Sisomicin Sulfate for Injection

Pharmacological action: This product belongs to the aminoglycoside antibiotics, and its antibacterial spectrum is similar to that of gentamicin. The mechanism of action of this product is to bind to the 30S subunit of bacterial ribosomes and inhibit the synthesis of bacterial proteins. In vitro studies have shown that sisomicin sulfate is effective against Gram-negative bacteria such as Staphylococcus aureus, Escherichia coli, Klebsiella, Proteus, Enterobacter, Pseudomonas aeruginosa, and Shigella dysenteriae; its antibacterial effect on Pseudomonas aeruginosa is stronger than that of gentamicin and similar to that of tobramycin; its effect on Serratia marcescens is lower than that of gentamicin, but higher than that of tobramycin. Toxicological study: Auditory toxicity: Guinea pigs were given intramuscular or intravenous injections of sisomicin sulfate for 30 consecutive days. The animals in the 50mg/Kg/day group all showed loss of auricular reflexes, decreased amplitude of auditory brainstem responses, damage to the spiral organ, and mild vestibular function damage. There was no difference in the degree of damage and frequency between the two routes of administration; in the 30mg/Kg/day group, 1 of 8 cases had mild vestibular function damage.

The main ingredient of this product is sisomicin sulfate, whose chemical name is O-3-deoxy-4-C-methyl-3-methylamino-β-L-arabinopyranosyl (1→4)-O-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-glyceryl-4-enylhexopyranosyl-(1→6)]-2-deoxy-L-streptamine sulfate. Its structural formula is: Molecular formula: (C19H37N5O7)2·5H2SO4 Molecular weight: 1385.43

This product is white or off-white loose lumps.

Antibiotics. This product is suitable for the following infections caused by Gram-negative bacteria Pseudomonas aeruginosa, Staphylococcus and other sensitive bacteria: respiratory system infections, urogenital system infections, biliary tract infections, skin and soft tissue infections, infectious diarrhea and sepsis, etc. This product should be used in combination with penicillin or cephalosporin when used for the above-mentioned serious infections.

Intravenous drip 1. Adults with normal renal function: 0.1g (as sisomicin) per day for mild infection, 0.15g (2 bottles) per day for severe infection, divided into 2-3 doses. Children: 2-3 mg/kg per day according to body weight, divided into 2-3 doses. The course of treatment should not exceed 7-10 days. Blood drug concentration should be monitored if conditions permit. 2. Patients with impaired renal function When using this product, the dosage should be adjusted according to renal function. If conditions permit, blood drug concentration should be monitored at the same time to adjust the dosage.

1. Common symptoms include hearing loss, tinnitus or fullness in the ears (ototoxicity), hematuria, proteinuria, tubular urine, significantly reduced urination frequency or urine volume, loss of appetite, extreme thirst (nephrotoxicity), unsteady gait, dizziness (ototoxicity, vestibular effects), nausea or vomiting (ototoxicity, vestibular effects, nephrotoxicity). 2. Rare symptoms include vision loss (optic neuritis), dyspnea, drowsiness, extreme weakness (neuromuscular blockade), allergic reactions such as rash, changes in blood count, changes in liver function, digestive tract reactions, pain at the injection site, nodules, phlebitis, etc. 3. Very rare symptoms include anaphylactic shock.

1. It is contraindicated for those who are allergic to this product or other aminoglycosides and bacitracin, or for those who have or have family members who have developed deafness or other hearing loss due to the use of streptomycin. 2. It is contraindicated for those with renal failure.

Precautions for children: Use this product with caution in premature infants, newborns, infants and young children. If this product is used, the dosage should be adjusted according to the blood drug concentration or creatinine clearance rate. Precautions for pregnancy and lactation: 1. This product can pass through the blood-placental barrier and reach a certain concentration in the amniotic fluid, which may cause damage to the eighth cranial nerve of the fetus, so it is forbidden for pregnant women. 2. Use with caution in lactating women, and suspend breastfeeding during the use of this product.

1. This product can increase ototoxicity, nephrotoxicity and neuromuscular blocking effects when used with other aminoglycosides or when applied topically or systemically one after the other. Hearing loss may occur, and may still progress to deafness after discontinuation of the drug; hearing damage may recover or become permanent. Neuromuscular blocking effects can lead to skeletal muscle weakness, respiratory depression or respiratory paralysis (apnea), and anticholinesterase drugs or calcium salts can help restore the blocking effect. 2. This product can aggravate neuromuscular blocking effects when used in combination with neuromuscular blocking drugs, leading to muscle weakness, respiratory depression or respiratory paralysis (apnea). It can increase ototoxicity and nephrotoxicity when used in combination with plasma substitutes such as dextran, sodium alginate, diuretics such as ethacrynic acid, furosemide, capreomycin, cisplatin, vancomycin, etc., or when applied topically or systemically one after the other, hearing damage may occur, and may still progress to deafness after discontinuation of the drug, and hearing damage may recover or become permanent. 3. This product can increase nephrotoxicity when used topically or systemically with cephalothin. 4. This product should not be used in combination with polymyxins, or applied topically or systemically in sequence, because it can increase nephrotoxicity and neuromuscular blocking effects, the latter of which can lead to skeletal muscle weakness, respiratory depression or respiratory paralysis (apnea). 5. This product should not be used in combination with other nephrotoxic or ototoxic drugs, or used sequentially, so as not to aggravate nephrotoxicity or ototoxicity. 6. This product should not be used in combination with amphotericin B, ceftriaxone sodium, nitrofurantoin sodium, sulfadiazine sodium and tetracycline (all of the above are injections), because incompatibility may occur. 7. This product can often achieve synergistic effects when used in combination with β-lactams (cephalosporins or penicillins). 8. This product mixed with β-lactams (cephalosporins or penicillins) can lead to mutual inactivation, and must be dripped in separate bottles when used in combination.

Keep tightly closed in a cool, dark place.

75,000 units (in C19H37N5O7)

24 months

Hainan Huluwa Pharmaceutical Group Co., Ltd.

• Founded in:

  2005-06-22

• Address:

  No. 8, Yaogu 4th Road, Phase II, Yaogu Industrial Park, Haikou National High-tech Zone, Haikou City, Hainan Province

• Tax NO.:

  91460100774262258E

• Registered Funds:

  400.108752 million yuan

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