Food and Drug Administration: Children under the age of 12 are prohibited from taking "Nimesulide"

The reporter learned from the State Food and Drug Administration on the 20th that the National Food and Drug Administration decided to adjust the "Nimesulide" clinical monitoring report on the adverse reactions of oral preparations of Nimesulide, research and supervision at home and abroad, and expert opinion. Use, prohibit it for children under the age of 12.

In the "Notice on strengthening the management of oral administration of nimesulide," the State Food and Drug Administration required that "Nimesulide" oral preparations be prohibited for children under 12 years of age; as a second-line drug for anti-inflammatory and analgesic drugs, Can only be used if at least one other non-steroidal anti-inflammatory drug fails treatment; indications are limited to pain such as chronic arthritis such as osteoarthritis, surgery, and post-traumatic pain, symptomatic treatment of primary dysmenorrhea; The maximum single dose should not exceed 100 mg. The course of treatment should not exceed 15 days. The minimum effective dose and the shortest course of treatment should be used according to the actual clinical conditions to reduce the occurrence of adverse drug reactions.

The National Food and Drug Administration reminded that Nimesulide is a prescription drug and must be used under the guidance of a doctor. Clinicians are advised to fully consider the patient's condition and possible risks in medication when choosing medications, weigh the advantages and disadvantages, and inform patients about the possible risks of medication. During the process of continuous medication, patients should pay attention to monitoring the liver and kidney function, blood routine of patients. Such indicators, abnormalities should be stopped immediately or take appropriate treatment measures.

Nimesulide is a non-steroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects. Listed in China in 1997.

According to reports, similar to other non-steroidal anti-inflammatory drugs, the most common adverse reactions of Nimesulide are gastrointestinal reactions such as nausea, vomiting and abdominal pain. In addition, the monitoring of adverse drug reactions at home and abroad has also found safety problems related to “nimesulide”-related allergic reactions, coagulopathy, leukopenia, and liver and kidney dysfunction.

In 2007, the State Food and Drug Administration evaluated the safety of Nimesulide, revised the instructions based on expert opinions, and adopted restrictive measures, such as the ban on children under 1 year of age; restrictions on the dose of drugs for children; and restrictions on children's fever treatment courses. Within 3 days; supplemental long-term medication should monitor liver function and other warning information.

Nimesulli was first listed in Italy in 1985. At present, it is used in more than 50 countries and regions in Europe, the Americas, and Asia.

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