Amodiaquine Hydrochloride USP
Equivalent to Amodiaquine USP……………..…270 mg
DESCRIPTION
PHARMACOLOGICAL CLASSIFICATION
Antimalarial Agent
PHARMACOLOGICAL ACTION:
PHARMACOKINETICS
ARTESUNATE
_ABSORPTION _
After oral administration, absorption is rapid. Most of the artesunate
is promptly
biotransformed, mainly through plasma esterases, into the active
metabolite
dihydroartemisinin (DHA).
After administration of two Artesunate & Amodiaquine 100m