GENERIC NAME OF THE MEDICINAL PRODUCT:

Ceftriaxone for Injection 0.25g (Ceftrataj 250mg)
Ceftriaxone for Injection 0.5g (Ceftrataj 500mg)
Ceftriaxone for Injection 1g (Ceftrataj 1000mg)
Ceftriaxone for Injection 2g (Ceftrataj 2000mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Each vial contains Ceftriaxone Sodium IP
Equivalent to Ceftriaxone Anhydrous 250mg
b) Each vial contains Ceftriaxone Sodium IP
Equivalent to Ceftriaxone Anhydrous 500mg
c) Each vial contains Ceftriaxone Sodium IP
Equivalent to Ceftriaxone Anhydrous 1000mg
d) Each vial contains Ceftriaxone Sodium IP
Equivalent to Ceftriaxone Anhydrous 2000mg

THERAPEUTIC INDICATIONS:

Ceftriaxone injection is used to treat infections of the brain (meningitis), the abdomen and abdominal wall (peritonitis), the urinary tract, bones and the skin or soft tissues, the blood. It can also be given to treat specific sexually transmitted infections (gonorrhoea and syphilis), to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection, to treat infections of the chest in adults, to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.

DIRECTION OF USE:

Reconstitute using 10ml of sterile water for injection IP.
Reconstituted solution should be used immediately after preparation.
Read enclosed leaflet before Reconstitution and use

CAUTION & SCHEDULE:

CAUTION: KEEP OUT OF REACH OF CHILDREN.
*NOT TO BE SOLD WITHOUT WATER FOR INJECTION.
To be sold by the retail on the prescription of a registered medical practitioner only.
SCHEDULE H1 DRUG: It is dangerous to take this preparation except in accordance with the medical advice. Not to be sold by retail without the prescription of 'Registered Medical Practitioner'.

STORAGE & DOSAGE:

STORAGE: Store below 25°C. Protect from light. Do not freeze.
DOSAGE: As directed by Physician.

Ceftriaxone Injection IP 1000mg (Ceftrataj) Taj Pharma

Overview

INTRODUCTION OF CEFTRATAJ POWDER FOR INJECTION

Ceftrataj 1000 mg Injection is an antibiotic belonging to the cephalosporin group, which is used to treat bacterial infections in your body. It is effective in infections of the brain (e.g., meningitis), lungs (e.g., pneumonia), ear, urinary tract, skin & soft tissues, bones & joints, blood and heart.

Ceftrataj 1000 mg Injection is also used to prevent infections after surgery. It fights the infection by killing bacteria. This helps to improve your symptoms and cure the underlying infection. It is given as a drip (intravenous infusion) or as an injection directly into a vein or a muscle under the supervision of a healthcare professional. Your doctor will decide the correct dose for you. You should use this medicine regularly at evenly spaced intervals as per the schedule prescribed by your doctor. Do not skip any doses and finish the full course of treatment even if you feel better. Stopping the medicine too early may lead to the infection returning or worsening.

The most common side effects of this medicine include diarrhea, rash, and changes in liver function tests and blood counts. Some people may develop temporary redness or pain at the site of injection. These side effects are usually mild but let your doctor know if they bother you or last more than a few days.

Before taking it, you should let your doctor know if you are allergic to any antibiotics or have any kidney or liver problems. You should also let your healthcare team know all other medicines you are taking as they may affect, or be affected by this medicine. Pregnant and breastfeeding women should consult their doctor before using it.

USES OF CEFTRATAJ POWDER FOR INJECTION

  • Bacterial infections

CEFTRATAJ POWDER FOR INJECTION SIDE EFFECTS

Common
  • Rash
  • Abnormal liver function tests
  • Diarrhea

HOW TO USE CEFTRATAJ POWDER FOR INJECTION

Your doctor or nurse will give you this medicine. Kindly do not self administer.

HOW CEFTRATAJ POWDER FOR INJECTION WORKS

Ceftrataj 1000 mg Injection is an antibiotic. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive.

CEFTRATAJ POWDER FOR INJECTION RELATED WARNINGS

warnings

Alcohol

SAFE
Consuming alcohol with Ceftrataj 1000 mg Injection does not cause any harmful side effects.
warnings

Pregnancy

SAFE IF PRESCRIBED
Ceftrataj 1000 mg Injection is safe to use during pregnancy. Most studies have shown low or no risk to the developing baby.
warnings

Lactation

CAUTION
Ceftrataj 1000 mg Injection should be used with caution during breastfeeding. Breastfeeding should be held until the treatment of the mother is completed and the drug is eliminated from her body.
warnings

Driving

UNSAFE
Ceftrataj 1000 mg Injection may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur.
warnings

Kidney

SAFE IF PRESCRIBED
Ceftrataj 1000 mg Injection is safe to use in patients with kidney disease. No dose adjustment of Ceftrataj 1000 mg Injection is recommended.
However, inform your doctor if you have any underlying kidney disease.
warnings

Liver

CAUTION
Ceftrataj 1000 mg Injection should be used with caution in patients with severe liver disease. Dose adjustment of Ceftrataj 1000 mg Injection may be needed. Please consult your doctor.
Dose adjustment of Ceftrataj 1000 mg Injection is not recommended in patients with mild to moderate liver disease.

WHAT IF YOU MISS A DOSE OF CEFTRATAJ POWDER FOR INJECTION?

If you miss a dose of Ceftrataj 1000 mg Injection, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Ceftriaxone 0.5g and 1g powder for solution for injection or infusion (Ceftrataj) Taj Pharma

  1. Name of the medicinal product

Ceftriaxone 0.5g powder for solution for injection or infusion

Ceftriaxone 1g powder for solution for injection or infusion

  1. Qualitative and quantitative composition

Each vial contains 0.595g Ceftriaxone sodium equivalent to 0.5g Ceftriaxone

Each vial contains 1.19g Ceftriaxone sodium equivalent to 1g Ceftriaxone

  1. Pharmaceutical form

Powder for solution for injection or infusion

A white or almost white powder

  1. Clinical particulars

4.1 Therapeutic indications

Ceftriaxone is indicated for the treatment of the following infections in adults and children including term neonates (from birth):

  • Bacterial Meningitis
  • Community acquired pneumonia
  • Hospital acquired pneumonia
  • Acute otitis media
  • Intra-abdominal infections
  • Complicated urinary tract infections (including pyelonephritis)
  • Infections of bones and joints
  • Complicated skin and soft tissue infections
  • Gonorrhoea
  • Syphilis
  • Bacterial endocarditis

Ceftriaxone may be used:

  • For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults
  • For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age.
  • For Pre-operative prophylaxis of surgical site infections.
  • In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection.
  • In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above.

Ceftriaxone should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration

Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.

Adults and children over 12 years of age (≥ 50 kg)

Ceftriaxone Dosage*Treatment frequency**Indications
1-2 gOnce dailyCommunity acquired pneumonia
Acute exacerbations of chronic obstructive pulmonary disease
Intra-abdominal infections
Complicated urinary tract infections (including pyelonephritis)
2 gOnce dailyHospital acquired pneumonia
Complicated skin and soft tissue infections
Infections of bones and joints
2-4 gOnce dailyManagement of neutropenic patients with fever that is suspected to be due to a bacterial infection
Bacterial endocarditis
Bacterial meningitis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:

Acute otitis media

A single intramuscular dose of Ceftriaxone 1-2 g can be given.

Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.

Pre-operative prophylaxis of surgical site infections

2 g as a single pre-operative dose.

Gonorrhoea

500 mg as a single intramuscular dose.

Syphilis

The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

2 g once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Paediatric population

Neonates, infants and children 15 days to 12 years of age (< 50 kg)

For children with bodyweight of 50 kg or more, the usual adult dosage should be given.

Ceftriaxone Dosage*Treatment frequency**Indications
50-80 mg/kgOnce dailyIntra-abdominal infections
Complicated urinary tract infections (including pyelonephritis)
Community acquired pneumonia
Hospital acquired pneumonia
50-100 mg/kg (Max 4 g)Once dailyComplicated skin and soft tissue infections
Infections of bones and joints
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
80-100 mg/kg (max 4 g)Once dailyBacterial endocarditis
100 mg/kg (max 4 g)Once dailyBacterial meningitis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

Pre-operative prophylaxis of surgical site infections

50-80 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

50–80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Neonates 0-14 days

Ceftriaxone is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Ceftriaxone Dosage*Treatment frequencyIndications
20-50 mg/kgOnce dailyIntra-abdominal infections
Complicated skin and soft tissue infections
Complicated urinary tract infections (including pyelonephritis)
Community acquired pneumonia
Hospital acquired pneumonia
Infections of bones and joints
Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
50 mg/kgOnce dailyBacterial meningitis
Bacterial endocarditis

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

A maximum daily dose of 50 mg/kg should not be exceeded.

Indications for neonates 0-14 days that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Ceftriaxone 50 mg/kg can be given.

Pre-operative prophylaxis of surgical site infections

20-50 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 – 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.

Older people

The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.

Patients with hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.

There are no study data in patients with severe hepatic impairment (see section 5.2).

Patients with renal impairment

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.

Patients with severe hepatic and renal impairment

In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.

Method of administration

Ceftriaxone can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4.3 and 4.4).

Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site. Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.

If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered.

Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).

Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to ceftriaxone or to any other cephalosporin.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated in:

Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)*

Full-term neonates (up to 28 days of age):

– with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired*

– if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt (see sections 4.4, 4.8 and 6.2).

*In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients.

Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4). See information in the Summary of Product Characteristics of lidocaine, especially contraindications.

Ceftriaxone solutions containing lidocaine should never be administered intravenously.

4.4 Special warnings and precautions for use

Hypersensitivity reactions

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis) have been reported; however, the frequency of these events is not known (see section 4.8).

Interaction with calcium containing products

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates 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 neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that neonates 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 intravenous 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 total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitationIf the 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, and the infusion lines flushed between solutions (see sections 4.3, 4.8, 5.2 and 6.2).

Paediatric population

Safety and effectiveness of Ceftriaxone in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.

Ceftriaxone is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).

Immune mediated haemolytic anaemia

An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Ceftriaxone (see section 4.8). Severe cases of haemolytic anaemia, including fatalities, have been reported during Ceftriaxone 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.

Long term treatment

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

Colitis/Overgrowth of non-susceptible microorganisms

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone (see section 4.8).

Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

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

Severe renal and hepatic insufficiency

In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).

Interference with serological testing

Interference with Coombs tests may occur, as Ceftriaxone may lead to false-positive test results. Ceftriaxone can also lead to false-positive test results for galactosaemia (see section 4.8).

Non-enzymatic methods for the glucose determination in urine may give false-positive results. Urine glucose determination during therapy with Ceftriaxone should be done enzymatically (see section 4.8).

Sodium

Each gram of Ceftriaxone contains 3.6 mmol sodium. This should be taken into consideration in patients on a controlled sodium diet.

Antibacterial spectrum

Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections, where suspected pathogens include organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered.

Use of lidocaine

In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection. Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously.

Biliary lithiasis

When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone. Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1 g per day and above. Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy. Rarely precipitates of calcium ceftriaxone have been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).

Biliary stasis

Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with ceftriaxone (see section 4.8). 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 of ceftriaxone-related biliary precipitation cannot be ruled out.

Renal lithiasis

Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.

4.5 Interaction with other medicinal products and other forms of interaction

Calcium-containing diluents, such as Ringer’s solution or Hartmann’s solution, should not be used to reconstitute Ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see sections 4.2, 4.3, 4.4, 4.8 and 6.2).

Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone (see section 4.8).

There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.

In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown.

There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).

In patients treated with ceftriaxone, the Coombs’ test may lead to false-positive test results.

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.

No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).

Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.

4.6 Fertility, pregnancy and lactation

Pregnancy

Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.

Breastfeeding

Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Reproductive studies have shown no evidence of adverse effects on male or female fertility.

4.7 Effects on ability to drive and use machines

During treatment with ceftriaxone, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machinery.

4.8 Undesirable effects

The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.

Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.

The following convention has been used for the classification of frequency:

Very common (≥ 1/10)

Common (≥ 1/100 – < 1/10)

Uncommon (≥ 1/1000 – < 1/100)

Rare (≥ 1/10000 – < 1/1000)

Not known (cannot be estimated from the available data)

System Organ ClassCommonUncommonRareNot Knowna
Infections and infestationsGenital fungal infectionPseudo-membranous colitisbSuperinfectionb
Blood and lymphatic system disordersEosinophilia

Leucopenia

Thrombocytopenia

Granulocytopenia

Anaemia

Coagulopathy

Haemolytic anaemiab

Agranulocytosis

Immune system disordersAnaphylactic shock

Anaphylactic reaction

Anaphylactoid reaction

Hypersensitivityb

Nervous system disordersHeadache

Dizziness

Convulsion
Ear and labyrinth disordersVertigo
Respiratory, thoracic and mediastinal disordersBronchospasm
Gastrointestinal disordersDiarrhoeab

Loose stools

Nausea

Vomiting

Pancreatitisb

Stomatitis

Glossitis

Hepatobiliary disordersHepatic enzyme increasedGall bladder precipitationb

Kernicterus

Skin and subcutaneous tissue disordersRashPruritusUrticariaStevens Johnson Syndromeb

Toxic epidermal necrolysisb

Erythema multiforme

Acute generalised exanthematous pustulosis

Renal and urinary disordersHaematuria

Glycosuria

Oliguria

Renal precipitation (reversible)

General disorders and administration site conditionsPhlebitis

Injection site pain

Pyrexia

Oedema

Chills

InvestigationsBlood creatinine increasedCoombs test false positiveb

Galactosaemia test false positiveb

Non enzymatic methods for glucose determination false positiveb

  1. Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
  2. See section 4.4

Infections and infestations

Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see section 4.4).

Ceftriaxone-calcium salt precipitation

Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4, and 5.2).

Cases of renal precipitation have been reported, primarily in children older than 3 years of age and who have been treated with either high daily doses (e.g. ≥ 80 mg/kg/day) or total doses exceeding 10 grams and who presented with other risk factors (e.g. fluid restrictions or confinement to bed). The risk of precipitate formation is increased in immobilized or dehydrated patients. This event may be symptomatic or asymptomatic, may lead to renal insufficiency and anuria, and is reversible upon discontinuation of ceftriaxone (see section 4.4).

Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily 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 – above 30 % in some studies. The incidence appears to be lower with slow infusion (20 – 30 minutes). This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases. Symptomatic treatment is recommended in these cases. Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins.

Mode of action

Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Resistance

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

o hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably depressed in certain aerobic Gram-negative bacterial species.

o reduced affinity of penicillin-binding proteins for ceftriaxone.

o outer membrane impermeability in Gram-negative organisms.

o bacterial efflux pumps.

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

PathogenDilution Test (MIC, mg/L)
SusceptibleResistant
Enterobacteriaceae≤ 1>2
Staphylococcus spp.aa
Streptococcus spp. (Groups A, B, C and G)bb
Streptococcus pneumoniae≤ 0.5c>2
Viridans group Streptococci≤ 0.5>0.5
Haemophilus influenzae≤ 0.12c>0.12
Moraxella catarrhalis≤ 1>2
Neisseria gonorrhoeae≤ 0.12>0.12
Neisseria meningitidis≤ 0.12c>0.12
Non-species related≤ 1d>2
  1. Susceptibility inferred from cefoxitin susceptibility.
  2. Susceptibility inferred from penicillin susceptibility.
  3. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re-tested and, if confirmed, should be sent to a reference laboratory.
  4. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1.

Clinical efficacy against specific pathogens

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.

Commonly susceptible species
Gram-positive aerobes

Staphylococcus aureus (methicillin-susceptible)£

Staphylococci coagulase-negative (methicillin-susceptible)£

Streptococcus pyogenes (Group A)

Streptococcus agalactiae (Group B)

Streptococcus pneumoniae

Viridans Group Streptococci

Gram-negative aerobes

Borrelia burgdorferi

Haemophilus influenzae

Haemophilus parainfluenzae

Moraxella catarrhalis

Neisseria gonorrhoea

Neisseria meningitidis

Proteus mirabilis

Providencia spp.

Treponema pallidum

Species for which acquired resistance may be a problem
Gram-positive aerobes

Staphylococcus epidermidis+

Staphylococcus haemolyticus+

Staphylococcus hominis+

Gram-negative aerobes:

Citrobacter freundii

Enterobacter aerogenes

Enterobacter cloacae

Escherichia coli%

Klebsiella pneumoniae%

Klebsiella oxytoca%

Morganella morganii

Proteus vulgaris

Serratia marcescens

Anaerobes:

Bacteroides spp.

Fusobacterium spp.

Peptostreptococcus spp.

Clostridium perfringens

Inherently resistant organisms
Gram-positive aerobes:

Enterococcus spp.

Listeria monocytogenes

Gram-negative aerobes:

Acinetobacter baumannii

Pseudomonas aeruginosa

Stenotrophomonas maltophilia

Anaerobes

Clostridium difficile

Others:

Chlamydia spp.

Chlamydophila spp.

Mycoplasma spp.

Legionella spp.

Ureaplasma urealyticum

£ All methicillin-resistant staphylococci are resistant to ceftriaxone.

Resistance rates >50% in at least one region

ESBL producing strains are always resistant

5.2 Pharmacokinetic properties

Absorption

After intravenous bolus administration of ceftriaxone 500 mg and 1 g, mean peak plasma ceftriaxone levels are approximately 120 and 200 mg/l respectively. After intravenous infusion of ceftriaxone 500 mg, 1 g and 2 g, the plasma ceftriaxone levels are approximately 80, 150 and 250 mg/l respectively. Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. The maximum plasma concentration after a single intramuscular dose of 1 g is about 81 mg/l and is reached in 2 – 3 hours after administration.

The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.

Distribution

The volume of distribution of ceftriaxone is 7 – 12 l. Concentrations well above the minimal inhibitory concentrations of most relevant pathogens are detectable in tissue including lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids. An 8 – 15 % increase in mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 48 – 72 hours depending on the route of administration.

Penetration into particular tissues

Ceftriaxone penetrates the meninges. Penetration is greatest when the meninges are inflamed. Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25 % of plasma levels compared to 2 % of plasma levels in patients with uninflamed meninges. Peak ceftriaxone concentrations in CSF are reached approximately 4-6 hours after intravenous injection. Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).

Protein binding

Ceftriaxone is reversibly bound to albumin. Plasma protein binding is about 95 % at plasma concentrations below 100 mg/l. Binding is saturable and the bound portion decreases with rising concentration (up to 85 % at a plasma concentration of 300 mg/l).

Biotransformation

Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.

Elimination

Plasma clearance of total ceftriaxone (bound and unbound) is 10 – 22 ml/min. Renal clearance is 5 – 12 ml/min. 50 – 60 % of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40 – 50 % is excreted unchanged in the bile. The elimination half-life of total ceftriaxone in adults is about 8 hours.

Patients with renal or hepatic impairment

In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone are only minimally altered with the half-life slightly increased (less than two fold), even in patients with severely impaired renal function.

The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone.

In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance. This is also due to an increase in plasma free fraction of ceftriaxone contributing to the observed paradoxical increase in total drug clearance, with an increase in volume of distribution paralleling that of total clearance.

Older people

In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.

Paediatric population

The half-life of ceftriaxone is prolonged in neonates. From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding. During childhood, the half-life is lower than in neonates or adults.

The plasma clearance and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults.

Linearity/non-linearity

The pharmacokinetics of ceftriaxone are non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose dependent if based on total drug concentrations, increasing less than proportionally with dose. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.

Pharmacokinetic/pharmacodynamic relationship

As with other beta-lactams, the pharmacokinetic-pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).

5.3 Preclinical safety data

There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible. Animal studies produced no evidence of toxicity to reproduction and genotoxicity. Carcinogenicity studies on ceftriaxone were not conducted,

  1. Pharmaceutical particulars

6.1 List of excipients

None

6.2 Incompatibilities

Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 6.6. In particular diluents containing calcium, (e.g. Ringer’s solution, Hartmann’s solution) should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).

6.3 Shelf life

36 months unopened.

Reconstituted solutions: Chemical and physical in-use stability has been demonstrated for 24 hours at 2-8°C and for 6 hours below 25°C. From a microbiological point of view the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not normally be longer than 24 hours at 2-8°C, unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Do not store above 25°C.

For shelf-life of reconstituted solutions, see section 6.3.

6.5 Nature and contents of container

Colourless Type III glass vial closed with a bromobutyl rubber stopper and sealed with an aluminium cap.

Packs of 1, 5, 10, 20, 50 or 100 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

Concentrations for the intravenous injection: 100 mg/ml,

Concentrations for the intravenous infusion: 50 mg/ml.

(Please refer to section 4.2 for further information).

This medicinal product is for single use only. Discard any unused contents. Reconstitute immediately before use.

Preparation of solutions:

PowderReconstitution solventVolume to be addedApprox. displacement volume
Intravenous injection250 mgWater for Injections BP2.5 ml0.2 ml
1 gWater for Injections BP10 ml0.6 ml
Intramuscular injection250 mg1.0% Lidocaine Hydrochloride BP1.0 ml0.06 ml
1 g1.0% Lidocaine Hydrochloride BP3.5 ml0.66 ml
Intravenous infusion2gGlucose Injection BP 5% or 10%,

0.9% Sodium Chloride Injection BP,

Sodium Chloride and Glucose Injection BP (0.45% Sodium Chloride and 2.5% Glucose),

Dextran 6% in Glucose Injection BP 5%.

40.0 ml1.2 ml

Solutions reconstituted with Lidocaine Hydrochloride BP solution should not be administered intravenously.

Dosages greater than 1g should be divided and injected at more than one site.

  1. Manufactured in India by:

TAJ PHARMACEUTICALS LTD.,

At: 615, GIDC, Kerala, Bavla Dist., Ahmedabad-438225, Gujarat, INDIA

  

Package leaflet: Information for the Patient
Ceftriaxone 0.5g and 1g Powder for Solution for Injection or Infusion
Ceftriaxone (as Ceftriaxone Sodium)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it
  • If you have any further questions, ask your doctor, pharmacist or
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet

  1. What Ceftriaxone injection is and what it is used for
  2. What you need to know before you are given Ceftriaxone injection
  3. How Ceftriaxone injection is given
  4. Possible side effects
  5. How to store Ceftriaxone injection
  6. Contents of the pack and other information

The name of your medicine is “Ceftriaxone Powder for Solution for Injection or Infusion” (referred to as Ceftriaxone injection throughout this leaflet).

1. What Ceftriaxone injection is and what it is used for

Ceftriaxone is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftriaxone injection is used to treat infections of:

  • the brain (meningitis)
  • the abdomen and abdominal wall (peritonitis).
  • the urinary tract and
  • bones and
  • the skin or soft tissues.
  • the blood.
  • the

It can be given:

  • to treat specific sexually transmitted infections (gonorrhoea and syphilis).
  • to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial
  • to treat infections of the chest in adults with chronic
  • to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.
  • to prevent infections during
  1. What you need to know before you are given Ceftriaxone injection You must not be given Ceftriaxone injection if:

  • You are allergic to ceftriaxone

You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.

  • You are allergic to lidocaine and you are to be given Ceftriaxone injection as an injection into a

Ceftriaxone injection must not be given to babies if:

  • The baby is
  • The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their

Warnings and precautions

Talk to your doctor or pharmacist or nurse before you are given Ceftriaxone injection if:

  • You have recently received or are about to receive products that contain
  • You have recently had diarrhoea after having an antibiotic
  • You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
  • You have liver or kidney
  • You have gall stones or kidney stones
  • You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
  • You are on a low sodium

If you need a blood or urine test

If you are given Ceftriaxone for a long time, you may need to have regular blood tests. Ceftriaxone can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

  • Tell the person taking the sample that you have been given

Children

Talk to your doctor or pharmacist or nurse before your child is administered Ceftriaxone if:

  • He/she has recently been given or is to be given a product that contains calcium into their

Other medicines and Ceftriaxone

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • A type of antibiotic called an
  • An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes).

Pregnancy and breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The doctor will consider the benefit of treating you with Ceftriaxone against the risk to your baby.

Driving and using machines

Ceftriaxone can cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.

Ceftriaxone injection contains sodium

This medicine contains 0.9 mmol (250mg vial), 3.6 mmol (1g vial) or 7.2 mmol (2g vial) of sodium. This should be taken into consideration by patients on a controlled sodium diet. Tell your doctor or nurse if you are on a low sodium diet.

3.  How Ceftriaxone injection is given

Ceftriaxone injection is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle. Ceftriaxone injection is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections. The usual dose

Your doctor will decide the correct dose of Ceftriaxone for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that you are given Ceftriaxone depends on what sort of infection you have.

Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):

1 to 2 g once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.

Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg: 50-80 mg Ceftriaxone for each kg of the child’s body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day. If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.

Children with a body weight of 50 kg or more should be giventhe usual adult dose.

Newborn babies (0-14 days)

20 – 50 mg Ceftriaxone for each kg of the child’s body weight once a day depending on the severity and type of infection. The maximum daily dose is not to be more than 50 mg for each kg of the baby’s weight.

People with liver and kidney problems

You may be given a different dose to the usual dose. Your doctor will decide how much Ceftriaxone you will need and will check you closely depending on the severity of the liver and kidney disease.

If you are given more Ceftriaxone than you should

If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you forget to use Ceftriaxone injection

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftriaxone injection

Do not stop taking Ceftriaxone unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

4.  Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Severe allergic reactions (not known, frequency cannot be estimated from the available data)

If you have a severe allergic reaction, tell a doctor straight away. The signs may include:

  • Sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or
  • Sudden swelling of the hands, feet and

Severe skin rashes (not known, frequency cannot be estimated from the available data)

If you get a severe skin rash, tell a doctor straight away. The signs may include a severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth.

Other possible side effects:

Common (may affect up to 1 in 10 people)

  • Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
  • Loose stools or
  • Changes in the results of blood tests for liver

Uncommon (may affect up to 1 in 100 people)

  • Fungal infections (for example, thrush).
  • A decrease in the number of white blood cells (granulocytopenia).
  • Reduction in number of red blood cells (anaemia).
  • Problems with the way your blood clots. The signs may include bruising easily and pain and swelling of your
  • Feeling sick or being
  • Pruritis (itching).
  • Pain or a burning feeling along the vein where Ceftriaxone has been
  • Pain where the injection was
  • A high temperature (fever).
  • Abnormal kidney function test (blood creatinine increased).

Rare (may affect up to 1 in 1,000 people)

  • Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and
  • Difficulty in breathing (bronchospasm).
  • A lumpy rash (hives) that may cover a lot of your body, feeling itchy and
  • Blood or sugar in your
  • Oedema (fluid build-up).

Not known (Frequency cannot be estimated from the available data)

  • A secondary infection that may not respond to the antibiotic previously
  • Form of anaemia where red blood cells are destroyed (haemolytic anaemia).
  • Severe decrease in white blood cells (agranulocytosis).
  • Vertigo (spinning sensation).
  • Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your
  • Inflammation of the mucus lining of the mouth (stomatitis).
  • Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the
  • Problems with your gallbladder, which may cause pain, feeling sick and being
  • A neurological condition that may occur in neonates with severe jaundice (kernicterus).
  • Kidney problems caused by deposits of calcium

There may be pain when passing water (urine) or low output of urine.

  • A false positive result in a Coombs’ test (a test for some blood problems).
  • A false positive result for galactosaemia (an abnormal build up of the sugar galactose).
  • Ceftriaxone may interfere with some types of blood glucose tests – please check with your

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Ceftriaxone injection

Keep out of the sight and reach of children.

Do not use Ceftriaxone injection after the expiry date which is printed on the label and carton.

Do not store above 25°C. Your doctor, pharmacist or nurse will know how to store Ceftriaxone Injection properly.

  1. Contents of the pack and other information

What Ceftriaxone injection contains

Each vial contains 500mg, 1g, or 2g ceftriaxone (as ceftriaxone sodium). The vials contain no other ingredients.

What Ceftriaxone injection looks like and contents of the pack Ceftriaxone injection is a white or almost white powder in a glass vial. Each carton contains 1, 5, 10, 20, 50 or 100 vials.

Not all pack sizes may be marketed.

  1. Manufactured in India by:

TAJ PHARMACEUTICALS LTD.,

At: 615, GIDC, Kerala, Bavla Dist., Ahmedabad-438225, Gujarat, INDIA