Ketorolac Tromethamine (Page 3 of 10)

5.7 Anaphylactic Reactions

Ketorolac has been associated with anaphylactic reactions in patients with and without known hypersensitivity to ketorolac and in patients with aspirin-sensitive asthma [see Contraindications (4) and Warnings and Precautions (5.8)].

Seek emergency help if an anaphylactic reaction occurs.

5.8 Exacerbation of Asthma Related to Aspirin Sensitivity

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Ketorolac Tromethamine is contraindicated in patients with this form of aspirin sensitivity [see Contraindications (4) ]. When Ketorolac Tromethamine is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

5.9 Serious Skin Reactions

NSAIDs, including ketorolac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of Ketorolac Tromethamine at the first appearance of skin rash or any other sign of hypersensitivity. Ketorolac Tromethamine is contraindicated in patients with previous serious skin reactions to NSAIDs [see Contraindications (4) ].

5.10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Ketorolac Tromethamine. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Ketorolac Tromethamine and evaluate the patient immediately.

5.11 Fetal Toxicity

Premature Closure of Fetal Ductus Arteriosus

Avoid use of NSAIDs, including Ketorolac Tromethamine, in pregnant women at about 30 weeks gestation and later. NSAIDs, including Ketorolac Tromethamine, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.

Oligohydramnios/Neonatal Renal Impairment

Use of NSAIDs, including Ketorolac Tromethamine, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.

Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.

If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit Ketorolac Tromethamine use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if Ketorolac Tromethamine treatment extends beyond 48 hours. Discontinue Ketorolac Tromethamine if oligohydramnios occurs and follow up according to clinical practice [see Use in Specific Population (8.1) ]

5.12 Hematologic Toxicity

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with Ketorolac Tromethamine has any signs or symptoms of anemia, monitor hemoglobin or hematocrit. Do not use Ketorolac Tromethamine in patients for whom hemostasis is critical [see Contraindications (4), Drug Interactions (7)].

NSAIDs, including Ketorolac Tromethamine, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [see Drug Interactions (7) ].

The concurrent use of ketorolac and therapy that affects hemostasis, including prophylactic low dose heparin (2500 to 5000 units q12h), warfarin and dextrans, has not been studied extensively, but may also be associated with an increased risk of bleeding. Until data from such studies are available, carefully weigh the benefits against the risks and use such concomitant therapy in these patients only with extreme caution. Monitor patients receiving therapy that affects hemostasis closely.

In clinical trials, serious adverse events related to bleeding were more common in patients treated with Ketorolac Tromethamine than placebo. In clinical trials and in postmarketing experience with ketorolac IV and IM dosing, postoperative hematomas and other signs of wound bleeding have been reported in association with peri-operative use. Therefore, use Ketorolac Tromethamine with caution in the postoperative setting when hemostasis is critical.

5.13 Masking of Inflammation and Fever

The pharmacological activity of Ketorolac Tromethamine in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

5.14 Laboratory Monitoring

Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID treatment with a CBC and a chemistry profile periodically [see Warnings and Precautions (5.2, 5.3, 5.6)].

5.15 Eye Exposure

Avoid contact of Ketorolac Tromethamine 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.

5.16 Limitations of Use

The total duration of use of Ketorolac Tromethamine alone or sequentially with other forms of ketorolac is not to exceed 5 days. Ketorolac Tromethamine must not be used concomitantly with other forms of ketorolac or other NSAIDs [see Dosage and Administration (2.1)].

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1) ]
  • GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2) ]
  • Hepatotoxicity [see Warnings and Precautions (5.3) ]
  • Hypertension [see Warnings and Precautions (5.4) ]
  • Heart Failure and Edema [see Warnings and Precautions (5.5) ]
  • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6) ]
  • Anaphylactic Reactions [see Warnings and Precautions (5.7) ]
  • Serious Skin Reactions [see Warnings and Precautions (5.9) ]
  • Hematologic Toxicity [see Warnings and Precautions (5.12) ]

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