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Hydroxychloroquine sulfate oral


Oral formulations of hydroxychloroquine sulfate.

Drugs List

  • hydroxychloroquine 200mg tablets
  • hydroxychloroquine 300mg tablets
  • QUINORIC 200mg tablets
  • Therapeutic Indications


    Juvenile chronic arthritis
    Lupus erythematosus - discoid
    Lupus erythematosus - systemic
    Rheumatoid arthritis
    Treatment of dermatological conditions caused or aggravated by sunlight



    200mg to 400mg daily (but not exceeding 6.5mg/kg/day based on ideal bodyweight).

    Patients able to receive 400mg daily
    Initially 400mg in divided doses. The dose can be reduced to 200mg when no further improvement is evident. The maintenance dose should be increased to 400mg daily if the response decreases.

    Patients able to receive 300mg daily
    Initially 300mg 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 decreases.


    5mg/kg/day up to a maximum dose of 6.5mg/kg/day based on ideal bodyweight.

    The 200mg tablet is therefore not suitable for use in children with an ideal bodyweight of less than 31kg.

    The 300mg tablet is therefore not suitable for use in children with an ideal bodyweight of less than 46kg.


    Ideal body weight below 31kg
    Long QT syndrome
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Patients over 65 years
    Acute porphyria
    Diabetes mellitus
    Electrolyte imbalance
    Epileptic disorder
    G6PD deficiency
    Glucose-galactose malabsorption syndrome
    Haematological disorder
    Hepatic impairment
    History of torsade de pointes
    Lactose intolerance
    Myasthenia gravis
    Poor vision
    Porphyria cutanea tarda
    Renal impairment
    Severe gastrointestinal disorder
    Severe neurological disorder

    Correct electrolyte disorders before treatment
    May exacerbate myasthenia gravis
    Advise patient blurred vision may affect ability to drive/operate machinery
    May reduce seizure threshold
    May trigger acute porphyria attacks
    Weight based doses should be calculated using ideal bodyweight
    Some formulations contain lactose
    Exclude pregnancy prior to initiation of treatment
    Perform ECG before and during treatment
    Perform ophthalmological examination before therapy and at least 12 monthly
    During long term use make clinical examinations at regular intervals
    If rash develops, consider possibility of Stevens-Johnson Syndrome
    Monitor blood counts regularly
    Monitor for signs and symptoms of cardiomyopathy
    Monitor plasma levels and adapt dose in patients with hepatic impairment
    Monitor plasma levels and adapt dose in patients with renal impairment
    Monitor serum electrolytes
    Monitor skeletal muscle function and tendon reflexes periodically
    Monitor skin changes
    Advise patient to report new visual problems and symptoms
    Advise patients/carers to seek medical advice if changes in behaviour/mood
    Advise patients/carers to seek medical advice if suicidal intent develops
    May cause or exacerbate extrapyramidal symptoms
    May exacerbate psoriasis
    May induce severe hypoglycaemia
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Discontinue and do not restart if severe cutaneous adverse reactions occur
    Discontinue if cardiomyopathy occurs
    Discontinue if first occurrence or worsening of visual disturbances
    Discontinue if haematological abnormalities develop
    Discontinue treatment if muscle or tendon weakness occurs
    Discontinue treatment if no response after 6 months in rheumatic disease
    Maintain treatment at the lowest effective dose
    Not licensed for all indications in all age groups
    Avoid antacids within 4 hours of dose
    Male & female: Contraception required during & for 3 months after treatment
    Advise patients of the warning signs of hypoglycaemia

    Ophthalmological examinations must be repeated at least every 12 months. The examination should include testing visual acuity, careful ophthalmoscopy, fundoscopy and central visual field testing with a red target, and colour vision. This examination should be more frequent and adapted to the patient in the following situations:
    Renal impairment
    Visual acuity below 6/8
    Age greater than 65 years
    Cumulative doses more than 200g

    Discontinue 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 monitored for possible progression of the changes.

    Use with caution in patients taking medicines which may cause adverse ocular or skin reactions. If the patient has developed drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of hydroxychloroquine, hydroxychloroquine must not be restarted in this patient at any time.

    In light-sensitive diseases, treatment should only be given during periods of maximum exposure to light.

    Porphyria cutanea tarda may be exacerbated by hydroxychloroquine.

    Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) as well as biventricular hypertrophy are diagnosed.

    Pregnancy and Lactation


    Hydroxychloroquine is contraindicated during pregnancy.

    Use of hydroxychloroquine during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of hydroxychloroquine during pregnancy. Potential risks are unknown, however hydroxychloroquine is known to cross the placenta.


    Hydroxychloroquine is contraindicated during breastfeeding.

    Use of hydroxychloroquine when breastfeeding is contraindicated by the manufacturer. Hydroxychloroquine is present in human breast milk at low concentrations, however due to the long half life and high daily dosage an accumulation must be expected. Exposed infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Acute generalised exanthematous pustulosis
    Aplastic anaemia
    Blurred vision
    Bone marrow depression
    Bullous eruption
    Cardiac failure
    Cardiovascular toxicity
    Conduction disturbances
    Corneal changes
    Corneal oedema
    Corneal opacities
    Decreased reflexes
    Depigmentation of hair
    Drug rash with eosinophilia and systemic symptoms (DRESS)
    ECG changes
    Emotional lability
    Erythema multiforme
    Exacerbation of psoriasis
    Exfoliative dermatitis
    Fulminant hepatic necrosis
    Gastro-intestinal disturbances
    Haematological disorders
    Hearing loss
    Muscle weakness
    Muscular atrophy
    Pigmentation (ophthalmic)
    Pigmentation of mucous membranes
    Prolongation of QT interval
    Sensory disturbances
    Skin pigmentation changes
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Toxic psychosis
    Transient disturbances of colour vision
    Visual field defects
    Visual haloes


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2020

    Reference Sources

    Summary of Product Characteristics: Hydroxychloroquine sulfate 200mg Film-coated Tablets. Zentiva. Revised January 2022.

    Summary of Product Characteristics: Quinoric 200mg Tablets. Bristol Laboratories Ltd. Revised November 2017.

    Summary of Product Characteristics: Hydroxychloroquine sulfate 300mg Film-Coated Tablets. Blackrock Pharmaceuticals Ltd. Revised March 2020.

    NICE Evidence Services Available at: Last accessed: 07 August 2020

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