Sodium aurothiomalate: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular
Progressive juvenile idiopathic arthritis

Child: 1 mg/kg weekly. Max: 50 mg weekly. Calculated initial weekly dose may be preceded by a smaller test dose such as 1/10 or 1/5 of the full dose for 2-3 weeks. Continue weekly doses until signs of remission occur then increase dosage intervals to 2 weeks. With full remission, dosage interval may be increased gradually to 4 weeks. If no improvement after 20 weeks, dose may be raised slightly or another antirheumatic drug may be tried.

Intramuscular
Active progressive rheumatoid arthritis

Adult: Initially, 10 mg in the 1st week as test dose, followed by 50 mg weekly until signs of remission occur. Dosage interval is then increased to 2 weeks until full remission, then increased gradually to 4-6 weeks. May continue for up to 5 years after complete remission. Discontinue if no major improvement is seen after a total of 1 g (excluding test dose) has been given, or alternatively, in the absence of toxicity, 100 mg may be given weekly for further 6 weeks. Discontinue if there is no sign of remission.

Renal Impairment

Severe: Contraindicated.

Hepatic Impairment

Severe: Contraindicated.

Contraindications

Exfoliative dermatitis, SLE, necrotising enterocolitis, pulmonary fibrosis. History of haematological disorders, toxicity to heavy metals. Severely debilitated patients. Severe renal or hepatic impairment. Concomitant use w/ antimalarials, immunosuppressive agents, penicillamine or phenylbutazone.

Special Precautions

Patient w/ DM, heart failure, marked HTN, compromised cerebral or CV circulation. History of urticaria, eczema or colitis. Mild to moderate renal or hepatic impairment. Childn. Pregnancy and lactation.

Adverse Reactions

Pruritus, stomatitis, erythema multiforme, urticaria, eczema, seborrhoeic dermatitis, lichenoid eruptions, alopecia, exfoliative dermatitis, glossitis, pharyngitis, vaginitis, photosensitivity reactions, chrysiasis, eosinophilia, thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, proteinuria, haematuria, nephrosis, pulmonary fibrosis, dyspnoea, toxic hepatitis, cholestatic jaundice, peripheral neuritis, encephalitis, psychoses, fever, weakness, flushing, palpitations, syncope. Rarely, iritis, corneal ulcers, golds deposit in the eye.
Potentially Fatal: Rarely, ulcerative colitis.

Monitoring Parameters

Perform CBC w/ differential, platelet count, urinalysis for protein and LFT prior to initiation of therapy. Skin and oral mucosa inspection.

Drug Interactions

Drug Interaction: May increase risk of aspirin-induced liver damage. Increased risk of severe anaphylactoid reaction when used w/ ACE inhibitors.
Potentially Fatal: Increased risk of blood dyscrasias and other severe adverse effects (e.g. proteinuria) when used concomitantly w/ myelossupressive agents, phenylbutazone, penicillamine and antimalarials.

Lab Interference

May interfere w/ serum protein-bound iodine measurement by chloric acid digestion method.

Action

Description: Sodium aurothiomalate is a disease-modifying antirheumatic drug, used in patients whose symptoms are unresponsive to or inadequately controlled by NSAID alone. The exact mechanism of action has not been established, but its predominant action appears to be a suppressive effect on the synovitis of active rheumatoid disease. It may act by altering function of other enzymes by inhibiting lysosomal enzymes, by suppressing phagocytic activity of macrophages and polymorphonuclear leukocytes, or by altering immune response.
Onset: Delayed; may require up to 3 mth.
Pharmacokinetics:
Absorption: Readily absorbed after IM inj. Time to peak serum concentration: 4-6 hr.
Distribution: Widely distributed in body tissues and fluids. Crosses placenta and enters breast milk. Plasma protein binding: 85-95%.
Excretion: Via urine (60%-90%) and faeces (10%-40%). Elimination half-life: Approx 5-6 days.

Chemical Structure

Storage

Store between 15-30°C. Protect from light.

MIMS Class

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

ATC Classification

M01CB01 - sodium aurothiomalate ; Belongs to the class of gold preparations of antirheumatic agents.

References

Anon. Gold Sodium Thiomalate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 12/07/2016.

Buckingham R (ed). Sodium aurothiomalate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/07/2016.

Joint Formulary Committee. Sodium aurothiomalate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 12/07/2016.

McEvoy GK, Snow EK, Miller J et al (eds). Aurothioglucose, Gold Sodium Thiomalate. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 12/07/2016.

Myochrysine Injection (Akorn, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 12/07/2016.

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