Consumer medicine information

Hydroxychloroquine AN Tablets

Hydroxychloroquine sulfate

BRAND INFORMATION

Brand name

Hydroxychloroquine AN Tablets

Active ingredient

Hydroxychloroquine sulfate

Schedule

What Is In This Leaflet

Read this leaflet carefully before taking your medicine. Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine.

This leaflet answers some common questions about hydroxychloroquine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Keep this leaflet with your medicine.

You may want to read it again.

What Hydroxychloroquine AN Is Used For

The name of your medicine is Hydroxychloroquine AN. It contains the active ingredient hydroxychloroquine sulfate.

It may be used for any of the following conditions:

Rheumatoid Arthritis

Rheumatoid arthritis is a form of arthritis with inflammation of the joints, characterized by stiffness, swelling and pain.

Hydroxychloroquine may be used for short or long-term rheumatoid arthritis treatment.

In treating rheumatoid arthritis, hydroxychloroquine may slow down the process of joint damage and relieve the symptoms of the disease.

Systemic Lupus Erythematous (SLE)

SLE is a disease in which a person's normal immunity is upset. The body produces an excess of blood proteins called antibodies and these antibodies may cause problems in any organ of the body.

These antibodies may end up, for example, in the skin causing a variety of skin rashes or deposit in the kidney, brain, lung and joints causing injury.

Discoid Lupus Erythematous (DLE)

DLE is similar to SLE except it only affects the skin and is characterized by a scaling, red rash.

Malaria (treatment and control of symptoms)

Malaria is an infectious disease caused by the presence of parasites in red blood cells.

The disease is characterized by chills, fever and sweats. In malaria, hydroxychloroquine destroys the harmful parasite which causes the illness.

Your doctor may have prescribed hydroxychloroquine for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Hydroxychloroquine is not addictive. This medicine is available only with a doctor's prescription.

Before You Take Hydroxychloroquine AN

When you must not take it

Do not take this medicine if you have had an allergic reaction to hydroxychloroquine, chloroquine or related products or any of the ingredients listed at the end of this leaflet. If you are uncertain whether you have had an allergic reaction to a related product ask your doctor or pharmacist.

Symptoms of an allergic reaction may include an asthma attack, facial swelling, skin rash or hay fever.

Ask your doctor about the risks and benefits of taking this medicine while you are pregnant.

When hydroxychloroquine is taken for long periods of time, there is an increased risk to the unborn child. It may cause problems with brain function, hearing, balance and vision.

Ask your doctor about the risks and benefits of taking this medicine while you are breastfeeding.

Do not take this medicine if you have previously experienced changes in your eyesight when taking medicines for rheumatoid arthritis or malaria.

Hydroxychloroquine should not be used in children under 6 years.

Hydroxychloroquine should not be used in children over 6 years for long periods.

Do not take this medicine after the expiry date (EXP) printed on the pack.

It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Do not take this medicine if the packaging is torn, shows signs of tampering or if it does not look quite right.

Do not take this medicine to treat any other complaint unless your doctor says it is safe.

Do not give this medicine to anyone else.

Before You Start To Take It

You must tell your doctor if:

You are allergic to quinine.
You have allergies to any ingredients listed under "Product Description" at the end of this leaflet.
You have any pre-existing eye disorders.
You have experienced low blood sugar levels (hypoglycaemia - a "hypo"). Hydroxychloroquine may increase the risk of you having a hypo.
You have or have had any of these medical conditions:

Chloroquine-resistant malaria
Liver or kidney problems
Diabetes
Stomach, brain or blood disorders
Disease of the heart muscle
Skin diseases, in particular psoriasis which is a kind of itchy rash
Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency which is a lack of a chemical substance which causes the breakdown of sugar in the body
Porphyria, which is a rare disease of blood pigments.

You plan to become pregnant or breast-feed.

If you have not told your doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and hydroxychloroquine may interfere with each other. These include:

Any medicine to treat depression
Digoxin - a medicine used to treat heart disease
Medicines to treat diabetes
Medicines used to suppress the immune system such as cyclosporine
Antiarrythmic drugs such as amiodarone
Other antimalarial drugs
Medicines to treat epilepsy

These medicines may be affected by hydroxychloroquine or may affect how well it works.

Your doctor and pharmacist can tell you if you are taking any of these medicines.

How To Take Hydroxychloroquine AN

Follow all directions given to you by your doctor or pharmacist carefully.

Swallow tablets whole with a little water or other liquid.

It is best to take it at meal times.

How much to take

Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.

The dosage will depend on why you are being treated with hydroxychloroquine.

The usual doses are:

Rheumatoid arthritis

Adults
2-3 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

SLE and DLE

Adults
2-4 tablets daily. Your doctor may later reduce this to 1-2 tablets daily.

Control of Malaria

Symptoms

Adults
2 tablets once a week. The tablets should be taken on exactly the same day of each week.

For example, if your first dose is taken on a Monday, then each weekly dose should be taken on a Monday.

Treatment of Malaria

Adults
The starting dose is 4 tablets. Take another 2 tablets six to eight hours later and two further tablets on each of the next 2 days.

Always follow the instructions given to you by your doctor. Dosages for children are calculated according to the child's body weight.

Your doctor will work out the correct dose for you.

Hydroxychloroquine should not be used in children for long periods.

Your doctor may ask you to take a different dose. You should follow the instructions on the label.

If you are unsure what dose to take ask your pharmacist or doctor.

How long to take it for

Continue taking your medicine for as long as your doctor tells you. Make sure you have enough to last over weekends and holidays.

If you forget to take it

If you are being given hydroxychloroquine for rheumatoid arthritis or SLE or DLE, do not take a double dose to make up for the dose missed. Just continue with the appropriate dose on the next day.

If you are being given hydroxychloroquine for suppression or treatment of malaria, you should take your tablets as soon as you remember, and go back to taking it as you would normally.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 for Australia) for advice, or go to the Accident and Emergency Department at the nearest hospital, if you think that you or anyone else may have taken too much hydroxychloroquine. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much hydroxychloroquine, you may experience headaches, drowsiness, visual disturbances or fits. These symptoms may occur within 30 minutes of overdose.

While You Are Taking Hydroxychloroquine AN

If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking hydroxychloroquine.

Tell all doctors, dentists and pharmacists who are treating you that you are taking hydroxychloroquine.

Tell your doctor if you experience any of the following symptoms including; weakness, trembling or shaking, sweating, light-headedness, headache, dizziness, lack of concentration, tearfulness or crying, irritability, hunger and numbness around the lips and fingers.

These symptoms may be associated with hypoglycaemia. If you experience any of the symptoms of hypoglycaemia, you need to raise your blood glucose urgently. You can do this by taking one of the following:

5-7 jelly beans
3 teaspoons of sugar or honey
1/2 can of ordinary (non-diet) soft drink
2-3 concentrated glucose tablets
unless you are within 10 to 15 minutes of your next meal or snack, follow up with extra carbohydrates e.g. plain biscuits, fruit or milk - when over the initial symptoms. Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

Make sure you, your friends, family and work colleagues can recognize the symptoms of hypoglycaemia and know how to treat them. Your doctor will need to perform the following tests during treatment with hydroxychloroquine:

Eye Tests
Your doctor will need to perform some eye tests every few months to check that your eyesight is not changing.

In extremely rare cases, hydroxychloroquine has been associated with blindness. This can be avoided by having regular eye tests.

It is recommended you wear sunglasses when out in the sun.

Blood Tests
Your doctor will need to perform occasional blood tests to check for any blood reactions.

Your doctor may monitor your blood sugar levels if you have experienced hypoglycaemia while taking Hydroxychloroquine.

Driving/Operating Machinery

Be careful driving or operating machinery until you know how Hydroxychloroquine affects you.

Hydroxychloroquine may cause problems with the eyesight of some people. Make sure you know how you react to Hydroxychloroquine before you drive a car, operate machinery, or do anything else that could be dangerous with blurred vision.

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking Hydroxychloroquine.

Tell your doctor immediately if you become pregnant.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Go to your doctor regularly for a check-up.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Do not take your medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop taking your medicine, or change the dosage, without checking with your doctor.

Things to be careful of

Be careful while driving or operating machinery until you know how hydroxychloroquine affects you.

Hydroxychloroquine may cause problems with the eyesight of some people. Make sure you know how you react to hydroxychloroquine before you drive a car, operate machinery, or do anything else that could be dangerous with blurred vision.

Side Effects of Hydroxychloroquine AN

All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time, they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking hydroxychloroquine.

Hydroxychloroquine helps most people with rheumatoid arthritis, SLE, DLE, treatment of malaria and the control of malaria symptoms, but it may have unwanted side effects in a few people.

You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Following is a list of possible side effects. Do not be alarmed by this list. You may not experience any of them.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

Less serious side effects

Stomach problems such as:

Nausea
Vomiting
Diarrhoea
Abdominal cramps

After Using Hydroxychloroquine AN

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Heat and dampness can destroy some medicines.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat, sunlight and dampness can destroy some medicines.

Keep it where children cannot reach it.

Children are particularly sensitive to the unwanted effects of hydroxychloroquine. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

Product Description

What Hydroxychloroquine AN Tablets looks like?

White to off-white, capsule-shaped tablets, embossed "HCQS" on one side, plain on the other side.

Packaged in bottles of 100 tablets.

Ingredients

Each tablet contains 200 mg of hydroxychloroquine sulfate as the active ingredient (equivalent to 155 mg hydroxychloroquine).

It also contains the following inactive ingredients:

anhydrous calcium hydrogen phosphate
pregelatinised maize starch
hypromellose
magnesium stearate
polysorbate 80
colloidal anhydrous silica
Opadry II White 85F18422.

This medicine is gluten-free, lactose free and free of other azo dyes.

Australian Registration Numbers

Hydroxychloroquine AN: 223694

Sponsor

Amneal Pharma Australia Pty Ltd
12 River Street
South Yarra
Vic 3141
Australia

This leaflet was last updated in March 2015.

BRAND INFORMATION

Brand name

Hydroxychloroquine AN Tablets

Active ingredient

Hydroxychloroquine sulfate

Schedule

Name of the medicine

Hydroxychloroquine sulfate.

Excipients.

Anhydrous calcium hydrogen phosphate, pregelatinised maize starch, hypromellose, magnesium stearate, polysorbate 80, anhydrous colloidal silica and Proprietary ingredient Opadry II White 85F18422.

Description

Chemical name: (RS)-2-N-[4-(7-chloro-4-quinolylamino)pentyl]- N-ethylaminoethanol sulfate. Molecular formula: C₁₈H₂₆ClN₃O.H₂SO₄. MW: 433.95. CAS: 747-36-4. Hydroxychloroquine sulfate is a colourless crystalline solid, soluble in water to at least 20%.

Pharmacology

Hydroxychloroquine is an antimalarial. It also exerts a beneficial effect in mild systemic and discoid lupus erythematosus and rheumatoid arthritis. The precise mechanism of action is not known.

Malaria.

Like chloroquine phosphate, hydroxychloroquine is highly active against the erythrocytic forms of Plasmodium vivax and P. malariae and most strains of P. falciparum (but not the gametocytes of P. falciparum).
Hydroxychloroquine does not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic. It is highly effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria, it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.

Indications

Rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

Contraindications

Hydroxychloroquine is contraindicated in:
patients with pre-existing maculopathy of the eye;
patients with known hypersensitivity to 4-aminoquinoline compounds;
long-term therapy in children;
children under 6 years of age.

Precautions

Hydroxychloroquine is not effective against chloroquine resistant strains of P. falciparum.
Patients should be warned to keep hydroxychloroquine out of the reach of children, as small children are particularly sensitive to 4-aminoquinolines.
Hydroxychloroquine should be used with caution, or not at all, in patients with severe gastrointestinal, neurological or blood disorders. If such severe disorders occur during therapy, hydroxychloroquine should be stopped. Periodic blood counts are advised.
When used in patients with porphyria or psoriasis, these conditions may be exacerbated. Hydroxychloroquine should not be used in these conditions unless in the judgement of the physician, the benefit to the patient outweighs the possible risk.
Cases of cardiomyopathy resulting in cardiac failure, in some cases with fatal outcome, have been reported in patients treated with hydroxychloroquine. Clinical monitoring for signs and symptoms of cardiomyopathy is advised and hydroxychloroquine should be discontinued if cardiomyopathy develops. Chronic toxicity should be considered when conduction disorders (bundle branch block/ atrioventricular heart block) as well as biventricular hypertrophy are diagnosed.
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.

Ophthalmological.

Irreversible retinal damage has been observed in some patients who had received long-term or high dosage 4-aminoquinolone therapy for discoid and systemic lupus erythematosus or rheumatoid arthritis. Retinopathy has been reported to be dose related.
If there is any indication of abnormality in the visual field or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks) which are not fully explainable by difficulties of accommodation or corneal opacities, hydroxychloroquine should be discontinued immediately and the patient closely observed for possible progression. Retinal changes (and visual disturbances) may progress after cessation of therapy. (See Adverse Effects.)
All patients being treated with hydroxychloroquine should have an initial ophthalmological examination. Ophthalmological testing should be conducted at 6 monthly intervals in patients receiving hydroxychloroquine at a dose of not more than 6 mg/kg bodyweight per day.
Ophthalmological testing should be conducted at 3-4 monthly intervals in the following circumstances: dose exceeds 6 mg/kg ideal (lean) bodyweight per day. Using absolute bodyweight, as a guide to dosage, could result in an overdosage in the obese; significant renal impairment; significant hepatic impairment; elderly; complaints of visual disturbances; duration of treatment exceeds 8 years.
The examination should include slit lamp microscopy (for corneal opacities) and fundus and visual field studies. A complete eye examination before treatment will determine the presence of any visual abnormalities, either coincidental or due to the disease, and establish a baseline for further assessment of the patient's vision.
Corneal changes often subside on reducing the dose or on interrupting therapy for a short period of time, but any suggestion of retinal change or restriction in the visual field is an indication for complete withdrawal of the drug.
The use of sunglasses in patients exposed to strong sunlight is recommended, as this may be an amplifying factor in retinopathy.
Observe caution in patients with hepatic or renal disease, in whom a reduction in dosage may be necessary, as well as in those taking medicines known to affect these organs. Also observe caution in patients with gastrointestinal, neurological, or blood disorders, in those with a sensitivity to quinine and in glucose-6-phosphate dehydrogenase deficiency, porphyria and psoriasis.

Skin reactions.

Pleomorphic skin eruptions (morbilliform, lichenoid, purpuric), itching, dryness and increased pigmentation sometimes appear after a few months of therapy. The rash is usually mild and transient. If a rash appears, hydroxychloroquine should be withdrawn and only started again at a lower dose.
Patients with psoriasis appear to be more susceptible to severe skin reactions than other patients.

Haematological reactions.

Patients on long-term therapy should have periodic full blood counts. If evidence of agranulocytosis, anaemia, aplastic anaemia, thrombocytopenia or leukopenia becomes apparent, and cannot be attributed to the disease being treated, hydroxychloroquine should be discontinued.

Miscellaneous.

Gastrointestinal disturbances such as nausea, anorexia, abdominal cramps or rarely vomiting, occur in some patients. The symptoms usually stop on reducing the dose or temporarily stopping the drug. Muscle weakness, vertigo, tinnitus, nerve deafness, headache and nervousness have been reported less frequently.
All patients on long-term therapy with hydroxychloroquine should be questioned and examined periodically, including the testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs discontinue the drug.
In the treatment of rheumatoid arthritis, if objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, hydroxychloroquine should be discontinued. Safe use of hydroxychloroquine in the treatment of juvenile rheumatoid arthritis has not been established.
Patients should be warned about driving and operating machinery since hydroxychloroquine can impair visual accommodation and cause blurring of vision. If the condition is not self limiting, the dosage may need to be temporarily reduced.
Suicidal behaviour has been reported in very rare cases in patients treated with hydroxychloroquine.

Use in pregnancy.

(Category D)
Hydroxychloroquine crosses the placenta. Data are limited regarding the use of hydroxychloroquine during pregnancy. It should be noted that 4-aminoquinolines in therapeutic doses have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal haemorrhages and abnormal retinal pigmentation.
The use of this drug in the treatment of malaria or suppression of malaria in high risk situations may be justified if the treating physician considers the risk to the foetus is outweighed by the benefits to the mother and foetus.

Use in lactation.

Nursing mothers.

Careful consideration should be given to using hydroxychloroquine during lactation, since it has been known to be excreted in small amounts in human breast milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinones.

Interactions

It has been suggested that 4-aminoquinolines are pharmacologically incompatible with monoamine oxidase inhibitors.
Concomitant hydroxychloroquine and digoxin therapy may result in increased serum digoxin concentrations. Consequently, serum digoxin concentrations should be closely monitored in patients receiving combination therapy.
As hydroxychloroquine may enhance the effects of a hypoglycaemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required.
Halofantrine prolongs the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias, including hydroxychloroquine. Also there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine is used concomitantly with other arrhythmogenic drugs, such as amiodarone and moxifloxacin.
Increased plasma cyclosporin level have been reported when cyclosporin and hydroxychloroquine are coadministered.
Hydroxychloroquine can lower the convulsive threshold. Coadministration of hydroxychloroquine with other antimalarials known to lower the convulsion threshold (e.g. mefloquine) may increase the risk of convulsions.
The activity of antiepileptic drugs might be impaired if coadministered with hydroxychloroquine.
In a single dose interaction study, chloroquine has been reported to reduce the bioavailability of praziquantel. It is not known if there is a similar effect when hydroxychloroquine and praziquantel are coadministered. Per extrapolation, due to the similarities in structure and pharmacokinetic parameters between hydroxychloroquine and chloroquine, a similar effect may be expected for hydroxychloroquine.
There is a theoretical risk of inhibition of intracellular α-galactosidase activity when hydroxychloroquine is coadministered with agalsidase.

Adverse Effects

Note.

Very common ≥ 1/10 (≥ 10%); common ≥ 1/100 and < 1/10 (≥ 1% and < 10%); uncommon ≥ 1/1000 and < 1/100 (≥ 0.1% and < 1%); rare ≥ 1/10,000 and < 1/1000 (≥ 0.01% and < 0.1%); very rare < 1/10,000 (< 0.01%). Not known frequency cannot be estimated from available data.

Ophthalmological.

Common.

Blurring of vision.

Uncommon.

Corneal changes, retinal changes.

Not known.

Cases of maculopathies and macular degeneration have been reported and may be irreversible.
Corneal changes including oedema and opacities have occurred from three weeks (infrequently) to some years after the beginning of therapy. They are either symptomless or may cause disturbances such as halos, blurring of vision or photophobia. They may be transient or are reversible on stopping treatment. Should these types of corneal changes occur with hydroxychloroquine, it should be either stopped or temporarily withdrawn.
Reversible extraocular muscle palsies and temporary blurring of vision due to interference with accommodation have also been noted.
Retinal changes such as abnormal macular pigmentation and depigmentation (sometimes described as a ‘bull's eye’), pallor of the optic disc, optic atrophy and narrowing of the retinal arterioles have been reported.
Retinopathy with changes in pigmentation and visual field defects can occur but is rare. In its early form, it appears reversible on discontinuation of hydroxychloroquine. 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 even have scotomatous vision with paracentral, pericentral ring types, temporal scotomas and abnormal colour visions. Originally, the condition was thought to be progressive and irreversible, but more recent evidence suggests that routine ophthalmological examinations may detect retinal changes, especially pigmentation, at an early and reversible stage when there is no apparent visual disturbance.
Much evidence suggests that there is a threshold of dosage above which retinopathy appears. These results seem to correlate more with daily dosage than with a cumulative dose, although the risk increases with increased duration of treatment.
It is recommended that all patients have an initial ophthalmological examination, repeated at 6 month intervals during therapy. This should include slit lamp microscopy, fundus and visual field studies.
Any adverse changes in the ocular findings or the appearance of scotoma, night blindness or other retinal changes require immediate discontinuation of hydroxychloroquine; these patients should not subsequently receive any pharmacologically similar drugs.

Allergic disorders.

Not known.

Urticaria, angioedema, bronchospasm.

Blood disorders.

Rare.

Bone marrow depression, anaemia, aplastic anaemia, leukopenia, thrombocytopenia.

Very rare.

Agranulocytosis.
Hydroxychloroquine may exacerbate porphyria.

Cardiovascular disorders.

Rare.

Cardiomyopathy which may result in cardiac failure, and in some cases a fatal outcome (see Precautions).

Central nervous system disorders.

Common.

Affect lability, headache.

Uncommon.

Vertigo, tinnitus, headache, nerve deafness, nervousness, dizziness.

Rare.

Convulsions, neuromyopathy.

Very rare.

Psychosis, suicidal behaviour, nightmares, nystagmus, ataxia.

Not known.

Hearing loss.

Dermatological.

Common.

Skin rashes, alopecia, pruritus.

Uncommon.

Pigmentary changes, bleaching of hair.

Very rare.

Acute generalised exanthematous pustulosis, exfoliative dermatitis and erythema multiforme, Stevens-Johnson syndrome, photosensitivity, pruritus, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), toxic epidermal necrolysis.

Gastrointestinal.

Very common.

Abdominal pain, nausea.

Common.

Diarrhoea, vomiting.

Metabolism and nutrition disorders.

Common.

Anorexia.

Not known.

Hypoglycaemia.

Liver disorders.

Uncommon.

Abnormal liver function tests.

Very rare.

Fulminant hepatitis.

Neuromuscular.

Uncommon.

Sensory motor disorders.

Not known.

Absent or hypoactive deep tendon reflexes, muscle weakness or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups (muscle weakness may be reversible after drug discontinuation, but recovery may take many months). Depression of tendon reflexes and abnormal nerve conduction studies.

Very rare.

Extraocular muscle palsies.

Miscellaneous.

Rare.

Exacerbation or precipitation of porphyria and attacks of psoriasis.

Very rare.

Weight loss, lassitude.

Dosage and Administration

Rheumatoid arthritis.

Hydroxychloroquine is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur relatively early. Several months of therapy may be required before maximum effects can be obtained.

Initial dosage.

In adults, a suitable initial dosage is from 400-600 mg daily, preferably taken at meal times. In a few patients the side effects may require temporary reduction of the initial dosage. Generally, after 5-10 days the dose may be gradually increased to the optimum response level, frequently without return of side effects.

Maintenance dosage.

When a good response is obtained (usually in 4-12 weeks) the dose can be reduced to 200-400 mg daily (but should not exceed 6 mg/kg per day) and can be continued as maintenance treatment. The minimum effective maintenance dose should be employed. The incidence of retinopathy has been reported to be higher when the maintenance dose is exceeded.
If objective improvement (such as reduced joint swelling or increased mobility) does not occur within six months the drug should be discontinued.
If a relapse occurs after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.
Safe use of hydroxychloroquine for the treatment of juvenile rheumatoid arthritis has not been established.

Use in combination therapy.

Hydroxychloroquine may be used safely and effectively in combination with corticosteroids, salicylates, NSAIDs and methotrexate and other second line therapeutic agents. Corticosteroids and salicylates can generally be decreased gradually in dosage or eliminated after hydroxychloroquine has been used for several weeks. When gradual reduction of steroid dosage is suggested, it may be done by reducing every 4-5 days the dose of cortisone by no more than 5-15 mg; of methylprednisolone from 1-2 mg and dexamethasone from 0.25-0.5 mg. Treatment regimens using agents other than corticosteroids and NSAIDs are under development. No definitive dose combinations have been established.

Lupus erythematosus.

In mild systemic and discoid cases, antimalarials are the drugs of choice.
The dose of hydroxychloroquine depends on the severity of the disease and the patient's response to treatment. For adults, an initial dose of 400-800 mg daily is recommended. This level can be maintained for several weeks and then reduced to a maintenance dose of 200-400 mg daily.

Malaria.

Hydroxychloroquine is active against the erythrocytic forms of P. vivax and P. malariae and most strains of P. falciparum (but not the gametocytes of P. falciparum).
Hydroxychloroquine does not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms, nor will it prevent vivax or malariae infection when administered as a prophylactic.
It is effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.

Malaria suppression.

Suppressive therapy should begin two weeks prior to exposure. Failing this, in adults an initial loading dose of 800 mg (620 mg base), or in children 10 mg base per kg, may be taken in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.

Adults.

400 mg (310 mg base) on exactly the same day of each week.

Children.

The weekly suppressive dose is 5 mg (base) per kg bodyweight, but should not exceed the adult dose regardless of weight.

Treatment of the acute attack.

Adults.

An initial dose of 800 mg followed by 400 mg 6-8 hours later and then 400 mg on each of two consecutive days (total dose of 2 g or 1.55 g base). A single dose of 800 mg (620 mg base) has also proved effective.

Children.

The dosage is calculated on the basis of bodyweight (total dose of 25 mg base per kg).
First dose: 10 mg base per kg (not exceeding a single dose of 620 mg base).
Second dose: 5 mg base per kg (not exceeding 310 mg base), six hours after first dose.
Third dose: 5 mg base per kg eighteen hours after second dose.
Fourth dose: 5 mg base per kg twenty four hours after third dose.
For radical cure of vivax and malariae malaria, concomitant therapy with an 8-aminoquinoline is necessary.

Overdosage

Symptoms.

Overdosage with 4-aminoquinolines is dangerous. Children are particularly sensitive to these compounds and a number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively small doses (0.75 or 1 gram in one 3 year old child).
The 4-aminoquinolines are very rapidly and completely absorbed after ingestion and toxic symptoms following overdosage may occur within 30 minutes. Toxic symptoms consist of headache, drowsiness, visual disturbances, hypokalaemia, cardiovascular collapse and convulsions followed by sudden and early respiratory and cardiac arrest. The ECG may reveal atrial standstill, nodal rhythm, prolonged intraventricular conduction time and progressive bradycardia leading to ventricular fibrillation and/or cardiac arrest. Immediate medical attention is required as these effects may appear shortly after the overdose.

Treatment.

Treatment is symptomatic and must be prompt. Emesis is not recommended because of the potential for CNS depression, convulsions and cardiovascular instability. Gastric lavage may be indicated if performed soon after ingestion or in patients who are comatose. In obtunded or comatose patients receiving gastric lavage the airway should be protected. Activated charcoal should be administered. The dose of activated charcoal should be at least five times the estimated amount of hydroxychloroquine ingested.
Consideration should be given to using diazepam parentally as there have been reports that it may decrease cardiotoxicity.
Respiratory support and management of shock should be instituted as necessary.
Contact the Poisons Information Centre on 131 126 (Australia) for advice on the management of overdosage.

Presentation

Tablets (white to off white, capsule shaped, marked HCQS, plain on reverse), 200 mg (≡ 155 mg base): 100's (HDPE bottle).

Storage

Store below 25°C. Protect from light.

Poison Schedule

S4.

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