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Amalar

Elbe Pharma Nig. Ltd
1, African Church close, off Coker Road, Ilupeju, Lagos, Nigeria
Email: elbepharma@gmail.com
Tel: 01-773-1473, 01-8179648, 08033160649
Fax: 01-452-8219

Brand Name

Amalar

Manufacturer

Micro Labs Ltd, 92, Sipcot Hosur 635 126 (TM) India

Therapeutic Class

Antimalarial drugs

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-0966): Sulfadoxine 500 mg, Pyrimethamine 25 mg.

Pack size: 3's

Amalar Tab

Suspension (NRN: 04-5637): Sulfadoxine 500 mg, Pyrimethamine 25 mg per 5 mL.

Pack size: 10 mL

Amalar Susp

Pharmacology

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.

Indications

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

Contra-indications

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.

Precautions/Warnings

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.

Interactions

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.

Adverse Effects

Dosage & Administration

(a) Treatment of acute attack of malaria

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

Adults  2-3 tablets 
Children 
 9-14 years  2 tablets 
 4-8 years  1 tablet 
 under 4 years  ½ tablet

(b) In Prophylaxis, the above dosage to be taken every two weeks.

Storage/Handling Recommendations

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

Review Date

2016-04-05 12:22:20