Fortum (Ceftazidime)

What Is Fortum and What Is It Used For?

Fortum (ceftazidime) is a third-generation cephalosporin antibiotic that works by killing bacteria that cause serious infections. It belongs to the beta-lactam family of antibiotics and is administered by injection or intravenous infusion in hospital settings. Ceftazidime is particularly valued for its strong activity against Pseudomonas aeruginosa, a difficult-to-treat bacterium commonly encountered in hospital-acquired infections and cystic fibrosis.

Ceftazidime exerts its bactericidal action by binding to penicillin-binding proteins (PBPs) on the bacterial cell wall, inhibiting the final transpeptidation step of peptidoglycan synthesis. This weakens the cell wall, causing osmotic instability and ultimately bacterial cell lysis and death. Unlike many older cephalosporins, ceftazidime is stable against a wide range of beta-lactamases produced by Gram-negative organisms, which gives it its broad spectrum of activity.

As a third-generation cephalosporin, Fortum has an expanded spectrum compared to first- and second-generation agents, with particularly strong activity against Gram-negative pathogens. While it has reduced activity against some Gram-positive organisms compared to first-generation cephalosporins, its anti-pseudomonal properties make it an indispensable tool in the treatment of serious nosocomial infections. The drug is included on the World Health Organization (WHO) Model List of Essential Medicines, underscoring its importance in global healthcare.

Fortum is approved and used for the treatment of the following serious bacterial infections in adults and children, including neonates:

• Lower respiratory tract infections including pneumonia and bronchopulmonary infections, particularly in patients with cystic fibrosis
• Bacterial meningitis caused by susceptible Gram-negative organisms
• Chronic suppurative otitis media (middle ear infections)
• Complicated urinary tract infections including pyelonephritis
• Skin and soft tissue infections including cellulitis, wound infections and burns
• Intra-abdominal infections including peritonitis and biliary tract infections
• Bone and joint infections including osteomyelitis and septic arthritis
• Febrile neutropenia as empirical therapy in immunocompromised patients
• Prophylaxis during transurethral resection of the prostate (TURP)

The prescribing physician will determine whether Fortum is the most appropriate antibiotic based on the suspected or confirmed causative organism, local resistance patterns (antibiogram data), the site of infection and the patient's clinical condition. In many cases, ceftazidime is used in combination with other antimicrobials to broaden coverage or achieve synergistic bactericidal activity.

What Should You Know Before Receiving Fortum?

Before receiving Fortum, your doctor needs to know about any allergies to antibiotics (especially penicillins, cephalosporins, carbapenems or monobactams), any kidney problems, and all other medications you are taking. Fortum may interact with certain antibiotics and diuretics, and dose adjustments are required in patients with impaired renal function.

Contraindications

You must not receive Fortum if you have a known hypersensitivity (allergy) to ceftazidime or to any of the excipients in the formulation. You should also not receive ceftazidime if you have a history of a severe allergic reaction (such as anaphylaxis or severe skin reaction) to any other beta-lactam antibiotic, including penicillins, monobactams or carbapenems. Cross-reactivity between cephalosporins and penicillins occurs in approximately 1-10% of patients, although the incidence of true clinical cross-reactivity is thought to be lower. The risk is highest with first-generation cephalosporins and is generally lower with third-generation agents like ceftazidime.

It is essential to inform your healthcare provider about all previous allergic reactions to any medications before treatment is initiated. Even mild reactions to penicillin in the past warrant careful consideration, and your physician may decide to administer the first dose under close observation.

Warnings and Precautions

You should be aware of certain symptoms that may develop during treatment with Fortum. These include allergic reactions, nervous system disturbances and gastrointestinal conditions such as diarrhoea. Early recognition of these symptoms helps minimise the risk of complications.

Clostridioides difficile-associated diarrhoea (CDAD) has been reported with the use of nearly all antibacterial agents, including ceftazidime, and may range from mild diarrhoea to fatal colitis. Antibiotic treatment alters the normal flora of the colon, leading to overgrowth of C. difficile. If significant diarrhoea occurs during or after treatment, contact your healthcare provider promptly, as this may require specific treatment.

Neurotoxicity including tremor, myoclonus, convulsions, encephalopathy and coma has been reported in patients receiving ceftazidime, particularly when doses were not appropriately reduced in patients with renal impairment. These effects are dose-related and are generally reversible upon dose reduction or discontinuation of the drug.

Laboratory test interference: Ceftazidime may cause a false-positive result in urinary glucose tests that use copper reduction methods (e.g. Benedict's solution, Clinitest). Enzymatic glucose oxidase methods are not affected. Ceftazidime may also cause a positive direct Coombs test, which should be considered if cross-matching blood or performing a Coombs test in neonates whose mothers received ceftazidime.

Pregnancy and Breastfeeding

Animal reproductive studies with ceftazidime have not revealed evidence of teratogenicity or adverse effects on fertility. However, there are no adequate and well-controlled studies in pregnant women. As with all medications, Fortum should be used during pregnancy only when the expected benefit to the mother outweighs the potential risk to the foetus. Your physician will carefully evaluate the risk-benefit ratio before prescribing ceftazidime during pregnancy.

Ceftazidime is excreted in human breast milk in low concentrations. While the amount transferred to the nursing infant is generally considered clinically insignificant, there is a theoretical risk of sensitisation or disruption of the infant's intestinal flora. The prescribing physician will consider whether to continue or discontinue breastfeeding during treatment, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

Driving and Operating Machinery

Fortum may cause side effects such as dizziness that could affect your ability to drive or use machines safely. You should not drive or operate machinery until you are certain that you are not adversely affected. If you experience dizziness, headache or any other neurological symptoms during treatment, refrain from driving and inform your healthcare team.

How Does Fortum Interact with Other Drugs?

Fortum has relatively few clinically significant drug interactions, but there are several important ones to be aware of. The most notable interactions involve chloramphenicol, aminoglycoside antibiotics and loop diuretics such as furosemide. Always inform your doctor of all medications you are taking, including over-the-counter medicines and supplements.

Although ceftazidime has a relatively favourable drug interaction profile compared to some other antibiotic classes, certain combinations warrant caution. The following interactions have been documented in clinical practice and should be discussed with your prescribing physician.

Major Interactions

Chloramphenicol is a bacteriostatic antibiotic that inhibits bacterial protein synthesis. When used concurrently with ceftazidime, which is bactericidal (dependent on actively dividing bacteria), chloramphenicol can antagonise the effect of ceftazidime by slowing bacterial growth. This combination should generally be avoided. If both drugs are deemed necessary for a polymicrobial infection, expert infectious disease consultation is recommended.

Moderate Interactions

Aminoglycosides such as gentamicin and tobramycin are frequently used in combination with ceftazidime, particularly for serious Pseudomonas infections and in febrile neutropenia. While the combination can provide synergistic antibacterial activity, it also carries an increased risk of nephrotoxicity. Importantly, ceftazidime and aminoglycosides must never be mixed in the same syringe or infusion bag, as they are physically incompatible and can form precipitates that reduce the efficacy of both drugs. Separate administration lines or a flush between infusions is required.

Furosemide and other high-ceiling (loop) diuretics can potentiate the nephrotoxic potential of cephalosporins. When concurrent use is unavoidable, serum creatinine and estimated glomerular filtration rate (eGFR) should be monitored regularly, particularly in elderly patients and those with pre-existing renal impairment.

What Is the Correct Dosage of Fortum?

Fortum is always administered by a doctor or nurse, either as an intravenous injection, intravenous infusion (drip) or intramuscular injection. The standard adult dose is 1-2 g three times daily, with a maximum of 9 g per day. Dosing depends on the type and severity of infection, the patient's age, weight and kidney function.

The dosage of Fortum is individualised by the prescribing physician based on multiple clinical factors. These include the site and severity of infection, the susceptibility of the causative organism(s), the patient's age and body weight, and renal function. Treatment is typically initiated empirically before culture results are available and may be adjusted once the causative organism and its antibiotic sensitivities are confirmed.

Adults and Adolescents (40 kg and over)

Children

Elderly Patients

In elderly patients, particularly those over 80 years of age, the daily dose should generally not exceed 3 g per day. Age-related decline in renal function is common, even when serum creatinine values appear normal. Therefore, creatinine clearance should be estimated (using the Cockcroft-Gault formula or similar) and dosing adjusted accordingly. Regular monitoring of renal function is recommended throughout the treatment course.

Dose Adjustment in Renal Impairment

Ceftazidime is primarily eliminated by the kidneys through glomerular filtration. In patients with impaired renal function, the dose of Fortum must be reduced to prevent accumulation and toxicity, particularly neurotoxicity. Your prescribing physician will calculate the appropriate dose based on your creatinine clearance (CrCl) and will monitor your kidney function regularly during treatment.

Missed Dose

Since Fortum is administered in a clinical setting by healthcare professionals, missed doses are uncommon. However, if a dose is missed, it should be given as soon as possible. A double dose should never be administered to compensate for a missed one. The next dose should then be given at the regularly scheduled time to maintain consistent drug levels in the bloodstream.

Overdose

Overdose with ceftazidime can lead to neurological complications including encephalopathy, seizures and coma. These effects are more likely in patients with impaired renal function where drug clearance is reduced. In the event of overdose, treatment is supportive. Ceftazidime serum levels can be reduced by haemodialysis or peritoneal dialysis. If you suspect an overdose, contact your healthcare provider or emergency services immediately.

What Are the Side Effects of Fortum?

Like all medicines, Fortum can cause side effects, although not everyone experiences them. The most common side effects include diarrhoea, injection site reactions (pain, swelling, inflammation) and skin rash. Serious but rare side effects include severe allergic reactions (anaphylaxis), neurological effects (seizures, tremors) and severe skin reactions.

The side effect profile of ceftazidime is well-characterised from decades of clinical use and post-marketing surveillance. Most adverse effects are mild to moderate in severity and resolve upon completion of treatment or dose adjustment. However, some rare reactions can be serious and require prompt medical attention. The following classification uses the standard frequency categories recommended by the Council for International Organizations of Medical Sciences (CIOMS).

If you experience persistent or worsening diarrhoea during or after treatment with Fortum, particularly if it contains blood or mucus, inform your healthcare provider immediately. This could be a sign of Clostridioides difficile colitis, which requires specific treatment and potentially discontinuation of ceftazidime.

Laboratory changes such as transient elevations in liver enzymes and changes in blood cell counts are generally mild and reversible. These are usually detected during routine monitoring and rarely require dose adjustment or treatment discontinuation. Your healthcare team will perform regular blood tests during extended treatment courses to monitor for these effects.

How Should Fortum Be Stored?

Fortum should be stored at or below 25°C in the original outer carton to protect from light. The reconstituted solution should be used within 6 days if refrigerated (4°C) or within 9 hours at room temperature (up to 25°C). As a hospital-administered medication, storage is typically managed by the pharmacy or nursing staff.

Unreconstituted Fortum powder has a shelf life of 3 years when stored according to the recommended conditions. The vials should be kept in the original outer carton because the product is sensitive to light. As with all medications, Fortum should be kept out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label.

Once reconstituted with water for injections or a compatible diluent, the chemical and physical stability of the solution has been demonstrated for up to 6 days at 4°C (refrigerator) and 9 hours at 25°C (room temperature). From a microbiological perspective, however, the reconstituted solution should ideally be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2-8°C, unless reconstitution has taken place under controlled and validated aseptic conditions.

The reconstituted solution may vary in colour from light yellow to amber. This colour variation is normal and does not affect the potency or safety of the product, provided the solution is clear and free from particulate matter. Small carbon dioxide bubbles in the reconstituted solution are expected due to the release of CO2 during dissolution and can be disregarded. Any unused medication or waste material should be disposed of in accordance with local requirements for pharmaceutical waste.

What Does Fortum Contain?

Fortum contains ceftazidime pentahydrate as the active substance, equivalent to ceftazidime 250 mg, 500 mg, 1 g or 2 g depending on the vial size. The only excipient is anhydrous sodium carbonate (sterile). The product is a white to cream-coloured sterile powder supplied in glass vials.

The active ingredient in Fortum is ceftazidime, present as ceftazidime pentahydrate. Ceftazidime is a semi-synthetic, broad-spectrum beta-lactam antibiotic belonging to the third-generation cephalosporin class. Its chemical name is 1-[[7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-3-yl]methyl]pyridinium hydroxide, inner salt, pentahydrate.

The sole excipient is anhydrous sodium carbonate (sterile), which serves as a buffer to adjust the pH of the reconstituted solution. The sodium content per vial is as follows:

• 250 mg vial: 13 mg sodium (0.57 mmol) — 0.65% of WHO recommended maximum daily intake
• 500 mg vial: 26 mg sodium (1.13 mmol) — 1.3% of WHO recommended maximum daily intake
• 1 g vial: 52 mg sodium (2.26 mmol) — 2.6% of WHO recommended maximum daily intake
• 2 g vial: 104 mg sodium (4.52 mmol) — 5.2% of WHO recommended maximum daily intake

Fortum is supplied in glass vials with bromobutyl rubber stoppers and aluminium seals with flip-off caps. Each pack contains 5 vials. The vials are supplied under reduced pressure; when the product is dissolved, carbon dioxide is released and a positive pressure develops. This is expected and the small CO2 bubbles in the reconstituted solution can be disregarded.

Ceftazidime is compatible with a wide range of intravenous fluids for dilution, including 0.9% sodium chloride, Hartmann's solution (Ringer's lactate), 5% glucose and various glucose-saline combinations. The reconstituted solution can also be added to metronidazole injection (500 mg in 100 ml) with both drugs retaining their activity. For intramuscular use, ceftazidime can be reconstituted with 0.5% or 1% lidocaine hydrochloride injection to reduce injection site pain.

Frequently Asked Questions About Fortum