Iodinated I-131 Albumin
Generic Name: iodinated i-131 albumin
Brand Names:
Megatope
DESCRIPTION Chemical Characteristics MEGATOPE (iodinated I 131 albumin) injection is a sterile, nonpyrogenic, radioactive diagnostic agent for intravenous use. Each mL contains albumin human (approximately 10 mg), dibasic sodium phosphate (16 mg), guanidine hydrochloride (not more than 0.4 mg), monobasic sodium phosphate (1.6 mg), sodium chloride for isotonicity, and benzyl alcohol (9 mg) as a preservative.
Overview
DESCRIPTION Chemical Characteristics MEGATOPE (iodinated I 131 albumin) injection is a sterile, nonpyrogenic, radioactive diagnostic agent for intravenous use. Each mL contains albumin human (approximately 10 mg), dibasic sodium phosphate (16 mg), guanidine hydrochloride (not more than 0.4 mg), monobasic sodium phosphate (1.6 mg), sodium chloride for isotonicity, and benzyl alcohol (9 mg) as a preservative.
Uses
INDICATIONS AND USAGE MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.
Dosage
DOSAGE AND ADMINISTRATION Premedication Administer 10 drops of Strong Iodine Solution, USP (e.g., Lugol’s Solution) three times daily, beginning at least 24 hours before administration of MEGATOPE and continue for 1 week or 2 weeks thereafter to minimize the uptake of iodine-131. Recommended Dosage The recommended dose of MEGATOPE for total blood or plasma volume determination in adult patients is from 0.185 MBq to 1.85 MBq (5 microCi to 50 microCi) administered intravenously. When a procedure such as a blood volume is to be repeated, do not exceed 7.4 MBq (200 microCi) in any 1 week. Administration Instructions • Measure the patient dose using a suitable dose calibrator immediately prior to administration. • Use a shielded syringe for withdrawing and injecting MEGATOPE.
Side Effects
ADVERSE REACTIONS The following adverse reactions have been identified with the use of radioiodinated albumin products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity
Warnings
WARNINGS Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use. CONTRAINDICATIONS None Known.
Storage
Store refrigerated at 2º to 8ºC (36° to 46°F) in suitable lead shield.
Frequently Asked Questions
What is Iodinated I-131 Albumin used for?▼
INDICATIONS AND USAGE MEGATOPE is indicated in adults for use in determinations of total blood and plasma volumes.
What are the side effects of Iodinated I-131 Albumin?▼
ADVERSE REACTIONS The following adverse reactions have been identified with the use of radioiodinated albumin products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune System Disorders: Hypersensitivity
What are the important warnings for Iodinated I-131 Albumin?▼
WARNINGS Aseptic meningitis and pyrogenic reactions have been reported following cisternography with MEGATOPE. The safety and effectiveness of MEGATOPE for cisternography have not been established. MEGATOPE is not approved for this use. CONTRAINDICATIONS None Known.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.