The State Food and Drug Administration revises the drug instructions for cefuroxime oral preparations and injection preparations

On April 6, the State Food and Drug Administration issued the "Announcement on Revising the Drug Inserts of Cefuroxime Preparations (No.

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Requirements for the revision of the instructions for cefuroxime oral preparations

Requirements for the revision of the instructions for cefuroxime oral preparations

[Adverse reactions] items should include:

[Adverse reactions] items should include:

The adverse drug reactions caused by cefuroxime axetil are mostly mild and transient.

Since most adverse events do not have data suitable for calculating frequency (for example, there is no placebo-controlled clinical study to observe the occurrence of certain adverse events), the following frequency classification of adverse reactions is estimated.

The data used to determine the incidence of various adverse events ranging from very common to rare are obtained from large-scale clinical studies.

The incidence of adverse events is defined as:

The incidence of adverse events is defined as:

Very common (1/10)

Common (1/100 and <1/10)

Uncommon (1/1000 and <1/100)

Rare (1/10000 and <1/1000)

Very rare (<1/10000)

Infections and invasive diseases

Infections and invasive diseases

Common: Candida overgrowth

Diseases of the blood and lymphatic system

Diseases of the blood and lymphatic system

Common: Eosinophilia

Uncommon: Coomb test positive, thrombocytopenia and leukopenia (sometimes more severe))

Very rare: hemolytic anemia.

Immune system diseases

Immune system diseases

Allergic reactions include

Uncommon: skin rash

Rare: urticaria, itching

Very rare: drug fever, serum sickness, and immediate allergic reactions.

Post-marketing surveillance found that this product had case reports of angioedema, severe allergic-like reactions, and anaphylactic shock.

Various neurological diseases

Various neurological diseases

Common: headache, dizziness

Post-marketing monitoring found that this product had a case report of convulsions, irritability, local numbness, and epileptic seizures.

Gastrointestinal diseases

Gastrointestinal diseases

Common: gastrointestinal disorders, including diarrhea, nausea, and abdominal pain

Uncommon: Vomiting

Rare: pseudomembranous colitis.

Post-marketing surveillance found that this product still had heartburn and oral ulcer cases.

Hepatobiliary system disease

Hepatobiliary system disease

Common: Eosinophilia and transient liver enzymes (ALT[ie SGPT], AST[ie SGOT] and LDH) levels increased

Very rare: jaundice (mainly cholestatic jaundice), hepatitis

Skin and subcutaneous tissue diseases

Skin and subcutaneous tissue diseases

Very rare: erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (rash necrolysis).

See other diseases of the immune system

Kidney and urinary system diseases

Kidney and urinary system diseases

Rare interstitial nephritis.

other

other

Post-marketing monitoring found that this product still has skin flushing, fatigue, edema (including generalized edema, periorbital edema, etc.

(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.

Annex 2

Head spore cefuroxime injection requirements specification revision

Head spore cefuroxime injection requirements specification revision

[Adverse reactions] items should include:

[Adverse reactions] items should include:

Adverse drug reactions are very rare (<1/10000), most of which are mild and transient.

Since most adverse reactions do not have data suitable for calculating the frequency of occurrence, the following frequency classification of adverse reactions is estimated.

The data used to determine the frequency of various adverse reactions ranging from very common to rare are obtained from large-scale clinical studies.
For the frequency of other adverse events (ie: adverse reactions with a frequency of <1/10000, etc.
), post-marketing monitoring data are mainly used and usually refer to the reporting rate instead of the actual frequency.

The frequency of adverse reactions is defined as:

The frequency of adverse reactions is defined as:

Very common 1/10

Commonly 1/100 and <1/10

Uncommon 1/1000 and <1/100

Rare 1/10000 and <1/1000

Very rare <1/10000

Infections and invasive diseases

Infections and invasive diseases

Rare: Candida overgrowth

Diseases of the blood and lymphatic system

Diseases of the blood and lymphatic system

Common: neutropenia, eosinophilia

Uncommon: Leukopenia, decreased hemoglobin concentration, positive Coomb's test

Rare: Thrombocytopenia

Very rare: hemolytic anemia.
Cephalosporins are easily absorbed to the surface of red blood cell membranes and interact with antibodies against such drugs, resulting in a positive Coomb's test (which can interfere with cross-matching) and, in very rare cases, hemolytic anemia.

Post-marketing surveillance found that this product still had pancytopenia, reduced hematocrit, prolonged prothrombin time, and bleeding.

Immune system diseases

Immune system diseases

Allergic reactions include

Uncommon: skin rash, hives, itching

Rare: Drug fever

Very rare: interstitial nephritis, allergic reaction, skin vasculitis.

Post-marketing monitoring found that this product still has case reports of angioedema, serous-like syndrome (urticaria with arthritis, arthralgia, myalgia, fever, etc.
), severe allergic-like reactions, and anaphylactic shock.

Other see skin and subcutaneous tissue diseases and kidney and urinary system diseases.

Gastrointestinal diseases

Gastrointestinal diseases

Uncommon: gastrointestinal disorders, including diarrhea and nausea

Very rare: pseudomembranous colitis.

Post-marketing monitoring found that this product still has case reports of abdominal distension, abdominal pain, and heartburn.

Hepatobiliary system disease

Hepatobiliary system disease

Common: transient increase in liver enzyme levels

Very rare: transient increase in bilirubin levels

Although transient increases in serum liver enzyme levels or bilirubin levels occur especially in patients with liver disease, there is no evidence of liver damage.

Skin and subcutaneous tissue diseases

Skin and subcutaneous tissue diseases

Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome

See other diseases of the immune system.

Kidney and urinary system diseases

Kidney and urinary system diseases

Very rare: elevated serum creatinine, elevated blood urea nitrogen, and decreased creatinine clearance.

See other diseases of the immune system.

Post-marketing monitoring found that this product still has case reports of hematuria, interstitial nephritis, and acute kidney injury (including acute renal failure).

Various neurological diseases

Various neurological diseases

Post-marketing monitoring revealed that this product still had case reports of dizziness, headache, convulsions, syncope, drowsiness, and local numbness, as well as individual cases of epileptic seizures.

Systemic diseases and various reactions at the site of administration

Systemic diseases and various reactions at the site of administration

Common: Injection site reactions may include pain and thrombophlebitis

There will be pain at the intramuscular injection site, especially when the dose is large, but there is no need to stop the treatment.

Post-marketing surveillance found that this product still had case reports of fever, chills, fatigue, edema, and local swelling.

other

other

Post-marketing monitoring found that this product still has case reports of skin flushing, tinnitus, hearing impairment, conjunctivitis, palpitations, chest tightness, tachycardia, dyspnea, abnormal blood pressure, irritability, abnormal appetite, disulfiram-like reaction, and laryngeal edema.

(Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
)