Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB, United Kingdom
Paludrine is an effective antimalarial agent. It is recommended for the prevention and suppression of malaria.
Oral use.
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.
Two tablets (200 mg) daily.
Under 1 year: ¼ tablet (25 mg) daily.
1 to 4 years: ½ tablet (50 mg) daily.
5 to 8 years: 1 tablet (100 mg) daily.
9 to 14 years: 1 ½ 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.
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.
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.
| 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.
The following effects have been reported in cases of overdosage:
Haematuria, renal irritation, epigastric discomfort and vomiting. There is no specific antidote and symptoms should be treated as they arise.
Consider activated charcoal in patients who have ingested 30 mg/kg or more within 1 hour. Check urea and electrolytes (U&Es), liver function test (LFTs) and full blood count (FBC) in all patients. Check FBC again 3 days and again one week after the overdose or in case any new symptoms appear.
5 years.
Store below 30°C.
HDPE bottles (100) and blister packs (98).
Use as directed by the prescriber.
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