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QUININE SULFATE is a brand name for Quinine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment of falciparum (malignant tertian) malaria:
Adults (including the elderly) and children aged 12 years and over: 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. Children aged 11 years and under: 10mg/kg every eight hours for 7 days.
For the treatment and prevention of nocturnal leg cramps Adults (including the elderly): The recommended dose is 200mg at bedtime. The 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 assess the need for continuation of treatment with quinine.
Paediatric population Treatment of chloroquine resistant falciparum malaria 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.
Method of administration For oral administration.
Adverse drug reactions are ranked by frequency, the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Adverse Reaction Frequency MedDRA system organ class Not Known Blood and lymphatic system disorders Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, oliguria, haemolytic uraemic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura.
Immune system disorders Eczematous dermatitis, oedema, erythema,lichen planus,hypersensitivity reactions such as asthma, angioneurotic oedema, photosensitivity, hot and flushed skin, fever, pruritus, thrombocytopenic purpura and urticaria.
Metabolism and nutritional disorders Hypoglycaemia Psychiatric disorders Agitation and confusion. Nervous system disorders Headache, vertigo, excitement, loss of consciousness, coma and death. Eye disorders Blurred vision, defective colour perception, visual field constriction, total blindness.
Ear and labyrinth disorders Tinnitus, impaired hearing. Cardiac disorders Atrioventricular conduction disturbances, a fall in blood pressure coupled with a feeble pulse, prolongation of the QT interval, widening of the QRS complex and T wave flattening.
Respiratory, thoracic and mediastinal disorders Bronchospasm, dyspnoea, asthma may occur Gastrointestinal Disorders Nausea, vomiting, diarrhoea, abdominal pain*, fever may occur after long term administration of quinine. Skin and subcutaneous tissue disorders Flushing, rash, urticaria, eczematous dermatitis, oedema, erythema, lichen planus, pruritus, photosensitivity, Stevens-Johnson syndrome.
Musculoskeletal and connective tissue disorders Muscle weakness, aggravation of myasthenia gravis. ), oliguria. Reproductive system and breast disorders Abortion**. General disorders and administration site conditions Fever, Cinchonism*** * May occur after long term administration of quinine.
Cinchonism Administration of quinine may give rise to cinchonism, which is generally more severe in overdose, but may also occur in normal therapeutic doses. Patients should be warned not to exceed the prescribed dose, because of the possibility of serious, irreversible side effects in overdose.
Treatment for night cramps should be stopped if symptoms of cinchonism emerge. 9). Hypersensitivity Hypersensitivity to quinine may also occur with symptoms of cinchonism together with urticaria, flushing, pruritus, rash, fever, angioedema, dyspnoea and asthma.
Serious hypersensitivity reactions including Stevens-Johnson syndrome have been reported with quinine. Cardiac disorders Quinine should be used with caution in patients with atrial fibrillation, other cardiac conduction defects and heart block or other serious heart disease.
It may cause hypoprothrombinaemia and enhance the effects of anticoagulants. Quinine has dose-dependent QT-prolonging effects. Caution is recommended in patients with conditions which predispose to QT-prolongation and in patients with atrioventricular block.
Glucose-6-Phosphate Dehydrogenase (G-6-PD) Deficiency Quinine has been implicated in precipitating blackwater fever when given for prolonged periods, although, in some cases deficiency of glucose-6-phosphate dehydrogenase may have been involved.
Patients with glucose-6-phosphate dehydrogenase deficiency may be at increased risk of haemolysis during quinine therapy and may develop acute haemolytic anaemia. 6). Treatment with quinine should be monitored in all patients in case signs of resistance develop.
8), should be carefully considered relative to the potential benefits. These risks are likely to be of particular concern in the elderly. Quinine should only be considered when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out, and when non- pharmacological measures have not worked.
1 - Tinnitus - Optic neuritis - Haemolysis or Haemoglobinuria - Myasthenia gravis (quinine may cause severe respiratory distress and dysphagia in these patients) - As quinine has been implicated in precipitating blackwater fever, it is generally contraindicated in patients who have already suffered an attack.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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** Toxic doses of quinine may induce abortion, but it is unwise to withhold the drug if less toxic antimalarials are not available. *** More common in overdose but may occur even after normal doses of quinine. In its mild form symptoms include tinnitus, impaired hearing, rashes, headache, nausea and disturbed vision.
9). Visual disorders (blurred vision, defective colour perception, visual field constriction and total blindness). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
6). Thrombocytopenia Quinine may cause unpredictable serious and life-threatening thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity reaction. Quinine should not be prescribed or administered to patients who have previously experienced any adverse reaction to quinine, including that in tonic water or other beverages.
Patients should be instructed to stop treatment and consult a physician if signs of thrombocytopenia such as unexplained bruising or bleeding occur. Reduce the dosage (or increase intervals between doses) in renal or hepatic disease.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine, as it contains lactose. e. is essentially ‘sodium-free’