1 INDICATIONS AND USAGE Iopamidol Injection, USP is a radiographic contrast agent indicated for: Intra-arterial Procedures * ( 1.1 ) 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 Intravenous Procedures * ( 1.2 ) 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 are recommended for each type of imaging procedure.

( 2.2 , 2.3 , 2.4 ) 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 )].

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 )] Most common adverse reactions (incidence >1%) are pain, hot flashes, burning sensation, nausea, and warmth.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, Inc.

at 1-888-341-9214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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