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Drug Details

PALUDRINE

• Drug Class Description
  Biguanides (antimalarials).
• Generic Name
  Proguanil
• Presentation
  Tablets for oral administration.
• Description
  Proguanil hydrochloride 100 mg
• Indications
  Paludrine is an effective antimalarial agent. It is recommended for the prevention and suppression of malaria.
• Adult Dosage
  

  Non-immune subjects entering a malarious area are advised to begin treatment with Paludrine 1 week before, or if this is not possible, then at least 2 days before entering the malarious area. The daily dose of Paludrine should be continued throughout exposure to risk and for 4 weeks after leaving the area.

  Adults:	Two tablets (200 mg) daily.
  Children:	Under 1 year:	1/4 tablet (25 mg) daily
  	1 to 4 years:	1/2 tablet (50 mg) daily
  	5 to 8 years:	1 tablet (100 mg) daily
  	9 to 14 years:	1 1/2 tablets (150 mg) daily
  	Over 14 years:	Adult dose daily

  The daily dose is best taken with water, after food, at the same time each day.

  Provided the tablet fragment gives the minimum amount specified, precise accuracy in children's dosage is not essential since the drug possesses a wide safety margin.

  For a young child, the dose may be administered crushed and mixed with milk, honey or jam. The treatment should be started at least two days before entering the malarious area and continued for the whole period of stay and 4 weeks after leaving the area.

  Elderly patients: There are no special dosage recommendations for the elderly, but it may be advisable to monitor elderly patients so that optimum dosage can be individually determined.

  Renal Impairment: Based on a theoretical model derived from a single dose pharmacokinetic study, the following guidance is given for adults with renal impairment.

  Creatinine clearance		Dosage
  	(ml/min 1.73 m2 )
  	60 20 to 59 10 to 19 < 10	200 mg once daily (standard dose) 100 mg once daily 50 mg every second day 50 mg once weekly

  The grade of renal impairment and/or the serum creatinine concentration may be approximately equated to creatinine clearance levels as indicated below.

  Creatinine Clearance (ml/min/1.73 m2 )	Approx* serum Creatinine (micromol/1)	Renal Impairment Grade (arbitrarily divided for dosage purposes)
  60	-	-
  20 to 59	150 to 300	Mild
  10 to 19	300 to 700	Moderate
  < 10	> 700	Severe

  *Serum creatinine concentration is only an approximate guide to renal function unless corrected for age, weight and sex.

• Child Dosage
  Under 1 year, / tablet; 1 - 4 years, / tablet; 5 - 8 years, 1 tablet; 9 - 14 years, 1/ tablets. All daily, after food. Start at least 24 hours before entering endemic area and continue for 4 weeks after leaving. Travel Pack, see data sheet.
• Contra Indications
  

  Paludrine should be used with caution in patients with severe renal impairment.

• Special Precautions
  

  Paludrine should be used with caution in patients with severe renal impairment. There have been rare reports of haematological changes in such patients.

  In any locality where drug-resistant malaria is known or suspected, it is essential to take local medical advice on what prophylactic regimen is appropriate. Prophylactic use of Paludrine alone may not be sufficient.

• Interactions
  

  Antacids may reduce the absorption of proguanil, so should be taken at least 2-3 hours apart.

  Proguanil can potentiate the anticoagulant effect of warfarin and related anticoagulants through a possible interference with their metabolic pathways. Caution is advised when initiating or withdrawing malaria prophylaxis with Paludrine in patients on continuous treatment with anticoagulants.

• Adverse Drug Reactions
  

  At normal dosage levels the side effect most commonly encountered is mild gastric intolerance, including diarrhoea and constipation. This usually subsides as treatment is continued.

  Mouth ulceration and stomatitis have on occasion been reported. Isolated cases of skin reactions and reversible hair loss have been reported in association with the use of proguanil.

  Rarely, allergic reactions, which manifest as urticaria or angioedema and very rarely vasculitis, have been reported.

  Drug fever and cholestasis may very rarely occur in patients receiving Paludrine.

  Haematological changes in patients with severe renal impairment have been reported.