Sodium Aurothiomalate

Sodium Aurothiomalate is a gold compound which is among the disease modifying antirheumatic drugs (DMARDs). Sodium Aurothiomalate is used mainly for its anti-inflammatory effect in active progressive rheumatoid arthritis and progressive juvenile chronic arthritis; they may also be beneficial in psoriatic arthritis. They are generally reserved for use as second line drugs in patients whose symptoms are unresponsive to or inadequately controlled by NSAIDs alone. Gold compounds suppress and prevent but do not cure arthritis. A patient should be warned to tell doctor immediately if sore throat, fever, infection. unexplained bleeding and bruising, mouth ulcers, skin rashes, edema, and metallic taste develop. If toxicity develops, gold therapy should be discontinued immediately.

Sodium Aurothiomalate is primarily indicated in conditions like Reversal of non-depolarizing neuromuscular blockade, small cell carcinoma.

Sodium Aurothiomalate is contraindicated in conditions like Pulmonary fibrosis, Bone marrow aplasia, Hematological disorders, Hypersensitivity to any component of product.

The symptomatic adverse reactions produced by Sodium Aurothiomalate are more or less tolerable and if they become severe, they can be treated symptomatically, these include Alopecia, Colitis, Mouth ulcers, Hepatotoxicity, Cholestatic Jaundice, Proteinuria, Skin reactions, Blood disorders, Pulmonary fibrosis, Nephrotic toxicity.

Concerns related to adverse effects: • Dermatologic reactions: Dermatitis and lesions of the mucous membranes are common and may be serious; pruritus may precede the early development of a skin reaction. Consider alternative therapy in patients with dermatitis; may increase risk and/or symptoms of gold toxicity may be more difficult to detect. Use is contraindicated in patients with significant dermatitis, including urticaria or eczema. • GI effects: Signs of toxicity include persistent diarrhea, stomatitis, and enterocolitis; avoid use in patients with prior inflammatory bowel disease. • Hematologic effects: Signs of toxicity include hematologic depression (depressed hemoglobin, eosinophilia, leukocytes, granulocytes, or platelets). Use is contraindicated in patients with a history of blood dyscrasias or a history of agranulocytosis, hemorrhagic diathesis, or drug-induced granulocytopenia or anemia. Symptoms of gold toxicity may be difficult to detect in patients with prior abnormalities; consider alternative therapy. • Hepatic effects: May be associated with the development of cholestatic jaundice. Use is contraindicated in patients with hepatic impairment. • Hypersensitivity reactions: Rare hypersensitivity reactions, including anaphylactic shock, syncope, bradycardia, thickening of the tongue, difficulty in swallowing and breathing, and angioedema have been reported in association with injections of sodium aurothiomalate; treatment should be discontinued if these reactions occur. In addition, a vasomotor (nitritoid) reaction characterized by acute flushing and tachycardia may occur within minutes of injection; this reaction should be differentiated from anaphylaxis and therapy may be continued, but a careful evaluation of risk versus benefit should be undertaken and extreme caution should be exercised before resuming therapy, particularly in patients with cardiovascular disease. • Pulmonary toxicity: May be associated with interstitial fibrosis; monitor closely. • Renal effects: Renal toxicity ranges from mild proteinuria to nephrotic syndrome. Use is contraindicated in patients with renal disease. Disease-related concerns: • Cardiovascular disease: Use caution in patients with heart failure, hypertension, or cerebrovascular disease. Other warnings/precautions: • Administration: Must not be injected IV. • Experienced physician: Physicians should be experienced with chrysotherapy and should be familiar with the toxicity and benefits of therapy. • Monitoring: Frequent monitoring of patients for signs and symptoms of toxicity will prevent serious adverse reactions.

Concerns related to adverse effects: • Dermatologic reactions: Dermatitis and lesions of the mucous membranes are common and may be serious; pruritus may precede the early development of a skin reaction. Consider alternative therapy in patients with dermatitis; may increase risk and/or symptoms of gold toxicity may be more difficult to detect. Use is contraindicated in patients with significant dermatitis, including urticaria or eczema. • GI effects: Signs of toxicity include persistent diarrhea, stomatitis, and enterocolitis; avoid use in patients with prior inflammatory bowel disease. • Hematologic effects: Signs of toxicity include hematologic depression (depressed hemoglobin, eosinophilia, leukocytes, granulocytes, or platelets). Use is contraindicated in patients with a history of blood dyscrasias or a history of agranulocytosis, hemorrhagic diathesis, or drug-induced granulocytopenia or anemia. Symptoms of gold toxicity may be difficult to detect in patients with prior abnormalities; consider alternative therapy. • Hepatic effects: May be associated with the development of cholestatic jaundice. Use is contraindicated in patients with hepatic impairment. • Hypersensitivity reactions: Rare hypersensitivity reactions, including anaphylactic shock, syncope, bradycardia, thickening of the tongue, difficulty in swallowing and breathing, and angioedema have been reported in association with injections of sodium aurothiomalate; treatment should be discontinued if these reactions occur. In addition, a vasomotor (nitritoid) reaction characterized by acute flushing and tachycardia may occur within minutes of injection; this reaction should be differentiated from anaphylaxis and therapy may be continued, but a careful evaluation of risk versus benefit should be undertaken and extreme caution should be exercised before resuming therapy, particularly in patients with cardiovascular disease. • Pulmonary toxicity: May be associated with interstitial fibrosis; monitor closely. • Renal effects: Renal toxicity ranges from mild proteinuria to nephrotic syndrome. Use is contraindicated in patients with renal disease. Disease-related concerns: • Cardiovascular disease: Use caution in patients with heart failure, hypertension, or cerebrovascular disease. Other warnings/precautions: • Administration: Must not be injected IV. • Experienced physician: Physicians should be experienced with chrysotherapy and should be familiar with the toxicity and benefits of therapy. • Monitoring: Frequent monitoring of patients for signs and symptoms of toxicity will prevent serious adverse reactions.

10 mg (10 (10)) As recommended. IM — INITIAL DOSE: 10 mg is for 1st week.25 mg the second week, then 25 to 50 mg weekly for the next 20 weeks or until toxicity occurs. 50 mg (50 (50)) As recommended. IM — MAINTANANCE DOSE: 50 mg i.m. tapered progressively to every 2 to 4 weeks according to clinical response and tolerance, and maintained indefinitely.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

Angiotensin-Converting Enzyme Inhibitors: May enhance the adverse/toxic effect of Gold Sodium Thiomalate. An increased risk of nitritoid reactions has been appreciated. Monitor therapy Aspirin: May enhance the adverse/toxic effect of Gold Sodium Thiomalate. Specifically, liver function tests may be elevated when these agents are combined. Monitor therapy PenicillAMINE: Gold Sodium Thiomalate may enhance the adverse/toxic effect of PenicillAMINE. Specifically, this combination may increase the risk for serious hematologic and/or renal adverse reactions. Avoid combination Phenylbutazone: May enhance the adverse/toxic effect of Gold Sodium Thiomalate. Specifically, the risk for hematologic adverse effects may be increased. Monitor therapy

Inj Store Between 15°C-25°C. Protect from Sunlight, Moisture and Heat.