Auroxone uses, side effects and dosage

Description and composition of Auroxone

Auroxone is a third generation cephalosporin antibacterial antibiotic. It is therefore used for the treatment of susceptible bacterial infections.

It contains ceftriaxone as its active ingredient. It also contains other inactive ingredients in sufficient quantities.

Pharmacology

Auroxone is a bactericidal antibiotic with broad-spectrum activity against Gram-positive and Gram-negative bacteria.

Ceftriaxone causes bacterial cell death by inhibiting cell-wall synthesis.

Ceftriaxone reaches peak plasma concentrations 2-3 hours after a single intramuscular injection and approx. 30 minutes after an intravenous infusion.

Elimination is via the kidneys and bile, with a half-life of approx. 8 hours. Lidocaine is present in the solvent for intramuscular injection to help minimize pain.

Uses of Auroxone

  • Auroxone is used for the treatment of serious and of course susceptible bacterial infections in septicaemia, pneumonia, and meningitis.
  • It is also used in the following disease conditions:
    • Osteomyelitis, septic arthritis;
    • Haemophilus influenzae epiglottis.
    • Surgical prophylaxis.
    • Prophylaxis of meningococcal meningitis.
    • Shigellosis, invasive salmonellosis.
    • Endocarditis.
    • Gonococcal conjunctivitis;
    • Gonorrhoea;
    • Pelvic inflammatory disease.
    • Lyme disease

Dosage of Auroxone

Adult dose

Infections due to susceptible organisms, by deep IM injection, by IV injection (over at least 2-4 minutes) or by IV infusion,

  • 1 g daily; severe infections 2-4 g daily.

Uncomplicated gonorrhoea and gonococcal conjunctivitis, by deep IM injection,

  • 125 mg as a single dose (also used with doxycycline and metronidazole to treat pelvic inflammatory disease).

Disseminated gonococcal infection, by deep IM injection or by IV injection,

  • 1 g daily for 7 days.

Surgical prophylaxis, by deep IM injection or by IV injection (over at least 2-4 minutes),

  • 1 g at induction.

Colorectal surgery (with antibacterial active against anaerobes), by deep IM injection or by IV injection (over at least 2-4 minutes), or by IV infusion,

  • 2 g as a single dose

Child dose

Infections due to susceptible organisms, by deep IM injection, by IV injection (over at least 2-4 minutes) or by IV infusion,

  • Infant and child under 50 kg
    • 20-50 mg/kg daily; up to 80 mg/kg daily in severe infections (doses of 50 mg/kg and over by IV infusion only); by IV infusion (over 60 minutes),
  • Neonates
    • 20-50 mg/kg daily (maximum 50 mg/kg daily).

Neonatal gonococcal conjunctivitis, by IM injection,

  • Neonate 50 mg/kg as a single dose (maximum 125 mg).

Dosage in renal impairment

Renal impairment: CrCl <10 mL/min and dialysis patients: max. daily dose is 2 g.

How to administer Auroxone

For Intramuscular or Intravenous administration.

  • Administer by deep IM injection into large mass muscle.
  • Intramuscular doses over 1 g divided between more than one site.
  • Do not administer the intramuscular formulation intravenously because it contains lidocaine.
  • Check injection site for induration, sterile abscess and tissue sloughing; change site every 3 days.
  • Administer by slow IV injection (over at least 2-4 minutes) or by intermittent IV infusion (over 30 mins).
  • Give IV after diluting in NS, D5W, or sterile H20 for injection.
  • Intravenous doses greater than or equal to 50 mg/kg body-weight in infants and children up to 12 years of age should be given by slow infusion over at least 30 minutes.
  • In neonates, administer intravenous doses over 60 minutes to reduce the potential risk of bilirubin  encephalopathy (see also under Contra-indications below).
  • Do not admix with aminoglycosides in same bottle/bag.
  • Avoid use with calcium-containing diluents or infusions for intravenous use e.g., Ringer’s solution (may cause the formation of a ceftriaxone-calcium precipitate).

Contraindications of Auroxone

Auroxone is contraindicated in the following conditions:

  • Hypersensitivity to ceftriaxone, any of the excipients, or any cephalosporin.
  • Hypersensitivity to lidocaine and other lidocaine contraindications (for intramuscular injection).
  • History of immediate and/or severe hypersensitivity to penicillin or any beta-lactam antibiotics.
  • Pseudomembranous colitis.
  • Severe cardiac conduction disturbances.
  • Acute decompensated heart failure.
  • Premature neonates.
  • Neonates with hyperbilirubinemia (as it may displace bilirubin from serum albumin).
  • Neonates (≤28 days) who require/are expected to require treatment with calcium-containing preparations.
  • Pregnancy (intramuscular formulation).

Precautions

Observe precaution while using ceftran if any of these is true.

  • Sensitivity to beta-lactam antibacterials (avoid if history of immediate hypersensitivity reaction).
  • Risk factors for cholestasis and biliary sludge.
  • Severe renal impairment.
  • Concurrent treatment with aminoglycosides and diuretics.
  • Hepatic impairment if accompanied by renal impairment.
  • Treatment longer than 14 days, renal failure, dehydration or concomitant total parenteral nutrition-risk of substances) and false positive Coombs’ test.
  • Lidocaine precautions:
  • Elderly patients, poor general health, atrioventricular block, severe liver disease, ceftriaxone precipitation in gallbladder.
  • False positive urinary glucose (if tested for reducing severe renal failure
  • Pregnancy (intravenous formulation)

Auroxone in Pregnancy and lactation

Ceftriaxone is recommended as safe for use during pregnancy and lactation as no teratogenic risk or significant adverse effects in the breastfeeding infants have been associated with it. 

Interactions of Auroxone with other drugs

  • Aminoglycosides (monitor renal function).
  • Calcium-containing diluents or infusions for intravenous use e.g., Ringer’s solution (may cause the formation of a ceftriaxone-calcium precipitate).
  • Vitamin K antagonists (may increase the risk of bleeding).
  • Interactions with the lidocaine present in the solvent for intramuscular injection: – CYP1A2 and CYP3A4 inhibitors (may inhibit lidocaine metabolism)
  • Antiarrhythmics e.g., mexiletine, tocainide (may increase risk of toxicity)
  • Muscle relaxants (may increase the effects of muscle relaxants).

Side effects of Auroxone

The following are some side effects of Auroxone.

  • Diarrhoea, nausea and vomiting, abdominal discomfort, headache;
  • Antibiotic-associated colitis (particularly with higher doses);
  • Allergic reactions including rashes, pruritus, urticaria, serum sickness-like reactions, fever and arthralgia, and anaphylaxis;
  • Erythema multiforme, toxic epidermal necrolysis reported;
  • Transient hepatitis and cholestatic jaundice;
  • Eosinophilia and blood disorders (including thrombocytopenia, leukopenia, agranulocytosis, aplast anaemia, and haemolytic anaemia);
  • Reversible interstitial nephritis, hyperactivity, nervousness, sleep disturbances, confusion, hypertonia and dizziness;
  • Calcium ceftriaxone precipitates in urine (particularly in very young, dehydrated, or those who are immobilized) or in gall bladder-consider discontinuation if symptomatic;
  • Rarely prolongation of prothrombin time, pancreatitis.

Please always report serious side effects to your doctor.

How to store Auroxone

  • Unopened Auroxone: Do not store above 25°C.
  • Protect from light after reconstitution
  • Store at 2-8°C in a fridge.
  • For reconstituted solutions, chemical and physical in-use stability are about eight hours at 25°C and 24 hours at 4°C.
  • From a microbiological standpoint, once opened, the product should be used immediately.
  • If not used immediately, in-use storage times and conditions prior to use would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place under strict aseptic conditions