Sagar Vitaceuticals Nigeria Limited

Sulfadoxine USP 500 mg Pyrimethamine USP 25 mg It is recommended for Intermittent Preventive Treatment of malaria in pregnancy (IPTp); Sulphadoxine/ Pyrimethamine has been found effective in infections with Toxoplasma gondii and in the prophylaxis of pneumonia due to pneumocystic carinii.

Vitadar

Sulfadoxine USP 500 mg
Pyrimethamine USP 25 mg

It is recommended for Intermittent Preventive Treatment of malaria in pregnancy (IPTp); Sulphadoxine/ Pyrimethamine has been found effective in infections with Toxoplasma gondii and in the prophylaxis of pneumonia due to pneumocystic carinii.

Sulfadoxine and Pyrimethamine combination acts by reciprocal potentiating of its two components achieved via a sequential blockade of two enzymes involved in the biosynthesis of folic acid in the parasites. Sulfadoxine plus Pyrimethamine is effective against strains of Plasmodium falciparum that are resistant to chloroquine.
Both Sulfadoxine and Pyrimethamine are absorbed orally and are excreted mainly by the kidneys. Following a single tablet administration, sulfadoxine peak plasma concentrations of 51 to 76 mcg/mL are achieved in 2.5 to 6 hours and the Pyrimethamine peak plasma concentrations of 0.13 to 0.4 mxg/mL are achieved in 1.5 to 8 hours. The mean elimination half life of Sulfadoxine is 169 hours whereas that of Pyrimethamine is 111 hours.

IPT: Intermittent Preventive Treatment of malaria in pregnancy One full treatment dose during the second and third trimesters. The last dose to be given not later than one month before date of delivery.
TOLERANCE: Well tolerated at the recommended dosage.
OTHER REACTIONS: SKIN: Mild reactions such as drug rash, pruritus and slight hair loss are observed in hypersensitive patients. Erythema multiforme, Stevents-Johnson Syndrome and yell’s syndrome can occur.
GASTROINTESTINAL: Nausea, vomitting, stomatities and rarely hepatitis.
Others: Headache, Pyrexia, Fatigue and Polyneurities can occur.
INTERACTIONS: When Vitadar administered along-with trimethoprim or trimethoprim-sulfonamide cominations there are possibilities of increased impairment of folic acid metabolism and the concurrent heamatological side effects and therefore administration along-with the above combination should be avoided.

Repeated use of Sulfadoxine plus Pyrimethamine is contraindicated in patients with severe renal insufficiency, marked liver parenchyma damage or blood dyscrasias. Hypersensitivity to Pyrimethamine and/or Sulfonamides Patients with documented megaloblastic anemia due for folate deficiency Infants less than 2 months of age Pregnancy at term and during the nursing period.

Sulfadoxine plus Pyrimethamine should be given with caution to patients with impaired renal or hepatic function, to those with possible folate deficiency and to those with severe allergy or brounchial asthma.
Patients should be warned that at the first appearance of a skin rash, they should stop use of Sulfadoxine plus Pyrimethamine and seek immediate medical attention.

There have been reports that incidence and severity of adverse effects may be increased by co-administering Chloroquine with Sulfadoxine plus Pyrimethamine.
Antifolic drugs such as Co-trimoxazole should not be used while the patients is receiving the combination of antimalarial prophylaxis.
In Pregnancy and Lactation: There are no adequate or wellcontrolled studies in pregnant women.
Since Sulfonamides are excreted in the human breast milk, the said combination is not recommended to nursing mothers.

Sulfadoxine plus Pyrimethamine should be given with caution to patients with impaired renal or hepatic function, to those with possible folate deficiency and to those with severe allergy or brounchial asthma.
Patients should be warned that at the first appearance of a skin rash, they should stop use of Sulfadoxine plus Pyrimethamine and seek immediate medical attention.

Store in a cool dry place and keep away from the reach of children. Protect from light.