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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. 5mg/kg/day (calculated from ideal body weight and not actual body weight) and will be either 200mg, 300mg or 400mg per day.
In patients able to receive 400mg daily:
Initially 400mg daily in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 300mg or 400mg daily if the response lessens. 5mg/kg/day based on ideal body weight.
The 200mg tablet is therefore not suitable for use in children with an ideal body weight of less than 31kg. 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. The tablets are for oral administration.
The following CIOMS frequency rating is used, when applicable:
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). Tabulated list of adverse reactions System Organ class Frequency Adverse reaction Immune system disorders Not known Urticaria, angioedema, bronchospasm Common Blurring of vision due to a disturbance of accommodation which is dose dependent and reversible Eye disorders 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), Sweet’s syndrome and Severe cutaneous adverse reactions (SCARSs) photosensitivity, exfoliative dermatitis,).
Visual Effects The occurrence of retinopathy is very 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.
All patients should have an ophthalmological examination before initiating treatment with Hydroxychloroquine sulfate. Thereafter, ophthalmological examinations must be repeated at least every 12 months. The examination should include testing visual acuity, careful ophthalmoscopy, fundoscopy, central visual field testing with a red target, and colour vision.
5mg/kg lean body weight. Absolute body weight used as a guide to dosage could result in an overdosage in the obese o renal insufficiency o visual acuity below 6/8 o age above 65 years o cumulative dose more than 200g. 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). 5). 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.
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.
• hypersensitivity to hydroxychloroquine or to any of the excipients • known hypersensitivity to 4-aminoquinoline compounds • pre-existing maculopathy of the eye
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. Musculoskeletal Uncommon Sensory motor disorders 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. Metabolism and nutrition disorders Common Anorexia Uncommon Vertigo, tinnitusEar and labyrinth disorders Not known Hearing loss Common Affect lability Uncommon Nervousness Psychiatric disorders Not known Suicidal behaviour, psychosis, depression, hallucinations, anxiety, agitation, confusion, delusions, mania and sleep disorders.
Reporting of side effects 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.
o patients with severe gastrointestinal, neurological or blood disorders. 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 sulfate should be discontinued if abnormalities develop. Hepatitis B reactivation Reactivation of hepatitis B virus has been reported in patients treated with hydroxychloroquine in combination with other immunosuppressants.
Hepatotoxicity Serious cases of drug-induced liver injury (DILI) including hepatocellular injury, cholestatic liver injury, acute hepatitis, mixed hepatocellular/cholestatic liver injury and fulminant hepatic failure (including fatal cases) have been reported during use of Hydroxychloroquine.
Risk factors may include pre-existing liver disease, or predisposing conditions such as uroporphyrinogen decarboxylase deficiency or concomitant hepatotoxic medications. Prompt clinical evaluation and measurement of liver function tests should be performed in patients who report symptoms that may indicate liver injury.
8), physicians should assess the benefits/risk of continuing the treatment. 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 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. Muscoskeletal 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 if symptoms or signs of SJS or TEN are present, Hydroxychloroquine treatment should be discontinued. If the patient has developed SJS or TEN with the use of Hydroxychloroquine, Hydroxychloroquine must not be restarted in this patient at any time Extrapyramidal disorders […]