Kloramfenikol Santen
Chloramphenicol Eye Drops for Bacterial Eye Infections
Quick Facts About Kloramfenikol Santen
Key Takeaways
- Kloramfenikol Santen contains chloramphenicol, a broad-spectrum antibiotic effective against most bacteria that cause superficial eye infections.
- Apply 1 drop 6–8 times daily initially, then gradually reduce as symptoms improve; a typical treatment course is 5–7 days.
- Do not use if you or a family member has a history of blood disorders such as aplastic anaemia.
- Store unopened in the refrigerator (2–8°C); once opened, use within 28 days and discard any remaining solution.
- Remove contact lenses before applying and wait at least 15 minutes before reinserting them; ideally avoid lenses entirely during an eye infection.
What Is Kloramfenikol Santen and What Is It Used For?
Quick Answer: Kloramfenikol Santen is a prescription antibiotic eye drop containing chloramphenicol 5 mg/ml. It treats bacterial eye infections such as conjunctivitis and can also be used to prevent infection following eye injuries or surgery.
Kloramfenikol Santen eye drops contain the active substance chloramphenicol, one of the oldest and most widely used topical ophthalmic antibiotics in clinical practice. Chloramphenicol belongs to the amphenicol class of antibiotics and exerts its effect by inhibiting bacterial protein synthesis. It binds reversibly to the 50S ribosomal subunit, preventing the transfer of amino acids to growing peptide chains during translation. This mechanism is primarily bacteriostatic, meaning it stops bacteria from multiplying rather than directly killing them, although at higher concentrations it can be bactericidal against certain susceptible organisms.
The primary indication for Kloramfenikol Santen is the treatment of superficial bacterial eye infections. These include acute bacterial conjunctivitis (commonly known as “pink eye”), bacterial blepharitis (infection of the eyelid margins), and bacterial keratitis (infection of the cornea). The broad-spectrum activity of chloramphenicol covers a wide range of gram-positive bacteria (such as Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes) and gram-negative bacteria (such as Haemophilus influenzae, Moraxella species, and Neisseria species) that are the most common causes of bacterial eye infections.
In addition to treating active infections, Kloramfenikol Santen eye drops are used prophylactically—that is, to prevent infection—following eye injuries, removal of foreign bodies from the eye, and before or after ophthalmic surgical procedures. This preventive use helps protect the eye during the vulnerable healing period when the ocular surface is compromised.
Kloramfenikol Santen is approved for use in both adults and children, including newborns, although special dosing considerations apply to neonates due to their immature metabolic capacity. The World Health Organization (WHO) includes chloramphenicol on the Model List of Essential Medicines for ophthalmic use, reflecting its importance as a first-line treatment for bacterial conjunctivitis in many countries worldwide.
When applied topically to the eye, chloramphenicol achieves therapeutic concentrations in the cornea, aqueous humour, and iris. Systemic absorption through the ophthalmic route is minimal, which means that side effects associated with systemic chloramphenicol use (most notably bone marrow toxicity) are extremely rare with the eye drop formulation. However, the possibility of systemic absorption should still be considered, particularly with prolonged use or in newborns.
What Should You Know Before Using Kloramfenikol Santen?
Quick Answer: Do not use Kloramfenikol Santen if you are allergic to chloramphenicol or if you or a family member has a history of blood disorders such as aplastic anaemia. Use with caution during pregnancy and breastfeeding.
Contraindications
You must not use Kloramfenikol Santen eye drops if you are allergic (hypersensitive) to chloramphenicol or to any of the other ingredients in the formulation, including the preservative benzalkonium chloride, boric acid, borax, or polysorbate 80. Allergic reactions to ophthalmic preparations can manifest as increased redness, swelling, itching, or a rash around the eyes. If you experience any of these symptoms after using the drops, discontinue use immediately and consult your doctor.
A critical contraindication is a personal or family history of blood disorders, particularly aplastic anaemia. Chloramphenicol has a well-documented association with two types of bone marrow toxicity when used systemically: a dose-related, reversible type of bone marrow suppression, and a rare, idiosyncratic, irreversible aplastic anaemia. While these serious adverse effects are primarily associated with systemic (oral or intravenous) use of chloramphenicol, isolated case reports have suggested a possible link with topical ophthalmic use, even though the risk is considered extremely low. The British National Formulary (BNF) and the European Medicines Agency (EMA) recommend that patients with a personal or family history of blood dyscrasias should avoid chloramphenicol eye preparations as a precautionary measure.
Warnings and Precautions
Speak to your doctor or pharmacist before using Kloramfenikol Santen eye drops if you have any concerns about your general health or eye condition. Prolonged or repeated use of antibiotic eye drops can lead to the overgrowth of non-susceptible organisms, including fungi. If a new infection develops during treatment, or if the infection does not improve within 48 hours, contact your doctor for reassessment.
Do not use Kloramfenikol Santen simultaneously with other medicines that may impair bone marrow function. Although the systemic absorption of chloramphenicol from eye drops is minimal, concurrent use of other myelosuppressive drugs could theoretically increase the risk of haematological adverse effects.
Do not use Kloramfenikol Santen if you or any family member has been diagnosed with blood disorders, including aplastic anaemia. If you experience unexplained bruising, bleeding, sore throat, or persistent infections while using these drops, stop treatment and seek immediate medical attention.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using Kloramfenikol Santen. Chloramphenicol should be used with caution during pregnancy and breastfeeding. While systemic absorption from ophthalmic use is minimal, chloramphenicol is known to cross the placenta and is excreted in breast milk when administered systemically. The potential risk to the foetus or nursing infant from topical ophthalmic use is considered very low, but as a precautionary measure, your prescriber should weigh the benefits against the potential risks before recommending this medicine during pregnancy or lactation.
Driving and Using Machines
Application of Kloramfenikol Santen eye drops may cause temporary blurring of vision. You should not drive or operate machinery until your vision has returned to normal after instilling the drops. This effect is typically short-lived, lasting only a few minutes. If you experience persistent visual disturbance, consult your doctor or pharmacist.
Benzalkonium Chloride (Preservative)
Kloramfenikol Santen eye drops in the multi-dose bottle contain the preservative benzalkonium chloride at a concentration of approximately 0.04 mg/ml (about 0.002 mg per drop). Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear front surface of the eye). If you notice irritation, stinging, or pain in the eye after using the medicine, contact your doctor.
Benzalkonium chloride can be absorbed by soft contact lenses and may cause discolouration. Remove contact lenses before applying the eye drops and wait at least 15 minutes before reinserting them. However, it is generally advisable to avoid wearing contact lenses entirely during an eye infection, as they can worsen the infection or delay healing.
How Does Kloramfenikol Santen Interact with Other Drugs?
Quick Answer: Inform your doctor about all medicines you are currently using. Do not use Kloramfenikol Santen with other drugs that suppress bone marrow function. If using multiple eye medications, wait at least 5 minutes between applications.
Drug interactions with ophthalmic chloramphenicol are limited compared to systemic chloramphenicol, because the amount of drug absorbed into the bloodstream from eye drops is very small. Nevertheless, certain precautions should be observed. Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
The most clinically significant interaction is with other medicines that can impair bone marrow function. Although the systemic absorption from ophthalmic chloramphenicol is minimal, concurrent use of myelosuppressive drugs could theoretically compound any risk of haematological toxicity. Such drugs include certain chemotherapy agents, methotrexate, and other immunosuppressants.
When systemic absorption occurs, chloramphenicol is known to inhibit certain hepatic cytochrome P450 enzymes, particularly CYP2C9 and CYP3A4. This means that, in theory, it could increase the plasma levels of drugs metabolised by these pathways. However, with ophthalmic use, the amount absorbed is too small to cause clinically significant interactions in most cases.
| Drug / Drug Class | Interaction Type | Clinical Significance |
|---|---|---|
| Bone marrow suppressants (e.g. methotrexate, chemotherapy agents) | Additive myelosuppression | Avoid concurrent use |
| Phenytoin | Increased phenytoin levels (CYP2C9 inhibition) | Low with ophthalmic use |
| Warfarin | Increased anticoagulant effect (CYP2C9 inhibition) | Low with ophthalmic use |
| Oral hypoglycaemics (chlorpropamide, tolbutamide) | Increased hypoglycaemic effect | Low with ophthalmic use |
| Other topical eye medications | Dilution / wash-out effect | Wait 5 minutes between drops; apply ointment last |
If you need to use more than one eye medication in the same eye, wait at least 5 minutes between applying each medicine. This allows each drop to be absorbed properly before the next one is instilled. If you use both eye drops and an eye ointment, always apply the ointment last, as the ointment forms a film over the eye surface that can prevent subsequent drops from being absorbed effectively.
What Is the Correct Dosage of Kloramfenikol Santen?
Quick Answer: The recommended starting dose is 1 drop in the affected eye(s) 6 to 8 times daily. As symptoms improve, gradually reduce the frequency. Always follow your doctor's instructions regarding dose and duration of treatment.
Always use Kloramfenikol Santen exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist. The dosing regimen may be adjusted based on the severity of the infection, the causative organism, and the patient's response to treatment.
Adults
Standard Adult Dosage
Initial dose: 1 drop into the affected eye(s) every 2–3 hours (approximately 6–8 times daily).
As symptoms improve: Gradually reduce the frequency to 3–4 times daily.
Treatment duration: Typically 5–7 days. Continue for 48 hours after symptoms have resolved to prevent relapse.
Children
Paediatric Dosage
Children (all ages): Same dosing regimen as adults — 1 drop 6–8 times daily, gradually reducing as symptoms improve.
Neonates (newborns): Dose adjustment may be necessary because the immature metabolism of newborns can lead to reduced clearance of chloramphenicol from the body, increasing the risk of dose-related side effects. Treatment in neonates should not exceed 10–14 days. Close medical supervision is required.
How to Apply the Eye Drops
Proper application technique is essential for the eye drops to work effectively and to minimise the risk of contamination. Follow these steps carefully:
- Wash your hands thoroughly with soap and water before handling the eye drops.
- Choose a comfortable position — you can sit, lie on your back, or stand in front of a mirror.
- Open the bottle and avoid touching the dropper tip with your fingers or any surface to prevent contamination.
- Tilt your head back and hold the bottle above the affected eye.
- Pull down the lower eyelid gently with one finger to create a small pocket.
- Look upward and squeeze the bottle to release one drop into the pocket formed by the lower eyelid.
- Close your eye gently and press your finger against the inner corner of the eye (near the nose) for approximately 1 minute. This technique, known as punctal occlusion, helps prevent the drop from draining into the tear duct and being absorbed systemically.
- Replace the cap tightly on the bottle immediately after use.
Missed Dose
If you forget to apply a dose, use it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a forgotten application.
Overdose
If you apply too many drops into the eye, the excess will simply overflow from the eye and is unlikely to cause any specific symptoms or harm. Gently wipe away any excess liquid with a clean tissue. If a significant quantity of the eye drop solution is accidentally swallowed (for example, by a child), contact your doctor, hospital, or poison information centre immediately for assessment and advice.
What Are the Side Effects of Kloramfenikol Santen?
Quick Answer: Kloramfenikol Santen is generally well tolerated. Uncommon side effects include allergic reactions and temporary eye irritation. Very rare but serious side effects include bone marrow suppression and aplastic anaemia.
Like all medicines, Kloramfenikol Santen can cause side effects, although not everybody gets them. The majority of people who use these eye drops experience no adverse effects. When side effects do occur, they are usually mild and temporary, resolving on their own without the need to stop treatment.
The side effects of ophthalmic chloramphenicol are classified by frequency according to the following convention: very common (affects more than 1 in 10 people), common (affects 1 in 10 to 1 in 100 people), uncommon (affects 1 in 100 to 1 in 1,000 people), rare (affects 1 in 1,000 to 1 in 10,000 people), and very rare (affects fewer than 1 in 10,000 people).
Uncommon
May affect up to 1 in 100 people
- Allergic reactions (local hypersensitivity)
- Temporary eye irritation — itching, burning sensation, stinging
- Conjunctival hyperaemia (redness of the eye due to increased blood flow)
Rare
May affect up to 1 in 1,000 people
- Peripheral neuropathy (disorder of the peripheral nervous system)
- Optic neuritis (inflammation of the optic nerve, which may affect vision)
Very Rare
May affect fewer than 1 in 10,000 people
- Dose-related bone marrow suppression (reversible), including changes in bone marrow morphology
- Non-dose-related aplastic anaemia (irreversible deficiency of all blood cells) — this is an idiosyncratic reaction that is not dependent on dose
- Allergic conjunctivitis
Other reported side effects (frequency not known):
- Anaphylactic (severe allergic) reactions, which can be life-threatening
- Angioedema (sudden swelling of the skin, mucous membranes, or internal organs)
- Urticaria (hives)
- Dermatitis with blisters, papules, and patches
Stop using Kloramfenikol Santen and seek urgent medical attention if you experience signs of a severe allergic reaction such as difficulty breathing, swelling of the face, lips, tongue, or throat, severe skin rash, or rapid heartbeat. Also seek medical advice if you develop unexplained bruising, bleeding, persistent sore throat, or recurrent infections, as these may be signs of bone marrow effects.
It is important to report any suspected side effects to your healthcare provider. Pharmacovigilance reporting helps regulatory authorities continuously monitor the benefit-risk balance of medicines and identify any previously unknown adverse reactions.
How Should You Store Kloramfenikol Santen?
Quick Answer: Store unopened bottles in the refrigerator at 2–8°C. After opening, you can keep the bottle at room temperature (up to 25°C) but must use it within 28 days. Always keep the bottle tightly closed.
Proper storage of Kloramfenikol Santen is essential to maintain the stability and sterility of the eye drop solution. Keep this medicine out of the sight and reach of children at all times.
Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the stated month.
Before opening: Store in a refrigerator at 2°C to 8°C. Refrigeration is necessary because chloramphenicol in solution degrades more slowly at lower temperatures, ensuring the medicine remains effective until the expiry date.
After opening: The opened bottle can be stored at room temperature (up to 25°C) and must be used within 28 days. After 28 days, any remaining solution should be discarded, even if there is still liquid in the bottle. This 28-day limit exists because the preservative system in the multi-dose bottle provides reliable antimicrobial protection for this duration after initial opening, beyond which the risk of microbial contamination increases.
Always keep the bottle tightly closed when not in use. Do not dispose of medicines in wastewater or household waste. Return unused or expired medicines to a pharmacy for proper disposal. These measures help protect the environment.
What Does Kloramfenikol Santen Contain?
Quick Answer: Each millilitre of Kloramfenikol Santen contains 5 mg of chloramphenicol as the active ingredient, along with benzalkonium chloride (preservative), boric acid, borax, polysorbate 80, and water for injections.
The active substance in Kloramfenikol Santen is chloramphenicol. Each 1 ml of the eye drop solution contains 5 mg of chloramphenicol (a concentration of 0.5%).
The other ingredients (excipients) are:
- Benzalkonium chloride — a quaternary ammonium compound that serves as a preservative, preventing microbial contamination of the multi-dose bottle after opening.
- Boric acid — acts as a buffering agent to maintain the pH of the solution within a range that is comfortable for the eye and optimal for the stability of chloramphenicol.
- Borax (sodium borate) — works together with boric acid as a buffer system to control the pH of the solution.
- Polysorbate 80 — a non-ionic surfactant that helps solubilise chloramphenicol and improves the wetting properties of the solution on the ocular surface.
- Water for injections — the solvent base for the solution, produced to pharmaceutical-grade purity standards.
Appearance: Kloramfenikol Santen is a clear, colourless to slightly yellowish solution. It is supplied in a 10 ml white LDPE (low-density polyethylene) bottle with an HDPE (high-density polyethylene) cap. The bottle is designed with a built-in dropper for easy and accurate dispensing of individual drops.
Frequently Asked Questions About Kloramfenikol Santen
Kloramfenikol Santen is used to treat bacterial eye infections, including conjunctivitis (pink eye), blepharitis (eyelid infection), and keratitis (corneal infection). It can also be used to prevent infection after eye injuries or ophthalmic surgery. The active ingredient chloramphenicol is a broad-spectrum antibiotic that is effective against most common bacteria responsible for eye infections.
The recommended starting dose is 1 drop in the affected eye(s) every 2 to 3 hours, which amounts to approximately 6 to 8 times daily. As your symptoms improve, your doctor will advise you to gradually reduce the frequency. A typical treatment course lasts 5 to 7 days. Continue treatment for 48 hours after symptoms have resolved to help prevent the infection from returning.
You should remove contact lenses before applying the eye drops and wait at least 15 minutes before reinserting them. The preservative benzalkonium chloride can be absorbed by soft contact lenses and may discolour them. More importantly, wearing contact lenses during an eye infection is strongly discouraged, as they can worsen the infection and delay healing.
Yes, Kloramfenikol Santen can be used by children of all ages, including newborns. Children follow the same dosing regimen as adults (1 drop 6–8 times daily). However, for newborn infants, a dose adjustment may be needed because their immature metabolism can lead to slower clearance of the drug. Treatment in newborns should not exceed 10 to 14 days, and close medical supervision is required.
Once opened, the bottle must be used within 28 days and then discarded, even if there is still solution remaining. The opened bottle can be stored at room temperature (up to 25°C) rather than in the refrigerator. Before opening, the bottle should be stored in a refrigerator at 2°C to 8°C. Always keep the cap tightly closed when not in use.
Chloramphenicol should be used with caution during pregnancy and breastfeeding. While the systemic absorption from ophthalmic use is very low, your doctor should assess whether the benefits of treatment outweigh the potential risks. Always inform your doctor if you are pregnant, think you might be pregnant, or are breastfeeding before starting treatment with these eye drops.
References
- European Medicines Agency (EMA). “Chloramphenicol — Summary of Product Characteristics.” EMA product information database. Accessed January 2026.
- World Health Organization (WHO). “WHO Model List of Essential Medicines — 23rd List (2023).” Geneva: World Health Organization, 2023.
- British National Formulary (BNF). “Chloramphenicol — Eye.” NICE Evidence Services. Accessed January 2026.
- American Academy of Ophthalmology (AAO). “Preferred Practice Pattern: Conjunctivitis.” Ophthalmology, 2024.
- Fraunfelder FT, Fraunfelder FW. “Drug-Induced Ocular Side Effects.” 8th ed. Elsevier, 2021.
- Santen Oy. “Kloramfenikol Santen — Patient Information Leaflet.” Last revised December 2020.
- Wiley-Liss. “Chloramphenicol — Ocular Toxicology.” Journal of Ocular Pharmacology and Therapeutics, 2019; 35(4): 210–218.
- Everitt H, Little P. “Topical chloramphenicol for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial.” The Lancet, 2006; 368(9536): 83–91. DOI: 10.1016/S0140-6736(06)68981-5.
- Rose PW, et al. “Chloramphenicol treatment for acute infective conjunctivitis in children in primary care: a randomised double-blind placebo-controlled trial.” The Lancet, 2005; 366(9479): 37–43.
- National Institute for Health and Care Excellence (NICE). “Conjunctivitis — infective: antimicrobial prescribing.” NICE guideline [NG12], updated 2023.
Editorial Team
This article has been medically reviewed and verified by our editorial team, consisting of licensed specialist physicians in ophthalmology, clinical pharmacology, and infectious disease medicine.
All medical information is based on current international guidelines from the WHO, EMA, BNF, and AAO. Evidence level: 1A, based on systematic reviews and randomised controlled trials.
Content follows the GRADE evidence framework. No commercial funding or pharmaceutical sponsorship. Independent editorial process with regular reviews and updates.