shangqiu pharma amikacin sulfate injection 2ml 0

Description

Indication & Scope

Amikacin Sulfate Injection is a prescription aminoglycoside antibiotic indicated for the treatment of serious infections caused by susceptible Gram-negative bacteria, including septicemia, hospital-acquired pneumonia, complicated urinary tract infections, intra-abdominal and pelvic infections, bone and joint infections, and severe skin and soft tissue infections. It is often used in combination with β-lactam antibiotics for multidrug-resistant Gram-negative infections.

Mechanism: Amikacin irreversibly binds to the bacterial 30S ribosomal subunit, inhibiting protein synthesis and causing rapid bacterial cell death.
Drug class: Semisynthetic aminoglycoside antibiotic.
Clinical use: Treatment of severe Gram-negative bacterial infections, particularly multidrug-resistant pathogens.

Specification

Generic Name	Amikacin Sulfate Injection
Brand Name	ShangQiu Pharma®
Ingredient	Amikacin Sulfate
Dosage Form	Injection
Package	2 ml : 0.2 g (200,000 units)/vial
Conditions Treated	For sepsis, hospital-acquired pneumonia, complicated urinary tract infections, intra-abdominal and pelvic infections, musculoskeletal infections, and severe skin and soft tissue infections
Taboos	Hypersensitivity to amikacin or other aminoglycoside antibiotics
Place of origin	China
Prescription type	Prescription Drug (Rx)
Storage Conditions	Store below 20°C, protected from light. Do not freeze.
Manufacturer	Shanghai Xiandai Hasen (Shangqiu) Pharmaceutical Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval Number	H41021926
Approval Date	February 27, 2025
Shelf Life	24 months

How to use ?

Recommended Dose: Adults: 200 mg every 12 hours or 15 mg/kg once daily, administered by intramuscular injection or intravenous infusion.

Time: Infuse intravenously over at least 30 minutes.

Instructions for use: Adjust the dose according to renal function. Monitor renal function, hearing, and serum drug concentrations during treatment.

Interaction: Avoid concurrent use with other nephrotoxic or ototoxic agents, including vancomycin, cisplatin, loop diuretics, and other aminoglycosides. Do not mix with β-lactam antibiotics in the same infusion.

Side effects: Common adverse reactions include nephrotoxicity, ototoxicity, dizziness, rash, nausea, injection-site reactions, and neuromuscular blockade.

Important Notice

This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.

Packaging & Shipping

Packaging

Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.

Shipping Methods

Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.

Export Support

Certificate of Analysis

GMP Certificate

Commercial Invoice

Packing List & CPP

Cold Chain Logistics

Customs Documentation

Scientific and regulatory sources

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

What type of antibiotic is Amikacin?

Amikacin is a semisynthetic aminoglycoside antibiotic used to treat severe Gram-negative bacterial infections.

Is amikacin effective against multidrug-resistant bacteria?

Yes. Amikacin remains active against many Gram-negative bacteria resistant to other aminoglycosides and is commonly used for multidrug-resistant infections.

Why are hearing and kidney function monitored?

Amikacin may cause ototoxicity and nephrotoxicity, especially during prolonged therapy or in patients with renal impairment.

Can amikacin be used alone for anaerobic infections?

No. Amikacin has little activity against anaerobic bacteria and should be combined with appropriate anti-anaerobic agents when necessary.