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SWIDAR®

Composition
1 tablet  contains 500 mg N’-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine).

Properties, effects
Swidar® is an antimalarial agent which acts by reciprocal potentiation of its two components, achieved by a sequential blockage of two enzymes involved in the biosynthesis of folinic acid in the parasites.  By virtue of this marked synergistic action. Swidar® is also effective against strains that are resistant to such antimalarial drugs as chloroquine and other 4-aminoquinoline derivatives or to pyrimethamine. With Swidar® the risk of resistance emerging is reduced to a minimum.  One of  the major advantages of Swidar® is that it attacks the different stages of the life cycle of the malaria parasite.  Effective concentrations are rapidly attained with a single dose and trophozoites and schizonts eliminated from the blood.  The pre-erythrocytic stages are also affected, not however, the secondary exoerythrocytic forms, which may cause recurrence of infection with Plasmodium vivax.  In such cases, therefore, consideration should be given to following up treatment with Swidar® with primaquine to prevent recurrence. Swidar® is compatible with other antimalarial drugs, particularly quinine and with antibiotics.  It has no hypoglycemic effect and does not influence the action of antidiabetic agents.

Indications
Treatment of all forms of malaria due to Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale and Plasmodium malariae. Swidar® should also be used for Intermittent Preventive treatment in Pregnancy (IPT). Swidar® has also been found effective in infections with Toxoplasma gondii and in the prophylaxis of pneumonia due to Pneumocystis carinii.

Contraindications
Swidar® is contraindicated in patients with hypersensitivity to sulfonamides or to any of the ingredients of Swidar®.  Fetal malformation has been observed in rats when Swidar® was administered in early pregnancy.  This was due to pyrimethamine, the folic acid antagonist contained in Swidar®.  Although pyrimethamine is not known to cause fetal malformation in
humans, Swidar®  should not be administered prophylactically in the first trimester of pregnancy.  In already existing malaria infections, the risk of fetal damage from the disease must be balanced against the possible implications of the above-mentioned animal experiments.  Swidar® should not be employed in premature and newborn infants during the first weeks of life, in view of the immaturity of their enzyme systems.  For the same reason, Swidar® should not be administered prophylactically in the last two weeks of pregnancy.  It is also contraindicated in cases of intolerance to sulfonamides.
Swidar®  belongs to the antifolate group of antimalarials.  There is evidence that folic acid administered concurrently with Swidar® can antagonize sulphadoxine action, therefore folic acid supplement should be delayed for one week after the use of Swidar® to avoid inhibitory effect on the antimalarial action.

Dosage and administration
a. Intermitent Preventive Treatment of Malaria in Pregnancy.
One full treatment dose during the second and third trimesters.  The last dose  should be given not later than one month before the expected date of delivery.  (Second trimester  starts from sixteen weeks or when the pregnant  woman notices the kicking of the baby)

b. Curative treatment  with a single dose.

  Once Only
Single Dose
  Tablets
Adults  
Weighing up to 60 kg
Weighing more than 60 kg
2 tablets
3 tablets
   
Children  
5 - 10 kg (ap. age £ 2 years)
10 - 20 kg (ap. age 2 - 5 years)
20 - 30 kg (ap. age 5 -10 years)
30 - 45 kg (ap. age 10 - 14 years)
½ tablet
1 tablet
1½ tablets
2 tablets
   


Caution:  Swidar® should be taken only in the doses recommended above.  Swidar®  must not be used in the first trimester of pregnancy.

Side effects
In the recommended dosage, Swidar® is generally well tolerated.  As with other drugs containing sulfonamides and/or pyrimethamine,the following side effects and hypersensitivity reactions may occur: 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, Stevens-Johnson syndrome and Lyell’s syndrome may occur.

Gastrointestinal reactions: feeling of fullness, nausea, rarely vomiting, stomatitis.  There have been isolated reports of hepatitis occuring conjointly with administration of Swidar® Hematological  changes:  In rare cases, leukopenia (usually asymptomatic),
thrombocytopenia and megaloblastic anemia have been observed.  In extremely rare cases, they  take the form of agranulocytosis or purpura.  As a rule, all these changes regress after withdrawal of the drug.  Other side effects:  Fatigue, headache, fever and polyneuritis may occasionally occur.  Pulmonary infiltrates such as occur in eosinophilic or allergic alveolitis have been reported in rare instances.  If symptoms such as cough or shortness of breath should occur under Swidar® therapy, the drug should be discontinued.

Interactions
Concurrent administration of Swidar® with trimethoprim or trimethoprim-sulfonamide combinations can result in increased impairment of folic acid metabolism and the consequent hematological side effects, and should therefore be avoided.
There have been reports which may indicate an increase in incidence and severity of adverse reactions when chloroquine is used with SwidarÒas compared with the use of Swidar®  alone.

Stability
See expiry date on the outside of the pack

Packs
Tablets              3,  500