The instructions for pediatric sputum cough preparations commonly used for children's coughs should be modified. On March 22, the State Food and Drug Administration's website issued a document saying that it was decided to uniformly revise the instructions for pediatric sputum and cough preparations [adverse reactions], [contraindications] and [precautions].
Pediatric sputum and cough preparation is a compound preparation of Chinese and Western medicine for expectorant and cough suppressant, which is suitable for children with mild lung fever and cough. This product should not be taken for a long time, take the drug for 3 days without relief of symptoms, should go to the hospital for treatment. Among them, the newly revised description mentions that whether it is a non-prescription drug or a prescription drug for pediatric sputum cough preparations, [adverse reactions] items should include: pediatric sputum cough preparations have vomiting, nausea, diarrhea, abdominal pain, rash, itching, sweating, dizziness, headache, allergic reactions and other adverse reactions. Inquiring about the previous pediatric sputum and cough preparations, the [adverse reactions] items are only vomiting and nausea.
The main components of pediatric sputum and cough preparations are platycodon stream extract, mulberry white skin flow extract, tugen tincture, and ephedrine hydrochloride. Since it contains ephedrine hydrochloride, it has a central excitatory effect, and athletes should use it with caution. According to the second department of the 2010 pharmacopoeia, the ephedrine hydrochloride components controlled by the State Food and Drug Administration include: ephedrine hydrochloride injection, ephedrine hydrochloride nasal drops, followed by pediatric sputum and cough granules, etc., while other compound preparations only need normal medical commercial channels to circulate due to their small content.
The announcement also suggests that the holders of the marketing authorization for pediatric sputum and cough suppressant preparations should submit a supplementary application for revision of the instructions in accordance with the relevant provisions of the Measures for the Administration of Drug Registration and other relevant provisions, in accordance with the requirements of the revision of the instructions, and report to the provincial drug supervision and management department for the record before June 17, 2022. Where the revised content involves drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents. Drugs produced from the date of filing shall not continue to use the original drug instructions. The holder of the drug marketing authorization shall replace the drug instructions and labels that have been shipped out of the factory within 9 months after filing.
Querying the website of the State Food and Drug Administration, there are a total of 69 approvals for pediatric cough and phlegm preparations, including three dosage forms such as pediatric sputum cough syrup (7), granules (61), and punching agents (1), involving Sunflower Pharmaceutical Group Chongqing Xiao sunflower children's pharmaceutical Co., Ltd., Guangxi Wuzhou Sanhe Pharmaceutical Co., Ltd., Taiji Group Sichuan Nanchong Pharmaceutical Co., Ltd., Sinopharm Group Tongjitang (Guizhou) Pharmaceutical Co., Ltd., China Resources Sanjiu (Tangshan) Pharmaceutical Co., Ltd. and many other pharmaceutical companies.
Editor-in-charge: Qiao Jingfang