The State Food and Drug Administration Revises the Instructions for Creatine Phosphate Sodium for Injection

Medical Network September 3 News
State Food and Drug Administration announcement on the revision of muscle sodium phosphate injection instructions (2021 No.
105)
according to Drug assessment of adverse reactions, to further protect public safety, the State Drug Administration decided The contents of the instructions for creatine phosphate sodium for injection have been revised and improved uniformly
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Relevant matters are hereby announced as follows: 1.
The marketing authorization holders of the above-mentioned drugs shall revise the instructions in accordance with the relevant provisions of the "Administrative Measures for Drug Registration " and other relevant regulations, in accordance with the contents of the corresponding instructions template (see attachment), and report to the country before November 20, 2021.
Recorded by the Drug Evaluation Center of the Drug Administration or the provincial drug regulatory authority
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If the revised content involves the label of a drug, it shall be revised together; the instructions and other content of the label shall be consistent with the original approved content
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Drugs produced on the date of filing shall not continue to use the original drug instructions
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The holder of the drug marketing authorization shall replace the instructions and labels of the drugs that have been shipped out of the factory within 9 months after filing
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2.
The drug marketing license holder shall conduct in-depth research on the mechanism of new adverse reactions , take effective measures to conduct publicity and training on drug use and safety issues, and instruct physicians and pharmacists to use drugs rationally
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3.
Clinicians and pharmacists should carefully read the revised contents of the above-mentioned drug inserts, and when choosing medications, they should conduct a sufficient benefit/risk analysis based on the newly revised inserts
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4.
Patients should read the drug instructions carefully before taking the medicine.
If using prescription drugs, they should strictly follow the doctor's advice
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5.
The provincial drug supervision and administration department shall supervise and urge the drug marketing authorization holders of the above-mentioned drugs in the administrative area to do the corresponding instructions revision and label and instruction replacement work as required, and severely investigate and punish violations of laws and regulations in accordance with the law.

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Hereby announce
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　　Attachment: Instruction template
for creatine phosphate sodium for injection National Food and Drug Administration August 20, 2021 Instruction template for creatine
　　phosphate sodium for
　　injection　　 Instruction manual for creatine phosphate for injection
Please read the instructions carefully and use it under the guidance of a physician
.
[Drug name] Generic name:
　　Creatine Phosphate Sodium for Injection English name: Creatine Phosphate Sodium for Injection Chinese Pinyin: Zhusheyong Linsuanjisuanna [Ingredients] The active ingredient of this product is creatine phosphate disodium salt tetrahydrate
.
Chemical name: N-[imino(phosphinoamino)methyl]-N-methylglycine disodium salt tetrahydrate
.
Structural formula: Molecular formula: C4H8N3Na2O5P·4H2O
.
Molecular weight: 327.
153 [Properties] [Indications] Cardioplegia is added to protect myocardium during cardiac surgery
.
Abnormal myocardial metabolism in ischemic state
.
[Specifications] [Usage and Dosage] 1.
Add cardioplegia to protect myocardium during cardiac surgery:
the concentration of standard cardioplegia is 10 mmol/L .
2.
Abnormal myocardial metabolism in ischemic state: The recommended dose is 1g each time, 1-2 times a day, intravenous drip within 30-45 minutes　　

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[Adverse Reactions] As individuals may be allergic to the active ingredients or one of its components, allergic reactions may occur after this product is administered
.
After the listing of adverse reactions: monitoring data show that the product can see the following adverse reactions (incidence unknown): systemic reactions: allergic reactions, anaphylactoid reactions, anaphylactic shock, chills, fever, pain, chills and fatigue
.
Skin and its appendages: rash, itching, flushing, sweating and so on
.
Digestive system: nausea, vomiting, abdominal pain and diarrhea
.
Nervous system: dizziness, headache, irritability and so on
.
Respiratory system: chest tightness, difficulty breathing, shortness of breath and so on
.
Cardiovascular system: palpitations, cyanosis, tachycardia, arrhythmia, or a fall in blood pressure
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Urinary system: renal impairment, facial edema, eyelid edema
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Metabolism and nutrition disorders: lower serum calcium and so on
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Other: injection site pain and phlebitis
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[Contraindications] People
who are allergic to creatine 　　phosphate sodium or the excipients of this product are forbidden
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Patients with chronic renal insufficiency are prohibited from using this product in large doses (5-10g/day)
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[Precautions] 　　1.
Use
with caution for people with allergies and abnormal renal function
.
2.
Rapid intravenous injection of creatine phosphate sodium may cause a drop in blood pressure.
It should be used strictly according to the usage and dosage, and intravenous injection is not allowed
.
3.
High-dose (5-10g/day) administration causes a large amount of phosphate intake, which may affect calcium metabolism and the secretion of hormones that regulate homeostasis, and affect renal function and purine metabolism
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The above large doses should be used with caution and only for short-term use
.
4.
After the listing, it is monitored that this product has a serious adverse reaction case report of anaphylactic shock .
It is recommended to use it in medical institutions with rescue conditions.
The patient's medication history and allergy history should be carefully asked before medication.
Pay attention to observation during medication.
Once allergy occurs Reactions or other serious adverse reactions must be discontinued immediately and treated in time
.
5.
Influence on driving and machine operation ability
　　This product has no influence on driving and machine operation ability
.
6.
Strictly grasp the indications of children's medication
.
Case reports of adverse reactions in neonates and premature infants with hypocalcemia have been monitored after the market.
During medication, blood calcium, blood phosphorus, renal function and other indicators should be monitored
.

　　[ Medication for pregnant women and lactating women] This product can be used under close medical supervision only when the potential benefit to the mother is significantly greater than the potential risk to the fetus, and it is very necessary
.
[Pediatric medication] This product has been used in heart surgery for neonates and pediatric patients (ages 9 days to 13 years).
The concentration in ordinary cardioplegia is 10mmol/L, which is well tolerated
.
【Medications for the elderly】 No pharmacokinetic studies for the elderly have been conducted
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However, in at least nine clinical studies that included elderly patients monitored after marketing, no differences were found between elderly patients and other adult patients in terms of drug safety and effectiveness
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Therefore, there are no special precautions for elderly patients, and there is no need to adjust the dose during medication
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【Drug Interactions】Drug interaction studies have not been carried out yet
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[Drug overdose] There is no specific antidote
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Symptomatic treatment can be taken if overdose
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[Pharmacology and Toxicology] Creatine phosphate plays an important role in the energy metabolism of muscle contraction
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It is the chemical energy reserve of myocardium and skeletal muscle, and is used for the resynthesis of ATP.
The hydrolysis of ATP provides energy for the contraction process of actomyosin
.
[Pharmacokinetics] After intravenous administration in rabbits, creatine phosphate sodium appears in the blood in an active form and gradually decreases within 30 minutes
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After that, the blood ATP level increased (increased by more than 24% at the peak) and returned to normal after 300 minutes
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The average elimination half-life of creatine phosphate administered intravenously in humans is 0.
09-0.
2 hours
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40 minutes after intravenous administration of 5g of creatine phosphate, the plasma concentration dropped below 5nmol/ml
.
40 minutes after intravenous administration of 10g of creatine phosphate, the blood concentration can reach 10nmol/ml
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The analysis of tissues showed that exogenous creatine phosphate was mainly distributed in myocardium and skeletal muscle, followed by brain and kidney tissues, and lung and liver tissues were the least
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The metabolism and excretion process in the body is that creatine phosphate is catalytically dephosphorylated to form creatine, then creatine is cyclized to creatinine, and finally excreted in urine
.
Children population: No pharmacokinetic studies for children have been conducted
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[Storage] [packaging] [validity] [Executive standard] [approval number] [marketing authorization holder] Name: Registered Address: [production company ] Production Address: Phone: Fax: Website: