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Gold Sodium Thiomalate

Pronunciation: gold SO-dee-uhm thigh-oh-MAL-ate
Class: Gold compound

Trade Names

Aurolate
- Injection 50 mg/mL

Pharmacology

Mechanism unknown; suppresses symptoms of rheumatoid arthritis and may slow progression of this disease.

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Pharmacokinetics

Absorption

Mean C ss is 1 to 5 mcg/mL. T max is 2 to 6 h.

Distribution

Protein binding is 95% to 99%.

Elimination

Plasma t 1/ 2 is 3 to 27 d (single dose); 14 to 40 d (third dose); up to 168 d (11 th dose). 70% is excreted in urine, 30% in feces.

Indications and Usage

Symptomatic relief of active adult and juvenile rheumatoid arthritis not adequately controlled by other therapies.

Unlabeled Uses

Treatment of pemphigus and psoriatic arthritis.

Contraindications

Previous severe reaction to gold compounds or other heavy metals; uncontrolled diabetes mellitus or CHF; severe debilitation; kidney disease; liver disease; severe hypertension; agranulocytosis or bleeding disorder; recent radiation exposure; systemic lupus erythematosus; urticaria; eczema.

Dosage and Administration

Adults

IM As weekly injections: First wk, 10 mg; second wk, 25 mg; third and following wks, 25 to 50 mg until major clinical improvement or toxicity occurs. If cumulative dose reaches 1 g without improvement, re-evaluate use of gold therapy. Once improvement occurs, dose may be decreased or dosing interval increased. Maintenance therapy: 25 to 50 mg every other wk for 2 to 20 wk. On basis of response, dosage interval may be increased to every third and subsequently fourth wk (maximum dose per injection: 100 mg).

Children

After test dose of 10 mg, give 1 mg/kg (maximum dose per injection: 50 mg). Dosage schedule similar to that for adults.

General Advice

  • Color of solution is pale yellow. Do not administer drug if it has darkened in color or contains precipitate.
  • Mix contents of vial thoroughly before withdrawing into syringe.
  • Administer drug only by IM injection into upper outer quadrant of gluteus maximus muscle.
  • Instruct patient to remain lying down for 10 to 15 min after injection.

Storage/Stability

Store in light-resistant containers at room temperature.

Drug Interactions

Antimalarials, penicillamine

Safety of combination antirheumatic therapy is unknown.

Cytotoxic drugs, immunosuppressives (except steroids), phenylbutazone

May increase risk of blood dyscrasias.

Laboratory Test Interactions

None well documented.

Adverse Reactions

May occur months after therapy is discontinued.

Dermatologic

Dermatitis; pruritus; exfoliative dermatitis; angioedema; chrysiasis (gray-blue skin pigmentation).

EENT

Stomatitis; corneal gold deposition; corneal ulceration; iritis; conjunctivitis; metallic taste. Children: Safety and efficacy in children younger than 6 yr of age have not been established.

GI

Diarrhea; nausea; cholestatic jaundice; ulcerative enterocolitis; GI bleeding; difficulty swallowing; abdominal pain and cramping.

Genitourinary

Nephrotic syndrome or glomerulitis with proteinuria and hematuria.

Hematologic

Anemia; thrombocytopenia; leukopenia; aplastic anemia.

Respiratory

Interstitial pneumonitis; pulmonary fibrosis.

Miscellaneous

Anaphylactoid reactions within minutes of injection, arthralgias for several days after injection, “nitritoid reaction” (eg, vasomotor reaction with flushing, fainting, weakness, dizziness, sweating, nausea, vomiting, malaise and headache).

Precautions

Monitor

Lab values

Review patient's laboratory values for indications of gold toxicity such as decreased hemoglobin, WBC less than 4,000 mm 3 , platelets less than 100,000 to 150,000/mm 3 , granulocytes less than 1,500/mm 3 , proteinuria and elevated liver enzymes.

Preinjection assessment

Prior to each injection, assess patient for early signs and symptoms of toxicity: pruritus, dermatitis, stomatitis, metallic taste, indigestion, diarrhea.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Elderly

Use with caution. Tolerance to gold decreases with age.

Special Risk Patients

Use with caution in patients with diabetes mellitus, CHF, history of blood dyscrasias, CV or cerebral circulation problems, skin rash, previous kidney or liver disease, marked hypertension, compromised circulation, or inflammatory bowel disease.

CNS

Confusion; hallucinations; seizures.

Overdosage

Symptoms

Hematuria, proteinuria, thrombocytopenia, granulocytopenia, fever, nausea, vomiting, diarrhea, skin lesions, urticaria, exfoliative dermatitis, severe pruritus.

Patient Information

  • Explain that adverse reactions can occur any time during therapy, even months after drug has been discontinued.
  • Caution patient to minimize exposure to sun and other sources of ultraviolet light (eg, sunlamp). Explain need to wear protective clothing outdoors.
  • Advise patient of importance of continued assessment of disease status and monitoring of renal, hepatic, and hematologic functions.
  • Teach patient to perform good oral hygiene, including use of soft toothbrush and daily flossing. If mild stomatitis develops, isotonic sodium chloride and sodium bicarbonate solution can be used. Advise patient to avoid strong commercial mouthwashes and spicy or acidic foods.
  • Inform patient that joint pain may continue for 1 to 2 days after injection but will usually decrease after first few injections. Therapeutic effects may not be seen until after 3 to 6 mo of treatment. Explain that drug will not reverse damage or cure disease but may slow or stop its progression.
  • Instruct patient to report these symptoms to health care provider: dermatitis, pruritus, weakness, metallic taste, fatigue, hematuria, unusual bruising or ecchymosis, nose bleeds, sore mouth, dark-colored stools.

Copyright © 2009 Wolters Kluwer Health.

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