Axosin- Ceftriaxone Sodium USP - IV / IM Injection

Description:
Axosin® - (Ceftriaxone) is a board spectrum parenteral third generation cephalosporin antibiotic. The drug is highly resistant to bacterial b-lactamases and has a good activity against many gram-positive and gram-negative areobic and some anaerobic bacteria. It inhibits bacterial cellwall synthesis in a manner similar to that of penicillin. Once a day dose for many infections is an advantage for this drug.

Composition:
Axosin® 250 mg IM and IV: Each vial contains Ceftriaxone 250 mg as sterile Ceftriaxone Sodium USP.
Axosin® 250 mg IM and IV: Each vial contains Ceftriaxone 500 mg as sterile Ceftriaxone Sodium USP.
Axosin® 1 gm IM and IV : Each vial contains Ceftriaxone 1 gm as sterile Ceftriaxone Sodium USP.

Indication:
Axosin® (Ceftriaxone) is indicated for the treatment of the following major infections when caused by susceptible ororganisms:

1. Renal & urinary tract infection
2. Lower respiratory tract infection particularly pneumonia
3. Gonococcal infection
4. Skin, soft tissue, bone & joint infection
5. Bacterial meningitis
6. Serious bacterial infection e.g. septicemia
7. ENT infection
8. Infection in cancer patients
9. Prevention of postoperative infection
10. Pre-operative prophylaxis of infection associated with surgery
11. Typhoid fever.

Dosage and Administration:
Adult : It is usually given to adults in a dose of 1 to 2 gm daily as a single dose or in two divided doses depending on the type and severity of infection. In severe infection up to 4 gm daily may be given. A single intramuscular dose of 250 mg is recommended for the treatment of uncomplicated gonorrhoea in adult. For surgical prophylaxis in adults, single dose of 1 gm may be administered 0.5 to 2 hours prior to surgery.

Children : Suggested doses for infants and children are 50 to 75 mg per kg body weight once a day; for servere infection up to 80 mg per kg body weight daily may be given.

Neonates : The maximum dose should not exceed 50 mg per kg; intravenous doses in neonates should be given over 60 minutes. Duration of Therapy: The duration of therapy varies according to the course of the diseases be continued for a minimum of 48-72 hours after the patients has become a febrile or evidence of bacterial eradication has been obtained.

Side effect:
Well tolerated, side effects are relatively infrequent, usually mild and transient. The most common side effects are gastro-intestinal consisting mainly of loose stool, diarrhoea, nausea, vomiting stomatitis and glossitis.

Contra-indication:
Ceftriaxone sodium should not given in patients with a history of hypersensitivity to cephalosporin antibiotics. It is contraindicated in premature infants and in fullterm infants during the first 6 weeks of life.

Pharmaceutical Precautions:
Storage:
The recommended maximum Storage temperature for Axosin® vials is 25 °C. Reconstituted solutions are stable for 6 hours at room temp in daylight, and for 24 hours at 5 °C.

How supplied:
Axosin® Supplied in a combipack as follows.
Axosin® 250 mg IM Injection : 1 vial of 250 mg Ceftriaxone Injection and one ampoule of 2 ml 1% Lidocaine USP injection.
Axosin® 500 mg IM Injection : 1 vial of 500 mg Ceftriaxone Injection and one ampoule of 2 ml 1% Lidocaine USP injection.
Axosin® 1 gm IM Injection : 1 vial of 1gm Ceftriaxone Injection and one ampoule of 3.5 ml 1% Lidocaine USP injection.
Axosin® 250 mg IV Injection : 1 vial of 250 mg Ceftriaxone Injection and one ampoule of 5 ml water for injection BP.
Axosin® 500 mg IV Injection : 1 vial of 500 mg Ceftriaxone Injection and one ampoule of 5 ml water for injection BP.
Axosin® 1 gm IV Injection : 1 vial of 1gm Ceftriaxone Injection and one ampoule of 10 ml water for injection BP.

Manufacturer’s Source: IBN SINA