Plot 303A, Abisogun Leigh Street, Adeniji Estate, Ogba GRA, Ogba, Ikeja, Lagos
PT Interbat, JI. H.R.M. Mangundiprojo no. 1 Buduran, Sidoarjo-61252, East java, Indonesia
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Injection (NRN:04-4657): Each vial contains: 1.193 g Ceftriaxone disodium 3.5 H2O equiv. to 1.0 g Ceftriaxone USP.
Pack Size: Box contains 1 vial of 1g and 1 ampoule of 4 mL of 1% lidocaine solution, and 1 ampoule of 10 mL of water for injection of water for injection.
A parenteral third generation cephalosporin, which acts by inhibiting mucopeptide synthesis in the microorganism cell wall. Starxon has broad spectrum of activity including gram-positive and gram negative aerobic and anaerobic bacteria, great stability to beta-lactamase, including penicillinase and cephalosporinase, long half-life, ease of administration and relatively few adverse effects.
Acute bacterial otitis media;
Lower respiratory tract infections and pneumonia;
Skin, bone, and soft tissue infections;
Urinary tract infections;
Pevic inflammatory disease;
Primary syphilis and chancroid;
Miscellaneous bacterial infections.
It is also indicated for surgical prophylaxis, except for procedures involving the central nervous system.
Hypersensitivity to cephalosporins and penicillins.
Caution for use in patients with a history of gastrointestinal disorder especially colitis.
Monitoring of prothrombin time in patients with impaired vitamin K synthesis or low vitamin K store.
Long-term therapy may result in the overgrowth of nonsusceptible microorganisms. If superinfection occurs, discontinue the drug and appropriate measures should be taken.
Safety and effectiveness for use in neonates, infants and children have been established for the dosage described below, caution for use in hyperbilirubinemic neonates, especially prematures.
The use in pregnant women only if clearly needed.
Caution for use in nursing mothers, because Starxon is excreted in breast-milk.
Starxon is well tolerated by most patients. As with other cephalosporins, the most common adverse effects associated with ceftriaxone are the following:
Hypersensitivity reactions (in approximately 2% of patients);
Transient elevations of hepatic function test (4%).
Dosage & Administration
Usual dose: 1-2 g a day in a single dose (or in 2 divided doses).
Maximum dosage: not more than 4 g.
Gonoccoccal infections: 250 mg a day in single dose, I.M. administration.
For perioperative prophylaxis infections: 1 g in a single dose ½ - 2 hours. I.V. administration before the surgery is recommended.
For treatment of skin and skin tissue infections, the recommended dosage is 50 - 75 mg a day (or in 2 divided doses). Maximum dosage is 2g/day.
In the treatment of meningitis, it is recommended that the initial therapeutic dose be 100 mg/kg daily (not to exceed 4 g) once daily; duration of therapy is 7 - 14 days (for Neisseria meningitides 4 days; Haemophilus influenzae 6 days; Streptococcus pneumoniae 7 days; Susceptible Enterobacteriaceae 10 - 14 days).
For infection caused by Streptococcus pyogenes, duration of therapy minimal 10 days. For treatment of other infections except meningitis, the recommended dosage is 50-75 mg/kg body weight/day in single or divided doses every 12 hours. Maximum dosage is 2 g/day.
No dosage adjustment is neccessary for patients with renal or hepatic function disorder; however serum concentrations should be monitored in patients with severe renal disorder (e.g. dialysis patients) and in patients with both hepatic and renal impairment.
|Dissolve Starxon powder for injection, with 1% lidocaine sterile solution|
|Dosage||Amount of I.M. diluent to be added|
|1.0 g||3.6 mL|
|After reconstitution, each mL of solution contains 250 mg equivalent of Ceftriaxone.|
|Dissolve Starxon powder for injection, with water for injection and discard enclosed lidocaine.|
|Dosage||Amount of I.V. diluent to be added|
|1.0 g||10 mL|
|After reconstitution, each mL of solution contains 100 mg equivalent of Ceftriaxone.|
Stability of reconstituted solution: Stability of starxon solution on reconstitution. Starxon intramuscular solution remain stable (loss of potency less than 10%) for the following period:
Diluents Concentration Room temp. Refrigerated
mg/ml (25oC) (4oC)
Sterile water 100 3 days 10 days
For injection 250 24 hours 3 days
0.9% sodium 100 3 days 10 days
Chloride solution 250 24 hours 3 days
5% dextrose 100 3 days 10 days
solution 250 24 hours 3 days
Bacteriostatics water 100 24hours 10 days
+0.9 Benzyl/Alcohol 250 24 hours 3 days
After the indicated stability time periods, unused portions of solutions should be discharded.
Starxon solution should not be physically mixed with or piggyback into solution containing other antimicrobial drugs or into diluent solutions other than these listed above, due to possible incompatibility.