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HYDROXYCHLOROQUINE SULFATE is a brand name for Hydroxychloroquine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Treatment of rheumatoid arthritis, discoid and systemic lupus erythematosus, and dermatological conditions caused or aggravated by sunlight. Paediatric Population Treatment of juvenile idiopathic arthritis (in combination with other therapies), discoid and systemic lupus erythematosus.
Verbatim from this product's MHRA label. Tap a section to expand.
Adults (including the elderly) The minimum effective dose should be employed. 5/kg/day (calculated from ideal body weight) and will be either 200mg, 300mg or 400mg per day.
In patients able to receive 300mg daily:
Initially 300mg daily in a single dose. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 300mg daily if the response lessens. 5mg/kg/day based on ideal body weight. The 300mg tablet is therefore not suitable for use in children with an ideal body weight of less than 46kg.
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. Method of Administration For oral administration. Each dose should be taken with a meal or glass of milk.
The following MedDRA frequency convention is used to evaluate adverse reactions, when applicable: Very common(>1/10); Common (>1/100, <1/10); Uncommon (>1/1,000, <1/100); Rare >1/10,000, <1/1000); Very rare (<1/10,000) including isolated reports.
Tabulated list of adverse reactions:
System Organ class Frequency Adverse reaction Immune system disorders Not known Urticaria, angioedema, bronchospasm Eye disorders Common Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible Uncommon Retinopathy with changes in pigmentation and visual field defects can occur but appears to be uncommon if the recommended daily dose is not exceeded.
In its early form it appears reversible on discontinuation of hydroxychloroquine sulfate. If allowed to develop, there may be a risk of progression even after treatment withdrawal. Patients with retinal changes may be asymptomatic initially, or may have scotomatous vision with paracentral, pericentral ring types, temporal scotomas and abnormal colour vision.
Corneal changes including oedema and opacities have been reported. They are either symptomless or may cause disturbances such as haloes, blurring of vision or photophobia. They may be transient and are reversible on stopping treatment.
Not known Cases of maculopathies and macular degeneration have been reported (the onset ranging from 3 months to several years of exposure to hydroxychloroquine) and may be irreversible Common Skin rash, Pruritus Uncommon Pigmentary disorders in skin and mucous membranes, bleaching of hair, alopecia These usually resolve readily on stopping treatment.
Skin and subcutaneous tissue disorders Not known Bullous eruptions including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome) photosensitivity, exfoliative dermatitis, acute generalised exanthematous pustulosis (AGEP).
Visual effects The occurrence of retinopathy is uncommon if the recommended daily dose is not exceeded. The administration of doses in excess of the recommended maximum is likely to increase the risk of retinopathy, and accelerate its onset.
73m2). Patients should be referred to a hospital eye department to have a baseline ocular examination within 6 to 12 months after initiation of therapy to screen for hydroxychloroquine retinopathy. Subsequent follow-up should be directed by an Ophthalmologist.
It should be emphasized that the lowest effective dose should be used to minimize the risk of ocular toxicity. Hydroxychloroquine sulfate should be discontinued immediately in any patient who develops a pigmentary abnormality, visual field defect, or any other abnormality not explainable by difficulty in accommodation or presence of corneal opacities.
Patients should continue to be observed for possible progression of the changes. Patients should be advised to stop taking the drug immediately and seek the advice of their prescribing doctor if any disturbances of vision are noted, including abnormal colour vision.
9). Clinical monitoring for signs and symptoms of cardiomyopathy is advised and hydroxychloroquine sulfate should be discontinued if cardiomyopathy develops. 8).
Caution is required in the following circumstances:
Hydroxychloroquine sulfate should be used with caution in patients taking medicines which may cause adverse ocular or skin reactions. 5). Caution should also be applied when it is used in the following: o patients with hepatic or renal disease, and in those taking drugs known to affect those organs.
Estimation of plasma hydroxychloroquine levels should be undertaken in patients with severely compromised renal or hepatic function and dosage adjusted accordingly. o patients with severe gastrointestinal, neurological or blood disorders.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Acute generalised exanthematous pustulosis (AGEP) has to be distinguished from psoriasis, although hydroxychloroquine may precipitate attacks of psoriasis. It may be associated with fever and hyperleukocytosis. Outcome is usually favourable after drug withdrawal.
Very common Abdominal pain, nauseaGastrointestinal disorders Common Diarrhoea, vomiting These symptoms usually resolve immediately on reducing the dose or on stopping treatment. Common Headache Uncommon Dizziness Nervous system disorders Not known Convulsions have been reported with this class of drugs.
4). 9) Chronic toxicity should be considered when conduction disorders (bundle branch block/atrioventricular heart block) as well as biventricular hypertrophy are found. Drug withdrawal may lead to recovery. Uncommon Sensory motor disordersMusculoskeletal and connective tissue disorders Not known Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups.
Myopathy may be reversible after drug discontinuation, but recovery may take many months. Depression of tendon reflexes and abnormal nerve conduction studies. 4), Hydroxychloroquine may precipitate or exacerbate porphyria. Uncommon Vertigo, tinnitusEar and labyrinth disorders Not known Hearing loss Common Affect lability Uncommon Nervousness Psychiatric disorders Not known Psychosis, suicidal behaviour, psychosis, depression, hallucinations, anxiety, agitation, confusion, delusions, mania and sleep disorders.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization 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.
o caution is also advised in patients with a sensitivity to quinine, those with glucose-6-phosphate dehydrogenase deficiency, those with porphyria cutanea tarda which can be exacerbated by hydroxychloroquine and in patients with psoriasis since it appears to increase the risk of skin reactions.
o patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Blood disorders Although the risk of bone marrow depression is low, periodic blood counts are advisable as anaemia, aplastic anaemia, agranulocytosis, a decrease in white blood cells, and thrombocytopenia have been reported.
Hydroxychloroquine should be discontinued if abnormalities develop. Toxic effects in children Small children are particularly sensitive to the toxic effects of 4- aminoquinolines; therefore patients should be warned to keep Hydroxychloroquine sulfate out of the sight and reach of children.
Hypoglycaemia Hydroxychloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with hydroxychloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms.
Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with hydroxychloroquine should have their blood glucose level checked and treatment reviewed as necessary. Musculoskeletal effects All patients on long-term therapy should undergo periodic examination of skeletal muscle function and tendon reflexes.
If weakness occurs, the drug should be withdrawn. Dermatological reactions Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with the use of Hydroxychloroquine.
Patients should be advised of the signs and symptoms and monitored closely for skin reactions. The highest risk for occurrence of SJS or TEN is within the first weeks of treatment. g. progressive skin rash often with blisters or mucosal lesions) are present, Hydroxychloroquine treatment should be discontinued.
The best results in managing SJS and TEN come from early diagnosis and immediate discontinuation of any suspect drug. Early withdrawal is associated with a better prognosis. If the patient has developed SJS or TEN with the use of Hydroxychloroquine, Hydroxychloroquine must not be re-started in this patient at any time.
8). 8). Psychiatric side effects typically occur within the first month after the start of treatment with hydroxychloroquine and have been reported also in patients with no prior history of psychiatric disorders. Patients should be advised to seek medical advice promptly if they experience psychiatric symptoms during treatment.