Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Strides Pharma UK Ltd, Unit 4 Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS
For the treatment of chloroquine resistant falciparum malaria in adults and children aged 5 years or older (and ≥20kg).
Treatment and prevention of nocturnal leg cramps in adults and the elderly, when cramps cause regular disruption of sleep (see section 4.2 and Section 4.4).
600mg of quinine sulfate given every 8 hours for 7
days. The dose may depend upon the size of the patient, severity of infection, and evidence of renal or liver disease
(when the intervals should be increased), due to a prolonged half-life of the drug.
Note:
If quinine resistance is known or suspected on completion of the course, additional treatment may be given. This may
be one of the following:
1. doxycycline 200mg daily (as a single dose or in 2 divided doses) for at least 7 days.
2. clindamycin 300mg four times daily for 5 days.
If part or all of the dose is vomited within 1 hour of administration, then the same amount must be administered
immediately.
The recommended dose is 200mg at bedtime. Maximum dose is 300mg.
A reduction in frequency of leg cramps may take up to 4 weeks to become apparent. Patients should be monitored
closely during the early stages of treatment for adverse effects. After an initial trial of 4 weeks, treatment should be
stopped if there is no benefit. Treatment should be interrupted at approximately three monthly intervals to reassess the
benefit of treatment.
The dosage regimen for children by mouth is 10mg of quinine sulfate per kg body weight given every 8 hours for 7 days.
Quinine sulfate 200mg tablets are not suitable for children weighing less than 20kg or less than 5 years old.
For oral administration.
Quinine overdosage may lead to serious side effects including irreversible visual loss and can be fatal. In acute overdosage, symptoms of cinchonism may occur, including convulsions, nausea, vomiting, tinnitus, deafness, headache vasodilation and disturbed vision.
Features of a significant overdose include convulsions, impairment of consciousness, coma, respiratory depression, QT prolongation, ventricular arrhythmia, cardiogenic shock and renal failure. Fatalities have been reported in adults after doses of 2-8g. High doses of quinine are teratogenic and may cause miscarriage. Hypokalaemia and hypoglycaemia may also occur.
Children (<5 years) who have ingested any amount should be referred to hospital.
Older children and adults should be referred to hospital if more than 30mg/kg of quinine base has been taken.
Note:
Each quinine sulfate 200mg tablet is equivalent to 165mg of quinine base.
Quinine is rapidly absorbed. Consider activated charcoal (50g for adults; 1g/kg for children) if the patient presents within 1 hour of ingestion of more than 30mg/kg quinine base or any amount in a child under 5 years. Multiple dose activated charcoal will enhance quinine elimination.
Observe patients for at least 12 hours after ingestion. Monitor cardiac conduction and rhythm, serum electrolytes, blood glucose and visual acuity.
Other treatment is symptomatic to maintain blood pressure, respiration, renal function and to treat arrhythmia, convulsions, hypoglycaemia and acidosis.
36 months.
This medicinal product does not require any special storage conditions.
PVC (250µm)/aluminium (25µm) foil blisters.
Pack sizes: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250 and 500.
Not all pack sizes may be marketed.
No special requirements.
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