*For medical professionals only
Let's take a look at what's revised
On January 12, the State Drug Administration (NMPA) issued an announcement on revising the instructions for cimetidine injection preparations.
Image source: Screenshot of NMPA's official website
The announcement has revised the adverse reactions, contraindications and precautions in the instructions for cimetidine injection, and the content is more, and it is recommended to read it after collection.
Next, let's take a look at the specific revisions with Jie Xiao Yao.
One
Adverse reactions of the drug
In terms of adverse reactions, the new version of the instructions for cimetidine injection has added a description of respiratory damage, immune dysfunction and infection, vascular damage and coagulation disorders, mental disorders and medication sites, and moved the "translucent blood-brain barrier" and "antiandrogen effect" to the "Precautions" section.
Table 1 Comparison of adverse reactions to the adverse reactions of the drug instructions for cimetidine injection
Click on the larger image to view it
Two
Contraindications to the drug
The revision of the instructions for cimetidine injection once again emphasizes that pregnant and lactating women are prohibited! It is also told that the drug can pass through the placental barrier and can enter the milk, causing liver dysfunction in the fetus and infant.
Table 2 Comparison of contraindications to the drug instructions for cimetidine injection
Three
Precautions for the drug
The contents of the project are carried out under the "adverse reactions" section of the old version of the manual.
Table 3 Cimetidine injection drug instructions precautions revision comparison
Four
Caution in the use of the drug
The content of the project has been updated less, and the two items of "caution for the elderly" and "caution for children" have been revised.
Table 4 Comparison of revision of cimetidine injection drug instructions with caution
Small medicine reminder:
Cimetidine is the first H2 receptor antagonist for clinical use on the market in 1976, which inhibits the secretion of gastric acid by antagonizing the histamine H2 receptor of gastric parietal cells, so as to improve the pH in the stomach.
Although its acid inhibition ability is not as good as that of proton pump inhibitors, it is still clinically favored in many occasions.
■The indications currently approved in the instruction manual are:
1. It is used to relieve stomach pain, heartburn and acid reflux caused by excessive stomach acid.
2. It is used for gastric and duodenal ulcers and the upper gastrointestinal bleeding caused by them.
3. For reflux esophagitis, stress ulcers, gastrinoma (Dro-Ai syndrome).
4. For recurrence after short-term treatment of duodenal ulcer.
5. It is used to prevent stress ulcers and bleeding in critical patients.
■The indications for the ultra-manual are:
1. Combination chemotherapy regimen for advanced breast cancer.
2. For the treatment of acne.
3. For the treatment of gastroesophageal reflux cough (GERC) in children.
4. For the treatment of itching caused by polycythemia vera.
5. For adjuvant therapy of androgenic alopecia.
6. For the treatment of functional dyspepsia (FD) in the elderly.
7. For the treatment of chronic gastritis.
■ Special reminder: The updated cimetidine injection drug instructions, the new column under adverse reactions "vascular damage and coagulation disorders" describes that it will lead to "henoch-scholastic purpura", and reminds children to use it with caution.
However, in all editions of Pediatrics published by the People's Medical Publishing House, it is mentioned that when gastrointestinal bleeding occurs in children with abdominal or mixed henoch-purpura, cimetidine (20-40 mg/kg) can be used for acid suppression therapy.
Therefore, in the future clinical work, if it is found that children with Henoch-Schönlein purpura have repeatedly appeared, they need to be vigilant about the possibility of cimetidine and stop the drug in time.
What other notable details did you find? Let's talk about the comments section!
Note: The NMPA uniformly revised the contents of the instructions for cimetidine injection preparations (including cimetidine injection, cimetidine for injection, cimetidine sodium chloride injection), requiring the drug marketing authorization holder to replace the drug instructions and labels that have been shipped out of the factory within 9 months after filing, and the 2020/12/30 version of the cimetidine injection drug instructions mentioned in the article do not represent the contents of all cimetidine injection instructions on the market, for reference only.
Resources:
[2] MCDEX Database of Clinical Medication Guidelines for Chinese Physicians and Pharmacists.
[3] Pediatrics (9th Edition), People's Medical Publishing House.
Source: Clinical Pharmacy Channel of the Medical Community
Editor-in-charge: Tian Wei
Proofreader: Zang Hengjia
Plate making: Xue Jiao