Amikacin Sulfate Injection

Specification: 2ml:100mg; 2ml:500mg
Therapeutic indications:
Amikacin sulfate is suitable for severe infections caused by various bacteria, such as bacteremia or septicemia, bacterial endocarditis, lower respiratory tract infection, bone and joint infection, biliary tract infection, abdominal infection, complex urinary tract infection, skin and soft tissue infection, etc.

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APIS

Active Pharmaceutical Ingredient	Latin Name	Molecular Formula	Defination	Structural Formula
Amikacin Sulfate Injection	Amikacin Sulfate Iniectio	C22H47N5O21S2	Butanamide, 4-amino-N-[(1R,2S,3S,4R,5S)-5-amino-2-[(3-amino-3-deoxy-α-D-glucopyranosyl)oxy]-4-[(6-amino-6-deoxy-β-D-glucopyranosyl)oxy]-3-hydroxycyclohexyl]-2-hydroxy-, (2S)-, sulfate (1:2) (sa lt)

Product Specifications

Products	Specification	Vomume of vials	Packing form
Amikacin Sulfate Injection	BP latest version	Colorless to slight yellow or slightly yellowish green, clarity liquid	10amps/tray, 10trays/box

Dosage

1. Adults: intramuscular injection or intravenous drip. Simple urinary tract infection was 0.2g per 12 hours for patients with common antimicrobial resistance. For other systemic infections 7.5mg/kg every 12 hours, or 15mg/kg every 24 hours. Adults should not exceed 1.5g a day, and the course of treatment should not exceed 10 days.

2. Children: intramuscular injection or intravenous drip. The first dose is 10mg/kg body weight, followed by 7.5mg/kg every 12 hours, or 15mg/kg every 24 hours.

3. Patients with renal dysfunction: creatinine clearance > 50-90ml/min should be given 60%-90% of the normal dose (7.5mg/kg) every 12 hours; Creatinine clearance of 10-50ml/min is 20%-30% with 7.5mg/kg every 24-48 hours.

API mixing

Filling

Vial sterilization

Adverse effect

Occasionally dizziness, insomnia, lethargy, nausea, diarrhea, constipation, rash, muscle pain and other symptoms. Arrhythmia, elevation of transaminase, changes of renal function, granulocytopenia, etc. may occur when large doses are used.

Matters need attention

Patients may develop hearing loss, tinnitus or a feeling of fullness in the ears. A few patients may also have symptoms such as vertigo and unsteady gait. Hearing loss generally does not worsen after withdrawal, but some may progress to deafness after withdrawal.
This product has a certain degree of renal toxicity, patients can appear hematuria, reduced frequency of urination or reduced urine volume, blood urea nitrogen, blood creatinine value increased. Most of the symptoms were reversible, with immediate relief after withdrawal, but there were also isolated reports of renal failure.
Weakness, lethargy, dyspnea and other neuromuscular blocking effects are rare.
Other adverse reactions include headache, numbness, acupuncture infection, tremor, convulsion, joint pain, drug fever, eosinophilia, abnormal liver function, blurred vision, etc.
This product belongs to the class D of pregnant women's drugs, that is, it has some harm to humans, but the advantages may outweigh the disadvantages after medication. This product can cross the placenta and reach fetal tissue, which may cause fetal hearing damage. Pregnant women must fully weigh the pros and cons before using this product. Breastfeeding women should stop breastfeeding when taking drugs.

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