Hydroxychloroquine: Patient Information for Australia
Basic Product Information
| International Nonproprietary Name (INN) | Hydroxychloroquine |
|---|---|
| Australia Brand Names | Plaquenil® (common), Hydroxychloroquine Sandoz® |
| ATC Code | P01BA02 |
| Available Forms & Strengths | Tablets, 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base) |
| Manufacturers | Sanofi-Aventis Australia, Sandoz Australia |
| Legal Status | Prescription only (Schedule 4, Prescription Medicine) |
Mechanism of Action
For Patients:
Hydroxychloroquine is a medicine that helps to lower inflammation in the body. It works especially well for conditions where your immune system is too active, such as lupus or rheumatoid arthritis. It also has a long history as an antimalarial.
For Medical Professionals:
Hydroxychloroquine is a 4-aminoquinoline. Its immunomodulatory effects are thought to be mediated through alkalinisation of lysosomes in antigen-presenting cells and inhibition of toll-like receptor signalling. This leads to reduced cytokine production (notably IFN-α and TNF-α), diminished autoantigen presentation, and decreased autoreactive T-cell and B-cell activity.
Pharmacokinetics
- Absorption: Well absorbed orally (74%; peak plasma 3–4 hrs after dose).
- Distribution: Widespread, high volume of distribution (Vd 5–10 L/kg), crosses placenta, enters breast milk.
- Metabolism: Hepatic (CYP2C8, CYP3A4, CYP2D6), active metabolites formed.
- Excretion: Urine (up to 60%, variable, as both drug and metabolite); t½: 40–50 days (prolonged).
- Duration of Action: Weeks to months, especially for immunomodulatory effects.
Hydroxychloroquine in Everyday Life
Hydroxychloroquine is usually prescribed long-term for ongoing conditions. In Australia, usage is most common in rheumatoid arthritis, systemic lupus erythematosus (SLE), and certain dermatological diseases such as cutaneous lupus. Notably, it is rarely used for malaria prevention anymore in Australia due to resistance.
- Take hydroxychloroquine once daily, often in the morning wherever possible. Some patients may take it twice daily if advised.
- Swallow the tablet whole, with a glass of water.
- Your pharmacist may recommend taking it at the same time each day – set a regular routine to help you remember it.
- It may be taken with or without food.
- Medical review is essential before starting hydroxychloroquine, including an eye exam. Ongoing monitoring is arranged by your doctor, usually every 6–12 months.
Dosing: Morning vs Evening
- Morning: Taking hydroxychloroquine in the morning with breakfast helps in establishing a routine, minimises the risk of forgetting, and can reduce night-time gastrointestinal side effects for some patients.
- Evening: Some patients prefer evening dosing if morning interference occurs. No robust evidence suggests significant difference in efficacy or safety, but discuss with your pharmacist or doctor for personalised advice.
- Tip: Consistency is key — always take at the same time each day with the same type of meal (light breakfast, for example).
Taking with Food or on an Empty Stomach
- Hydroxychloroquine can be taken with or without food.
- Taking it with food or a glass of milk can help reduce stomach upset or nausea.
- UK and Australian practical advice often recommends swallowing with main meals (breakfast or dinner).
- Dietary factors typical in Australia do not usually pose an issue, but avoid taking with high-fat meals as this can occasionally increase absorption and side effect risk.
- Alcohol does not interact directly but should be limited to recommended Australian safe drinking levels.
Interaction Warnings
| Interaction | Details | Advice |
|---|---|---|
| Other medicines for arrhythmia | e.g., amiodarone, sotalol, quinidine | Risk of irregular heart rhythm (QT prolongation) – avoid unless prescribed by specialist |
| Antiepileptics | Carbamazepine, phenytoin | May increase risk of seizures; check with doctor |
| Antacids | Containing magnesium or aluminium | Can reduce absorption; take hydroxychloroquine at least 4 hours apart |
| Digoxin | Used for heart problems | Hydroxychloroquine may raise digoxin levels; monitor closely |
| Alcohol | All types | Not a direct interaction but may worsen liver/metabolic risk; limit to standard Australian guidelines |
Indications for Use
| Indication | Official (TGA Approved) | Off-Label |
|---|---|---|
| Rheumatoid arthritis | Yes | — |
| Systemic lupus erythematosus (SLE) | Yes | — |
| Discoid/cutaneous lupus | Yes | — |
| Other connective tissue diseases | — | Occasional off-label (e.g., Sjögren’s syndrome) |
| Malaria prevention/treatment | Yes (rare use in Australia now) | — |
| COVID-19 | No | Not supported outside clinical trials |
Dosing According to Indication
| Indication / Age Group | Typical Dose | Notes |
|---|---|---|
| Rheumatoid arthritis (adults) | 200–400 mg once daily | Maximum: 6.5 mg/kg based on ideal body weight |
| SLE, cutaneous lupus (adults) | 200–400 mg once daily | Consider lowest effective dose |
| Paediatric use | 3–6 mg/kg/day (max 400 mg) | Prescribed by specialist, not first-line in children |
| Elderly patients | 200 mg daily or alternate day | Start low, careful monitoring for side effects |
Safety Profile & Side Effects
Most patients in Australia tolerate hydroxychloroquine well, especially at standard doses. However, regular medical monitoring is crucial, especially for changes in vision.
| Side Effect | Common | Rare/Serious | Action |
|---|---|---|---|
| Nausea, diarrhoea, stomach upset | Yes | No | Usually settles with food or dose reduction |
| Skin rash, itching | Yes | No | See doctor if severe or widespread |
| Headache, dizziness | Yes | No | If persistent/worsening, discuss with prescriber |
| Eye problems (retinopathy) | No | Yes | Requires specialist eye monitoring – urgent review if vision changes |
| Heart rhythm problems | No | Yes | Very rare, more likely if other risk factors – inform doctor of faintness, palpitations |
| Low blood counts | No | Yes | Routine blood test monitoring |
Guidelines for Proper Use (Australia)
- Take as prescribed, for as long as recommended, even if you feel well.
- Routine baseline and yearly eye checks are mandatory (retinal specialist preferred).
- Carry a medication alert card, especially if on other immune-suppressing drugs.
- Keep up with regular blood tests as per your specialist team’s advice.
- Pregnancy: hydroxychloroquine is considered relatively safe during pregnancy and breastfeeding under specialist care in Australia; always inform your prescriber if pregnant or planning a family.
- Do not stop this medicine suddenly without advice, as your condition may flare up.
Alternative Treatment Options
- Other Disease-Modifying Anti-Rheumatic Drugs (DMARDs):
- Methotrexate – Most commonly used; effective, but needs regular blood tests and monitoring for liver/lung side effects.
- Sulfasalazine – Often used in combination with hydroxychloroquine or methotrexate; can cause gut upset.
- Leflunomide – Effective but may cause high blood pressure or liver problems; needs monitoring.
- Biological agents (e.g., etanercept, adalimumab) – Used if conventional DMARDs are not effective; administered as injections, and more expensive; available through PBS (Pharmaceutical Benefits Scheme) with specialist approval.
- Comparison: Hydroxychloroquine is slow-acting but has a good safety profile, especially in mild and moderate disease. It does not require as frequent blood monitoring as methotrexate but does require regular eye checks.
Legal, Registration, and Reimbursement Status in Australia
- Regulatory Authority: Registered and regulated by the Therapeutic Goods Administration (TGA).
- Prescription Status: Schedule 4, requiring a doctor’s prescription.
- Subsidy: Available under the Pharmaceutical Benefits Scheme (PBS) for approved indications (mainly rheumatoid arthritis, SLE, lupus).
- Not subsidised or approved for COVID-19 or off-label autoimmunity use except by specialist authority.
- For full details, consult the PBS Medicines Listing.
Latest Research & Clinical Guidance (2022–2025)
- Hydroxychloroquine remains a first-line treatment for systemic lupus erythematosus as per recent EULAR/ANZ guidelines (2023; Australian Rheumatology Association).
- No clinical benefit of hydroxychloroquine for COVID-19 prevention or treatment in large RCTs (Lancet, NEJM, BMJ 2022–2024; TGA statement August 2023).
- Retinopathy risk is closely linked to cumulative dose and body weight; annual retinal exams are now mandated after 5 years’ use, or sooner if higher risk (RANZCO 2022 guidelines).
- Combination therapy with methotrexate or sulfasalazine may offer improved control in rheumatoid arthritis with manageable side effect profile (ARA 2023).
Availability & Delivery in Australia
| Pack Size | Tablets per pack | Indicative Retail Price (AUD) |
|---|---|---|
| Standard | 100 | $22–$36 for PBS-eligible patients (higher private script) |
| Small | 60 | $16–$28 |
| City | Standard Delivery (from metro pharmacy) | Express Delivery |
|---|---|---|
| Sydney, Melbourne, Brisbane | 1–2 working days | Next business day |
| Perth, Adelaide, Hobart | 2–4 days | 1–2 days |
| Regional & remote Australia | 4–7 days | 2–4 days |
Frequently Asked Questions (FAQ)
Q1: How long does hydroxychloroquine take to work?A: It often takes 6–12 weeks before you notice significant benefits, especially for arthritis or lupus. It is important to continue treatment as prescribed and attend all routine check-ups.
Q2: What should I do if I miss a dose?
A: Take your missed dose as soon as you remember on the same day. If it’s already the next day, skip the missed dose—do not double up. Keep your regular schedule and set reminders to help you remember.
Q3: Do I really need eye checks with hydroxychloroquine?
A: Yes. Regular eye exams are essential because, after long use, hydroxychloroquine can sometimes affect the retina and vision. Schedule a baseline check before you start, then usually every 12 months.
Q4: Can I keep taking hydroxychloroquine if I am pregnant or breastfeeding?
A: This medicine is often continued in pregnancy and breastfeeding under specialist advice as the benefits usually outweigh the risks, especially in lupus. Always report pregnancy plans to your doctor.
Q5: Is hydroxychloroquine safe for use in children or the elderly?
A: Hydroxychloroquine can be used at specialist-recommended doses for children and older adults, with careful dose adjustment and regular monitoring due to different side effect risks.
For any questions not covered here, speak to your pharmacist or healthcare team for personalised, up-to-date advice.
