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On April 6, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Amikacin Injection (No.

annex

Amikacin injection drug label revision requirements

1.

2.

All aminoglycoside drugs can cause ototoxicity, nephrotoxicity and neuromuscular blockade.

Changes in renal function after drug withdrawal are usually reversible.

Toxic effects on the eighth cranial nerve can cause hearing loss, imbalance, or both.

According to reports, intravitreal injection of amikacin can cause macular infarction and sometimes permanent blindness.

When the recommended preventive measures and dosages are followed, the incidence of poisoning reactions is lower, such as tinnitus, dizziness and some reversible deafness, skin rash, drug fever, headache, paresthesia, nausea and vomiting.

3.

1.

2.

The neurotoxicity of aminoglycoside drugs is mainly manifested in vestibular and/or permanent bilateral ototoxicity.

3.

Aminoglycoside drugs have potential nephrotoxicity, and the risk of nephrotoxicity is greater for patients with abnormal renal function, higher doses or prolonged treatment time.

Where feasible, the blood concentration of amikacin should be monitored to ensure that it reaches a sufficient therapeutic concentration and to avoid potential toxicity.

Enough water should be given to patients during treatment.

Note: When the patient is adequately hydrated and renal function is normal, if the recommended dose is not exceeded, the risk of nephrotoxicity of amikacin is low.

4.
Neuromuscular toxicity

It has been reported that neuromuscular blockade and respiratory paralysis can occur after parenteral administration, local injection (for example, in orthopedics or abdominal irrigation or local treatment of empyema), and oral aminoglycoside drugs.
Regardless of the route of administration of aminoglycoside drugs, the possibility of these symptoms should be considered, especially when receiving anesthesia or neuromuscular blockers (such as tubocrine, succinylcholine, decahydroxy quaternary amine, atraxine) Curonium, rocuronium, vecuronium, etc.
) or patients who use large amounts of citrate for anticoagulation.
If the block occurs, calcium salt can reverse these manifestations, but mechanical respiratory assistance may be required.

Patients with muscle diseases such as myasthenia gravis or Parkinson's disease should be cautious with aminoglycoside drugs, because these drugs may have a curare-like effect on the neuromuscular junction, thereby exacerbating muscle weakness.

5.
Allergic reactions

This product has the risk of severe allergic reactions, including anaphylactic shock.
Once symptoms such as dyspnea, blood pressure drop, and loss of consciousness occur, the drug should be stopped immediately and appropriate treatment measures should be taken.
Cross allergy to aminoglycoside drugs has been confirmed, that is, patients who are allergic to one aminoglycoside may be allergic to other aminoglycosides.

Note: If the auxiliary material of this product contains sulfite, the following content should be added:

The excipients of this product contain sulfites, which may cause allergic reactions in some susceptible people, including allergy-like symptoms and life-threatening or mild asthma attacks.
The overall prevalence of sulfite allergy in the general population is unknown and is likely to be low.
Sulfite sensitivity is more common in patients with asthma than in non-asthmatic patients.

6.
Like other antibiotics, the use of amikacin may lead to overgrowth of insensitive microorganisms.
If this happens, appropriate treatment should be given.

7.
Almost all antibacterial drugs including amikacin have been reported in the application of Clostridium difficile associated diarrhea (CDAD, Clostridium difficile associated diarrhea), the severity of which ranges from mild diarrhea to fatal Colitis varies.
Antimicrobial treatment can change the normal flora of the patient’s colon, leading to the overgrowth of Clostridium difficile.

The toxins A and B produced by Clostridium difficile are responsible for the occurrence of CDAD.
High-level toxin-producing strains of Clostridium difficile can cause increased morbidity and mortality of CDAD.
Since these infections are refractory to antimicrobial drugs, colectomy may be required for such patients.
All patients who develop diarrhea after antibiotics must consider the possibility of CDAD.
It has been reported in the literature that CDAD occurs 2 months after the end of antimicrobial treatment, so it is necessary to carefully understand the patient's medical history when performing CDAD identification.

Once it is suspected or confirmed that the patient has CDAD, it may be necessary to stop the antibiotics the patient is receiving (except for antibiotics that have a direct inhibitory effect on Clostridium difficile).
At the same time, appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment for Clostridium difficile infection and surgical evaluation should be performed on the patient based on clinical indications.

4.
[Drug Interactions] is revised to the following content:

1.
Avoid simultaneous or continuous administration of systemic, oral or local other nephrotoxic or neurotoxic drugs, especially bacitracin, cisplatin, amphotericin B, cephalothin, cefazolin, polymyxin or other drugs Aminoglycoside drugs.
Other factors contributing to the increased risk of toxicity include advanced age and dehydration.

2.
Amikacin and a strong diuretic (estanic acid or furosemide) cannot be given at the same time, because the diuretic itself can cause ototoxicity.
In addition, when administered intravenously, diuretics increase their toxic effects by changing the concentration of aminoglycoside drugs in the blood and tissues.

3.
According to reports, parenteral combined administration of aminoglycoside antibiotics and cephalosporins may lead to a false increase in the measured value of serum creatinine.

4.
When aminoglycoside drugs or penicillin drugs are administered by different routes of administration, the half-life and blood concentration will decrease.
Only in patients with severe renal impairment, the inactivation of aminoglycoside drugs has clinical significance.
The body fluid samples collected for analysis may continue to be inactivated, resulting in inaccurate determination of aminoglycoside drugs.
Such samples should be handled properly (determined in time, frozen or treated with β-lactamase).

In vitro mixing of aminoglycoside drugs and β-lactam antibiotics (penicillins or cephalosporins) may cause mutual inactivation.
When combined with the above antibiotics, the infusion must be divided into bottles.

5.
When aminoglycoside drugs are used in combination with bisphosphonates, the risk of hypocalcemia increases.

6.
When aminoglycoside drugs are used together with platinum compounds, the risk of nephrotoxicity and ototoxicity increases.

7.
Under the influence of anesthetics or muscle relaxants (including ether, halothane, d-tubocurarine, succinylcholine and decamethylammonium), it is not recommended to use amikacin in the abdominal cavity because nerves may occur Muscle block and subsequent respiratory depression.

8.
Indomethacin may increase the blood concentration of neonatal amikacin.