PLAQUENIL 200/MG TAB 60/TAB

Indications

Approved Uses

Rheumatoid arthritis; systemic lupus erythematosus (SLE); discoid lupus erythematosus; malaria-treatment of acute attacks and prophylaxis of malaria in susceptible strains.

Off-Label Uses

Commonly used off-label: Sjögren’s syndrome; antiphospholipid syndrome (adjunct, especially in SLE); cutaneous dermatomyositis; sarcoidosis (selected cases); porphyria cutanea tarda (selected cases); chronic Q fever (in combination regimens). COVID-19 is not recommended due to lack of benefit and safety concerns.

Dosage & Administration

Dosing by Condition

Rheumatoid arthritis: 400-600 mg/day initially (in divided doses), then 200-400 mg/day maintenance (do not exceed 5 mg/kg/day actual body weight for chronic therapy). SLE/discoid lupus: typically 200-400 mg/day (max 5 mg/kg/day actual body weight). Malaria prophylaxis: 400 mg once weekly, start 2 weeks before exposure and continue 4 weeks after leaving endemic area. Acute malaria (susceptible strains): 800 mg once, then 400 mg at 6, 24, and 48 hours.

Initial Dose

400mg daily (e.g., 200mg twice daily) for rheumatoid arthritis; may reduce to 200mg daily for maintenance. Ensure total daily dose does not exceed 5 mg/kg/day (actual body weight) to reduce retinopathy risk.

Maintenance Dose

200mg to 400mg daily for rheumatoid arthritis or lupus.

Maximum Dose

5 mg/kg/day (actual body weight) to reduce retinopathy risk.

Children's Dosage

Malaria prophylaxis: 6.5mg/kg (max 400mg) once weekly. Malaria treatment: 13mg/kg (max 800mg) initial dose, then 6.5mg/kg (max 400mg) at 6, 24, and 48 hours. Not approved for chronic use in children for autoimmune conditions

Dose Adjustment Notes

Use actual body weight to limit retinopathy risk; for long-term rheumatologic use, keep dose ≤5 mg/kg/day (actual body weight). Consider dose reduction/closer monitoring in significant renal impairment (and consider in hepatic impairment) due to increased exposure and toxicity risk.

How to Take

Oral: take with food or a glass of milk to reduce gastrointestinal upset; swallow tablets with water (tablets may be split if needed for dose, but do not crush/chew unless specifically directed). For malaria prophylaxis, take the weekly dose on the same day each week.

Side Effects

Common Side Effects

Common: nausea, vomiting, diarrhea, abdominal pain/cramps, headache, skin rash and pruritus (itching).

Side Effect Frequency

Common: GI upset (nausea, diarrhea, abdominal pain, vomiting), headache, and rash/pruritus. Uncommon to rare but serious: retinopathy/visual field changes, cardiomyopathy and QT prolongation/arrhythmias, severe cutaneous adverse reactions (e.g., SJS/TEN), blood dyscrasias, hypoglycemia, and neuromyopathy.

Safety & Warnings

Contraindications

Known hypersensitivity to hydroxychloroquine/4-aminoquinoline compounds; pre-existing retinopathy/maculopathy (or retinal field changes attributable to 4-aminoquinolines).

Warnings & Precautions

Key precautions: baseline ophthalmologic exam and periodic screening (typically annually after 5 years, earlier/higher frequency if high-risk such as high dose, renal disease, or tamoxifen); do not exceed recommended weight-based dosing to reduce retinopathy risk; monitor for cardiomyopathy/QT prolongation (especially with cardiac disease or QT-prolonging drugs); monitor for severe hypoglycemia; periodic CBC with long-term use; caution in hepatic/renal impairment; may exacerbate psoriasis/porphyria; monitor for neuromuscular weakness, severe skin reactions, and neuropsychiatric symptoms.

Age Restriction

No absolute minimum age; pediatric use is weight-based. For malaria, tablets are generally not suitable for children <31 kg because the 200 mg film‑coated tablet cannot be accurately divided; long-term therapy in children should be avoided/only if clearly necessary with specialist oversight due to higher risk of toxicity (not an absolute contraindication).

Drug Interactions

Drug Interactions

Clinically important interactions include: antacids/kaolin (decrease absorption; separate by ~4 hours), digoxin (may increase levels), QT‑prolonging drugs (additive QT risk), antidiabetic agents/insulin (increased hypoglycemia risk), mefloquine (increased seizure risk), cyclosporine (increased levels), cimetidine (may increase hydroxychloroquine exposure), tamoxifen (increased retinopathy risk).

Interaction Severity

MAJOR: other QT-prolonging drugs (e.g., amiodarone, certain macrolides/fluoroquinolones/antipsychotics) due to additive QT prolongation/torsades risk; mefloquine (increased seizure risk and potential QT effects). MODERATE: digoxin (may increase levels), antidiabetic agents (may increase hypoglycemia risk), cyclosporine (may increase levels), tamoxifen (increases retinopathy risk), cimetidine (may increase exposure). MINOR/ADMINISTRATION: aluminum/magnesium antacids can reduce absorption-separate by ~4 hours.

Food Interaction

Take with food or milk to reduce gastrointestinal upset; no clinically required food restriction otherwise.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Malaria prophylaxis: 6.5mg/kg (max 400mg) once weekly. Malaria treatment: 13mg/kg (max 800mg) initial dose, then 6.5mg/kg (max 400mg) at 6, 24, and 48 hours. Not approved for chronic use in children for autoimmune conditions

Elderly

Use the lowest effective dose; dose based on actual body weight (max 5mg/kg/day); increased risk of retinal toxicity and cardiac conduction abnormalities; monitor renal and hepatic function

Kidney Impairment

No specific labeled adjustment; use with caution in renal impairment and consider dose reduction with close monitoring in moderate-severe CKD (higher retinopathy risk with reduced clearance).

Liver Impairment

No specific labeled dose adjustment; use with caution and consider dose reduction/close monitoring in hepatic impairment.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered unless it is close to the next scheduled dose; if close, skip the missed dose and resume the regular schedule-do not double doses. (For weekly malaria prophylaxis: take as soon as possible and continue weekly on the usual day.)

Stopping the Medicine

Do not stop without prescriber advice for chronic autoimmune indications (risk of flare); for malaria treatment/prophylaxis, stopping early can lead to treatment failure-stop only if serious adverse effects occur and seek urgent medical advice; no taper is required pharmacologically.

Overdose

Overdose is a medical emergency and can be rapidly fatal (especially in children). Symptoms: nausea/vomiting, headache, drowsiness, visual disturbances, seizures, hypokalemia, QT prolongation/ventricular arrhythmias, cardiovascular collapse, respiratory arrest; management: immediate emergency care/poison center, GI decontamination (activated charcoal if appropriate), aggressive cardiac/airway support, treat seizures (e.g., benzodiazepines), correct electrolytes and monitor ECG.

Patient Counseling

Take by mouth with food or milk to reduce stomach upset; take exactly as prescribed and do not stop without prescriber advice (benefit in RA/SLE may take weeks to months). Get a baseline eye exam and periodic retinal screening during therapy (risk increases with higher daily dose, long duration, renal disease, and tamoxifen use); report any vision changes immediately. Seek urgent care for symptoms of serious toxicity: palpitations/fainting (QT prolongation/cardiomyopathy), severe muscle weakness, severe rash, or signs of hypoglycemia (sweating, shakiness, confusion). If used for malaria prophylaxis, start 1-2 weeks before exposure, take weekly during travel, and continue 4 weeks after leaving. Keep out of reach of children-accidental overdose can be rapidly fatal.

Monitoring Requirements

Ophthalmology: baseline retinal exam within the first year of starting; then annually after 5 years if low risk, but earlier/more frequent if high risk (e.g., >5 mg/kg/day, renal disease, tamoxifen use, pre-existing retinal disease). Consider periodic CBC and liver/renal function in long-term therapy; monitor glucose in diabetics/at-risk patients; consider ECG if cardiac disease or concomitant QT-prolonging drugs.

Pharmacology

Mechanism of Action

Accumulates in lysosomes/endosomes increasing intravesicular pH, which interferes with antigen processing/presentation and reduces toll-like receptor (e.g., TLR7/9) signaling and downstream cytokine production; antimalarial activity relates to disruption of parasite intracellular processes in acidic compartments.

Duration of Effect

Long-acting: terminal elimination is prolonged (tissue half-life on the order of weeks), so clinical effects and drug presence can persist for weeks after discontinuation.

Half-Life

Terminal half-life approximately 40-50 days (often cited range ~32-50 days) due to extensive tissue distribution.

Bioavailability

Approximately 16-30% (mean); up to 30-100% in RA patients.

Metabolism

Hepatic metabolism (primarily via CYP3A4, CYP2C8, and CYP2D6) to active metabolites including desethylhydroxychloroquine (and desethylchloroquine).

Excretion

Renal and fecal: a substantial fraction is eliminated in urine (including unchanged drug and metabolites), with additional fecal/biliary elimination; elimination is slow due to extensive tissue distribution.

Product Information

Available Dosage Forms

Film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 200mg hydroxychloroquine sulfate (equivalent to 155mg hydroxychloroquine base)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Pain Type

Joint

Nsaid

No

Opioid

No

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