I. Contraindications
II. Warnings and Precautions
- Cardiovascular Embolistic Events: Based on multiple clinical trials of selective COX-2 inhibitors and non-selective NSAIDs, it has been found that using these drugs for up to three years increases the risk of serious cardiovascular embolic events, including myocardial infarction and stroke, which may be fatal. However, based on current research data, it cannot be confirmed whether various NSAIDs have a similar risk of cardiovascular embolic events. Furthermore, regardless of whether the patient has cardiovascular disease or related risk factors, the relative risk of serious cardiovascular embolic events is similarly increased. However, individuals with cardiovascular disease or related risk factors already have a higher risk of heart attack or stroke, therefore, the absolute risk of serious cardiovascular embolic events is higher after using these drugs. Other observational studies have found that serious cardiovascular embolic events may occur within the first few weeks of using these drugs, and the risk of cardiovascular embolic events increases with increasing dosage. Studies have shown a slight increase in the risk of arterial embolic events associated with ibuprofen use, especially high-dose ibuprofen (2400 mg daily). Overall, epidemiological studies have not shown an association between low-dose ibuprofen (less than 1200 mg daily) and an increased risk of arterial embolic events. Patients with cardiovascular event risk factors (e.g., hypertension, hyperlipidemia, diabetes, smoking) should be carefully evaluated before starting ibuprofen, especially if a high-dose ibuprofen (2400 mg daily) is required. To reduce the potential risk of adverse cardiovascular events associated with this class of drugs, it is recommended to use the shortest possible treatment duration and the lowest effective dose. During treatment, healthcare professionals and patients should be vigilant for adverse cardiovascular events, even if no cardiovascular-related adverse symptoms have been previously observed. Patients need to be informed of the symptoms of serious adverse cardiovascular events and how to manage them. Following coronary artery bypass surgery (CABG): Two large clinical trials showed that the use of COX-2 selective inhibitors within 10 ~ 14 days after CABG increased the risk of myocardial infarction and stroke. Therefore, this product should not be used within 14 days after coronary artery bypass surgery. Patients with recent myocardial infarction: Observational studies showed that the use of NSAIDs after myocardial infarction increased the incidence of re-infarction, cardiovascular-related death, and overall mortality during the first week of treatment. Studies also showed that the first-year mortality rate for those using NSAIDs after myocardial infarction was 20 per 100 people per year, compared to 12 per 100 people per year for those not using NSAIDs. Although the mortality rate decreased year by year after the first year for those using NSAIDs, the mortality rate remained relatively high over the following four years. Therefore, this medication should be avoided in patients who have recently experienced a myocardial infarction unless the benefits of using the medication are assessed to outweigh the risk of recurrent cardiovascular embolism. If this medication is used in patients who have recently experienced a myocardial infarction, they should be closely monitored for signs of myocardial ischemia. Heart Failure and Edema: Randomized controlled trials have shown that patients treated with selective COX-2 inhibitors and non-selective NSAIDs are twice as likely to be hospitalized for heart failure compared to the placebo group. Observational studies have also found that patients with heart failure using these medications have an increased risk of myocardial infarction, hospitalization for heart failure, and death. Some patients using NSAIDs have been observed to experience fluid retention and edema. Therefore, the use of this medication may diminish the cardiovascular effects of some medications, such as diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs). Therefore, this medication should be avoided in patients with severe heart failure unless the benefits of using the medication are assessed to outweigh the risk of worsening heart failure. If this medication is used in a patient with severe heart failure, close monitoring for signs of worsening heart failure is necessary. Alcohol Warning: If you drink three or more alcoholic beverages daily, consult your doctor about taking Ibuprofen or other analgesics and antipyretics, as Ibuprofen may cause stomach bleeding. Non-steroidal anti-inflammatory drugs (NSAIDs) should be avoided in pregnant women over 30 weeks of gestation as they may cause premature closure of the fetal ductus arteriosus and pulmonary hypertension. NSAIDs in pregnant women at 20 weeks of gestation or older may cause fetal renal dysfunction, oligohydramnios, or even neonatal renal impairment. If a healthcare professional deems it necessary for a patient to use NSAIDs between 20 and 30 weeks of gestation, treatment should be limited to the lowest effective dose and the shortest possible duration. If treatment exceeds 48 weeks… Within hours, medical professionals should consider using ultrasound to monitor the amniotic fluid status.
III. Other Precautions
- The use of anti-inflammatory analgesics is symptomatic treatment, not a treatment for the underlying cause.
- When using them to treat chronic diseases (chronic rheumatoid arthritis), the following should be considered:
- With long-term administration, regular clinical examinations (urine tests) are necessary.
(Including blood tests and liver function tests). If any abnormalities are found, appropriate measures such as dose reduction or discontinuation of the medication must be taken. Consider using non-pharmacological therapies. When treating acute illnesses, the following should be considered: For acute inflammation, the severity of pain and fever should be considered when administering medication. In principle, long-term use of the same class of drugs should be avoided. If there is an underlying cause, it should be used.
- Patients must be carefully observed for any side effects. Excessive hypothermia, collapse, and cold extremities may occur. Special attention must be paid to monitoring the condition of young children with high fever, the elderly, or patients with wasting diseases after administration.
- It may mask the appearance of infection symptoms; therefore, when used to treat inflammation caused by infection, it must be used in combination with appropriate antibiotics, and administration must be cautious and closely monitored.
- Avoid contact with…
- Hematologic Disorders: May cause aplastic anemia, agranulocytosis, thrombocytopenia, and other hematologic disturbances. Therefore, blood tests must be performed and the patient carefully monitored. If any abnormalities occur, the medication must be discontinued immediately.
- Allergic Reactions: Sometimes, STEVENS-JOHNSON syndrome (fever, skin and mucous membrane rash, erythema, necrotizing conjunctivitis, etc.) or Lyell’s syndrome may occur. Symptoms include toxic epidermal necrosis syndrome, rash, or triggering asthma. If such allergic symptoms occur, the medication must be discontinued immediately. Sensory organs: Eyes: Visual abnormalities may occur. If such symptoms occur, the medication must be discontinued immediately. Ears: Hearing loss and tinnitus may occur. Liver: Jaundice and transaminase levels may occur. Abnormal values. Digestive organs: May cause gastrointestinal bleeding. If this occurs, discontinue use immediately. Sometimes it may also cause loss of appetite, nausea, vomiting, stomach pain, diarrhea, stomach discomfort, indigestion, gastrointestinal disturbances, or stomatitis, constipation, etc. Mental and nervous system: Sometimes headache, dizziness, and depression may occur. Cardiovascular system: Sometimes hypotension may occur. Other: Edema may occur. VII. Overdose There is no specific antidote for this product, but gastric lavage and proper administration of blood electrolytes are recommended in case of overdose.
He used it in combination with anti-inflammatory and analgesic drugs. Special caution should be exercised when using this product in patients with asthma, especially after taking other non-steroidal anti-inflammatory drugs, particularly in cases of bronchospasm. Do not use if the expiration date stated on the packaging has passed. Administer with caution to the following patients: Patients with a history of peptic ulcer disease. Patients with blood abnormalities or a history of such conditions. Patients with liver disorders or a history of such conditions. Patients with a history of allergies. Patients with bronchial asthma. **P** **
IV. Precautions for Special Groups** **Pregnancy:** **According to animal studies, this drug is toxic to fetuses. Its safety in pregnant and lactating women has not been established. Do not administer to pregnant women, women who may become pregnant, or lactating women.** **Inhibition of prostaglandin synthesis may affect pregnancy and/or embryonic/fetal development.** Some epidemiological studies show that the use of prostaglandin synthase inhibitors in early pregnancy increases the risk of miscarriage and heart malformations. Animal studies have confirmed that the use of prostaglandin synthase inhibitors leads to increased pre- and post-implantation embryo loss and embryonic/fetal mortality rates; furthermore, some animal studies have reported that… Animals given prostaglandin synthase inhibitors during organogenesis have an increased incidence of embryonic malformations (including cardiovascular malformations). **Administration to Lactating and Pregnant Women:** Based on animal studies, this drug is toxic to fetuses. Its safety in pregnant and lactating women has not been established. Do not administer to pregnant women, women who may become pregnant, or lactating women. **Children:** Special attention should be paid to the occurrence of side effects in children and elderly patients, and the lowest possible dose should be used. Administer with caution at the lowest effective dose. Elderly: Special attention should be paid to the occurrence of side effects in children and elderly patients, and the lowest effective dose should be used with caution. V. Interactions No clinical evidence has been found of any interactions with other commonly used medications within the therapeutic dose range. However, if other nonsteroidal anti-inflammatory agents are used concurrently with oral anticoagulants and… Patients taking THIAZIDE diuretics should exercise special caution. VI. Important Clinical Side Effects/Adverse Reactions