Maldox Sulfadoxine Pyrimethamine Tablet

Maldox (SULFADOXINE + PYRIMETHAMINE)

Composition, Description, Indication, Contraindication, Caution, Dosage and administration, Tolerability, Interactions, Presentation, Storage and Marketer of Maldox Tablet, Suspension Medicine for Malaria.

 

COMPOSITION

Each tablet/5 ml of Madox suspension contains 500mg sulfadoxine (N- 5,6-dimethoxy-4- pyrimidinyl) sulphanilamide), and 25mg pyrimethamine (2-4 diamino-5(p-chlorophenyl)-6 ethylpyrimidine.

 

DESCRIPTION

Maldox is an antimalarial agent containing two components which act synergistically to block the enzyme mediated biosynthetic pathway of folinic acid in the malaria parasite. Due to its enhanced activity, Maldox is effective against malaria resistant to chloroquine, and other 4- aminoquinolines, pyrimethamine, proguanil.

Different stages of the malaria parasite life cycle are susceptible to Maldox. With a single dose effective blood concentration are quickly achieved to eliminate the pre-erythrocyte stage, trophozoites and schizonts.

In treatment of recurrent Plasmodium vivax, a course of Maldox followed by primaquine is useful to eliminate the exoerythrocytic forms.

 

INDICATION

Maldox is indicated in the prophylaxis of all types of malaria due to Plasmodium falciparum, P. ovale, P. malariae and P. vivax in pregnancy (intermittent prevention therapy {IPTp}) during the 2nd  and 3rd  trimester. It is also indicated for the treatment of uncomplicated P. falciparum malaria incombination with amodiaquine or artesunate.

 

CONTRA-INDICATION

Maldox is contr-indicated in patients with known hypersensitivity to sulphonamide and its components. Pyrimethamine has been demonstrated to cause foetal consequences in rats; such malformation has not been reported in humans. In premature and newborn infants, during the early weeks of life. Maldox is not to be used, due to poorly matured enzymes system. It should likewise not be given prophylatically in the last weeks of pregnancy, Sulphadoxine/Pyrimethamine belong to the antifolate group of antimalarias, there is evidence that folic acid supplement should be delayed for one week after the use of the drug to avoid inhibitory effect of the antimalarial action.

 

CAUTION

Maldox should not used in the first trimester of pregnancy.

 

DOSAGE AND ADMNINISTRATION

Prophylaxis 3 tablets or 15ml of suspension.

In pregnancy, one full treatment dose at the beginning of the 2nd  and 3rd  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 pregnancy woman notices the kicking of the baby).

 

TOLERABILITY

Maldox is generally tolerated at recommended doses. As with other drugs containing sulphonamide, side effects like skin reactions may occur. Skin reactions like rash, pruritus and hair loss have been reported. The reactions are however mild and remit with the withdrawal of the drug.

Gastro-intestinal reactions include feeling of fullness, nausea, rarely vomiting and stomatitis.

Haematological changes have also been observed and include thrombo-cytpenia and leucopenia in rare cases. Other side effects include fatigue and headache.

 

INTERACTIONS

Administration of Maldox along with trimethoprim or contrimoxazole can result in increased interference with folic acid metabolism and consequently haematological side effects. It should therefore be avoided. There is a reported increase in severity of adverse effects associated with the co-administration of Maldox with chloroquine.

 

PRESENTATION

Maldox is available in blisters of 3’s and as 15ml suspension.

 

Store in a dry place away from heat and strong light.

 

Keep all medicines out of reach of children.

 

Marketed by

Emzor Pharmaceutical Industries Limited

Plot 3C, Block A, Aswani Market Road,

Off Oshodi Apapa Way,

Isolo-Lagos