Aprokam: Uses, Dosage & Side Effects
A sterile intracameral cefuroxime injection used to prevent bacterial eye infections after cataract surgery
Aprokam is a sterile antibiotic preparation containing cefuroxime, a second-generation cephalosporin, specifically formulated for intracameral injection (directly into the anterior chamber of the eye) at the conclusion of cataract surgery. Its sole indication is the prevention of postoperative endophthalmitis, a rare but potentially sight-threatening intraocular infection. Aprokam is administered exclusively by the ophthalmic surgeon in the operating theatre and is not a medication the patient takes at home. The landmark ESCRS multicenter study demonstrated that intracameral cefuroxime reduces the risk of endophthalmitis by approximately five-fold, making it one of the most significant safety advances in modern cataract surgery.
Quick Facts: Aprokam
Key Takeaways
- Aprokam contains cefuroxime, a second-generation cephalosporin antibiotic, and is the first licensed product specifically developed for intracameral injection during cataract surgery to prevent postoperative endophthalmitis.
- Intracameral cefuroxime has been shown in the landmark ESCRS study and subsequent large-scale observational research to reduce the rate of postoperative endophthalmitis by approximately five-fold, from around 0.35% to 0.07%.
- Aprokam is administered exclusively by the ophthalmic surgeon in the operating theatre as a single 0.1 ml injection (containing 1 mg cefuroxime) into the anterior chamber of the eye at the end of surgery.
- Do not receive Aprokam if you have a known allergy to cefuroxime or other cephalosporin antibiotics; inform your surgeon if you have any penicillin allergy due to the risk of cross-reactivity.
- Side effects are very rare because of the extremely small dose and localized administration, but may include macular edema (blurred or wavy central vision) and, very rarely, severe allergic reactions.
What Is Aprokam and What Is It Used For?
Aprokam contains the active ingredient cefuroxime in the form of cefuroxime sodium, a well-established second-generation cephalosporin antibiotic. Cephalosporins belong to the broader class of beta-lactam antibiotics, which also includes penicillins and carbapenems. What makes Aprokam unique is not the antibiotic itself—cefuroxime has been in widespread clinical use since the 1970s—but rather its formulation. Aprokam is the first commercially licensed product specifically developed and approved for intracameral injection during cataract surgery. Prior to its introduction, surgeons who wished to use intracameral cefuroxime had to prepare it by diluting systemic-use cefuroxime powder, a process that carried risks of dilution errors, contamination, and incorrect dosing.
Cataract surgery (phacoemulsification) is one of the most commonly performed surgical procedures in the world, with an estimated 20 million operations carried out globally each year. While modern cataract surgery is remarkably safe, one of the most feared complications is postoperative endophthalmitis—an infection of the interior of the eye that can develop within days of surgery. Although the overall incidence is low (historically estimated at 0.1–0.4% of cataract operations), the consequences can be devastating, including permanent severe vision loss or even loss of the eye. The causative organisms are most commonly bacteria from the patient's own skin and conjunctival flora, particularly coagulase-negative staphylococci (such as Staphylococcus epidermidis), Staphylococcus aureus, streptococci, and occasionally Gram-negative bacteria such as Pseudomonas aeruginosa.
The rationale for intracameral antibiotic prophylaxis is to deliver a high concentration of antibiotic directly to the site where infection originates—the anterior chamber of the eye—at the critical moment when the eye is most vulnerable, immediately following surgery. By injecting cefuroxime directly into the anterior chamber, concentrations far exceeding the minimum inhibitory concentration (MIC) for the most common causative pathogens are achieved. Cefuroxime has a broad spectrum of activity against both Gram-positive organisms (including most staphylococci and streptococci) and many Gram-negative organisms, making it an ideal choice for prophylaxis in this setting.
The evidence supporting intracameral cefuroxime for endophthalmitis prophylaxis is strong. The landmark multicenter randomized controlled trial conducted by the European Society of Cataract and Refractive Surgeons (ESCRS), published in 2007 by Barry et al. in the Journal of Cataract and Refractive Surgery, demonstrated a statistically significant reduction in the rate of postoperative endophthalmitis when intracameral cefuroxime was used. The study showed approximately a five-fold reduction in endophthalmitis rates, from 0.35% in the control group to 0.07% in the cefuroxime group. This finding was subsequently confirmed by numerous large-scale national registry studies and retrospective analyses from countries including Sweden, France, the Netherlands, Portugal, and Australia. Sweden, which was among the first countries to adopt intracameral cefuroxime prophylaxis on a national scale, reported a dramatic decline in endophthalmitis rates from 0.11% to 0.02% after widespread implementation.
It is important to understand that Aprokam is administered exclusively by the ophthalmic surgeon during the cataract operation. The patient does not need to prepare, handle, or administer this medication themselves. Each vial of Aprokam contains 50 mg of cefuroxime as a sterile white powder, which is reconstituted by the surgical team with 5 ml of sodium chloride 0.9% solution for injection immediately before use. From this reconstituted solution, 0.1 ml (containing 1 mg of cefuroxime) is drawn up through a sterile filter needle and injected slowly into the anterior chamber of the eye at the conclusion of the surgical procedure.
Aprokam is authorized in multiple European countries under slightly different trade names. It is marketed as Aprokam in most EU/EEA member states including Austria, Belgium, Denmark, Finland, France, Germany, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, and the United Kingdom. In Cyprus, Greece, and Spain it is available as Prokam, and in Ireland it is known as Aprok. All versions contain the same active ingredient (cefuroxime 50 mg) from the same manufacturer, Laboratoires Théa (France).
What Should You Know Before Receiving Aprokam?
Contraindications
There is one absolute contraindication for Aprokam. Understanding this is essential to avoid a potentially life-threatening adverse reaction, even though the dose administered is extremely small.
- Cephalosporin allergy: Do not receive Aprokam if you have a known allergy (hypersensitivity) to cefuroxime or to any other antibiotic belonging to the cephalosporin group. Cephalosporins share a common beta-lactam ring structure with penicillins, and although the cross-reactivity rate is relatively low (estimated at 1–2%), patients with a documented severe allergy to any cephalosporin must not be given Aprokam. If you are uncertain whether you have a cephalosporin allergy, inform your surgeon and discuss alternative prophylactic strategies.
Warnings and Precautions
Although extremely rare due to the small dose (1 mg), serious hypersensitivity reactions including anaphylaxis have been reported with cephalosporin antibiotics. Patients with a history of penicillin allergy have a slightly elevated risk of cross-reactivity. If you have ever experienced a severe allergic reaction to any beta-lactam antibiotic (including penicillins, cephalosporins, or carbapenems), inform your ophthalmic surgeon before the procedure. The surgical team will have resuscitation equipment and medications available.
Before receiving Aprokam, you should inform your ophthalmic surgeon if any of the following apply to you:
- Penicillin allergy: If you have a known allergy to penicillin or any other antibiotic, tell your surgeon. Although the risk of cross-reactivity between penicillins and cephalosporins is low (approximately 1–2%), your surgeon needs this information to make an informed risk-benefit assessment. In cases of documented severe penicillin anaphylaxis, an alternative prophylactic agent (such as intracameral vancomycin or moxifloxacin) may be considered.
- Risk of MRSA infection: If you have been colonized with or previously infected by methicillin-resistant Staphylococcus aureus (MRSA), inform your surgeon. MRSA is inherently resistant to all cephalosporins including cefuroxime, and your surgeon may need to choose a different prophylactic antibiotic or add supplementary antimicrobial measures.
- Risk of serious infection: If you are immunosuppressed, taking immunosuppressive medications, or have any condition that increases your susceptibility to infection, your surgical team should be aware so they can take additional precautions.
- Complicated cataract: If your cataract has been diagnosed as complicated (for example, due to previous eye trauma, prior intraocular surgery, or anatomical abnormalities), your surgeon will assess whether Aprokam remains the appropriate prophylactic choice and whether additional measures are needed.
- Combined eye surgery: If a combined surgical procedure is planned (for example, cataract surgery combined with glaucoma surgery or vitrectomy), the pharmacokinetics and safety profile of intracameral cefuroxime may differ from those in isolated cataract surgery. Your surgeon will consider the most appropriate approach.
- Severe thyroid disease: Patients with severe thyroid disease (particularly Graves' disease with associated thyroid eye disease) should inform their surgeon, as the ocular anatomy and surgical considerations may be affected.
Aprokam is formulated exclusively for intracameral injection (into the anterior chamber of the eye) and must not be administered by any other route. It must not be injected intravenously, intramuscularly, subconjunctivally, or intravitreally. Administration must occur under strict aseptic (sterile) conditions in an ophthalmic operating theatre. Each vial is for single-patient use only and must be discarded after use.
Other Medicines and Aprokam
Because Aprokam is administered as a single, extremely small dose (1 mg) directly into the eye, systemic drug interactions are not considered clinically relevant. The amount of cefuroxime that enters the systemic circulation after intracameral injection is negligible. No formal interaction studies with Aprokam have been conducted, and no incompatibilities with commonly used products in cataract surgery (such as viscoelastic substances, mydriatic agents, or topical anesthetics) have been reported in the published literature.
However, as a matter of good medical practice, you should always inform your surgeon and anesthetist about all medicines you are currently taking, including prescription medications, over-the-counter products, herbal remedies, and dietary supplements. This is particularly important for:
- Anticoagulants and antiplatelet agents: While these do not interact with cefuroxime directly, they may affect the surgical procedure and post-operative healing. Medications such as warfarin, aspirin, clopidogrel, apixaban, rivaroxaban, and dabigatran should be discussed with your surgeon well before the day of surgery.
- Alpha-adrenergic blockers: Medications such as tamsulosin (commonly used for prostate enlargement) can cause intraoperative floppy iris syndrome (IFIS), which complicates cataract surgery. Your surgeon needs to know about these medications even if you have stopped taking them.
Pregnancy and Breastfeeding
Cataract surgery is rarely performed during pregnancy, as cataracts typically develop gradually and surgery can usually be postponed until after delivery. However, if surgery is considered necessary during pregnancy, Aprokam may be used if your doctor considers the benefit to outweigh any potential risk. The dose administered intracamerally is extremely small (1 mg), and systemic absorption is negligible, making the theoretical risk to the fetus minimal. Animal reproductive studies with cefuroxime have not demonstrated evidence of harm to the developing fetus.
Similarly, the extremely small intracameral dose of 1 mg cefuroxime would result in negligible systemic levels, and the amount that could potentially be transferred to breast milk would be clinically insignificant. If cataract surgery with Aprokam prophylaxis is considered necessary during breastfeeding, it is unlikely to pose a risk to the nursing infant. Nonetheless, the decision should be made jointly with your ophthalmologist and obstetrician or midwife.
Sodium Content
Aprokam contains less than 1 mmol (23 mg) of sodium per dose and is therefore considered essentially sodium-free. This is relevant for patients on a sodium-restricted diet, although given the extremely small volume injected (0.1 ml), the sodium content is clinically insignificant regardless of dietary restrictions.
How Does Aprokam Interact with Other Drugs?
Formal drug interaction studies have not been conducted with Aprokam specifically, and the extremely small intracameral dose of 1 mg cefuroxime makes systemic drug interactions virtually impossible. When cefuroxime is administered systemically at much higher doses (250–1,500 mg intravenously or orally), certain drug interactions can occur. While these are not expected to be relevant with intracameral Aprokam, it is important for completeness and clinical context to understand how systemic cefuroxime interacts with other medications, as this information may be relevant if the patient is also receiving systemic cefuroxime for other indications.
Potential Interactions of Systemic Cefuroxime (Not Clinically Relevant at Intracameral Dose)
| Interacting Drug | Effect | Clinical Relevance for Aprokam |
|---|---|---|
| Probenecid | Inhibits renal tubular secretion of cefuroxime, increasing and prolonging plasma levels of the antibiotic | Not clinically relevant at the 1 mg intracameral dose, as systemic absorption is negligible |
| Aminoglycoside antibiotics | Potential additive nephrotoxicity when cephalosporins are combined with aminoglycosides (e.g., gentamicin, tobramycin) at systemic doses | Not relevant at intracameral dose. Topical aminoglycoside eye drops used perioperatively do not pose a nephrotoxicity risk |
| Loop diuretics (furosemide) | High-dose systemic cephalosporins combined with loop diuretics may increase the risk of renal impairment | Not relevant at the intracameral dose of 1 mg |
| Oral anticoagulants (warfarin) | Systemic cephalosporins may enhance anticoagulant effect by disrupting vitamin K–producing gut flora | Not expected at intracameral dose. However, patients on warfarin should ensure INR is managed before any surgical procedure |
Incompatibilities in the Operating Theatre
No incompatibilities between reconstituted Aprokam and the products most commonly used during cataract surgery have been reported in the literature. These include viscoelastic substances (such as sodium hyaluronate), balanced salt solutions (BSS), mydriatic agents (such as tropicamide, phenylephrine, and cyclopentolate), topical anesthetic drops (such as tetracaine or oxybuprocaine), and povidone-iodine antiseptic. However, as a standard pharmaceutical precaution, Aprokam must not be mixed with any other medication except the sterile 0.9% sodium chloride solution used for reconstitution.
While not a drug interaction in the traditional sense, the antimicrobial spectrum of cefuroxime is an important consideration. Cefuroxime is not effective against MRSA (methicillin-resistant Staphylococcus aureus), enterococci, or certain Gram-negative organisms such as Pseudomonas aeruginosa. Patients known to be colonized with these resistant organisms should inform their surgeon, who may consider alternative or additional prophylactic strategies. The overall contribution of intracameral cefuroxime to the global burden of antimicrobial resistance is considered negligible due to the extremely small doses used.
What Is the Correct Dosage of Aprokam?
Aprokam is unique among medications in that it has a single, fixed dose that does not vary by patient weight, age, or infection severity. This is because the drug is delivered directly to its site of action (the anterior chamber of the eye) in a precise, surgically controlled manner. The entire reconstitution and injection process is performed by trained ophthalmic surgical staff under aseptic conditions.
Standard Dose for All Patients
Intracameral Injection
Dose: 1 mg cefuroxime in 0.1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection
Route: Intracameral injection (into the anterior chamber of the eye)
Timing: Single injection at the end of the cataract operation
Frequency: One dose only (not repeated)
Preparation and Administration
The following preparation steps are performed by the ophthalmic surgical team. This information is provided for patient understanding and transparency, and for the reference of healthcare professionals.
- Inspect the vial: Check that the flip-off cap is intact before removing it. Each vial is for single use only.
- Disinfect: Clean the surface of the rubber stopper with an appropriate disinfectant.
- Reconstitute: Hold the vial upright and insert a sterile needle vertically through the center of the rubber stopper. Inject 5 ml of sterile sodium chloride 0.9% solution for injection aseptically.
- Mix: Shake gently until the solution is free from visible particles. The reconstituted solution should be colorless to slightly yellowish and clear.
- Draw up: Attach a sterile needle (18G × 1½", 1.2 mm × 40 mm) fitted with a 5-micrometer filter (acrylic copolymer membrane on nylon fiber) to a sterile 1 ml syringe. Draw up at least 0.1 ml of the reconstituted solution through the filter.
- Prepare the syringe: Remove the filter needle and attach a sterile anterior chamber cannula. Carefully expel air from the syringe and set the dose to the 0.1 ml mark.
- Inject: The surgeon injects 0.1 ml (containing 1 mg cefuroxime) slowly into the anterior chamber of the eye at the conclusion of surgery.
Injecting more than 1 mg of cefuroxime (0.1 ml of the reconstituted solution) into the anterior chamber could cause toxic anterior segment syndrome (TASS), a serious inflammatory reaction that may result in permanent damage to the corneal endothelium and other intraocular structures. The dose must be measured precisely using the syringe markings. Any remaining solution in the vial must be discarded and not used for another patient or a second injection.
Special Populations
| Patient Group | Dose | Notes |
|---|---|---|
| Adults (all ages) | 1 mg in 0.1 ml | Standard dose; no adjustment required for body weight |
| Elderly patients | 1 mg in 0.1 ml | No dose adjustment. Cataract surgery is most common in elderly patients and Aprokam has been extensively used in this population |
| Renal impairment | 1 mg in 0.1 ml | No dose adjustment needed. Systemic exposure is negligible at the intracameral dose |
| Hepatic impairment | 1 mg in 0.1 ml | No dose adjustment needed |
| Children | Not established | Pediatric cataract surgery is uncommon. Safety and efficacy in children have not been formally established. Use at the discretion of the pediatric ophthalmologist |
Overdose
Because Aprokam is administered by the ophthalmic surgeon in a controlled surgical setting, overdose is extremely unlikely. However, if an excessive dose of cefuroxime is inadvertently injected into the anterior chamber, it could lead to toxic anterior segment syndrome (TASS). TASS is a sterile inflammatory reaction characterized by diffuse corneal edema, anterior chamber fibrin, hypopyon (pus in the anterior chamber), and elevated intraocular pressure. It typically presents within 12–48 hours of surgery and requires urgent ophthalmological management, which may include intensive topical corticosteroids, intraocular pressure-lowering agents, and in severe cases, anterior chamber washout.
If you experience any unusual visual symptoms, severe eye pain, or increasing redness after cataract surgery, contact your ophthalmologist or attend the emergency eye department immediately, regardless of whether overdose is suspected. Early recognition and treatment of any postoperative complication is critical for preserving vision.
Missed Dose
The concept of a missed dose does not apply to Aprokam in the conventional sense, as it is given as a single injection during surgery. If the surgeon decides not to inject Aprokam during the procedure (for example, due to surgical complications or an allergy discovered at the last moment), alternative perioperative antibiotic prophylaxis may be employed, such as enhanced topical fluoroquinolone drops. The decision to use alternative prophylaxis is made by the surgeon based on clinical judgment.
What Are the Side Effects of Aprokam?
Like all medicines, Aprokam can cause side effects, although not everybody experiences them. Because Aprokam is administered as an extremely small dose (1 mg) directly into the anterior chamber of the eye, systemic side effects are exceedingly unlikely. The systemic absorption following intracameral injection is negligible, and the local exposure is brief as the aqueous humor (the fluid in the anterior chamber) turns over rapidly. The adverse effect profile of intracameral Aprokam is therefore much more favorable than that of systemic cefuroxime.
It is important to distinguish between side effects caused by Aprokam itself and the normal expected symptoms following cataract surgery (such as mild discomfort, slight redness, temporary blurring, and sensitivity to light), which are attributable to the surgical procedure rather than the antibiotic injection. If you experience any unusual or severe symptoms after your cataract operation, contact your ophthalmologist promptly.
Very Rare
- Severe allergic reaction (anaphylaxis): Difficulty breathing, swelling of the face, lips, tongue, or throat, dizziness, rapid heartbeat, and a feeling of faintness. This is a medical emergency requiring immediate treatment. Although extremely rare with the 1 mg intracameral dose, the surgical team is prepared to manage anaphylaxis should it occur.
Frequency Not Known
- Macular edema: Blurred, distorted, or wavy vision near or in the center of your visual field. This is an inflammatory swelling of the central retina (macula) that can develop in the days to weeks following cataract surgery. While macular edema (also known as Irvine-Gass syndrome or cystoid macular edema) is a recognized complication of cataract surgery itself, it has been reported in association with Aprokam use. Most cases respond to treatment with topical anti-inflammatory drops.
Side Effects Known from Systemic Cefuroxime Use
When cefuroxime is administered systemically (intravenously or orally) at much higher doses (250–1,500 mg), a wider range of side effects can occur. While these are not expected with the 1 mg intracameral dose of Aprokam, they are listed here for completeness and to provide context about the active ingredient:
- Common (systemic use): Diarrhea, nausea, headache, rash
- Uncommon (systemic use): Vomiting, abdominal pain, oral thrush (candidiasis), eosinophilia, positive Coombs test
- Rare (systemic use): Drug fever, serum sickness-like reactions, hemolytic anemia, pseudomembranous colitis (Clostridioides difficile infection)
- Very rare (systemic use): Interstitial nephritis, anaphylaxis, Stevens-Johnson syndrome, toxic epidermal necrolysis
These systemic side effects are presented for informational context only. At the intracameral dose used in Aprokam (1 mg), systemic absorption is negligible, and these effects are not expected to occur. The safety profile of intracameral cefuroxime at this dose has been confirmed by decades of clinical experience in millions of cataract procedures worldwide.
If you experience any side effects after your cataract surgery that you think may be related to Aprokam, inform your ophthalmologist. You can also report suspected side effects through your national adverse drug reaction reporting system. In the UK, this is the Yellow Card Scheme (yellowcard.mhra.gov.uk). In the EU, contact your national competent authority. Reporting helps authorities continuously monitor the benefit-risk balance of medicines.
How Should Aprokam Be Stored?
Because Aprokam is a hospital-use medication administered during surgery, its storage is the responsibility of the pharmacy or ophthalmic department, not the patient. However, understanding the storage requirements provides important context about the medication's stability and the importance of proper handling.
- Temperature: Store at or below 25°C (77°F). Do not refrigerate or freeze.
- Light protection: Keep the vial in the outer carton to protect from light, as cefuroxime sodium can be degraded by prolonged light exposure.
- Shelf life: Check the expiry date printed on the carton and vial label (after “EXP”). The expiry date refers to the last day of that month. Do not use Aprokam after this date.
- After reconstitution: The reconstituted solution must be used immediately. It cannot be stored, even briefly, for later use. Any unused reconstituted solution must be discarded.
- Single use: Each vial of Aprokam is for one patient only. A single vial must not be used for more than one patient, even if reconstituted solution remains.
- Disposal: Unused medicine and waste material should be disposed of in accordance with local pharmaceutical waste requirements. Used needles must be discarded in sharps containers.
Keep this medicine out of the sight and reach of children, although given that Aprokam is used exclusively in hospital settings, this is managed by the healthcare institution rather than the patient.
What Does Aprokam Contain?
Aprokam is a remarkably simple pharmaceutical formulation, containing only the active ingredient with no excipients (inactive ingredients). This simplicity is advantageous for an intracameral preparation, as it minimizes the risk of adverse reactions to non-active components.
Active Ingredient
The active substance is cefuroxime, present in the form of cefuroxime sodium. Each vial contains 50 mg of cefuroxime. After reconstitution with 5 ml of sodium chloride 0.9% solution for injection, the concentration is 10 mg/ml. The administered dose of 0.1 ml therefore contains 1 mg of cefuroxime.
Cefuroxime is a semi-synthetic second-generation cephalosporin antibiotic with a molecular weight of 424.39 Da (as the free acid) or 446.37 Da (as the sodium salt). It is chemically described as (6R,7R)-3-[(carbamoyloxy)methyl]-7-{[(Z)-2-(furan-2-yl)-2-(methoxyimino)acetyl]amino}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. The sodium form provides enhanced water solubility, which is essential for reconstitution and injection.
Excipients
Aprokam contains no excipients. The vial contains only cefuroxime sodium as a sterile white to off-white powder. The diluent used for reconstitution (sodium chloride 0.9% solution for injection) is not supplied in the Aprokam package and must be sourced separately by the pharmacy.
Appearance and Packaging
Aprokam is supplied as a white to almost white powder in a glass vial with a rubber stopper and aluminum seal with a plastic flip-off cap. The powder dissolves readily in sodium chloride 0.9% solution to produce a clear, colorless to slightly yellowish solution. If the reconstituted solution is turbid or contains visible particles, it must not be used.
Aprokam is available in the following pack sizes:
- 1 vial
- 10 vials
- 20 vials
- 10 vials together with 10 sterile filter needles
Not all pack sizes may be marketed in all countries. The marketing authorization holder is Laboratoires Théa, 12 rue Louis Blériot, 63017 Clermont-Ferrand Cedex 2, France.
Frequently Asked Questions About Aprokam
Aprokam is used exclusively for the prevention of postoperative endophthalmitis (a serious eye infection) after cataract surgery. It contains the antibiotic cefuroxime and is injected directly into the anterior chamber of the eye by the ophthalmic surgeon at the end of the cataract operation. It is not used for any other purpose and is not a medication you take at home. The landmark ESCRS study demonstrated that intracameral cefuroxime reduces the risk of this sight-threatening infection by approximately five-fold.
Aprokam is prepared by the surgical team under sterile conditions. The 50 mg powder is dissolved in 5 ml of sterile saline solution. From this, 0.1 ml (containing 1 mg cefuroxime) is drawn up through a special filter needle into a syringe, which is then fitted with a fine anterior chamber cannula. The surgeon injects this tiny volume directly into the anterior chamber of the eye at the very end of the cataract procedure. The patient feels nothing during this injection as the eye is already anesthetized from the surgery.
You must not receive Aprokam if you have a known allergy to cephalosporin antibiotics. If you have a penicillin allergy, inform your surgeon before the procedure. While the cross-reactivity between penicillins and cephalosporins is low (approximately 1–2%), your surgeon will carefully assess the risk. For patients with a history of severe anaphylaxis to penicillin, your surgeon may choose an alternative prophylactic antibiotic, such as intracameral vancomycin or moxifloxacin. In cases of mild, non-anaphylactic penicillin reactions, most ophthalmologists consider cefuroxime safe to use.
Without intracameral antibiotic prophylaxis, the risk of postoperative endophthalmitis is higher. The ESCRS study showed a baseline endophthalmitis rate of approximately 0.35% without intracameral antibiotics, compared to 0.07% with intracameral cefuroxime. While 0.35% may seem low, endophthalmitis is a devastating complication that can result in permanent severe vision loss or loss of the eye. Given that cataract surgery is one of the most commonly performed surgical procedures worldwide, even a small percentage translates to a significant number of patients affected. For this reason, most European ophthalmic societies now recommend routine use of intracameral antibiotic prophylaxis.
Cataract surgery is rarely needed during pregnancy or breastfeeding. However, if it is considered necessary, Aprokam can be used when the benefit is judged to outweigh any potential risk. The intracameral dose (1 mg) is extremely small, and systemic absorption is negligible. This means that the theoretical risk to a fetus or nursing infant is minimal. Animal studies with cefuroxime have not shown harmful effects on the developing fetus. The decision should be made jointly by your ophthalmologist and your obstetrician or midwife.
Intracameral cefuroxime is highly effective. The ESCRS randomized controlled trial (2007) demonstrated an approximately five-fold reduction in postoperative endophthalmitis rates. The Swedish National Cataract Register data showed a decline from 0.11% to 0.02% after nationwide adoption. Large observational studies from France, the Netherlands, Portugal, and Australia have confirmed similar reductions. A 2017 Cochrane systematic review concluded that there is moderate-quality evidence supporting the use of intracameral antibiotics for endophthalmitis prevention after cataract surgery. Intracameral cefuroxime is now considered standard of care in most European countries.
References
- 1 ESCRS Endophthalmitis Study Group. Prophylaxis of postoperative endophthalmitis following cataract surgery: results of the ESCRS multicenter study and identification of risk factors. Journal of Cataract and Refractive Surgery. 2007;33(6):978-988.
- 2 European Medicines Agency (EMA). Aprokam – Summary of Product Characteristics. Laboratoires Théa. Last updated 2024.
- 3 Friling E, Lundström M, Stenevi U, Montan P. Six-year incidence of endophthalmitis after cataract surgery: Swedish national study. Journal of Cataract and Refractive Surgery. 2013;39(1):15-21.
- 4 Kessel L, Flesner P, Andresen J, Erngaard D, Tendal B, Hjortdal J. Antibiotic prevention of postcataract endophthalmitis: a systematic review and meta-analysis. Acta Ophthalmologica. 2015;93(4):303-317.
- 5 Cochrane Database of Systematic Reviews. Intracameral antibiotics for the prevention of endophthalmitis after cataract surgery. 2017.
- 6 ESCRS Guidelines on Prevention and Treatment of Endophthalmitis Following Cataract Surgery: Data, Dilemmas and Conclusions. 2013.
- 7 World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. 2023.
- 8 Montan PG, Wejde G, Koranyi G, Rylander M. Prophylactic intracameral cefuroxime. Evaluation of safety and kinetics in cataract surgery. Journal of Cataract and Refractive Surgery. 2002;28(6):982-987.
- 9 British National Formulary (BNF). Cefuroxime Monograph. NICE. 2024.
- 10 Behndig A, Cochener B, Guell JL, et al. Endophthalmitis prophylaxis in cataract surgery: overview of current practice patterns in 9 European countries. Journal of Cataract and Refractive Surgery. 2013;39(9):1421-1431.
About Our Medical Team
This article was written by the iMedic Medical Editorial Team, which includes licensed specialist physicians in clinical pharmacology and ophthalmology. Our team reviews all content according to international guidelines and the GRADE evidence framework.
All content undergoes multi-stage review: initial drafting by medical writers with specialist knowledge, clinical fact-checking against primary sources (EMA SmPC, ESCRS guidelines, Cochrane reviews, WHO recommendations), and final review by board-certified physicians. We declare no conflicts of interest and receive no pharmaceutical industry funding.