Remopain 3% Special Precautions

The combined therapy duration (oral and parenteral) should not exceed 5 days due to the increased risk of serious adverse events.
Hematological effects: Inhibits platelet function, contraindication in patients with cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, and patients at high risk for bleeding.
Platelet adhesion and aggregation may be decreased, may prolong bleeding time. Patients with coagulation disorders or who are receiving anticoagulants should be monitored closely.
Anemia may occur, Patients on long term NSAIDs therapy should be monitored for anemia.
Cardiovascular and cerebrovascular effects: NSAIDs cause an increased risk of serious adverse cardiovascular thrombolytic events, including MI (myocardial infarction) and stroke. Risk may occur early during treatment and may increase with duration of use.
Relative risk appears to be similar in those with and without known cardiovascular disease or risk factors for cardiovascular disease. However, absolute incidence of serious cardiovascular thrombotic events (which may occur early during treatment) was higher in patients with known cardiovascular disease or risk factors and in those receiving higher doses.
New onset hypertension or exacerbation of hypertension may occur (NSAIDs may also impair response to angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics). These occurrences may contribute to cardiovascular events, monitor blood pressure. Use with caution in patients with hypertension.
May cause sodium and fluid retention. Use with caution in patients with edema.
Avoid use in heart failure.
Avoid use in patients with a recent MI unless benefits outweigh risk of cardiovascular thrombolytic events.
Use the lowest effective dose for the shortest duration to reduce risk of cardiovascular events.
Renal Impairment: Ketorolac is contraindicated in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion.
NSAIDs use may compromise existing renal function. Dose-dependent decreases in prostaglandin synthesis may result from NSAIDs use, reducing renal blood flow, which may cause renal decompensation (usually reversible).
Patients at greatest risk of renal toxicity are those with impaired renal function, hypovolemia, heart failure, hepatic impairment, those taking diuretics and ACE inhibitors, and the elderly.
Discontinuation of ketorolac or other nonsteroidal anti-inflammatory therapy is usually followed by recovery to the pre-treatment state.
Hepatic Impairment: Use with caution on patients with hepatic impairment or a history of hepatic disease. Transaminase elevations have been reported with use, closely monitor patients with any abnormal liver function test.
Rare (sometimes fatal) severe hepatic reactions (e.g. jaundice, fulminant hepatitis, hepatic necrosis, hepatic failure) have occurred with NSAIDs use, discontinue immediately if signs or symptoms of hepatic disease develop or if systemic manifestations occur.
Gastrointestinal (GI) ulceration, bleeding and perforation: NSAIDs cause increased risk of serious GI inflammation, ulceration, bleeding, and perforation (may be fatal).
Elderly patients and patients with history of peptic ulcer disease and/or GI bleeding are at greater risk of serious GI events. These events may occur at any time during therapy and without warning.
Avoid use in patients with severe GI bleeding. In patients with history of acute lower GI bleeding, avoid use of non-aspirin NSAIDs, especially if due to angioectasia or diverticulosis.
Use caution with a history of GI ulcers, inflammatory bowel disease, concurrent therapy known to increase the risk of GI bleeding (e.g. aspirin, anticoagulants, and/or corticosteroids, selective serotonin reuptake inhibitors), advanced hepatic disease, coagulopathy, smoking, use of alcohol, or in the elderly or debilitated patients.
Concomitant gastroprotective therapy (e.g. proton pump inhibitors) is recommended.
Skin reactions: Ketorolac is contraindicated in patients with prior hypersensitivity reaction to aspirin or NSAIDs.
NSAIDs may cause potentially fatal serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN), may occur without warning. The onset of the reactions occurring in the majority of cases within the first month of treatment. Ketorolac tromethamine should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Hypersensitivity or anaphylactoid reactions may occur, even without prior exposure.
Patients with "aspirin triad" (bronchial asthma, aspirin intolerance, rhinitis) may be at increased risk.
Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.
Drug abuse and dependence: Ketorolac is devoid of addictive potential. No withdrawal symptoms have been observed following abrupt discontinuation of ketorolac IV.
Use in Pregnancy & Lactation: Precautions related to fertility: The use of ketorolac tromethamine, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. In women who have difficulty conceiving or are undergoing investigation of fertility, withdrawal of ketorolac tromethamine should be considered.
Use in Children: Ketorolac given parenterally is not recommended in children younger than 2 years of age.
Use in the Elderly: Dosage adjustment is required for patients ≥65 years of age.
Elderly patients are at greater risk for serious GI, cardiovascular, and/or renal adverse events. Use with caution. NSAID use may increase the risk of hyperkalemia, particularly in the elderly, diabetics, renal disease, and with concomitant use of other agents capable of inducing hyperkalemia (e.g. ACE inhibitors). Monitor potassium closely.