PALUDRINE TAB :It is recommended for the prevention and suppression of malaria
Therapeutic indications
Paludrine is an effective antimalarial agent. It is recommended for the prevention and suppression of malaria.
Posology and method of administration
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. (See also Sections 4.3 and 4.4)
Creatinine clearance (ml/min 1.73 m2)
Dosage
> 60
200 mg once daily (standard dose)
20 to 59
100 mg once daily
10 to 19
50 mg every second day
< 10
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.
*Serum creatinine concentration is only an approximate guide to renal function unless corrected for age, weight and sex.
Contraindications
Paludrine should be used with caution in patients with severe renal impairment
Special warnings and precautions for use
Paludrine should be used with caution in patients with severe renal impairment. (See also Section 4.2) 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.
Interaction with other medicinal products and other forms of interaction
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.
Pregnancy and lactation
Pregnancy: Paludrine has been widely used for over 40 years and a causal connection between its use and any adverse effect on mother or foetus has not been established.
However, Paludrine should not be used during pregnancy unless, in the judgement of the physician, potential benefit outweighs the risk.
Malaria in pregnant women increases the risk of maternal death, miscarriage, still-birth and low birth weight with the associated risk of neonatal death. Although travel to malarious areas should be avoided during pregnancy, if this is unavoidable effective prophylaxis is therefore strongly advised in pregnant women.
Lactation: Although Paludrine is excreted in breast milk, the amount is insufficient to confer any benefit on the infant. Separate chemoprophylaxis for the infant is required.
Effects on ability to drive and use machines
There is no evidence to suggest that Paludrine causes sedation or is likely to affect concentration.
Undesirable effects
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.
