Hydroxychloroquine sulfate oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of hydroxychloroquine sulfate.
Juvenile chronic arthritis
Lupus erythematosus - discoid
Lupus erythematosus - systemic
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
Glucose-galactose malabsorption syndrome
History of torsade de pointes
Porphyria cutanea tarda
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:
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.
Abnormal liver function tests
Acute generalised exanthematous pustulosis
Bone marrow depression
Depigmentation of hair
Drug rash with eosinophilia and systemic symptoms (DRESS)
Exacerbation of psoriasis
Fulminant hepatic necrosis
Pigmentation of mucous membranes
Prolongation of QT interval
Skin pigmentation changes
Toxic epidermal necrolysis
Transient disturbances of colour vision
Visual field defects
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: April 2020
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: www.nice.org.uk Last accessed: 07 August 2020
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.