Ophthajod (Povidone-Iodine Eye Drops)

What Is Ophthajod and What Is It Used For?

Ophthajod is a sterile povidone-iodine eye drop solution (50 mg/ml) belonging to the antimicrobial and antiseptic drug class. It is used to disinfect the eye surfaces, eyelids, eyelashes, and surrounding facial skin before ophthalmic (eye) surgery to prevent postoperative infections such as endophthalmitis.

Ophthajod contains the active substance povidone-iodine, a well-established broad-spectrum antimicrobial agent that has been used in medical practice for decades. Povidone-iodine works by slowly releasing free iodine, which penetrates microbial cell walls and disrupts essential cellular processes including protein synthesis and membrane integrity. This mechanism of action makes it effective against a wide range of microorganisms, including bacteria, bacterial spores, fungi, and viruses.

The primary indication for Ophthajod is the preoperative antiseptic preparation of the eye and periocular area before ophthalmic surgery. Eye surgeries, including cataract extraction, vitrectomy, and corneal transplantation, carry a risk of introducing pathogens into the eye from the patient's own skin flora and conjunctival bacteria. Postoperative endophthalmitis – a devastating intraocular infection – is one of the most feared complications of eye surgery, and preoperative antisepsis with povidone-iodine is a cornerstone of its prevention.

Extensive clinical evidence supports the use of povidone-iodine for preoperative ocular antisepsis. The European Society of Cataract and Refractive Surgeons (ESCRS) and the American Academy of Ophthalmology (AAO) both recommend povidone-iodine application to the conjunctival sac as a standard preoperative measure to reduce the bacterial load on the ocular surface and lower the incidence of postoperative endophthalmitis. Multiple randomized controlled trials and meta-analyses have demonstrated that preoperative povidone-iodine application significantly reduces bacterial colony counts on the conjunctiva and decreases the rate of postoperative intraocular infections.

It is important to understand that Ophthajod is designed exclusively for topical ophthalmic and periocular use. It must never be injected into the eye (intraocularly) or into the tissues surrounding the eye (periocularly). Additionally, Ophthajod is not intended for eye irrigation (flushing particles or chemicals from the eye surface) and should not be used as a long-term treatment for any eye condition. The medication is administered in a single application by qualified healthcare personnel in a clinical or surgical environment.

How Does Povidone-Iodine Work as an Antiseptic?

Povidone-iodine is a chemical complex of polyvinylpyrrolidone (povidone) and elemental iodine. The povidone acts as a carrier molecule that releases free iodine gradually over time. This controlled release is important because it provides sustained antimicrobial activity while reducing the tissue irritation that pure iodine solutions would cause.

When applied to the eye surface and surrounding skin, the released iodine penetrates the cell walls of microorganisms and oxidizes key cellular structures including amino acids, nucleotides, and fatty acids. This non-specific mechanism of action means that microbial resistance to povidone-iodine is extremely rare – a significant advantage over antibiotic-based antiseptics. The broad-spectrum activity encompasses gram-positive and gram-negative bacteria (including methicillin-resistant Staphylococcus aureus), fungi (including Candida species), enveloped and non-enveloped viruses, and bacterial spores.

Why Is Preoperative Eye Antisepsis Important?

The ocular surface harbors a diverse microbiome that normally coexists harmlessly with the host. However, during eye surgery, this bacterial flora can gain access to the interior of the eye through the surgical incision. Postoperative endophthalmitis, while rare (occurring in approximately 0.04–0.2% of cataract surgeries), can result in permanent vision loss if not promptly treated. By reducing the microbial load on the ocular surface before the surgical incision is made, povidone-iodine significantly lowers this risk. Studies have shown that a single preoperative application of 5% povidone-iodine can reduce conjunctival bacterial colony counts by more than 90%.

What Should You Know Before Ophthajod Is Used?

Ophthajod must not be used in infants under 3 months, in people allergic to povidone-iodine, or together with mercury-based eye drops. Caution is needed in patients with thyroid disorders, dry eye syndrome, or corneal damage. Inform your surgeon about all medications you take, especially amiodarone and lithium.

Although Ophthajod is administered by healthcare professionals, patients should be aware of the important safety information below and communicate relevant medical history to their surgeon or anesthesiologist before the procedure. Open communication between patient and medical team is essential for safe use of any medication.

Contraindications

Ophthajod must not be used in the following situations:

• Allergy to povidone-iodine or any other ingredient in the product (see the full ingredients list in the section below)
• Infants under 3 months of age – the immature thyroid gland in very young infants is particularly susceptible to iodine absorption, which could disrupt thyroid hormone production
• Intraocular or periocular injection – Ophthajod is intended only for topical application on the eye surface and skin, not for injection into or around the eye
• Eye irrigation – the product should not be used to flush particles or chemicals from the eye surface
• Concurrent use with mercury-based preservatives – such as thiomersal (thimerosal), which is found in some older eye drop formulations

Warnings and Precautions

Ophthajod should be used with particular caution in the following circumstances:

• Eye conditions that increase iodine absorption: Patients with dry eye syndrome (keratoconjunctivitis sicca), corneal ulceration, or other conditions that compromise the integrity of the ocular surface may absorb more iodine into the bloodstream than expected. This could potentially affect thyroid function.
• Thyroid disorders: Because iodine can be absorbed through the eye, patients with existing thyroid conditions (hypothyroidism, hyperthyroidism, goiter, thyroid nodules) require careful monitoring. Iodine exposure may worsen thyroid dysfunction in susceptible individuals.
• Children under 6 years undergoing general anesthesia: Cases of abnormal breathing patterns (apnea or respiratory arrest) have been reported in children under 6 years old when Ophthajod was used during eye surgery performed under general anesthesia. Careful respiratory monitoring is essential in this patient population.
• Severe corneal damage: The phosphate content in Ophthajod (1.5 mg per ml) may, in very rare cases, cause calcium deposits and corneal clouding (calcification) in patients with severely damaged corneas.

Pregnancy and Breastfeeding

Ophthajod may be used during pregnancy and breastfeeding when the benefit is judged to outweigh the risk. Several factors support its safety profile in this context. First, the medication is typically used only once (as a preoperative antiseptic), resulting in very limited total exposure. Second, the systemic absorption of povidone-iodine through the intact ocular surface is low. Third, the amount of iodine that could potentially reach the fetus or nursing infant is minimal with a single application.

Nevertheless, the decision to use Ophthajod during pregnancy or breastfeeding should always be made by the treating physician, who will weigh the benefits of preventing postoperative eye infection against any theoretical risks. Women who are pregnant, breastfeeding, or planning pregnancy should inform their ophthalmologist before the surgical procedure.

Driving and Operating Machinery

Ophthajod itself has no significant effect on the ability to drive or operate machinery. However, patients who have undergone eye surgery will typically have specific postoperative restrictions on driving and operating machinery as determined by their surgeon. Any temporary visual disturbances following the surgical procedure should be considered when assessing fitness to drive.

How Does Ophthajod Interact with Other Drugs?

Ophthajod has significant interactions with amiodarone, lithium, mercury-based preservatives, sodium thiosulfate, hydrogen peroxide, silver-containing agents, and octenidine-based antiseptics. It can also interfere with thyroid function tests and radioiodine therapy. Always inform your surgeon about all medications you are taking.

Drug interactions with Ophthajod are primarily related to the iodine component and its potential to affect thyroid function or react chemically with other substances. Although the medication is used only once in most cases, the interactions listed below should be carefully considered, especially in patients who may have residual iodine effects from the application.

Major Interactions

Minor Interactions

Interference with Thyroid Tests and Radioiodine Therapy

Ophthajod should not be used before thyroid diagnostic tests (such as thyroid scintigraphy or protein-bound iodine determination) or radioiodine diagnostic procedures, as the absorbed iodine may interfere with test results and produce false readings. Similarly, use of Ophthajod before radioiodine therapy (iodine-131) for hyperthyroidism or thyroid cancer can reduce the effectiveness of the treatment by saturating the thyroid gland with non-radioactive iodine. If a patient requires thyroid testing or radioiodine therapy, the timing of ophthalmic surgery should be coordinated with the endocrinologist to allow sufficient washout of iodine.

What Is the Correct Dosage of Ophthajod?

Ophthajod is administered as a single preoperative application by a healthcare professional. The sterile solution is used to clean the eyelashes, eyelid margins, and surrounding skin, then instilled onto the eye surface. After a 3-minute contact time, the solution is rinsed away with sterile saline. There is no ongoing dosing regimen for patients.

Ophthajod is not a medication that patients self-administer or take on a regular schedule. It is used exclusively in a clinical setting by trained healthcare professionals as part of the preoperative preparation for eye surgery. The following information describes the standard administration procedure.

Administration Procedure (For Healthcare Professionals)

Important Administration Notes

• The sterile outer pouch of the dropper container should only be opened immediately before use to maintain sterility
• If the outer pouch is damaged or already open, the dropper container is no longer considered externally sterile and should not be used
• The dropper container must be discarded after use, even if it still contains remaining solution – it is a single-use product
• Each dropper container holds 4.0 ml of solution

Children

Ophthajod must not be used in infants under 3 months of age. In children under 6 years undergoing eye surgery under general anesthesia, the medication should be used with caution and with appropriate respiratory monitoring, as apnea (temporary cessation of breathing) has been reported in this age group.

Overdose

If an overdose occurs in the eye, the eye should be irrigated copiously with sterile 0.9% sodium chloride solution. In the rare event of accidental ingestion of a significant amount of the solution, gastric lavage (stomach pumping) may be performed if the ingestion was recent. Otherwise, supportive treatment should be provided. Accidental ingestion or inhalation of certain disinfectant solutions can have serious, sometimes fatal consequences, so immediate medical attention is essential.

What Are the Side Effects of Ophthajod?

The most serious side effect is a hypersensitivity (allergic) reaction, which can include anaphylaxis. Other reported side effects include conjunctival redness, eye irritation, superficial punctate keratitis, dry eye syndrome, contact dermatitis, and temporary discoloration of the eye or skin. Very rarely, corneal calcification may occur in patients with pre-existing corneal damage.

Like all medicines, Ophthajod can cause side effects, although not everyone experiences them. Since this medication is administered as a single application before surgery, side effects are generally limited to the immediate perioperative period. Your surgical team is trained to monitor for and manage any adverse reactions that may occur.

Understanding Thyroid-Related Side Effects

Although thyroid effects are listed as a potential side effect, it is important to place this in context. Thyroid dysfunction associated with povidone-iodine is primarily a concern with regular and prolonged use of iodine-containing products, not with a single preoperative application. The amount of iodine absorbed from a one-time ophthalmic application is generally very small and unlikely to cause thyroid problems in most patients. However, patients with pre-existing thyroid conditions or those who are particularly sensitive to iodine should inform their surgeon, who may arrange thyroid function monitoring.

Reporting Side Effects

If you experience any side effects after Ophthajod has been used during your eye surgery, report them to your ophthalmologist at your follow-up appointment. Reporting side effects helps regulatory authorities continuously monitor the benefit-risk balance of medicines. In the European Union, side effects can be reported through the national reporting systems of each member state.

How Should Ophthajod Be Stored?

Ophthajod should be stored below 25°C. The dropper container is for single use only and must be discarded after the surgical procedure, even if solution remains. Patients do not need to store this medication at home.

As Ophthajod is administered in a clinical setting by healthcare professionals, patients will not typically need to store this medication. The following storage information is provided for completeness and is primarily relevant to hospital pharmacies and surgical facilities:

• Temperature: Store at or below 25°C (77°F)
• Shelf life: Do not use after the expiration date printed on the carton, pouch, and dropper container (marked "EXP"). The expiration date refers to the last day of the stated month.
• Single use: The dropper container must be discarded after use, even if it contains remaining solution
• Sterility: The dropper container is stored inside double sterile pouches. The outer pouch should only be opened immediately before use. If the pouch is damaged or has been opened, the product should not be used.
• Disposal: Any unused product or waste material should be disposed of in accordance with local hospital waste management policies

What Does Ophthajod Contain?

Ophthajod contains povidone-iodine 50 mg/ml as the active ingredient. Inactive ingredients include glycerol, citric acid monohydrate, polysorbate 20, disodium phosphate dodecahydrate, sodium chloride, potassium iodate, sodium hydroxide, and purified water.

Active Ingredient

The active substance is povidone-iodine. Each milliliter of solution contains 50 mg of povidone-iodine, which corresponds to approximately 5% w/v available iodine. Povidone-iodine is a water-soluble complex of iodine with the synthetic polymer polyvinylpyrrolidone (PVP). This complexation reduces the irritation and toxicity associated with free iodine while maintaining its antimicrobial activity through the gradual release of free iodine molecules.

Inactive Ingredients (Excipients)

• Glycerol – provides viscosity and helps maintain moisture on the ocular surface
• Citric acid monohydrate – buffer to help maintain the pH of the solution
• Polysorbate 20 – non-ionic surfactant that helps distribute the solution evenly
• Disodium phosphate dodecahydrate – buffer component (note: this is the source of the phosphate content, 1.5 mg per ml)
• Sodium chloride – helps maintain isotonicity with body fluids
• Potassium iodate – stabilizer for the iodine content
• Sodium hydroxide – pH adjustment
• Purified water – solvent

Packaging

Ophthajod is supplied as a sterile polyethylene dropper container holding 4.0 ml of eye drop solution. The dropper container is enclosed in double sterile pouches to maintain external sterility until the moment of use. The product is manufactured by Netpharmalab Consulting Services, S.L. (Madrid, Spain) for the marketing authorization holder XGX Pharma ApS (Copenhagen, Denmark).

Frequently Asked Questions About Ophthajod