23 Nov 2011

Rocephin 250mg, (ceftriaxone disodium, hydrated) - United Kingdom

Updated: 23 Nov 2011

Rocephin 250mg, 1g and 2g vials

Ceftriaxone is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible micro-organisms and when parenteral therapy is required: Pneumonia. septicaemia. Meningitis. Bone, skin and soft tissue infections. Infections in neutropenic patients. Gonorrhoea. Peri-operative prophylaxis of infections associated with surgery. Treatment may be started before the results of susceptibility tests are known. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Rocephin 250mg, Description, Presentation and Dosage

Rocephin 250mg, Description

Rocephin 250mg, Drug Class Description

Cephalosporins.

Rocephin 250mg, Drug Description

Each 250mg vial contains 250mg ceftriaxone as 298.3mg hydrated disodium ceftriaxone. Each 1g vial contains 1g ceftriaxone as 1.19g hydrated disodium ceftriaxone. Each 2g vial contains 2g ceftriaxone as 2.39g hydrated disodium ceftriaxone.

Rocephin 250mg, Generic Name

ceftriaxone disodium, hydrated

Rocephin 250mg, Presentation

Rocephin 250mg, Presentation

Powder for solution for injection.

Rocephin 250mg, Manufacturer

Roche Products Limited

Free Medical Education Resources

Rocephin 250mg, Dosage

Rocephin 250mg, Adult Dosage

Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution according to the directions given below. Dosage and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient's condition. Under most circumstances a once-daily dose - or, in the specified indications, a single dose - will give satisfactory therapeutic results.

Adults and children 12 years and over

Standard therapeutic dosage: 1g once daily.

Severe infections: 2 - 4g daily, normally as a single dose every 24 hours.

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of Rocephin 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.

Acute, uncomplicated gonorrhoea: A single dose of 250mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated.

Peri-operative prophylaxis: Usually 1g as a single intramuscular or slow intravenous dose. In colorectal surgery, 2g should be given intramuscularly (dosages greater than 1g should be divided and injected at more than one site), or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.

Elderly

These dosages do not require modification in elderly patients provided that renal and hepatic function are satisfactory (see below).

Renal and hepatic impairment

In patients with impaired renal function, there is no need to reduce the dosage of Rocephin provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance < 10ml per minute) should the daily dosage be limited to 2g or less.

In patients with liver damage there is no need for the dosage to be reduced provided renal function is intact.

In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of Rocephin should be determined at regular intervals and dosage adjusted.

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

Rocephin 250mg, Child Dosage

Neonates, infants and children up to 12 years

The following dosage schedules are recommended for once daily administration:

 

Neonates

A daily dose of 20 - 50mg/kg body weight, not to exceed 50mg/kg. In the neonate, the intravenous dose should be given over 60 minutes to reduce the displacement of bilirubin from albumin, thereby reducing the potential risk of bilirubin encephalopathy (see section 4.4).

 

Infants and children of up to 12 years

Standard therapeutic dosage: 20 - 50mg/kg body weight once daily.

In severe infections up to 80mg/kg body weight daily may be given. For children with body weights of 50kg or more, the usual adult dosage should be used. Doses of 50mg/kg or over should be given by slow intravenous infusion over at least 30 minutes. Doses greater than 80mg/kg body weight should be avoided because of the increased risk of biliary precipitates.

Rocephin 250mg, Precautions, Reactions and Contraindications

Rocephin 250mg, Special Precautions

Rocephin 250mg, Special Precautions

As with other cephalosporins, anaphylactic reactions with fatal outcome were also reported, even if a patient is not known to be allergic or previously exposed.

Before therapy with ceftriaxone is instituted, careful inquiry should be made to determine whether the patient has had any previous hypersensitivity reactions to ceftriaxone, any other cephalosporin, or to any penicillin or other beta-lactam drug. Ceftriaxone is contraindicated in patients who have had a previous hypersensitivity reaction to any cephalosporin. It is also contraindicated in patients who have had a previous immediate and/or any severe hypersensitivity reaction to any penicillin or to any other beta-lactam drug. Ceftriaxone should be given with caution to patients who have had any other type of hypersensitivity reaction to a penicillin or any other beta-lactam drug.

Ceftriaxone should be given with caution to patients who have other allergic diatheses.

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term newborns aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than newborns, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that newborns have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing IV solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used, or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing TPN solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitationIf use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion, considering the advice to flush infusion lines between solutions.

Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including Rocephin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.

An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin. 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.

Antibiotic-associated diarrhoea, colitis and pseudomembranous colitis have all been reported with the use of ceftriaxone. These diagnoses should be considered in any patient who develops diarrhoea during or shortly after treatment. Ceftriaxone should be discontinued if severe and/or bloody diarrhoea occurs during treatment and appropriate therapy instituted.

Ceftriaxone should be used with caution in individuals with a previous history of gastro-intestinal disease, particularly colitis.

As with other cephalosporins, prolonged use of ceftriaxone may result in the overgrowth of non-susceptible organisms, such as enterococci and Candida spp.

In severe renal and hepatic insufficiency, dosage should be reduced according to given recommendations.

Rocephin may precipitate in the gallbladder and then be detectable as shadows on ultrasound. This can happen in patients of any age, but is more likely in infants and small children who are usually given a larger dose of Rocephin on a body weight basis. In children, doses greater than 80mg/kg body weight should be avoided because of the increased risk of biliary precipitates. There is no clear evidence of gallstones or of acute cholecystitis developing in children or infants treated with Rocephin. As the condition appears to be transient and reversible upon discontinuation, therapeutic procedures are not normally indicated.

Shadows, which have been mistaken for gallstones are however, precipitates of calcium ceftriaxone which disappear on completion or discontinuation of Rocephin therapy. Rarely have these findings been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended.

Discontinuation of Rocephin treatment in symptomatic cases should be at the discretion of the physician.

Cephalosporins as a class tend to be absorbed onto the surface of the red cell membranes and react with antibodies directed against the drug to produce a positive Coombs' test and occasionally a rather mild haemolytic anaemia. In this respect, there may be some cross-reactivity with penicillins.

Cases of pancreatitis, possibly of biliary obstruction aetiology, have been rarely reported in patients treated with Rocephin. Most patients presented with risk factors for biliary stasis and biliary sludge, e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor role of Rocephin-related biliary precipitation can not be ruled out.

Safety and effectiveness of Rocephin in neonates, infants and children have been established for the dosages described under Dosage and administration. Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.

During prolonged treatment a complete blood count should be performed at regular intervals.

In case lidocaine is used as a solvent Ceftriaxone solutions should only be used for intramuscular injection.

The stated dosage should not be exceeded.

Each gram of Rocephin contains approximately 3.6mmol sodium. To be taken into consideration by patients on a controlled sodium diet.

Rocephin 250mg, Adverse Reactions

Rocephin 250mg, Adverse Reactions

The most frequently reported adverse events for ceftriaxone are diarrhoea, nausea and vomiting. Other reported adverse events include hypersensitivity reactions such as allergic skin reactions and anaphylactic reactions, secondary infections with yeast, fungi or resistant organisms as well as changes in blood cell counts.

Infections and infestations

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Mycosis of the genital tract.

Superinfections of various sites with yeasts, fungi or other resistant organisms are possible.

Blood and lymphatic system disorders

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Neutropenia, leucopenia, eosinophilia, thrombocytopenia, anaemia (including haemolytic anaemia), slight prolongation of prothrombin time.

Very rare (< 0.01 %) including isolated reports: Positive Coombs' test, coagulation disorders, agranulocytosis (< 500/m3), mostly after 10 days of treatment and following total doses of 20g ceftriaxone and more.

Immune system disorders

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Anaphylactic (e.g. bronchospasm) and anaphylactoid reactions

Nervous system disorders

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Headache, dizziness.

Gastrointestinal disorders

Common (GREATER-THAN OR EQUAL TO (8805) 1% - < 10%): Loose stools or diarrhoea, nausea, vomiting.

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Stomatitis, glossitis. These side effects are usually mild and commonly disappear during treatment or after discontinuation of treatment.

Very rare (< 0.01%) including isolated reports: Pseudomembranous colitis (mostly caused by Clostridium difficile), pancreatitis (possibly caused by obstruction of bile ducts).

Hepato-biliary disorders

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Increase in serum liver enzymes (AST, ALT, alkaline phosphatase).

Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, mostly in patients treated with doses higher than the recommended standard dose. In children, prospective studies have shown a variable incidence of precipitation with intravenous application, in some studies to above 30 %. The incidence seems to be lower with slow infusion (20-30 minutes). This effect is usually asymptomatic, but in rare cases, the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting. Symptomatic treatment is recommended in these cases. Precipitation is usually reversible upon discontinuation of ceftriaxone.

Skin and subcutaneous tissue disorders

Uncommon (GREATER-THAN OR EQUAL TO (8805) 0.1% - < 1%): Allergic skin reactions such as maculopapular rash or exanthema, urticaria, dermatitis, pruritus, oedema.

Very rare (< 0.01%) including isolated reports: Erythema multiforme, Stevens Johnson Syndrome, Lyell's Syndrome/toxic epidermal necrolysis.

Renal and urinary disorders

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Increase in serum creatinine, oliguria, glycosuria, haematuria.

Very rare (< 0.01%) including isolated reports: Renal precipitation, mostly in children older than 3 years who have been treated with either high daily doses (80 mg/kg/day and more) or total doses exceeding 10g and with other risk factors such as dehydration or immobilisation. Renal precipitation is reversible upon discontinuation of ceftriaxone. Anuria and renal impairment have been reported in association.

General disorders and administration site conditions

Rare (GREATER-THAN OR EQUAL TO (8805) 0.01% - < 0.1%): Phlebitis and injection site pain following intravenous administration. This can be minimised by slow injection over at least 2-4 minutes. Rigors, pyrexia.

An intramuscular injection without lidocaine is painful.

Rocephin 250mg, Contraindications

Rocephin 250mg, Contraindications

Hypersensitivity to ceftriaxone or to any of the cephalosporins.

Previous immediate and/or severe hypersensitivity reaction to a penicillin or to any other type of beta-lactam drug.

Rocephin should not be given to neonates with jaundice or to those who are hypoalbuminaemic or acidotic or have other conditions, such as prematurity, in which bilirubin binding is likely to be impaired.

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