Frixon

Frixon® 500 mg i.v./i.m. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg.

Frixon® 1 gram i.v./i.m. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 gram.

Frixon® 2 gram i.v. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 2 gram.

Frixon® Solvent for parenteral use: The solvent ampoule for i.m. injection contains 1% lidocaine hydrochloride solution & for i.v. injection sterile water for injections.

The bactericidal activity of ceftriaxone results from inhibition of bacterial cell wall synthesis. Ceftriaxone exerts in-vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ceftriaxone is highly stable to most b-lactamases, both penicillinases and cephalosporinases, of gram-positive and gram-negative bacteria. Ceftriaxone is usually active against the following microorganisms in vitro and in clinical infections (see Indications and usage.):

Gram-positive aerobes:

◆ Staphylococcus aureus (Including penicillancase Producing strains), ◆ Staphylococci epidermis, ◆ Streptococcus pneumoniae, ◆ Streptococcus group A (Str. pyogenes), ◆ Streptococcus group B (Str. agalactiae), ◆ Streptococcus viridans, ◆ Streptococcus bovis.

Gram-negative aerobes:

◆ Aeromonas spp., ◆ Alcaligenes spp., ◆ Branhamella catarrhalis (ꞵ-lactamase negative and positive), ◆ Citrobacter spp., ◆ Enterobacter spp. (some strains are resistant), ◆ Escherichia coli, ◆ Haemophilus ducreyi, ◆ Haemophilus influenzae (including penicillinase-producing strains), ◆ Haemophilus parainfluenzae (including penicillinase-producing strains), ◆ Klebsiella spp. (including Kl. pneumoniae), ◆ Moraxella spp., ◆ Morganella morganii, ◆ Neisseria gonorrhoeae (including penicillinase-producing strains), ◆ Neisseria meningitidis, ◆ Plesiomonas shigelloides, ◆ Proteus mirabilis, ◆ Proteus vulgaris, ◆ Providencia spp., ◆ Pseudomonas aeruginosa (some strains are resistant), ◆ Salmonella spp. (including S. typhi), ◆ Serratia spp. (including S. marcescens), ◆ Shigella spp., ◆ Vibrio spp. (including V. cholerae), ◆ Yersinia spp. (including Y. enterocolitica).

Infections caused by pathogens sensitive to Frixon®, e.g.: ◆ Sepsis, ◆ Meningitis, ◆ Abdominal infections (peritonitis, infections of the biliary and gastrointestinal tracts), ◆ Infections of the bones, joints, soft tissue, skin and of wounds, ◆ Infections in patients with  impaired defence mechanisms, ◆ Renal & urinary tract infections, ◆ Respiratory tract infections, particularly pneumonia, & ear, nose and throat infections, ◆ Genital infections, including gonorrhoea, ◆ Perioperative prophylaxis of infections.

Route of administration: Parenteral

Standard dosage

Adults and children over 12 years: The usual dosage is 1-2 g of Frixon® once daily (every 24 hours). In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 g, once daily.

Elderly patients: The dosages recommended for adults require no modification in the case of geriatric patients.

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of Frixon® should be continued for a minimum of 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

Combination therapy

Synergy between ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacilli under experimental conditions. Although enhanced activity of such combinations is not always predictable, It should be considered in severe, life threatening infections due to microorganisms such as Pseudomonas aeruginosa. Because of physical incompatibility the two drugs must be administered separately at the recommended dosages.

Special dosage instructions

Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg/kg (not to exceed 4 g) once daily. As soon  as the causative organism has been identified and its sensitivity determined, the dosage can be reduced accordingly. The best results have been found with the following duration of therapy:

Neisseria meningitidis                                          4 days

Haemophilus influenzae                                       6 days

Streptococcus pneumoniae                                  7 days

Susceptible Enterobacteriaceae                           10-14 days

Lyme borreliosis: 50 mg/kg up to a maximum of 2 g in children and adults, once daily for 14 days.

Gonorrhoea (penicillinase-producing and nonpenicillinase-producing strains): For the treatment, a single i.m. dose of 250 mg Frixon® is recommended.

Perioperative prophylaxis: A single dose of 1-2 gram depending on the risk of infection of 30-90 minutes prior to surgery. In colorectal surgery, administration of Frixon® with or without a 5-nitroimidazole, e.g. ornidazole (separate administration, see Method of administration) has been proven effective.

Impaired renal and hepatic function: In patients with impaired renal function, there is no need to reduce the dosage of Frixon® provided hepatic function is intact. Only in cases of preterminal renal failure (creatinine clearance <10 ml/min) should the Frixon® dosage not exceed 2 gram daily. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact.

In patients with both severe renal and hepatic dysfunction, the plasma concentrations of Ceftriaxone should be determined at regular intervals and if necessary the dose should be adjusted.

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Plasma concentrations should , however, be monitored, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be altered.

Frixon® is generally well tolerated. During the use of Frixon®, the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed:

Systemic side-effects

Neuropsychiatric symptom such as convulsion.

Gastrointestinal complaints (about 2% of cases): Loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.

Hematological changes (about 2%): Eosinophilia, leukopenia, granulocytopenia, hemolytic anemia and thrombocytopenia.

Skin reactions (about 1%):

exanthema, allergic dermatitis, pruritus, urticaria, edema and erythema multiforme.

Other rare side-effects:

headache and dizziness, increase in liver enzymes, gallbladder sludge, oliguria, increase in serum creatinine, mycosis of the genital tract, shivering and anaphylactic or anaphylactoid reactions. Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects.

Local side-effects:

In rare cases, phlebitic reactions occurred after i.v. administration. These may be minimized by slow (2-4 minutes) injection. Intramuscular injection without lidocaine solution is painful.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. In-vitro studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Cautions should be exercised when considering Frixon® for hyperbilirubinemic neonates, especially prematures. During prolonged treatment the blood picture should be checked at regular intervals.

a) With Medicine: No impairment of renal function has so far been observed after concurrent administration of large doses of Ceftriaxone and potent diuretics (e.g. Furosemide). There is no evidence that Frixon® increases renal toxicity of aminoglycosides. No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of Frixon®. Ceftriaxone does not contain an N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins. The elimination of Frixon® is not altered by probenecid.

b) With food & others: No

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.

Store below 30º C.

Frixon® i.m. injection

Frixon® 500 mg i.m. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg, 1 ampoule containing 2 ml of 1% lidocaine solution. It also contains a complementary pouch comprised of 1 sterile disposable syringe (5 ml), 1 baby needle, 1 alcohol pad, 1 first aid bandage.

Frixon® 1 gram i.m. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 gram, 1 ampoule containing 3.5 ml of 1% lidocaine solution. It also contains a complementary pouch comprised of 1 sterile disposable syringe (5 ml), 1 disposable needle, 1 alcohol pad, 1 first aid bandage.

Frixon® i.v. injection

Frixon® 500 mg i.v. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg, 1 ampoule containing 5 ml of sterile water for injections. It also contains a complementary pouch comprised of 1 sterile disposable syringe (5 ml), 1 scalp vein set, 1 alcohol pad, 1 first aid bandage.

Frixon® 1 gram i.v. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 gram, 1 ampoule containing 10 ml of sterile water for injections. It also contains a complementary pouch comprised of 1 sterile disposable syringe (10 ml), 1 scalp vein set, 1 alcohol pad, 1 first aid bandage.

Frixon® 2 gram i.v. injection: Each vial contains Ceftriaxone Sodium USP equivalent to Ceftriaxone 2 gram, 2 ampoules containing 10 ml of sterile water for injections. It also contains a complementary pouch comprised of 1 sterile disposable syringe (20 ml), 1 scalp vein set, 1 alcohol pad, 1 first aid bandage.