*For medical professionals only
This medicine can cause anaphylactic shock!
On January 26, 2022, the State Drug Administration (NMPA) successively issued a revised announcement on the instructions for three kinds of drugs, which made specific revision requirements for the instructions for Coenzyme Q10 injection, iodine-containing contrast media, and nifuratel oral preparations.
Image source: Screenshot of NMPA's official website
What are the new changes in the instructions for these drugs, and what should be paid attention to in clinical use? Hurry up and learn with the world small medicine!
1
About CoQ10 injections
1. Coenzyme Q10 injection increases the warning language, "anaphylactic shock" is focused, and the new adverse reactions involve multiple systems
The specific amendments are as follows:
【Warning】Added:
This product can occur anaphylactic shock, should be used in medical institutions with rescue conditions, anaphylactic shock or other serious adverse reactions after medication must be stopped immediately and timely treatment.
2
[Adverse reactions] items increased:
The following adverse reactions/events were detected after the listing of this product:
Systemic damage: chills, fever, chest tightness, chills, fatigue, etc.
Skin and its adnexal damage: rash (such as urticaria, erythematous rash, maculopapular rash, etc.), itching, hyperhidrosis, etc.
Gastrointestinal damage: nausea, vomiting, stomach discomfort, abdominal pain, diarrhea, etc.
Cardiovascular system damage: palpitations, increased blood pressure, decreased blood pressure, tachycardia, etc.
Nervous system damage: dizziness, headache, local numbness, tremors, etc.
Respiratory damage: dyspnea, shortness of breath, asthma, etc.
Immune disorders and infections: anaphylactoid reactions, anaphylactic shock, etc.
Vascular and coagulation disorders: flushing, phlebitis, etc.
Damage at the site of medication: pain at the injection site, redness and swelling at the injection site, etc.
3
【Contraindications】 items increased:
It is forbidden for those who are allergic to the ingredients of this product.
4
【Precautions】Items added:
1. This product can cause anaphylactic shock. Patients should be asked about the history of drug allergies before taking the drug, closely monitored during the medication, and if there are signs and symptoms such as rash, itching, dyspnea, and blood pressure drop, the drug should be stopped immediately and treated in time.
2. This product is easy to decompose when seen in light. When infusing intravenously, measures should be taken to avoid light.
3. This product may appear mist crystallization, should be carefully checked before use. If there is crystallization or abnormal drip rate during infusion, discontinue use immediately.
4. When combining this product with other drugs, it should be noted that the drug is compatibility contraindicated due to changes in pH and ionic strength, such as this product is mixed with tinidazole for injection to produce a white precipitate, mixed with lomefloxacin solution for aspartate to precipitate yellow flocculent precipitate, and mixed with chuanqizine for injection to reduce the solubility of precipitation precipitation. Combinations should be instillated separately and the tubes should be flushed or changed.
2. Safe medication tips:
Coenzyme Q10 is a derivative of Coenzyme, also known as Vitamin Q, is an activator of cell metabolism and cell respiration, and is also an essential coenzyme for the production of adenosine triphosphate (ATP) in the mitochondria of cardiomyocytes, which has a certain protective effect on the myocardium.
For the name "CoQ10", presumably everyone is not unfamiliar, The oral preparation of CoQ10 is a very popular health care product in recent years, and even some people claim that CoQ10 can not only enhance myocardial function, improve myocardial hypoxia, but also antioxidant, anti-aging, anti-tumor... Simply "omnipotent".
However, it should be noted that CoQ10 should only be used as an adjunctive therapy, not as a first-line agent.
Source of the instructions: Clinical Decision App
Moreover, the NMPA revised its injection instructions this time, specifically pointing out that Coenzyme Q10 injection may cause anaphylactic shock. Previously, some coenzyme Q10 sodium chloride injection instructions did not have this label.
Therefore, clinical staff should do a good job of monitoring and equipped with corresponding rescue measures when taking drugs in the future to avoid serious consequences.
Source of the instructions: Clinical decision-making app
Under adverse reactions, compared to before the revision, "there may be stomach discomfort, loss of appetite, nausea, diarrhea, but there is no need to stop the drug." Occasional urticaria and transient palpitations" brief content, a number of new adverse reactions content, need to attract the attention of clinicians.
Under the precautions, in addition to re-emphasizing "this product is easy to decompose" and "there may be aerosol crystallization", it is also mentioned that attention should be paid to close monitoring of anaphylactic shock, and when CoQ10 injection is combined with other drugs, it should be noted that the drug is contraindicated due to changes in pH and ion strength.
In the description of "possible mist crystallization", some drug instructions were originally described as "if there is crystallization, heat in boiling water protected from light for 10-15 minutes, take it out, shake it, put it at room temperature to clarify, and then use it." The revision indicates the need to add "if there is crystallization or if there is an abnormal drip rate during the infusion process, stop using it immediately."
About oral preparations of nifurater
1. The adverse reactions of nifuratel oral preparations are no longer "unknown", and patients with fava bean disease are banned, and "disulfiram" reactions are vigilant
【Adverse reactions】Under the item, the following are amended:
The following adverse reactions (incidence unknown) were monitored post-marketing with oral nifurate preparations:
Skin and subcutaneous tissue diseases: rash, itching, urticaria, erythema, drug rash, maculopapular rash, skin swelling, hyperhidrosis;
Gastrointestinal disorders: nausea, vomiting, abdominal pain, diarrhea, abdominal discomfort, bloating, dry mouth, bitter mouth, flatulence;
Neurological disorders: dizziness, dizziness, headache, drowsiness, insomnia, hypoesthesia, numbness;
Systemic diseases and reactions at the site of administration: chest discomfort, fever, fatigue, pain, edema (face, mucous membranes, peripheral), disulfiram-like reactions;
Diseases of the immune system: allergic reactions, anaphylactoid reactions, anaphylactic shock;
Diseases of the reproductive system: itching of the vulva, swelling of the vulva, burning sensation of the vulva;
Other: dyspnea, laryngeal edema, palpitations, flushing, arthralgia, tinnitus, hematuria, discoloration of urine, jaundice, elevated transaminases, hemolytic anemia.
Under [Contraindications], add the following:
It is contraindicated in patients with glucose-6-phosphate dehydrogenase deficiency (commonly known as fava bean disease).
【Notes】Under this item, the following is amended:
1. Drinking alcohol or using other drugs containing ethanol during oral administration of this product can cause disulfiram-like reactions, manifested as skin flushing, itching, fever, headache, nausea, abdominal pain, tachycardia, increased blood pressure, chest tightness, irritability, etc., so it is forbidden to drink alcohol during taking the drug, and avoid the use of other drugs containing ethanol.
2. Patients with glucose-6-phosphate dehydrogenase deficiency can use this product to cause hemolytic anemia.
2. Safe medication tips:
At present, there are only 5 words under the [1] adverse reactions in the instructions of some nifurate tablets, so the new content under the adverse reactions should arouse the attention of clinicians and pharmacists, and there is no small matter of safe medication.
Under the contraindications, "glucose-6-phosphate dehydrogenase deficiency (commonly known as fava bean disease) is contraindicated", and it is recommended to carefully ask the medical history and measure the activity of red blood cells G-6-PD enzyme before taking the drug.
Nifuratel can also cause disulfiram-like reactions. In addition to the cephalosporins of the methiazole group, nitricazole drugs (such as metronidazole, isoprenidazole, ornidazole, etc.), sulfonamides (sulfamethoxazole), and certain hypoglycemic drugs (such as gliclazide, glibenclamide, phenethylbiguanide, etc.) [2], "take medicine with wine, say go" has added a new member.
About iodine-containing contrast media
1. Keywords of adverse reactions of iodine-containing contrast media: "anaphylactic shock", "hypersensitivity reaction"
The revised requirements for iodine-containing contrast agents announced this time include a total of 3 types of drug instructions, and the specific amendments are as follows:
Table 1 NMPA Announcement on Revised Instructions for Iodine-Containing Contrast Media
For patients with allergy risk factors, attention should be paid to preparing for the treatment of allergic reactions at any time, and should also be vigilant against delayed allergic reactions.
People with a history of allergies or asthma should use with caution;
Be wary of combinations that increase the risk of serious adverse reactions, such as biguanide hypoglycemic agents, antidepressants, interleukin-2, β-blockers, etc.
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