Numetrax

Each vial contains: Ceftriaxone Sodium 1 g.

Spectrum of activity: Staphylococcus aureus (including penicillinase producing strains), Staphylococcus epidermidis, Streptococcus pneumonia, Streptococcus group A (Str. pyogenes), Streptococcus group (Str. agalactiae), Streptococcus Viridans, Streptococcus bovis, Aeromonas spp., Alcaligenes Spp., Branhamella catarrhalis, Citrobacter Spp., Enterobacter Spp., Enterobacter Spp., (some strains are resistant), Escherichia coli, Haemophilus ducreyi, Haemophilus influenza (including ampicillin-resistant strains), Haemophilus parainfluenzae, Klebsiella spp. (including KI. Pneumoniae), Moraxella spp., Proteus morgani, Proteus mirabilis, Proteus Vulgaris, Providencia Spp., Neisseria gonorrhoeae (including penicillinase-producing strains), Neisseria meningitides, Plesiomonas shigelloides, Pseudomonas aeruginosa (some strains are resistant), Salmonella Spp. (including S. typhi), Serratia Spp. (including S. marcescens), Shigella spp., Yersinia Spp. (including Y. enterocolitica), Treponema pallidum, Bacteroides spp. (including some strains of B. fragilis), Clostridium Spp. (except Cl. Difficile), Fusobacterium spp (except F. mortiferum and D. varium), Peptococcus spp., Peptostreptococcus spp.
Main indications: Respiratory tract infections such as pneumonia, bronchitis, etc; Ear, nose and throat infections; Renal and Urinary tract infections; Sepsis, meningitis; Perioperative prophylaxis of infections of bones and joints infections of skin, wounds and soft tissue infections of gastrointestinal tract such as Cholecystitis, cholangitis, etc; Genital infections such as gonorrhoea, etc.
Can be used in the following disease infections in patients with impaired defence mechanisms.

Adults and children over twelve years: 1-2 grams of Ceftriaxone sodium is administered once daily intravenously or intramuscularly. In severe cases or infections caused by moderately sensitive organisms, the dosage may be increased up to 4 g once daily.
Neonates (up to 14 days): A daily dose is 20-50 mg/kg bodyweight not to exceed 50 mg/kg. It is not necessary to differentiate between premature and infants born at term.
Infants and children (15 days to twelve years): A daily dose of 20-80 mg/kg for children of 50 kg bodyweight or more, the usual adult dosage should be used. Intravenous dose if 50 mg or more per kg bodyweight should be given by infusion over at least 30 minutes. The recommended dosage for adults.
Elderly patients: The dosages recommended for adults require no modification in the case of geriatric patients.
Meningitis: In bacterial meningitis in infants and children, treatment begins with doses of 100 mg per 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 following duration of therapy has shown to be effective. (See table.)

Click on icon to see table/diagram/image

Gonorrhea: for the treatment of gonorrhoea (penicillinase-producing and non penicillinase-producing strains), a single I.M. dose of 250 mg is recommended.
Perioperative and postoperative prophylaxis: To prevent postoperative infection in contaminated or potentially contaminated surgery. The recommended approach-depending on the risk of infection is a single dose of 1-2 grams administered 30-90 minutes prior to surgery in colorectal surgery. In colorectal surgery, concurrent (but separately administered) administration of the drug with a 5-nitroimidazole (e.g. ornidazole) has proven effective.
Impaired renal and hepatic function: In patients with impaired renal function, there is no need to reduce the dosage of Ceftriaxone provided hepatic function is intact. But in case of preterminal renal failure (creatinine clearance < 10 ml/min) the dosage should not exceed 2 g daily. In patients with liver damage, there is no need for the dosage to be reduced if renal function is intact. In cases of combined severe renal function and hepatic dysfunction, the plasma concentrations of Ceftriaxone should be determined at regular intervals. In patients undergoing dialysis, no additional supplementary dosing is required in the dialysis. Serum concentrations should be monitored. However, to determine whether dosage adjustment is necessary, Since the elimination rate in these patients may be reduced.
Duration of Therapy: The duration of therapy varies according to the recovery from the disease. As with antibiotic therapy in general, administration of the drug should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.
Preparation of Injectable Solution: Intramuscular injection: I.M. injection, 0.25 g or 0.5 g is dissolved in 2 ml, and 1 g in 3.5 ml of 1% Lidocaine Hydrochloride Solution and injected well within the body of a relatively large muscle. It is recommended that not more than 1 g is injected at one site I.M. injection without Lidocaine Solution is painful. The Lidocaine Solution must never be administered intravenously. Intravenous injection: For I.V. injection, 0.25 g or 0.5 g is dissolved in 5 ml, and 1 g in 10 ml Sterile Water for Injection. The intravenous administration should be given over two or four minutes. In case of intravenous infusion, the infusion should last at least 30 minutes. For I.V. infusion, 2 g are dissolved in 40ml of one of the following calcium-free infusion solutions; Sodium Chloride 0.9% , Sodium Chloride 0.45% + Dextrose 2.5% , Dextrose 5%, Dextrose 10%, Dextran 6% in Dextrose 5%, Hydroxy ethyl starch 6~10% infusions and Sterile Water for Injection. The solutions should not be mixed with our piggybacked into solutions containing other antimicrobial drugs or into diluent solutions other than those listed mentioned previously, owing to possible incompatibility. Reconstituted solutions retain their physical and chemical stability for six hours at room temperature of 24 hours at +5˚C. As general rule, However, the solutions should be used immediately after preparation. They range in colour from pale yellow to amber, depending on the concentration and the length of storage. This characteristic of the active ingredient is of no significance for the efficacy or tolerance of the drug. This is for single use only, discard any remaining portion.

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.

Patients with history of shock to Ceftriaxone Sodium.
Patients with hypersensitivity to Cephalosporins.
Patients with hypersensitivity of history of Hypersensitivity to Penicillins.
Patients with hypersensitivity to anilide local anesthetics such as Lidocaine, etc. (in case of I.M. injection).
The product is contraindicated in the following patients as general rule. If necessary, However, it could be administered with caution patients with a history of hypersensitivity to any of the ingredients of this product of other cephalosporin antibiotics.

In order to prevent appearance of the resistant microorganisms, susceptibility should be determined and treatment should be continued only for the minimum period of time required.
In order to predict adverse reaction such as shock, etc. patient history should be taken in detail and skin reaction test should be performed.
Emergency measures have to be available in preparation for occurrence of shock (if anaphylactic shock occurs, intravenous epinephrine has to be followed by a glucocorticoid injection), and even after measures taken the patient should be observed cautiously in stable condition.
It is desirable to perform laboratory test ( hepatic function, renal function, blood etc.) at regular intervals during treatment.
Shadows which have been mistaken for gallstone have been detected on sonograms of the gallbladder, usually following doses higher than the standard recommended dose. These shadows are, However, precipitates of ceftriaxone calcium which disappear on completion or discontinuation of its therapy. Rarely, these findings have been associated with symptoms. In symptomatic cases, conservative non-surgical management is recommended. Discontinuation of its treatment in symptomatic cases should be at the discretion of the clinician.
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.
It is not reported to have adverse effect on a person's ability to drive vehicles or operate machinery.
Careful administrations: Patients with history of drug allergy.
Patients oneself or whose parents, sisters or brothers are prone to suffer from allergic symptoms such as bronchial asthma, exanthema, urticarial, etc.
Patients with severe renal disorder (as the plasma concentration is maintained for a long period of time, decreased dosage or increased interval between treatments are required.
Patients with poor oral or parenteral nutrition patients, elderly patients, patients with poor general conditions (cautious monitoring is required since Vitamin K deficiency may occur).

Pregnancy: Ceftriaxone permeates placenta.
As safety in human pregnancy has not been established, it should not be administered to pregnant women or women bearing potential child unless therapeutic benefit is considered to exceed the possible risk.
Lactation: As the drug is excreted in the breastmilk at low concentration, caution is advised in nursing mothers.
Neonates and Prematures: Safety on neonates and prematures has not been established.
Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin. Special caution should be exercised on the development of bilirubin encephalopathy when considering it for hyperbilirubinemic neonates, especially prematures.

Shock: As shock may rarely occur cautious monitoring is required, and in case that unpleasantness, stridor, dizziness, tenesmus tinnitus, perspiration etc. occur, further administration should be discontinued and appropriate measures taken.
Hypersensitivity: In case exanthema, urticarial, erythema, flare, pruritus, shivering, fever, allergic dermatitis, edema, erythema multiforme, anaphylactic- react occur, further administration should be discontinued and appropriate measures taken. Severe dermal adverse reaction (erythema multiforme). Stevens Johnson syndrome (muco-cutaneo-ocular syndrome). Lyell syndrome (toxic epidermal necrolysis) may rarely occur.
Blood: Occasionally agranulocytosis, granulocytopenia. Eosinophilia thrombocytosis, leukopenia, rarely anemia, haemolytic anemia, thrombocytopenia, prothrombin abnormality may occur.
Liver: Occasionally elevation of AST, ALT, AL-P and symptoms due to precipitation of ceftriaxone calcium salt in gallbladder, rarely elevation of bilirubin, y-GTP may occur.
Kidney: As severe renal disorder such as acute renal insufficiency is reported rarely, cautious monitoring is required and if abnormality is acknowledged further administration should be discontinued and appropriate measures taken. Very rarely precipitation of calcium salt of Ceftriaxone in renal has been observed in children over age 3. Precipitations in renal, which could caused renal insufficiency are symptomatic or asymptomatic. These effects resolved following discontinuance of the drug. In above case, high dosage (over 10 g/day) was administered to a patient who had a risk factor such as medicated over daily dosage, restricted water intake and mainly lay sick in bed.
GI system: rarely severe enterocolitis with hemaseca such pseudomembranous enterocolitis may occur. If abdominal pain and frequent diarrhea occur, appropriate measure such as immediate discontinuation of Ceftriaxone, should be taken. Also occasionally nausea, vomiting, loose stools, diarrhea or rarely abdominal pain, anorexia, etc. may occur.
Respiratory system: Since interstitial pneumonia, PE syndrome, etc. accompanied with fever, cough, dyspnea, abnormal chest x-ray, eosinophilia, etc., may rarely occur. With other cephems, in case that such symptoms occur further administration should be discontinued and appropriate measures such as administration of corticosteroids, etc. should be taken.
Superinfection: rarely stomatitis, candidiasis may occur.
Vitamin deficiency: rarely symptoms of vitamin K deficiency (hypoprothrombinemia, hemorrhage tendency, etc.) and vitamin B deficiency (glossitis, stomatitis, anorexia, neuritis, etc.) may occur.
Others: Occasionally headache and rarely vertigo, edema, precipitation in gallbladder, ventricular extrasystole, elevation of creatinine and mycosis in genital organ, etc.
Patient should seek medical attention immediately at the first sign of any adverse drug reaction. For suspected adverse drug reaction, report to the FDA.

Drug interactions: Cautious treatment is required as renal insufficiency may be worsened with combination of similar compounds (other cephalosporin antibiotics) and diuretics such as furosemide, etc.
Synergy between ceftriaxone and aminoglycosides has been demonstrated with many gram-negative bacilli under experimental conditions and it is of special importance in sever 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. There is no evidence that ceftriaxone increases renal toxicity of aminoglycosides.
No effect similar to that of disulfiram has been demonstrated after ingestion of alcohol subsequent to the administration of ceftriaxone.
The elimination of the drug is not altered by probenecid.
Ceftriaxone does not contain N-methylthiotetrazole moiety associated with possible ethanol intolerance and bleeding problems of certain other cephalosporins.
In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone.
Interference with laboratory test: Caution should be taken as urine glucose test using Benedict's reagent, Fehling's reagent, clinitest, except for test-tape reaction, may give false positive results.
Caution should be taken as direct Coombs-test may give false positive results.
Ceftriaxone, like other antibiotics, may result in false positive tests for galactosemia.

Precautions on application: As vascular pain, venous thrombosis, flushing, nausea, vomiting may rarely occur by large intravenous dose, caution should be taken on preparation of injectable solution, site of injection, method of administration, etc., and injection should be given as slowly as possible (I.V. injection).
Ceftriaxone should be used immediately after reconstitution. Particularly, caution should be taken when dissolving in glutathione preparation or high concentration amino acid solution.
Incompatibility: Calcium containing solutions or with aminoglycosides, fluconazole, vancomycin or amsacrine.

Store at temperatures not exceeding 30°C.

Cephalosporins

J01DD04 - ceftriaxone ; Belongs to the class of third-generation cephalosporins. Used in the systemic treatment of infections.

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