ARTHOSAVE 200/MG TAB 100/TAB

Indications

Approved Uses

Treatment of rheumatoid arthritis; treatment of systemic lupus erythematosus (SLE); treatment of chronic discoid lupus erythematosus; treatment and prophylaxis of malaria due to susceptible Plasmodium species in areas without chloroquine resistance.

Dosage & Administration

Dosing by Condition

Rheumatoid arthritis: 400-600 mg/day initially (often divided), then 200-400 mg/day maintenance. SLE/cutaneous lupus: 200-400 mg/day. Malaria prophylaxis: 400 mg once weekly starting 1-2 weeks before exposure and continuing for 4 weeks after leaving. Acute malaria treatment (susceptible strains): 800 mg once, then 400 mg at 6, 24, and 48 hours.

Initial Dose

400 mg/day orally in 1-2 divided doses (e.g., 200 mg twice daily) for RA/SLE; adjust to the lowest effective dose based on response and weight; do not exceed 5 mg/kg/day (actual body weight) for long-term therapy.

Maintenance Dose

200 mg to 400 mg daily.

Maximum Dose

5 mg/kg/day (actual body weight) for long-term therapy to reduce retinopathy risk; do not exceed 400 mg/day.

Children's Dosage

For malaria treatment or prophylaxis in children weighing ≥31 kg, dosing is weight-based (6.5 mg/kg to 13 mg/kg depending on indication). Not recommended for children <31 kg as tablets cannot be divided.

Dose Adjustment Notes

Use the lowest effective dose to reduce retinal toxicity risk (current guidance commonly targets ≤5 mg/kg/day based on actual body weight for long-term therapy); consider dose reduction and closer monitoring in renal impairment and, if clinically indicated, hepatic impairment.

How to Take

Swallow tablet whole with food or a glass of milk to reduce gastrointestinal upset; do not crush or chew. If used for malaria prophylaxis, take the weekly dose on the same day each week.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Contraindicated in: (1) known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline compounds; (2) pre-existing retinopathy/maculopathy (or significant retinal disease) where risk of worsening is unacceptable.

Warnings & Precautions

Key precautions: baseline eye exam and periodic screening for retinopathy (earlier/more frequent if high-risk such as high dose, renal disease, tamoxifen use, or long duration); assess cardiac risk and avoid/monitor with QT-prolonging drugs (consider ECG in at-risk patients); monitor for hypoglycemia (especially in diabetics); caution in hepatic/renal impairment; caution in seizure disorders; may exacerbate psoriasis/porphyria; consider periodic CBC with prolonged therapy.

Age Restriction

No fixed minimum age; pediatric use is allowed when indicated with weight-based dosing, but for malaria prophylaxis/treatment many references use a practical lower limit of ~31 kg for the 200 mg tablet strength (to allow accurate dosing), and long-term rheumatologic use in children requires specialist oversight and ophthalmic monitoring.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MAJOR: Other QT-prolonging drugs (e.g., amiodarone, azithromycin, fluoroquinolones such as ciprofloxacin, and cisapride where available) due to additive QT prolongation/torsades risk. MODERATE: Digoxin (may increase levels), insulin/oral antidiabetics (may increase hypoglycemia risk), antacids containing magnesium/aluminum (reduced absorption-separate by at least 4 hours).

Food Interaction

Take with food or milk to reduce gastrointestinal side effects; no clinically important food restrictions are required.

Special Populations

Pregnancy

Category C

Children

For malaria treatment or prophylaxis in children weighing ≥31 kg, dosing is weight-based (6.5 mg/kg to 13 mg/kg depending on indication). Not recommended for children <31 kg as tablets cannot be divided.

Kidney Impairment

No fixed dose adjustment schema; use with caution in renal impairment and consider dose reduction/closer monitoring in moderate-severe renal dysfunction (higher retinopathy risk).

Liver Impairment

No specific standardized dose adjustment; use with caution in hepatic impairment and consider dose reduction/closer monitoring in severe hepatic disease.

Storage & Patient Advice

Overdose

Overdose is a medical emergency and can be rapidly fatal (especially in children): early symptoms include nausea/vomiting, dizziness, visual disturbance, CNS depression, seizures, hypokalemia, QRS/QT prolongation, ventricular arrhythmias, hypotension/cardiovascular collapse, and respiratory arrest; management is immediate emergency care with decontamination when appropriate, aggressive cardiac/airway support, continuous ECG monitoring, correction of electrolytes (notably potassium), and benzodiazepines for seizures (some protocols use high-dose diazepam and vasopressors per toxicology guidance).

Patient Counseling

Take with food or milk; swallow whole. Keep regular eye screening appointments and report any vision changes promptly. Benefit for arthritis/lupus may take weeks to months-do not stop without medical advice. Separate antacids (Mg/Al) by at least 4 hours. Watch for low blood sugar symptoms (especially if diabetic/on antidiabetics). Seek care for palpitations/syncope (QT risk, especially with interacting drugs). Keep out of reach of children due to severe overdose risk.

Monitoring Requirements

Ophthalmologic screening: baseline exam and periodic screening (typically starting by 5 years of therapy earlier if high-risk such as high dose, renal disease, or tamoxifen use) using automated visual fields and spectral-domain OCT. Consider baseline/periodic CBC and liver/renal function for prolonged therapy; monitor glucose in diabetics and consider ECG if cardiac risk factors or concomitant QT-prolonging drugs.

Pharmacology

Mechanism of Action

Accumulates in lysosomes/endosomes and increases intravesicular pH, impairing antigen processing/presentation and reducing Toll-like receptor signaling (notably TLR7/9), leading to decreased downstream inflammatory cytokine production; antimalarial activity relates to interference with parasite heme detoxification in the food vacuole.

Onset of Action

Rheumatic disease benefit is delayed: initial response often in 4-12 weeks with maximal effect by ~3-6 months; antimalarial therapeutic effect occurs within days.

Duration of Effect

Long-acting; due to extensive tissue distribution and a long terminal half-life, effects and drug levels may persist for weeks after discontinuation.

Product Information

Available Dosage Forms

Tablet

Composition per Dose

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

Generic Availability

Yes

Pain Type

Joint

Nsaid

No

Opioid

No

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