Generic

Ceftriaxone

Therapeutic Class

Antibacterial

Pack Size

Rofecin 500 mg IM Injection: Each box contains 1 vial with 1 ampoule containing 2 ml of 1% of Lidocaine solution in Blister Pack.
Rofecin 500 mg IV injection: Each box contains 1 vial with 1 ampoule containing 5 ml of water for injection in Blister Pack.
Rofecin 1 gm IM Injection: Each box contains 1 vial with 1 ampoule containing 3.5 ml of 1% of Lidocaine solution in Blister Pack.
Rofecin 1 gm IV injection: Each box contains 1 vial with 1 ampoule containing 10 ml of water for injection in Blister Pack.
Rofecin 2 gm IV injection: Each box contains 1 vial with 2 ampoules containing 10 ml of water for injection of each in a plastic tray.

Indications

Infections caused by pathogens sensitive to Rofecin® 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 defense mechanisms; - renal and urinary tract infections; - respiratory tract infections, particularly pneumonia, and ear, nose and throat infections; - genital infections, including gonorrhoea. Perioperative prophylaxis of infections.

Therapeutic Class

Antibacterial

Dosage & Administration

Standard dosage Adults and children over 12 years: The usual dosage is 1-2 g of Rofecin® 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. Neonates, infants and children up to 12 years: The following dosage schedules are recommended for once daily administration: Neonates (up to 14 days): A daily dose of 20-50 mg/kg bodyweight, not to exceed 50 mg/kg, on account of the immaturity of the infant’s enzyme systems. It is not necessary to differentiate between premature and term infants. Infants and children (15 days to 12 years): A daily dose of 20-80 mg/kg. For children with bodyweights of 50 kg or more, the usual adult dosage should be used. Intravenous doses of ≥50 mg/kg body weight should be given by infusion over at least 30 minutes. 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 Rofecin® 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 Rofecin® and aminoglycosides has been demonstrated with many gram-negative bacteria 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 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 Rofecin® is recommended. Perioperative prophylaxis: A single dose of 1-2 g depending on the risk of infection of 30-90 minutes prior to surgery. In colorectal surgery, administration of Rofecin® 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 Rofecin® provided hepatic function is intact. Only in cases of preterminal renal failure (creatinine clearance <10 ml/min) should the Rofecin® dosage not exceed 2 g 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. Method of administration : As a general rule the solutions should be used immediately after preparation. Reconstituted solutions retain their physical and chemical stability for six hours at room temperature (or 24 hours at 2°-8°C). The solutions range in colour from pale yellow to amber, depending on the concentration and the length of storage. The colouration of the solutions is of no significance for the efficacy or tolerance of the drug. Intramuscular injection: For i.m. injection, Rofecin® 0.25 g or 0.5 g is dissolved in 2 ml, and Rofecin® 1 g in 3.5 ml, of 1% lidocaine hydrochloride solution and administered by deep intragluteal injection. It is recommended that not more than 1 g be injected at one site. The lidocaine solution must never be administered intravenously. Intravenous injection: For i.v. injection, Rofecin® 0.25 g or 0.5 g is dissolved in 5 ml, and Rofecin® 1 g in 10 ml sterile water for injections, and then administered by i.v. injection lasting two to four minutes. Intravenous infusion: The infusion should last at least 30 minutes. For i.v. infusion, 2 g Rofecin® is dissolved in 40 ml of one of the following calcium-free infusion solutions: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, hydroxy ethyl starch 6-10%, levulose 5%, dextran 6% in dextrose 5%, sterile water for injections. Rofecin® solutions should not be mixed with or piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed above, owing to possible incompatibility.

Contraindications

Ceftriaxone is contraindicated in patients with known hypersensitivity to the cephalosporin class of antibiotics. In patients hypersensitive to penicillin, the possibility of allergic cross-reactions should be borne in mind. Hyperbilirubinaemic newborns and preterm newborns should not be treated with ceftriaxone. In vitro studies have shown that ceftriaxone can displace bilirubin from its binding to serum albumin and bilirubin encephalopathy can possibly develop in these patients. Rofecin® should not be administered concurrently with calcium treatment in newborns because of the risk of precipitation of ceftriaxone-calcium salt

Side Effects

Gastrointestinal complaints (about 2% of cases) : loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis. Hematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia. Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, edema, 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 (two to four minutes) injection. Intramuscular injection without lidocaine solution is painful. ceftriaxone is generally well tolerated. During the use of Rofecin®, the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed:

Precautions

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 Rofecin® therapy . Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals. Pharmaceutical Precaution : A medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you. - Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament. - The doctor and the pharmacist are experts in medicine, its benefits and risks. - Do not repeat the same prescription without consulting your doctor.

Storage Conditions

Store below 30° C. Keep out of reach of children