Ceftriaxone for Injection USP 1000 mg

Ceftriaxone is indicated in 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.
Ceftriaxone may be used:
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.
In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.
Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Adults and children over twelve years
The usual dosage is 1-2 g of ceftriaxone administered once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, administered once daily.
Elderly patients
The dosages recommended for adults require no modification in the case of geriatric patients.

Ceftriaxone is generally well tolerated. During the use of ceftriaxone, the following side effects, which were reversible either spontaneously or after withdrawal of the medicine, have been observed:
Systemic side effects
Gastrointestinal complaints (about 2% of cases): loose stools or diarrhoea, nausea, vomiting, stomatitis and glossitis.
Haematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia.
Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, oedema, erythema multiforme.
Other, rare side effects: headache and dizziness, increase in liver enzymes, jaundice and hepatitis, symptomatic precipitation of the calcium salt of ceftriaxone in the gallbladder, oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactic or anaphylactoid reactions and secondary infection.
Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects. Pancreatitis and Steven Johnson Syndrome have also been reported as very rare side effects.
Local side effects: Phlebitis at the site of injection and cutaneous vasculitis may occur. These may be minimized by slow (two to four minutes) injection of the substance.
Intramuscular injection without lidocaine solution is painful.

Hypersensitivity reactions may occur in susceptible individuals.
As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures.
Hepatitis and hepatocellular injury:
Cases of hepatitis and hepatocellular injury with or without jaundice have been observed during ceftriaxone therapy and may occur early in the treatment period and independently of cholelithiasis. Patients should be advised to report immediately any symptoms suggestive of liver injury.
Antibiotic associated pseudomembranous colitis:
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including ceftriaxone. A toxin produced by Clostridium difficile appears to be the primary cause. The severity of the colitis may range from mild to life threatening. It is important to consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine, may prolong and/or worsen the condition and should not be used.
Other causes of colitis should be considered.
Therefore, it is important to consider this diagnosis in patients who present with diarrhoea subsequent to the administration of antibacterial agents.
Superinfections with non-susceptible microorganisms may occur as with other antibacterial agents.
Immune mediated haemolytic anaemia:
Immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials. Severe cases of haemolytic anaemia, including fatalities, have been reported during treatment in both adults and children. If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.
Alterations in clotting time:
Alterations in prothrombin times have occurred rarely in patients treated with ceftriaxone. Patients with impaired vitamin K synthesis or low vitamin K stores (e.g. chronic hepatic disease and malnutrition) may require monitoring of prothrombin time during ceftriaxone treatment. Vitamin K administration (10 millgram weekly) may be necessary if the prothrombin time is prolonged before or during therapy. During prolonged treatment the blood profile should be checked at regular intervals.
Interactions with calcium-containing products:
There are no reports to date of intravascular or pulmonary precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing IV solutions. However, the theoretical possibility exists for an interaction between ceftriaxone and calcium-containing IV solutions in patients other than neonates. Therefore, ceftriaxone and calcium-containing solutions, including continuous calcium containing infusions such as parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites.
As a further theoretical consideration and based on 5 half-lives of ceftriaxone, calcium- containing IV solutions and ceftriaxone should not be administered within 48 hours of each other, in any patient.
No data are available on the potential interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (IV or oral).

Unopened: Store below 30°C temperature. Protect from light.
After reconstitution: The reconstituted solution to be used immediately. If not used, can be stored for 24 hours at 2 – 8°C in aseptic condition. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Keep the medicine out of reach of children.

WAYXON-1g is supplied in glass vials closed with a rubber stopper and a flip-off cap. Such 01 vial packed a carton with diluent (water for injection USP, 10 ml plastic ampoule) and pack insert.