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FARENAX® (Adult) |
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Artesunate (200 mg) & Sulfadoxine
(500 mg) + Pyrimethamine (25 mg) |
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Artemisinin based Combination
Therapy (ACT) |
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FARENAX® (Children) |
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Artesunate (50 mg) & Sulfadoxine
(500 mg) + Pyrimethamine (25 mg) |
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Artemisinin based Combination
Therapy (ACT) |
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Properties, effects: |
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FARENAX® exerts it’s
antimalarial effect through |
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the synergistic activity of all its
components (Sulfadoxine, Pyrimethamine and Artesunate).
Sulfadoxine and
Pyrimethamine act by reciprocal potentiation of its two
components, achieved by a sequential blockage of two
enzymes
involved in the biosynthesis of folic acid in parasites. |
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ARTESUNATE
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Artesunate has a rapid and potent
schizonticidal activity against malaria parasites. It
has a peroxide bond which breaks up inside the parasite
forming singlet oxygen (free radicals) which exert a
direct cytotoxic effect on the cells. By virtue of this
marked synergistic action, FARENAX® is also
effective against strains that are resistant to other
commonly used antimalarial drugs, such as chloroquine
and other 4-aminoquinoline derivatives, Proguanil,
Pyrimethamine and Sulfonamide-Pyrimethamine
combinations. FARENAX® being an Artemisinin
based Combination product, has a marked reduction of the
likelihood of resistance development to the individual
components |
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Pharmacokinetics: |
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Following oral administration ,
FARENAX® is rapidly absorbed, peak plasma
levels for Sulfadoxine is reached after about 16 hours,
Pyrimethamine after 2 to 4 hours and Artesunate in 1 -2
hours. In humans, binding to plasma protein is 87.6% for
Sulfadoxine, 92.5% for Pyrimethamine and
50% for Artesunate. Elimination half - life is 200 hours
for Sulfadoxine, 100 hours for Pyrimethamine and
approximately 2 to 4 hours for Artesunate. Artesunate is
metabolised in the liver by hydrolysis giving rise to
dihydroartemisinin, which is also effective against
malaria by the same mechanism of action. |
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Indications: |
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Treatment of all forms of malaria due
to Plasmodium falciparum, Plasmodium vivax, Plasmodium
ovale and Plasmodium malariae. |
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Contraindications: |
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FARENAX® is contraindicated in patients who
are hypersensitive to any of its active substances or to
any of it’s excipients. Fetal malformation has been
observed in rats when Sulfadoxine + Pyrimethamine alone
was administered in early pregnancy, this was due to
Pyrimethamine, the
folic acid antagonist. Although Pyrimethamine is not
known to cause fetal malformation in humans, FARENAX®
should not be administered in the first trimester of
pregnancy. |
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| FARENAX®
(Adult) |
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| A pack contains: |
| I. 3 round Sulfadoxine + Pyrimethamine
tablets each containing 500 mg Sulfadoxine and
25 mg Pyrimethamine. |
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| Dosage
and administration: |
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| Adult dose: (Above 12 years) |
3 round tablets of Sulfadoxine +
Pyrimethamine and 1 oblong caplet of Artesunate
to be taken at once on the first day, then 1
oblong caplet of
Artesunate on the second and third day
respectively. |
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| FARENAX®
for Children |
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| A pack contains: |
| I. 1 blue Sulfadoxine + Pyrimethamine tablet
containing 500 mg Sulfadoxine, and 25 mg
Pyrimethamine. |
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| II. 3 white Artesunate tablets each
containing 50 mg Artesunate base. |
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| Dosage and administration: |
| Children: (2-6 years) |
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1 blue tablet of Sulfadoxine +
Pyrimethamine and 1 white Artesunate
tablet to be taken at once, then 1 white tablet
of Artesunate to be taken on the second and
third day respectively.
Tablets to be crushed, mixed in water and taken
immediately. |
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Caution: |
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FARENAX® should
be taken only in recommended doses. |
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Side effects: |
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In the recommended dosage FARENAX®
is generally well tolerated. The following side-effects
and hypersensitive reactions may occur, as with other
drugs containing Sulfonamides and/ or Pyrimethamine.
Skin reactions: Drug rash, pruritus and slight hair loss
have been observed. These reactions are usually mild and
regress spontaneously on withdrawal of the drug. In rare
cases, particularly in hypersensitive patients, severe
possibly life threatening skin reactions such as
erythema multiforme, Steven - Johnson syndrome and Lyell
Syndrome may occur.
Gastrointestinal reactions: Feeling of fullness, nausea,
rarely vomiting, stomatitis. There have been isolated
records of hepatitis occurring conjointly with
administration of Sulfadoxine + Pyrimethamine. |
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Storage: |
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The tablets should
preferably be kept dry and in their original package.
They should be stored below 30oC. |
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Stability: |
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See expiry date on the
outside of the pack. |
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