Amalar Sulfadoxine and Pyrimethamine Tablets

AMALAR®

SULFADOXINE and PYRIMETHAMINE TABLETS USP

 

For the use of Medical Profession, Hospital or a Laboratory only

 

COMPOSITION

Each tablet contains

Pyrimethamine USP 25 mg and Sulfadoxine USP 500 mg

 

PHARMACOLOGICAL CATEGORY

A combination of Sulfadoxine and Pyrimethamine as an antimalarial agent.

 

PHARMACOLOGY

MECHANISM OF ACTION

Sulfadoxine and Pyrimethamine combination acts by reciprocal potentiation of its two components, achieved by a sequential blockade of two enzymes involved in the biosynthesis of folic acid in the parasites. Sulfadoxine and pyrimethamine is effective against strains of plasmodium falciparum that are resistant to chloroquine.

 

PHARMACOKINETICS

Both SuIfadoxine and Pyrimethamine are absorbed orally and are excreted mainly by the kidney. 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 mcg/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.

 

INDICATIONS AND USES

Treatment of P. falciparum malaria for those patients, in whom Choloroquine resistance is suspected.

 

CONTRAINDICATION

Repeated use of Sulfadoxine and Pyrimethamine is contraindicated in patients with severe renal insufficiency, marked liver parenchymal damage or blood dyscrasias.

— Hypersensitivity to Pyrimethamine or Sulphonamides.

— Patients with documented megaloblastic anaemia due to Folate deficiency.

— Infants less than 2 months of age.

— Pregnancy at term and during nursing period.

 

PRECAUTIONS AND WARNINGS

Sulfadoxine and 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 bronchial asthma, patients should be warned that at the first appearance of a skin rash, they should stop use of Sulfadoxine and Pyrimethamine and seek immediate medical attention.

 

DRUG INTERACTION

There have been reports that incidence and severity of adverse effects may be increased by co-administering chloroquine with Sulfadoxine and Pyrimethamine. Antifolic drugs such as contrimoxazole should not be used while the patient is receiving the combination for antimalaria prophylaxis.

 

USE IN PREGNANCY AND LACTATION

There are no adequate or well controlled studies in pregnant women. Since Sulphonamides are excreted in the human breast milk, the said combination is not recommended to nursing mothers.

 

DOSAGE AND ADMINISTRATION

Treatment of acute attack of malaria

A single dose of the following number of Pyrimethamine plus Sulfadoxine combination is used in sequence with quinine or alone.

Adults 2-3 tablets

9-14 years 2 tablets

4-8 years 1 tablet

Under 4 years ½ tablet

In Prophylaxis the above dosage to be taken every two weeks.

 

STORAGE

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

 

PACK

50 x 3’s / 25 x 3’s / 1 x 3’s

 

DATE OF PUBLICATION

March 2000

 

Manufactured by

MICRO LABS LIMITED

92, SIPCOT, HOSUR-635 126, INDIA.

FORMERLY KNOWN AS

BROWN & BURK PHARMACEUTICAL LTD.

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