Giga-S Injection

Before instituting treatment with Ceftriaxone for Injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for Injection, USP and other antibacterial drugs, Ceftriaxone for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …

• Ceftriaxone may be administered intravenously or intramuscularly
• However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only
• Ceftriaxone should be administered intravenously by infusion over a period of 30 minutes
• Do not use diluents containing calcium, such as Ringer ’ s solution or Hartmann ’ s solution, to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form
• Precipitation of ceftriaxone-calcium can also occur when Ceftriaxone is mixed with calcium-containing solutions in the same IV administration line
• Ceftriaxone must not be administered simultaneously with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site
• However, in patients other than
• Neonates, Ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid (see WARNINGS )
• There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral)
• NEONATES: Hyperbilirubinemic
• Neonates, especially prematures, should not be treated with Ceftriaxone
• Ceftriaxone is contraindicated in premature
• Neonates (see CONTRAINDICATIONS ). …

• Safety and effectiveness of Ceftriaxone in
• Neonates, infants and
• Pediatric patients have been established for the dosages described in the DOSAGE AND ADMINISTRATION section
• In vitro studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin
• Ceftriaxone should not be administered to hyperbilirubinemic
• Neonates, especially prematures (see CONTRAINDICATIONS )

• Patients should be counseled that antibacterial drugs including Ceftriaxone should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When Ceftriaxone is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed
• Skipping doses or not completing the full course of therapy may decrease the effectiveness of the immediate treatment and increase the likelihood that bacteria will develop resistance and will not be treatable by Ceftriaxone or other antibacterial drugs in the future. …

• Hypersensitivity Ceftriaxone is contraindicated in patients with known hypersensitivity to ceftriaxone, any of its excipients or to any other cephalosporin
• Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to ceftriaxone (see WARNINGS – Hypersensitivity ). …

Hypersensitivity Reactions Before therapy with Ceftriaxone is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs. This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients. Antibacterial drugs should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs. Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures. …

Ceftriaxone is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Ceftriaxone therapy or of uncertain etiology, were observed: LOCAL REACTIONS - pain, induration and tenderness was 1% overall. Phlebitis was reported in

Pregnancy Teratogenic Effects Pregnancy Category B Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose. There are, however, no adequate and well-controlled studies in pregnant women. …

In the case of overdosage, drug concentration would not be reduced by hemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdosage should be symptomatic.

Storage Prior to Reconstitution Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.