SPRIX (Page 3 of 7)

5.12 Eye Exposure

Avoid contact of SPRIX with the eyes. If eye contact occurs, wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Gastrointestinal effects [see Boxed Warning and Warnings and Precautions (5.2)]
  • Hemorrhage [see Boxed Warning and Warnings and Precautions (5.3)]
  • Renal effects [see Boxed Warning and Warnings and Precautions (5.4)]
  • Anaphylactoid reactions [see Warnings and Precautions (5.5)]
  • Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.6)]
  • Hypertension [see Warnings and Precautions (5.6)]
  • Congestive heart failure and edema [see Warnings and Precautions (5.6)]
  • Serious skin reactions [see Warnings and Precautions (5.7)]
  • Hepatic effects [see Warnings and Precautions (5.9)]

The most frequently reported adverse reactions were related to local symptoms, i.e., nasal discomfort or irritation. These reactions were generally mild and transient in nature.

The most common drug-related adverse events leading to premature discontinuation were nasal discomfort or nasal pain (rhinalgia).

6.1 Experience from SPRIX Clinical Studies

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.

The data described below reflect exposure to SPRIX in patients enrolled in placebo-controlled efficacy studies of acute pain following major surgery. The studies enrolled 828 patients (183 men, 645 women) ranging from 18 years to over 75 years of age.

The patients in the postoperative pain studies had undergone major abdominal, orthopedic, gynecologic, or other surgery; 455 patients received SPRIX (31.5 mg) three or four times a day for up to 5 days, and 245 patients received placebo. Most patients were receiving concomitant opioids, primarily PCA morphine.

Table 1. Post-operative Patients with Adverse Reactions Observed at a rate of 2% or more and at least twice the incidence of the placebo group.
SPRIX (N=455) Placebo (N= 245)
Nasal discomfort 15% 2%
Rhinalgia 13% <1%
Lacrimation increased 5% 0%
Throat irritation 4% <1%
Oliguria 3% 1%
Rash 3% <1%
Bradycardia 2% <1%
Urine output decreased 2% <1%
ALT and/or AST increased 2% 1%
Hypertension 2% 1%
Rhinitis 2% <1%

In controlled clinical trials in major surgery, primarily knee and hip replacements and abdominal hysterectomies, seven patients (N=455, 1.5%) treated with SPRIX experienced serious adverse events of bleeding (4 patients) or hematoma (3 patients) at the operative site versus one patient (N=245, 0.4%) treated with placebo (hematoma). Six of the seven patients treated with SPRIX underwent a surgical procedure and/or blood transfusion and the placebo patient subsequently required a blood transfusion.

6.2 Adverse Reactions Reported in Clinical Trials with Other Dosage Forms of Ketorolac or Other NSAIDs

Adverse reaction rates increase with higher doses of ketorolac. It is necessary to remain alert for the severe complications of treatment with ketorolac, such as GI ulceration, bleeding, and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions, and liver failure. These complications can be serious in certain patients for whom ketorolac is indicated, especially when the drug is used inappropriately.

In patients taking ketorolac or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:

Gastrointestinal (GI) experiences including:

*Incidence greater than 10%

abdominal pain constipation/diarrhea dyspepsia
flatulence GI fullness GI ulcers (gastric/duodenal)
gross bleeding/perforation heartburn nausea*
stomatitis vomiting
Other experiences:
abnormal renal function anemia dizziness
drowsiness edema elevated liver enzymes
headache* hypertension increased bleeding time
injection site pain pruritus purpura
rash tinnitus sweating

Additional adverse experiences reported occasionally (<1% in patients taking ketorolac or other NSAIDs in clinical trials) include:

Body as a Whole: fever, infection, sepsis

Cardiovascular System: congestive heart failure, palpitation, pallor, tachycardia, syncope

Digestive System: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding

Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia

Metabolic and Nutritional: weight change

Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise

Respiratory: asthma, dyspnea, pulmonary edema, rhinitis

Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss

Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention

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