CEFTRIAXONE SODIUM FOR INJECTION

Indications1.Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth): Bacterial Meningitis; Community acquired pneumonia; Hos

  • Product No.: AMC13009-07
  • Specification: 1g/10ml, 10ampoules/box
  • Trademark: Shinepharm
  • Support OEM/ODM: Yes
  • Mini. Order: 20000Boxes
  • Delivery Time: 30~60 Days
  • Trade Term: FOB,CIF
  • Payment Term: T/T,L/C
  • Standard Available: CP,BP
  • Documents: GMP,COPP,CTD

Indications

1.Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth): Bacterial Meningitis; Community acquired pneumonia; Hospital acquired pneumonia; Acute otitis media; Intra-abdominal infections; Complicated urinary tract infections (including pyelonephritis); Infections of bones and joints; Complicated skin and soft tissue infections; Gonorrhoea; Syphilis; Bacterial endocarditis.

2.For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults; For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age; For Pre-operative prophylaxis of surgical site infections; In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.

Dosage and Administration

Usage: I.V./I.M.

Dosage:

1.Adults and children 12 years and over: Standard therapeutic dose: 1 g once daily. Severe infections: 2 - 4 g daily, normally as a single dose every 24 hours. Acute, uncomplicated gonorrhoea: A single dose of 250 mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated. Peri-operative prophylaxis: Usually 1 g as a single intramuscular or slow intravenous dose. In colorectal surgery, 2 g should be given intramuscularly by slow intravenous injection or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.

Precautions & Warning:

1.Hypersensitivity reactions:

2.Interaction with calcium containing products

3.Paediatric population

4.Immune mediated haemolytic anaemia

5.Long term treatment

6.Colitis/Overgrowth of non-susceptible microorganisms

7.Severe renal and hepatic insufficiency

8.Interference with serological testing

9.Antibacterial spectrum

10.Use of lidocaine

Contraindications:

1.Hypersensitivity to ceftriaxone or to any of the cephalosporins. Previous immediate and/or severe hypersensitivity reaction to penicillin, or to any other type of betalactam drug.

2.Ceftriaxone should not be given to neonates with jaundice or to those who are hypoalbuminaemic or acidotic or have other conditions, such as prematurity, in which bilirubin binding is likely to be impaired.

3.Ceftriaxone should not be administered simultaneously with calcium containing products in paediatric patients.

Adverse Reactions:

1.General disorders and administration site conditions: Pain or discomfort at the injection site can occur with intravenous or intramuscular administration.

2.Infections and infestations:Rare (≥0.01% - 0.1%): Mycosis of the genital tract. Other superinfections of various sites are possible.

3.Blood and lymphatic system disorders: A positive Coombs’ test is possible.

3.Immune system disorders: shivering, chills. See also skin reactions for other allergic manifestations.

4.Nervous system disorders:Rare (≥1.01% - 0.1%): Headache, dizziness

5.Gastrointestinal disorders:Common (≥1% - < 10%): Diarrhoea, loose stools, nausea, vomiting.

6.Hepato-biliary disorders.

7.Skin and subcutaneous tissue disorders.

8.Renal and urinary disorders.

Storage instructions:

Unopened vial: Store below 25°C. Keep the vial in the outer carton