ASP Special Precautions

Take special care with ASP 100: The doctor who prescribed ASP 100 to the patient should be aware of the patient's clinical history and the patient's current condition.
Concomitant administration of ASP 100 with other medicines used to treat pain and inflammation, including selective cyclooxygenase-2 inhibitors (NSAIDs), should be avoided.
If the patient experiences abdominal symptoms, vomiting of blood or tarry stools, please contact the doctor.
In these patients, treatment should be started with the lowest effective dose. Co-administration of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered in these patients, as well as in patients concomitantly treated with other medicines likely to increase the risk of ulceration or bleeding, such as corticosteroids, anticoagulants (such as warfarin), selective serotonin reuptake inhibitors and antiplatelet agents.
Elderly patients; because of the risk of gastrointestinal bleeding and perforations, continuous prolonged use of ASP should be avoided.
ASP 100 should be administered with caution in the following situations, and only if the expected benefits outweigh potential risks: During pregnancy; Breast-feeding; Allergy to other non-steroidal anti-inflammatory agents; Concomitant treatment with other antiplatelet and/or anticoagulant agents; Glucose-6-phosphate dehydrogenase deficiency; History of hypoprothrombinaemia; Vitamin K deficiency; Severe hepatic disease; Chronic alcoholism, since these patients have an increased risk of upper gastrointestinal bleeding; Severe renal disease; History of gastrointestinal disease; Uncontrolled hypertension; Proliferative diabetic retinopathy; Bronchial asthma, chronic obstructive pulmonary disease, hay fever and nasal polyps; Prolonged periods without clinical monitoring.
Warnings and Precautions: Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk of serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal disease: No information is available from controlled clinical studies regarding the use of ASP 100 in patients with advanced renal disease. Therefore, treatment with ASP 100 is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Driving and using machines: Not applicable.