MISPANTON CAPSULES 500MG

I. Contraindications

1. Patients with peptic ulcers, severe hematologic abnormalities, severe hepatic or renal dysfunction, hypersensitivity to this drug, or those who experience asthma with Aspirin.
2. This drug is contraindicated within 14 days after coronary artery bypass graft (CABG) surgery.
3. Use with caution: Patients with a history of peptic ulcers, hematologic abnormalities, hypersensitivity to this drug, newborns, and patients with bronchial asthma.

II. Warnings and Precautions

1. Cardiovascular embolic events: Based on multiple clinical trials of selective COX-2 inhibitors and non-selective NSAIDs, it has been found that using this type of drug for up to three years increases the risk of serious cardiovascular embolic events, including myocardial infarction and stroke, which may be fatal.

Based on current research data, it is impossible to confirm whether various NSAIDs carry a similar risk of cardiovascular embolism. Furthermore, regardless of the presence or absence of cardiovascular disease or related risk factors, the relative risk of serious cardiovascular embolism is similarly increased. However, individuals with cardiovascular disease or related risk factors have a higher absolute risk of serious cardiovascular embolism after using these drugs, as they already have a higher risk of heart attack or stroke. Other observational studies have found that serious cardiovascular embolism can occur within the first few weeks of using these drugs, and the risk increases with increasing dosage. To reduce the potential risk of adverse cardiovascular events associated with these drugs, it is recommended to use the shortest possible treatment duration and the lowest effective dose. During medication, 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 drug is contraindicated within 14 days after CABG. 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 its use are assessed as outweighing the risk of recurrent cardiovascular events. If this medication is used in a patient with a recent myocardial infarction, close monitoring for signs of myocardial ischemia is necessary. 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 due to 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 its use are assessed as outweighing the risk of worsening heart failure. If this medication is used in patients with severe heart failure, close monitoring for signs of worsening heart failure is necessary. “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 high pulmonary artery pressure. 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 lasts longer than 48 hours, a healthcare professional should consider…” Use ultrasound to monitor blood status.

 

III. Other Precautions

2. Anti-inflammatory and analgesic agents are for symptomatic treatment. If necessary, they can be taken in combination with other medications depending on the cause.
3. For chronic diseases (deformed joints), please note the following:
4. For long-term use, regular urine, blood, and liver function tests are recommended. If any abnormal values are found, please reduce the dosage or discontinue use.
5. It can be used in conjunction with other treatments.
6. For acute diseases, please note the following:
7. Dosage should be considered based on the severity of acute inflammation, pain, and fever.
8. In principle, long-term use of the same medication should be avoided.
9. Please consult…

Seek treatment to address the underlying cause. **Note potential side effects after administration:** Excessive drop in body temperature, collapse, cold extremities, etc. Extreme caution is required for infants with high fever and elderly individuals with digestive disorders. **If the inflammation is caused by an infection, use in conjunction with antibiotics and observe the patient.** **Avoid using in conjunction with other anti-inflammatory and analgesic drugs as much as possible.** **Cardiovascular embolic events:** **NSAIDs** This medication increases the risk of serious cardiovascular embolic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the course of use and increases with the duration of use. This medication is contraindicated within 14 days after coronary artery bypass graft (CABG) surgery. **Pregnancy:** **The safety of this medication in pregnant and breastfeeding women has not been established. Please take it only when the benefits outweigh the risks.** **Inhibition of prostaglandin synthesis may affect pregnancy and/or embryonic/fetal development. Some epidemiological studies show that use of prostaglandin synthase inhibitors in early pregnancy increases the risk of miscarriage and heart malformations. Animal studies have confirmed the use of prostaglandin synthase inhibitors.** Enzyme inhibitors can increase pre- and post-implantation embryo loss and embryo/fetal mortality rates. Furthermore, animal studies have reported an increased incidence of embryonic malformations (including arteriovenous malformations) in animals treated with prostaglandin synthase inhibitors during organogenesis. Lactation: The safety of this medication in pregnant and lactating women has not been established. Please administer only when the therapeutic benefits outweigh the risks. Children: Use the minimum recommended dose and administer with caution in the elderly and infants. Elderly: Use the minimum recommended dose and administer with caution in the elderly and infants. V. Interactions When used concurrently with anticoagulants, such as Warfarin, the effect is enhanced; please reduce the dosage. VI. Important Clinical Side Effects Adverse Reactions

The following side effects may occasionally occur; symptoms will disappear after discontinuation of the medication.

1. Hematologic disorders: Occasionally, autoimmune hemolytic anemia, agranulocytosis, leukopenia, thrombocytopenic purpura, and other hematologic disorders may occur. Blood tests may be performed if necessary; discontinue use if abnormalities are found.
2. Allergic reactions: If symptoms such as shock, rash, redness, urticaria, itching, chest tightness, cold sweats, difficulty breathing, numbness in the extremities, low blood pressure, and conjunctival congestion occur, discontinue use and seek immediate medical attention.
3. Occasionally, blurred vision may occur.
4. Liver disorders: Occasionally, jaundice, elevated SGOT and SGPT levels, and other liver dysfunction may occur.
5. Kidney disorders: If urinary retention, hematuria, proteinuria, BUN creatinin occur…

If elevated blood pressure or other signs of renal dysfunction occur, please discontinue use. Digestive system: Occasionally, symptoms such as loss of appetite, nausea, vomiting, stomach pain, abdominal pain, diarrhea, stomach discomfort, constipation, and thirst may occur. Mental and psychiatric system: Occasionally, fever and edema may occur.