Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Bristol Laboratories Ltd., Unit 3, Canalside, Northbridge Road, Berkhamsted, Herts, HP4 1EG, United Kingdom
Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight.
Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.
The minimum effective dose should be employed. This dose should not exceed 6.5 mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200 mg or 400 mg per day.
Initially 400 mg daily in divided doses. The dose can be reduced to 200 mg when no further improvement is evident. The maintenance dose should be increased to 400 mg daily if the response lessens.
The minimum effective dose should be employed and should not exceed 6.5 mg/kg/day based on ideal body weight. The 200 mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg.
The tablets are for oral administration.
Each dose should be taken with a meal or glass of milk.
Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial effects, whereas minor side effects may occur relatively early. For rheumatic disease treatment should be discontinued if there is no improvement by 6 months. In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light.
Overdose with the 4-aminoquinolines is dangerous particularly in infants, as little as 1-2g having proved fatal.
The symptoms of overdose may include headache, visual disturbances, cardiovascular collapse, convulsions and hypokalaemia. Rhythm and conduction disorders, including QT prolongation, Torsade de Pointes, ventricular tachycardia and ventricular fibrillation, width increased QRS complex, bradyarrhythmias, nodal rhythm, atrioventricular block followed by sudden potentially fatal respiratory and cardiac arrest. Immediate medical attention is required, as these effects may appear shortly after the overdose.
The stomach should be immediately evacuated, either by emesis or gastric lavage. Finely powdered activated charcoal in a dose at least five times of the overdose may inhibit further absorption if introduced into the stomach by tube following lavage and within 30 minutes of ingestion of the overdose.
Consideration should be given to administration of parenteral diazepam in cases of overdose; it has been shown to be beneficial in reversing chloroquine cardiotoxicity.
Respiratory support and shock management should be instituted as necessary.
Containers: 3 years.
Blisters: 4 years.
Store in the original package.
Al/PVC blister, pack sizes of 30, 60 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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