SOY-DOME

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SOY-DOME (SOY-DOME).

How it works

Soybean oil is a source of essential fatty acids (linoleic and linolenic acids) that are incorporated into cellular membranes and serve as precursors for eicosanoid synthesis. Iodine provides elemental iodine for thyroid hormone synthesis.

What the body does with it

Metabolism	Iodine is reduced to iodide in the gastrointestinal tract and rapidly absorbed. Soybean oil is hydrolyzed by pancreatic lipase to free fatty acids and glycerol.
Excretion	Primarily renal excretion of sulfate and glucuronide conjugates; minimal biliary/fecal elimination.
Half-life	Terminal elimination half-life is approximately 4.6 hours after oral administration.
Protein binding	99% bound to plasma proteins, primarily albumin.
Volume of Distribution	0.8-1.2 L/kg, indicating distribution into total body water.
Bioavailability	Oral: approximately 70% due to first-pass metabolism.
Onset of Action	Oral: onset of therapeutic effect within 2-4 hours; topical: within 1-2 hours.
Duration of Action	Oral: duration of effect approximately 12-24 hours; topical: duration up to 12 hours.

Classification & Brands

Dosing & administration

Not applicable. Soy-Dome is a topical product (soybean oil and hydrocortisone) with no standard systemic dosing.

Dosage form	EMULSION
Renal impairment	No renal adjustment required for topical application.
Liver impairment	No hepatic adjustment required for topical application.
Pediatric use	Apply a thin layer to affected area twice daily. Use under medical supervision in children under 2 years.
Geriatric use	No specific adjustments; use caution in elderly with thin skin or prolonged use.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SOY-DOME (SOY-DOME).

Breastfeeding	No data on excretion into breast milk. Topical use likely results in negligible systemic absorption; risk to nursing infant is minimal. No M/P ratio available due to lack of systemic absorption.
Teratogenic Risk	Soy-Dome (allantoin, aminacrine HCl, benzocaine, oxyquinoline, sulfur) is not systemically absorbed. No fetal risks have been reported. For topical use, risk is minimal. No data on oral administration.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to iodine or soy components. Tuberculosis, goiter (except for preoperative preparation), and autoimmune thyroid disease (e.g., Hashimoto's thyroiditis).

Clinical Precautions

Precautions

May cause hyperkalemia in patients with renal impairment due to potassium iodide content. Hypersensitivity reactions including rash, angioedema may occur. Long-term use may lead to thyroid dysfunction (hyper- or hypothyroidism).

Clinical Tips & Counseling

Drug interactions

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SOY-DOME

Clinical safety rating: caution

Comprehensive clinical and safety monograph for SOY-DOME (SOY-DOME).

How it works

What the body does with it

Metabolism	Iodine is reduced to iodide in the gastrointestinal tract and rapidly absorbed. Soybean oil is hydrolyzed by pancreatic lipase to free fatty acids and glycerol.
Excretion	Primarily renal excretion of sulfate and glucuronide conjugates; minimal biliary/fecal elimination.
Half-life	Terminal elimination half-life is approximately 4.6 hours after oral administration.
Protein binding	99% bound to plasma proteins, primarily albumin.
Volume of Distribution	0.8-1.2 L/kg, indicating distribution into total body water.
Bioavailability	Oral: approximately 70% due to first-pass metabolism.
Onset of Action	Oral: onset of therapeutic effect within 2-4 hours; topical: within 1-2 hours.
Duration of Action	Oral: duration of effect approximately 12-24 hours; topical: duration up to 12 hours.

Classification & Brands

Dosing & administration

Not applicable. Soy-Dome is a topical product (soybean oil and hydrocortisone) with no standard systemic dosing.

Dosage form	EMULSION
Renal impairment	No renal adjustment required for topical application.
Liver impairment	No hepatic adjustment required for topical application.
Pediatric use	Apply a thin layer to affected area twice daily. Use under medical supervision in children under 2 years.
Geriatric use	No specific adjustments; use caution in elderly with thin skin or prolonged use.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for SOY-DOME (SOY-DOME).

Breastfeeding	No data on excretion into breast milk. Topical use likely results in negligible systemic absorption; risk to nursing infant is minimal. No M/P ratio available due to lack of systemic absorption.
Teratogenic Risk	Soy-Dome (allantoin, aminacrine HCl, benzocaine, oxyquinoline, sulfur) is not systemically absorbed. No fetal risks have been reported. For topical use, risk is minimal. No data on oral administration.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

None.

Side Effect Profile

Serious Effects

Absolute Contraindications

Hypersensitivity to iodine or soy components. Tuberculosis, goiter (except for preoperative preparation), and autoimmune thyroid disease (e.g., Hashimoto's thyroiditis).