ANTIMALARIAL [Sulfadoxine & Pyrimethamine Tablets USP]
1 Tablet of MALARCRUSH contains 500 mg sulfadoxine and 25 mg of pyrimethamine
MALARCRUSH, is an antimaIarial agent which acts against the malarial pathogens by reciprocal potentiation of its two components. By virtue of this marked synergistic action, the asexual erythrocytic forms of the malarial parasites (trophozoites schizonts) are killed with a single dose. This effect is achieved by blockade of two enzymes involved in the biosynthesis of folinic acid in the parasites.
MALARCRUSH is active against all human pathogenic Plasmodia (P. falciparum, P. ovale, P. malariae) and is also effective against strains that are resistant to certain antimalarial agents such as chloroquine and other 4-aminoquinoline derivatives or to pyrimethamine.
MALARCRUSH may be combined with quinine as well as antibiotics, it has no hypoglycaemic effect. Foetal damage has been observed in the rat when MALARCRUSH) may be combined with quinine as well antibiotics. It has no hypoglycaemic effect. Foetal damage is caused by the folic acid antagonist, pyrimethamine, contained in (MALARCRUSH), and can be prevented by concomitant administration of high doses of folinic acid. Both pyrimethamine and sulfadoxine pass into maternal breast milk.
Therapy and prophylaxis of malaria.
Therapy of malaria: ‘MALARCRUSH’ is indicated for the treatment of P. falciparum malaria as long as the infection occurs in an area with chloroquine resistance.
Prophylaxis of malaria: Whenever malaria prophylaxis is prescribed, the malaria situation, and in particular resistance trends at the traveller’s destination, as well as possible side effect of the available antimalarial must be considered. At present there is no antimalarial agent which provides absolute protection against malaria, but conscientiously performed drug prophylaxis can usually prevent serious progress of the disease. Pregnant women must be made aware of the particular risks of, contracting malaria during pregnancy and should be advised not to undertake unnecessary joumeys to endemic areas. Malaria prophylaxis with MALARCRUSH is indicated for travellers to areas where chloroquine resistant P. falciparum malaria is endemic.
MALARCRUSH has also been found effective in infections with Toxoplasma gondii and in the prophylaxis of pneumonia due to Pneumocystis carinii.
Dosage and administration
(a) Curative treatment of malaria with a single dose.
In order to achieve a more rapid therapeutic response and to prevent relapses (recrudescences), it is advisable to administer quinine in addition in the usual dosage for three to seven days either orally or (in severe cases) by i. v. infusion.
Children under 4 years (5-10kg) ½ tablet
4-8 years (11-20 kg) 1 tablet
7-9 years (21-30kg) 1 ½ tablets
10-14 years (31-45kg) 2 tablets
(b) Prophylaxis or suppressive management of malaria
The amount Indicated below Is to be taken as single dose.
Once every four weeks
Once a week
2 or 3 tablets 1 tablet
(according to body weight, high dose for persons over 60kg
|2 or 3 tablets||1 tablet|
|Once every four weeks||Once every two weeks|
Or as directed by the Physician.
For Malaria prophylaxis the first dose of ‘MALARCRUSH’ should be administered about one week before departure for an endemic area. Administration should be continued at the above dosages during the stay and also for the first six weeks after returning.
Duration of prophylaxis or suppressive management at the most 18 months for the time being since no experience of more prolonged administration has been gained to date.
Restrictions on use precautions, special remarks, MALARCRUSH is contraindicated in patients with known hypersensitivity to sulfonamides. If skin reactions are observed, the drug should be withdrawn immediately and a doctor consulted. Excessive exposure to the sun should be avoided.
Clinical experience has not yielded any indication of foetal damage such as might have been feared in the light of the animal experiment findings. Nevertheless MALARCRUSH should not be administered in early pregnancy or where there is a possibility of conception unless it is absolutely imperative.
Prophylactic (repeated) use of MALARCRUSH is contraindicated in patients with severe renal insufficiency marked liver parenchymal damage or blood dyscrasias.
MALARCRUSH should not be given to infants below the age of 2 months. Nursing mothers should not take ‘MALARCRUSH’. If they do, they must discontinue breast feeding during the treatment.
Regular bIood counts are indicated whenever ‘MALARCRUSH’ is administered for more than three months.
On prolonged administration of high doses as in the treatment of toxoplasmosis, any folic acid deficiency can be prevented by administration of folinic acid.
In the recommended dosage, ‘MALARCRUSH’ is generally well tolerated. As with other drugs containing sulfonamides and/or pyrimethamine, the following side effects and hypersensitivity reactions may occur.
Skin reactions: Skin rash, pruritus and alopecia have been observed. These reactions are usually mild and regress spontaneously on withdrawal of the drug. In some 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 occurring conjointly with administration of MALARCRUSH.
Hematological changes: In rare cases, leukopenia (usually asymptomatic), thrombocytopenia and megaloblastic anemia have been observed. In extremely rare cases, they take the form of agranulocytes 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 occur under MALARCRUSH therapy, the drug should be discontinued.
Interaction: Concurrent administrations of MALARCRUSH with trimethoprin 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 MALARCHRUSH as compared with the use of MALARCRUSH alone.
Overdosage: Possible symptoms : anorexia, nausea, vomiting, signs of excitation and possibly convulsions and hematological changes (megaloblastic anemia, leukopenia, thrombocytopenia)
Measures to be taken: Gastric lavage, fluid replacement in acute intoxication; praenteral diazepamor a barbiturate in cases of convulsions. Monitoring of renal function and repeated blood counts for up to four weeks after the overdosage. If the above hematological changes are found, folinic acid should be administered intramuscularly.
Storage: Store in a cool, dry & dark place. Protect from light. Keep all medicines out of reach of children.
Presentation: Strip pack of 3 Tablets.
Ghatkopar (W), Mumbai-400 086
Factory: A-188, T.T.C., MIDC,
Khairne, Navi Mumbai-400 710, India
De Godstime Industries Nig. Ltd.
9, Belonwu Street, Fegge, Onitsha,
Anambra state, Nigeria.
NAFDAC Reg. No. 04-5631