IOPAMIDOL injection, solution

iopamidol by

Drug Labeling and Warnings

iopamidol by is a Prescription medication manufactured, distributed, or labeled by Slate Run Pharmaceuticals, LLC, Hainan Poly Pharm. Co., Ltd., Divi's Laboratories Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • BOXED WARNING (What is this?)

    WARNING: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION

    Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema [see Warnings and Precautions ( 5.1)] . Iopamidol Injection, USP is for intra-arterial or intravenous use only [see Dosage and Administration ( 2.1)] .

  • 1 INDICATIONS AND USAGE

    1.1 Intra-arterial Procedures*

    • Cerebral arteriography in adults
    • Peripheral arteriography in adults
    • Selective visceral arteriography and aortography in adults
    • Coronary arteriography and cardiac ventriculography in adults
    • Angiocardiography in pediatric patients

    1.2 Intravenous Procedures*

    • Excretory urography in adults and pediatric patients
    • Computed tomography (CT) of head and body in adults and pediatric patients
    • Peripheral venography in adults

    *Specific concentrations of Iopamidol Injection, USP are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2, 2.3, 2.4)].

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Important Dosing and Administration Information

    • Iopamidol Injection, USP is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1)] .
    • Specific concentrations of Iopamidol Injection, USP are recommended for each type of imaging procedure [see Dosage and Administration ( 2.2, 2.3, 2.4)] .
    • Individualize the volume, concentration, and injection rate of iopamidol injection according to the specific dosing tables [see Dosage and Administration ( 2.2, 2.3, 2.4)] . Consider factors such as: age, body weight, blood vessel size and blood flow rate, anticipated pathology and degree and extent of opacification required, structures or area to be examined, concomitant medical conditions, imaging equipment, and technique to be employed.
    • Hydrate patients before and after Iopamidol Injection, USP administration [see Warnings and Precautions ( 5.3)] .
    • Use aseptic technique for all handling and administration of Iopamidol Injection, USP.
    • Iopamidol Injection, USP may be administered at either body temperature (37°C, 98.6°F) or room temperature (20°C to 25°C, 68°F to 77°F).
    • Visually inspect Iopamidol Injection, USP for particulate matter or discoloration before administration. Do not administer Iopamidol Injection, USP if particulate matter or discolorations are observed.
    • Do not mix Iopamidol Injection, USP with other drugs or inject in intravenous lines containing other drugs or total nutritional admixtures.
    • Iopamidol Injection, USP single-dose containers are intended for one procedure only. Discard any unused portion.

    2.2 Recommended Dosage for Intra-arterial Procedures in Adults

    The recommended doses for intra-arterial procedures in adults are shown in Table 1.

    Table 1: Recommended Concentrations and Volumes of Iopamidol Injection, USP for Intra-arterial Procedures in Adults

    Imaging Procedure

    Concentration

    (mg Iodine/mL)

    Volume to Administer per Single Injection for Selected Injection Sites

    Maximum Cumulative

    Total Dose

    Cerebral Arteriography

    300

    8 mL to 12 mL by carotid puncture or transfemoral catheterization

    90 mL

    Peripheral Arteriography

    300

    5 mL to 40 mL into the femoral artery or subclavian artery

    25 mL to 50 mL into the aorta for a distal runoff

    250 mL

    Selective Visceral Arteriography and

    Aortography

    370

    Up to 10 mL for the renal arteries

    Up to 50 mL into the larger vessels such as the aorta or celiac artery

    225 mL

    Coronary Arteriography

    and Cardiac Ventriculography

    370

    2 mL to 10 mL for selective coronary artery injection

    25 mL to 50 mL for cardiac ventriculography or for nonselective opacification of multiple coronary arteries following injection at the aortic root

    200 mL

    2.3 Recommended Dosage for Intravenous Procedures in Adults

    The recommended doses for intra-arterial procedures in adults are shown in Table 2.

    Table 2: Recommended Concentrations and Volumes of Iopamidol Injection, USP for Intravenous Procedures in Adults

    Imaging

    Procedure

    Concentration

    (mg Iodine/mL)

    Volume to Administer

    Excretory

    Urography

    250

    300

    370

    50 mL to 100 mL by rapid injection

    50 mL by rapid injection

    40 mL by rapid injection

    CT of the Head

    250

    300

    130 mL to 240 mL

    100 mL to 200 mL

    CT of Body

    250

    300

    370

    130 mL to 240 mL by rapid infusion or bolus injection

    100 mL to 200 mL by rapid infusion or bolus injection

    80 mL to 160 mL by rapid infusion or bolus injection

    Peripheral

    Venography

    200

    25 mL to 150 mL per lower extremity; the maximum total dose is 350 mL

    2.4 Recommended Dosage in Pediatric Patients

    The recommended doses in pediatric patients are shown in Table 3.

    Table 3: Recommended Concentrations and Volumes per Body Weight of Iopamidol Injection, USP for Intra-arterial and Intravenous Procedures in Pediatric Patients

    Imaging

    Procedure

    Concentration

    (mg Iodine/mL)

    Volume per Body Weight to Administer

    Maximum Dose

    Intra-arterial Procedures

    Angiocardiography

    370

    0.5 mL/kg to 2 mL/kg per single injection

    Maximum Cumulative Dose by Weight

    Neonates: 5 mL/kg

    Aged 4 weeks and older: 8 mL/kg

    Do not exceed maximum

    cumulative doses by age below.

    Maximum Cumulative Dose by Age

    <2 years 40 mL

    2 years to 4 years 50 mL

    5 years to 9 years 100 mL

    10 years to 18 years 125 mL

    Intravenous Procedures

    Excretory Urography

    250

    1.2 mL/kg to

    3.6 mL/kg

    120 mL

    300

    1 mL/kg to

    3 mL/kg

    100 mL

    CT of the Head and Body

    250

    1.2 mL/kg to

    3.6 mL/kg

    120 mL

    300

    1 mL/kg to

    3 mL/kg

    100 mL
  • 3 DOSAGE FORMS AND STRENGTHS

    Injection: Clear, colorless to pale yellow solution available in the following concentrations of iodine:

    Concentration

    (mg Iodine/mL)

    Package Size

    Package Type

    200

    50 mL

    Single-Dose Vial

    250

    50 mL

    Single-Dose Vial

    300

    30 mL, 50 mL, 100 mL

    Single-Dose Vial

    370

    50 mL, 75 mL, and 100 mL

    Single-Dose Vial
  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Risks Associated with Intrathecal Administration

    Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Iopamidol injection is for intra-arterial or intravenous use only and must not be administered intrathecally [see Dosage and Administration ( 2.1)].

    5.2 Hypersensitivity Reactions

    Iopamidol injection can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2)] . Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur. There is increased risk of hypersensitivity reactions in patients with a history of previous reactions to contrast agents, and allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies) or other hypersensitivities.

    Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions does not prevent serious life-threatening reactions but may reduce both their incidence and severity. Obtain a history of allergy, hypersensitivity, or hypersensitivity reactions to iodinated contrast agents and always have emergency resuscitation equipment and trained personnel available prior to iopamidol injection administration. Monitor all patients for hypersensitivity reactions.

    5.3 Acute Kidney Injury

    Acute kidney injury, including renal failure, may occur after iopamidol injection administration. Risk factors include: pre-existing renal insufficiency, dehydration, diabetes mellitus, congestive heart failure, advanced vascular disease, elderly age, concomitant use of nephrotoxic or diuretic medications, multiple myeloma or other paraproteinemias, and repetitive or large doses of iopamidol injection.

    Use the lowest necessary dose of iopamidol injection in patients with renal impairment. Adequately hydrate patients prior to and following iopamidol injection administration. Do not use laxatives, diuretics, or preparatory dehydration prior to iopamidol injection administration.

    5.4 Cardiovascular Adverse Reactions

    Iopamidol injection increases the circulatory osmotic load and may induce acute or delayed hemodynamic disturbances in patients with congestive heart failure, severely impaired renal function, combined renal and hepatic disease, and combined renal and cardiac disease, particularly when repetitive or large doses are administered. Fatal cardiovascular reactions have occurred mostly within 10 minutes of iopamidol injection; the main feature was cardiac arrest with cardiovascular disease as the main underlying factor. Hypotensive collapse and shock have occurred. Cardiac decompensation, serious arrhythmias, and myocardial ischemia or infarction can occur during coronary arteriography and ventriculography.

    The administration of iopamidol injection may cause pulmonary edema in patients with heart failure. Based upon published reports, deaths associated with the administration of iodinated contrast agents range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Use the lowest necessary dose of iopamidol injection in patients with congestive heart failure and always have emergency resuscitation equipment and trained personnel available. Monitor all patients for severe cardiovascular reactions.

    5.5 Thromboembolic Events

    Serious, in some cases fatal, thromboembolic events, including myocardial infarction and stroke, can occur during angiographic procedures. During these procedures, increased thrombosis and activation of the complement system occurs. Risk factors for developing thromboembolic events include: length of procedure, catheter and syringe material, underlying disease state, and concomitant medications.

    To minimize thromboembolic events, use meticulous angiographic techniques and minimize the length of the procedure. Avoid blood remaining in contact with syringes containing iodinated contrast agents, which increases risk of clotting. Avoid angiocardiography in patients with homocystinuria because of the risk of inducing thrombosis and embolism.

    5.6 Extravasation and Injection Site Reactions

    Extravasation can occur with iopamidol injection administration, particularly in patients with severe arterial or venous disease. Inflammation, blistering, skin necrosis, and compartment syndrome have been reported following extravasation. In addition, injection site reactions such as pain and swelling at the injection site can also occur [see Adverse Reactions ( 6.2)] . Ensure intravascular placement of catheters prior to injection. Monitor patients for extravasation and advise patients to seek medical care for progression of symptoms.

    5.7 Thyroid Storm in Patients with Hyperthyroidism

    Thyroid storm has occurred after the intravascular use of iodinated agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule. Evaluate the risk in such patients before use of iopamidol injection

    5.8 Thyroid Dysfunction in Pediatric Patients 0 Years to 3 Years of Age

    Thyroid dysfunction characterized by hypothyroidism or transient thyroid suppression has been reported after both single exposure and multiple exposures to iodinated contrast agents in pediatric patients 0 years to 3 years of age.

    Younger age, very low birth weight, prematurity, underlying medical conditions affecting thyroid function, admission to neonatal or pediatric intensive care units, and congenital cardiac conditions are associated with an increased risk of hypothyroidism after iodinated contrast agent exposure. Pediatric patients with congenital cardiac conditions may be at greatest risk given that they often require high doses of contrast during invasive cardiac procedures.

    An underactive thyroid during early life may be harmful for cognitive and neurological development and may require thyroid hormone replacement therapy. After exposure to iodinated contrast agents, individualize thyroid function monitoring based on underlying risk factors, especially in term and preterm neonates.

    5.9 Hypertensive Crisis in Patients with Pheochromocytoma

    Hypertensive crisis in patients with pheochromocytoma has occurred with iodinated contrast agents. Closely monitor patients when administering iopamidol injection if pheochromocytoma or catecholamine-secreting paragangliomas are suspected. Inject the minimum amount of iopamidol injection necessary and have measures for treatment of hypertensive crisis readily available.

    5.10 Sickle Cell Crisis in Patients with Sickle Cell Disease

    Iodinated contrast agents can promote sickling in individuals who are homozygous for sickle cell disease. Hydrate patients prior to and following iopamidol injection administration and use only if the necessary imaging information cannot be obtained with alternative imaging modalities.

    5.11 Severe Cutaneous Adverse Reactions

    Severe cutaneous adverse reactions (SCAR) may develop from 1 hour to several weeks after intravascular contrast agent administration. These reactions include Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). Reaction severity may increase and time to onset may decrease with repeat administration of a contrast agent; prophylactic medications may not prevent or mitigate severe cutaneous adverse reactions. Avoid administering iopamidol injection to patients with a history of a severe cutaneous adverse reaction to iopamidol injection.

    5.12 Interference with Laboratory Tests

    Iopamidol injection can interfere with protein-bound iodine test [see Drug Interactions ( 7.2)] .

  • 6 ADVERSE REACTIONS

    The following adverse reactions are described in greater detail in other sections:

    • Risks Associated with Intrathecal Administration [see Warnings and Precautions ( 5.1)]
    • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2)]
    • Acute Kidney Injury [see Warnings and Precautions ( 5.3)]
    • Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4)]
    • Thromboembolic Events [see Warnings and Precautions ( 5.5)]
    • Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6)]
    • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.8)]
    • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11)]

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    Adverse Reactions in Adults

    The safety of iopamidol injection was evaluated in 2,246 adult patients receiving iopamidol injection by intra-arterial or intravenous route in clinical studies. Table 4 shows the common adverse reactions (>1%).

    Table 4: Adverse Reactions Reported in >1% of Patients Receiving Intra-arterial or Intravenous Injection of Iopamidol in Clinical Studies

    Adverse Reaction

    Iopamidol Injection

    (N=2,246)

    %

    Pain

    2.8

    Hot flashes

    1.5

    Burning sensation

    1.4

    Nausea

    1.2

    Warmth

    1.1

    The following adverse reactions occurred in ≤ 1% of patients receiving intra-arterial or intravenous injection of iopamidol injection:

    Cardiovascular disorders: tachycardia, hypotension, hypertension, myocardial ischemia, circulatory collapse, S-T segment depression, bigeminy, extrasystoles, ventricular fibrillation, angina pectoris, bradycardia, transient ischemic attack, thrombophlebitis

    Gastrointestinal disorders: vomiting, anorexia

    General disorders: headache, fever, chills, excessive sweating, back spasm

    Nervous system disorders: vasovagal reaction, tingling in arms, grimace, faintness

    Renal and urinary disorders: urinary retention

    Respiratory: throat constriction, dyspnea, pulmonary edema

    Skin and subcutaneous tissues: rash, urticaria, pruritus, flushing

    Special senses: taste alterations, nasal congestion, visual disturbances

    Adverse Reactions in Pediatric Patients

    In a clinical trial with 76 pediatric patients undergoing angiocardiography, two adverse reactions (2.6%) were reported: worsening cyanosis and worsening peripheral perfusion.

    6.2 Postmarketing Experience

    The following adverse reactions have been identified during post approval use of iopamidol injection. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

    Blood and lymphatic system disorders: thrombocytopenia

    Cardiovascular disorders: cardiopulmonary arrest, cardiac decompensation, arrhythmias, myocardial infarction, shock, electrocardiographic changes (e.g., increased QTc, increased R-R, increased T-wave amplitude), decreased systolic pressure, deep vein thrombosis, arterial spasms, vasodilation, chest pain, pallor

    Endocrine disorders: hyperthyroidism, hypothyroidism

    Eye disorders: lacrimation increased, conjunctivitis, eye pruritus, transient blindness, visual disturbance, photophobia

    Gastrointestinal disorders: retching, abdominal pain, salivary hypersecretion, salivary gland enlargement

    General disorders and administration site conditions: injection site pain, malaise

    Immune system disorders: anaphylaxis characterized by cardiovascular, respiratory, and cutaneous manifestations (e.g., chest tightness, laryngeal edema, periorbital edema, facial edema); delayed hypersensitivity reactions including generalized maculopapular rash,erythema, pruritus, localized blistering, skin peeling

    Musculoskeletal disorders: compartment syndrome following extravasation, muscle spasm, musculoskeletal pain, muscular weakness

    Nervous system disorders: coma, seizure, tremors, syncope, depressed level of consciousness or loss of consciousness, encephalopathy

    Psychiatric disorders: confusional state

    Respiratory system disorders: respiratory arrest, respiratory failure, acute respiratory distress syndrome, respiratory distress, apnea, asthma, sneezing, choking, laryngeal edema, bronchospasm, rhinitis

    Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP), erythema multiforme and drug reaction with eosinophilia and systemic symptoms (DRESS), skin necrosis, face edema

  • 7 DRUG INTERACTIONS

    7.1 Drug-Drug Interactions

    Metformin

    In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function.

    Stop metformin at the time of, or prior to, iopamidol injection administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast agents. Re-evaluate eGFR 48 hours after the imaging procedure and reinstitute metformin use only after renal function is stable.

    Radioactive Iodine

    Administration of iopamidol injection may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy. Avoid thyroid therapy or testing for up to 6 weeks post iopamidol injection

    7.2 Drug-Laboratory Test Interactions

    Protein-Bound Iodine Test

    Iodinated contrast agents, including iopamidol injection, will temporarily increase protein-bound iodine in blood. Avoid protein-bound iodine test for at least 16 days following administration of iopamidol injection . However, thyroid function tests that do not depend on iodine estimations, e.g., triiodothyronine (T 3) resin uptake and total or free thyroxine (T 4) assays, are not affected.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    Available data from published literature and postmarketing cases from decades of use with iopamidol during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Iopamidol crosses the placenta and reaches fetal tissues in small amounts (see Data). In animal reproduction studies, no adverse developmental outcomes were observed with intravenous administration of iopamidol to pregnant rats and rabbits during organogenesis at doses up to 2.7 and 1.4 times, respectively, the maximum recommended human dose (see Data).

    The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    Data

    Human Data

    Literature reports show that intravenously administered iopamidol crosses the placenta and is visualized in the digestive tract of exposed infants after birth.

    Animal Data

    Iopamidol did not affect fetal development and did not induce teratogenic changes in the offspring in either rats or rabbits at the following dose levels tested: 600 mg, 1,500 mg, or 4,000 mg iodine/kg in rats, administered intravenously once a day during days 6 through 15 of pregnancy; 300 mg, 800 mg, or 2,000 mg iodine/kg in rabbits, administered intravenously once a day during days 6 through 18 of pregnancy.

    8.2 Lactation

    Risk Summary

    There are no data on the presence of iopamidol in human milk, the effects on the breastfed infant, or the effects on milk production. Iodinated contrast agents are present unchanged in human milk in very low amounts, with poor absorption from the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for iopamidol injection and any potential adverse effects on the breastfed infant from iopamidol injection or from the underlying maternal condition.

    Clinical Considerations

    Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 half-lives) after iopamidol injection administration in order to minimize drug exposure to a breastfed infant.

    8.4 Pediatric Use

    The safety and effectiveness of iopamidol injection have been established in pediatric patients for angiocardiography, excretory urography, and contrast computed tomography (head and body).

    Pediatric patients at higher risk of experiencing adverse reactions during and after contrast medium administration may include those having asthma, sensitivity to medication or allergens, cyanotic heart disease, congestive heart failure, or serum creatinine greater than 1.5 mg/dL, or those less than 12 months of age.

    Thyroid function tests indicative of thyroid dysfunction, characterized by hypothyroidism or transient thyroid suppression have been reported following iodinated contrast media administration in pediatric patients, including term and preterm neonates; some patients were treated for hypothyroidism. After exposure to iodinated contrast media, individualize thyroid function monitoring in pediatric patients 0 years to 3 years of age based on underlying risk factors, especially in term and preterm neonates [see Warning and Precautions ( 5.8) and Adverse Reactions ( 6.2)] .

    The safety and effectiveness of iopamidol injection for cerebral, peripheral, and selective visceral arteriography, aortography, coronary arteriography, cardiac ventriculography, and peripheral venography have not been established in pediatric patients.

    8.5 Geriatric Use

    Iopamidol is excreted by the kidney, and the risk of adverse reactions to iopamidol injection may be greater in patients with renal impairment. Because patients 65 years of age and older are more likely to have renal impairment, care should be taken in dose selection, and it may be useful to monitor renal function [see Warnings and Precautions ( 5.3) and Use in Specific Populations ( 8.6)] .

    8.6 Renal Impairment

    The clearance of iopamidol decreases with increasing degree of renal impairment and results in delayed opacification of the urinary system. In addition, preexisting renal impairment increases the risk for acute kidney injury [see Warnings and Precautions ( 5.3)]. Iopamidol can be removed by dialysis.

  • 10 OVERDOSAGE

    The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdose is directed toward support of all vital functions and the prompt institution of symptomatic therapy. Iopamidol can be removed by dialysis.

  • 11 DESCRIPTION

    Iopamidol Injection, USP is a radiographic contrast agent for intra-arterial or intravenous use.

    Iopamidol is designated chemically as (S)-N,N’-bis[2-hydroxy-1-(hydroxymethyl)-ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide with a molecular weight of 777.09, an empirical formula of C 17H 22I 3N 3O 8, and the following structural formula:

    image-01.jpg

    Iopamidol Injection, USP is a sterile, clear, colorless to pale yellow solution available in four concentrations of iodine:

    • Iopamidol Injection, USP, 200 mg iodine/mL: Each mL contains 408 mg iopamidol (providing 200 mg organically bound iodine) and the following inactive ingredients: 0.26 mg edetate calcium disodium (providing 0.029 mg (0.001 mEq) sodium) and 1 mg tromethamine.
    • Iopamidol Injection, USP, 250 mg iodine/mL: Each mL contains 510 mg iopamidol (providing 250 mg organically bound iodine) and the following inactive ingredients: 0.33 mg edetate calcium disodium (providing 0.036 mg (0.002 mEq) sodium) and 1 mg tromethamine.
    • Iopamidol Injection, USP, 300 mg iodine/mL: Each mL contains 612 mg iopamidol (providing 300 mg organically bound iodine) and the following inactive ingredients: 0.39 mg edetate calcium disodium (providing 0.043 mg (0.002 mEq) sodium) and 1 mg tromethamine.
    • Iopamidol Injection, USP, 370 mg iodine/mL: Each mL contains 755 mg iopamidol (providing 370 mg organically bound iodine) and the following inactive ingredients: 0.48 mg edetate calcium disodium (providing 0.053 mg (0.002 mEq) sodium) and 1 mg tromethamine.

    The pH of Iopamidol Injection, USP has been adjusted to 6.5 to 7.5 with hydrochloric acid and/or sodium hydroxide.

    Physicochemical characteristics are shown in Table 5. Iopamidol Injection, USP is hypertonic as compared to plasma and cerebrospinal fluid (approximately 285 and 301 mOsm/kg water, respectively).

    Table 5: Physicochemical Characteristics of Iopamidol Injection, USP

    Concentration (mg Iodine/mL)

    200

    250

    300

    370

    Osmolality @ 37°C (mOsm/kg water)

    413

    524

    616

    796

    Viscosity (cP) @ 37°C

    2.0

    3.0

    4.7

    9.4

    Viscosity (cP) @ 20°C

    3.3

    5.1

    8.8

    20.9

    Specific Gravity @ 37°C

    1.227

    1.281

    1.339

    1.405
  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Intravascular injection of iopamidol opacifies those vessels where the contrast agent is present, permitting radiographic visualization through attenuation of photons.

    In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space. In normal brain with an intact blood-brain barrier, contrast does not diffuse into the extravascular space. In patients with a disrupted blood-brain barrier, contrast agent accumulates in the extravascular space in the region of disruption.

    12.2 Pharmacodynamics

    Following administration of iopamidol injection, the degree of enhancement is related to the iodine concentration in the tissue of interest. However, the exposure-response relationships and time course of pharmacodynamic response of iopamidol have not been fully characterized.

    12.3 Pharmacokinetics

    Distribution

    Plasma concentrations of iodine fall within 5 to 10 minutes due to distribution into the vascular and extracellular fluid compartments. Equilibration with the extracellular compartments is reached in about 10 minutes.

    The apparent volume of distribution suggests that iopamidol is distributed evenly between blood and extracellular fluid. Iopamidol may be visualized in the renal parenchyma within 30 to 60 seconds following rapid intravenous administration. Iopamidol did not bind to serum or plasma proteins at 1 hour after administration.

    Elimination

    The plasma half-life is approximately 2 hours; the half-life is not dose dependent.

    Metabolism

    Iopamidol does not undergo significant metabolism, deiodination, or biotransformation.

    Excretion

    Iopamidol is excreted primarily through the kidneys. In patients with normal renal function, the cumulative urinary excretion for iopamidol, expressed as a percentage of administered intravenous dose, is approximately 35% to 40% at 60 minutes, 80% to 90% at 8 hours, and 90% or greater in the 72- to 96-hour period after administration. In patients with normal renal function, approximately 1% or less of the administered dose appears in cumulative 72- to 96-hour fecal samples.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term studies in animals have not been performed with iopamidol to evaluate carcinogenic potential. No evidence of genetic toxicity was obtained in in vitro tests. In animal reproduction studies performed on rats, intravenously administered iopamidol did not induce adverse effects on fertility or general reproductive performance.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    How Supplied

    Iopamidol Injection, USP is a clear, colorless to pale yellow solution available in the following presentations:

    Concentration

    (mg Iodine/mL)

    Package Size

    Package Type

    Sale Unit

    NDC

    200

    50 mL

    Single-dose vial

    Carton of 1

    70436-211-80

    250

    50 mL

    Single-dose vial

    Carton of 10

    70436-125-82

    300

    30 mL

    Single-dose vial

    Carton of 10

    70436-219-52

    300

    50 mL

    Single-dose vial

    Carton of 10

    70436-219-62

    300

    100 mL

    Single-dose vial

    Carton of 10

    70436-219-82

    370

    50 mL

    Single-dose vial

    Carton of 10

    70436-127-52

    370

    75 mL

    Single-dose vial

    Carton of 10

    70436-127-62

    370

    100 mL

    Single-dose vial

    Carton of 10

    70436-127-82

    Storage and Handling

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light.

  • 17 PATIENT COUNSELING INFORMATION

    Hypersensitivity Reactions

    Advise the patient concerning the risk of hypersensitivity reactions that can occur both during and after iopamidol injection administration. Advise the patient to report any signs or symptoms of hypersensitivity reactions during the procedure and to seek immediate medical attention for any signs or symptoms experienced after discharge [see Warnings and Precautions ( 5.2)].

    Advise patients to inform their physician if they develop a rash after receiving Iopamidol Injection, USP [see Warnings and Precautions ( 5.11)] .

    Acute Kidney Injury

    Advise the patient concerning appropriate hydration to decrease the risk of contrast induced kidney injury [see Warnings and Precautions ( 5.3)] .

    Extravasation

    If extravasation occurs during injection, advise patients to seek medical care for progression of symptoms [see Warnings and Precautions ( 5.6)] .

    Thyroid Dysfunction

    Advise parents/caregivers about the risk of developing thyroid dysfunction after iopamidol injection administration. Advise parents/caregivers about when to seek medical care for their child to monitor for thyroid function [see Warnings and Precautions ( 5.8)] .

    Lactation

    Advise a lactating woman that interruption of breastfeeding is not necessary, however, to minimize exposure to a breastfed infant, a lactating woman may consider pumping and discarding breast milk for 10 hours after iopamidol injection administration [see Use in Specific Populations ( 8.2)] .

    Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Zone, Haikou, Hainan, China 571127

    Distributed by: Slate Run Pharmaceuticals, LLC Columbus, Ohio 43215

    10000333/03

    Revised 07/2025

  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-211-37

    Iopamidol Injection, USP, 41%

    50 mL single-dose vial

    iimage-02.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-125-37

    Iopamidol Injection, USP, 51%

    50 mL single-dose vial

    image-03.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-219-36

    Iopamidol Injection, USP, 61%

    30 mL single-dose vial

    image-04.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-219-37

    Iopamidol Injection, USP, 61%

    50 mL single-dose vial

    image-05.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-219-40

    Iopamidol Injection, USP, 61%

    100 mL single-dose vial

    image-06.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-127-37

    Iopamidol Injection, USP, 76%

    50 mL single-dose vial

    image-07.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-127-39

    Iopamidol Injection, USP, 76%

    75 mL single-dose vial

    image-08.jpg
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    NDC: 70436-127-40

    Iopamidol Injection, USP, 76%

    100 mL single-dose vial

    image-09.jpg
  • INGREDIENTS AND APPEARANCE
    IOPAMIDOL 
    iopamidol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70436-211
    Route of AdministrationINTRAVASCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44) IOPAMIDOL408 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V) 1 mg  in 1 mL
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) 0.26 mg  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70436-211-801 in 1 CARTON04/15/2024
    1NDC: 70436-211-3750 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21713404/15/2024
    IOPAMIDOL 
    iopamidol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70436-125
    Route of AdministrationINTRAVASCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44) IOPAMIDOL510 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V) 1 mg  in 1 mL
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) 0.33 mg  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70436-125-8210 in 1 CARTON04/15/2024
    1NDC: 70436-125-3750 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21713404/15/2024
    IOPAMIDOL 
    iopamidol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70436-219
    Route of AdministrationINTRAVASCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44) IOPAMIDOL612 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V) 1 mg  in 1 mL
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) 0.39 mg  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70436-219-5210 in 1 CARTON04/15/2024
    1NDC: 70436-219-3630 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC: 70436-219-6210 in 1 CARTON04/15/2024
    2NDC: 70436-219-3750 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    3NDC: 70436-219-8210 in 1 CARTON04/15/2024
    3NDC: 70436-219-40100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21713404/15/2024
    IOPAMIDOL 
    iopamidol injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 70436-127
    Route of AdministrationINTRAVASCULAR
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IOPAMIDOL (UNII: JR13W81H44) (IOPAMIDOL - UNII:JR13W81H44) IOPAMIDOL755 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V) 1 mg  in 1 mL
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF) 0.48 mg  in 1 mL
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 70436-127-5210 in 1 CARTON04/15/2024
    1NDC: 70436-127-3750 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    2NDC: 70436-127-6210 in 1 CARTON04/15/2024
    2NDC: 70436-127-3975 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    3NDC: 70436-127-8210 in 1 CARTON04/15/2024
    3NDC: 70436-127-40100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21713404/15/2024
    Labeler - Slate Run Pharmaceuticals, LLC (039452765)
    Registrant - Slate Run Pharmaceuticals, LLC (039452765)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hainan Poly Pharm. Co., Ltd.654561638manufacture(70436-211, 70436-125, 70436-219, 70436-127)
    Establishment
    NameAddressID/FEIBusiness Operations
    Divi's Laboratories Ltd.918598199api manufacture(70436-211, 70436-125, 70436-219, 70436-127)
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