Caution should be exercised in the use of calcium gluconate injections

Guangzhou Daily News (All-media reporter Tu Duanyu) Since the State Food and Drug Administration previously issued a notice on the unqualified quality problems of the sampling of 10% calcium gluconate injection produced by a factory in Henan, the total number of unqualified sampling reports has reached more than 20 times, involving a number of enterprises, and the common reason for the unqualified is the detection of visible foreign bodies leading to unqualified products. In order to further protect the safety of public medication, the State Food and Drug Administration previously issued an announcement requiring modifications to the instructions for 10% calcium gluconate injection, clarifying its properties: "The solubility of calcium gluconate in water is about 3.3%, so this product is a supersaturated solution, and crystallization may occur." In the instructions of the same variety abroad, it is proposed that if there is crystallization, it can be used after the water bath is heated and re-dissolved. However, it is not recommended to use after crystallization"; it also requires that the instructions must indicate the following contraindications: it is forbidden for those who are allergic to any of the ingredients in this product; the use of this product is prohibited during the application of cardiac glycosides; and it is forbidden for patients with hypercalcemia. It is reported that calcium gluconate injection plays a role in the treatment of patients with calcium deficiency, acute blood calcium is too low, allergic diseases, cardiac resuscitation and so on. However, since its inception, it has been supplied to the clinic in a supersaturated dosage form (10% 10ml), and the safety hazard caused by crystallization precipitation, which is very common, has always existed. The announcement stipulates the responsibilities of enterprises, hospitals, doctors and patients in the production and application of this product, and requires the producer to "take effective measures to do a good job in publicity and training on the use and safety issues of this drug, and guide doctors to use drugs rationally".