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Source: NMPA Editor: wangxinglai2004
Enterprises are required to report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before January 14, 2023.
Original text of the notice
According to the results of adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the instructions of pentoxifylline injection (including pentoxifylline injection, pentoxifylline for injection, pentoxifylline sodium chloride injection, pentoxifylline glucose injection).
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before January 14, 2023 in accordance with the requirements for the revision of the instructions for pentoxifylline injection (see annex).
Where the revised content involves drug labels, they shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
1.
The following content should be included under [Adverse Reactions].
The following adverse reactions/events have been detected after the marketing of this product:
-
Immune system damage: allergic reactions such as hypersensitivity, immediate-like anaphylaxis, rarely anaphylactic shock, angioedema, bronchospasm
.
-
Gastrointestinal damage: nausea, vomiting, abdominal discomfort, bloating, abdominal pain, diarrhea, dry mouth, belching, dyspepsia, gastroesophageal reflux, loss of taste, increased saliva, gastrointestinal bleeding
.
-
Various types of neurological damage: dizziness, headache, head discomfort, decreased sensation, tremor
.
-
Ocular organ damage: blurred vision, visual impairment, conjunctival hemorrhage, retinal hemorrhage
.
-
Skin and subcutaneous tissue damage: pruritus, urticaria, maculopapular rash, erythema, mucocutaneous bleeding, sweating
.
-
Damage to the cardiovascular system: palpitations, palpitations, arrhythmias, tachycardia, angina
.
-
Mental system damage: irritability, tics, anxiety, sleep disturbance
.
-
Respiratory damage: dyspnea, shortness of breath, choking, bronchospasm
.
-
Systemic damage: chest discomfort, chest pain, fatigue, chills, fever, edema
.
-
Vascular and lymphatic damage: flushing, phlebitis, pain at the injection site, hypotension
.
-
Hepatobiliary system damage: abnormal liver function, elevated
hepatic aminotransferases or alkaline phosphatase.
-
Damage to the blood and lymphatic system: rarely thrombocytopenia, leukopenia
.
-
Others such as increased blood pressure, decreased blood pressure, hypoglycemia, genitourinary bleeding, nosebleeds, etc
.
2.
The following content should be included under [Precautions].
1
.
This product can cause anaphylactic shock.
Before medication, patients should be asked about the history of drug allergy, closely monitored during medication, if rash, itching, dyspnea, blood pressure drop and other signs and symptoms appear, the drug should be stopped immediately and treated
in time.
2.
If retinal hemorrhages occur during pentoxifylline treatment, the drug
should be discontinued immediately.
3.
Pentoxifylline can increase the effect of anticoagulants, if the patient has a tendency to bleed, at the same time taking anticoagulants, it is likely to cause bleeding
.
When pentoxifylline is used, oral anticoagulants (vitamin K antagonists) can be used, but the risk of bleeding should be strictly monitored and a coagulation test (INR)
is recommended.
4.
Patients with bleeding tendency or recent bleeding history should not use this drug
.
5.
People with hypotension and unstable circulatory status should use this product with caution, because this product can cause transient hypotension, accompanied by a tendency to
collapse.
6.
For patients with renal insufficiency (creatinine clearance less than 30ml/min) or patients with severe liver dysfunction, the amount of pentoxifylline should be reduced, and liver and kidney function
should be monitored.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
