Softacort (Hydrocortisone Sodium Phosphate)
Preservative-free corticosteroid eye drops for mild allergic and inflammatory eye conditions
Quick Facts: Softacort
Key Takeaways
- Softacort is a preservative-free corticosteroid eye drop that treats mild allergic and inflammatory conditions of the conjunctiva (the outer surface of the eye).
- It comes in convenient single-dose containers, eliminating the need for preservatives that can irritate the ocular surface.
- Treatment is typically short-term (up to 14 days) and should be tapered gradually to prevent relapse.
- Do not use Softacort if you have an active eye infection (viral, bacterial, or fungal) unless it is being treated concurrently with appropriate anti-infective therapy.
- Contact lenses must not be worn during treatment. Regular eye examinations are recommended during use, especially for monitoring intraocular pressure.
What Is Softacort and What Is It Used For?
Softacort belongs to the class of ophthalmic corticosteroids, which are medications designed to suppress inflammatory and allergic responses in the eye. The active substance, hydrocortisone sodium phosphate, works by inhibiting the release of inflammatory mediators, reducing vascular permeability, and preventing the accumulation of inflammatory cells at the site of ocular inflammation. This results in decreased swelling, redness, itching, and discomfort associated with allergic and inflammatory eye conditions.
Unlike many other ophthalmic corticosteroid preparations, Softacort is formulated as a preservative-free solution packaged in individual single-dose containers. This is a significant advantage because preservatives commonly used in multi-dose eye drop bottles, such as benzalkonium chloride (BAK), are known to cause dose-dependent toxicity to the ocular surface, particularly to the corneal epithelium. Preservative-free formulations are especially beneficial for patients with sensitive eyes, those with dry eye disease, and patients requiring multiple topical eye medications simultaneously.
The medication is specifically indicated for mild allergic conjunctivitis and mild non-infectious inflammatory conditions of the conjunctiva. Common conditions that may benefit from Softacort include seasonal allergic conjunctivitis (hay fever-related eye symptoms), mild contact allergic conjunctivitis, and post-procedural superficial ocular inflammation. Hydrocortisone is considered a low-potency corticosteroid compared to more potent agents such as dexamethasone or prednisolone, making it particularly suitable for mild inflammatory conditions where a gentler approach is appropriate.
It is critically important that the eye is not infected when using Softacort, as corticosteroids can worsen infections by suppressing the local immune response. If an infection is present, it must be treated concurrently with appropriate antimicrobial therapy before or alongside corticosteroid use. Your healthcare provider will assess your condition and determine whether Softacort is appropriate for your specific situation.
Hydrocortisone, the active component of Softacort, is included on the World Health Organization (WHO) Model List of Essential Medicines, reflecting its established safety profile and clinical utility when used appropriately. As an ophthalmic preparation with the ATC code S01BA02, Softacort occupies a well-defined therapeutic niche in ocular pharmacology.
What Should You Know Before Using Softacort?
Before starting treatment with Softacort, your doctor will evaluate your overall eye health and medical history to ensure this medication is appropriate for you. Several important conditions must be ruled out or addressed before beginning therapy. Understanding these precautions will help you use Softacort safely and effectively.
Contraindications
You must not use Softacort under the following circumstances:
- You are allergic to hydrocortisone sodium phosphate or any of the other ingredients in this medication.
- You have elevated intraocular pressure (ocular hypertension) known to be caused by glucocorticoids or other causes.
- You have an active herpes simplex virus infection or other viral infection of the eye with corneal ulceration, unless concurrent antiviral treatment is given.
- You have conjunctivitis with corneal ulceration (keratitis), even if the infection is in an early stage.
- You have an acute bacterial eye infection, including purulent infections, bacterial conjunctivitis, eyelid inflammation (blepharitis), or stye (hordeolum).
- You have a fungal infection of the eye (ocular mycosis).
- You have ocular tuberculosis.
Warnings and Precautions
Several important precautions should be observed during treatment with Softacort. You should discuss all of these with your healthcare provider before starting the medication.
Undiagnosed red eye: If you have a red eye that has not been properly diagnosed by a healthcare professional, do not use this medication. Redness can be caused by infections, acute glaucoma, or other conditions that may be worsened by corticosteroid use. Always seek a proper diagnosis before initiating treatment.
Herpes simplex keratitis: If you have a history of herpes simplex virus infection of the eye, Softacort should only be used if antiviral treatment is administered concurrently. Careful and frequent monitoring of the eye by an ophthalmologist is required in these cases, as corticosteroids can reactivate dormant herpes virus and worsen the infection.
Corneal thinning: Patients with conditions that cause thinning of the cornea or sclera (the outer layers of the eye) face a higher risk of perforation when using topical corticosteroids. If you have a history of corneal thinning, ulceration, or surgical procedures affecting the cornea, your doctor will weigh the risks and benefits carefully.
Corneal ulcers and fungal infections: If you have been using corticosteroid eye drops for an extended period and develop a corneal ulcer, a fungal infection should be suspected. Corticosteroids can mask the signs and symptoms of infection, making diagnosis more difficult.
Intraocular pressure and glaucoma: Long-term use of corticosteroid eye drops has been shown to increase intraocular pressure (IOP), potentially leading to glaucoma. This is particularly concerning for patients who already have elevated IOP or are at risk for developing it. Regular monitoring of intraocular pressure is recommended during treatment, especially if treatment extends beyond a few days.
Cataract formation: Prolonged use of corticosteroid eye drops has been associated with the development of posterior subcapsular cataracts, particularly in children and elderly patients. Treatment should be kept as short as possible to minimize this risk.
Immunosuppressed patients: Corticosteroid eye drops can cause or exacerbate ocular infections in patients with weakened immune systems. These medications can also mask the signs and symptoms of infection, potentially delaying appropriate treatment.
You must not wear contact lenses during treatment with Softacort. Contact lenses should be removed before applying the eye drops and should not be reinserted until your treatment course is completed, as directed by your prescribing physician.
Contact your doctor if you experience blurred vision or other visual disturbances during treatment. Temporary blurring may occur immediately after applying the drops, but persistent visual changes should be reported promptly.
Use in Children
The safety and efficacy of Softacort in children have not been established. If your doctor prescribes this medication for a child, close monitoring is essential. Children are particularly susceptible to the adverse effects of corticosteroid eye drops, including adrenal suppression with prolonged use, and they tend to develop increased intraocular pressure more frequently, more severely, and more rapidly than adults.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using Softacort.
Pregnancy: The use of Softacort during pregnancy is not recommended unless your doctor considers it essential and it is used under strict medical supervision. Although systemic absorption from ophthalmic use is generally low, corticosteroids have been associated with adverse effects on fetal development in animal studies when given at high doses.
Breastfeeding: It is not known whether hydrocortisone sodium phosphate passes into breast milk following ophthalmic administration. Your doctor will determine whether you should use Softacort while breastfeeding, weighing the benefit to you against the potential risk to your baby.
Driving and Operating Machinery
Temporary blurred vision or other visual disturbances may occur immediately after applying Softacort. Do not drive or operate machinery until your vision has returned to normal. You are responsible for judging whether you are fit to drive or perform tasks requiring alertness after using this medication.
How Does Softacort Interact with Other Drugs?
Because Softacort is applied topically to the eye and systemic absorption is generally low, the potential for drug interactions is relatively limited compared to oral or injectable corticosteroids. However, some interactions are clinically relevant and should be discussed with your prescribing physician.
Tell your doctor or pharmacist about all medications you are currently using, have recently used, or may be planning to use, including over-the-counter products. This is important because even topical medications can interact with systemically absorbed drugs, and multiple eye medications may affect each other's efficacy.
Known Interactions
| Interacting Drug | Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Ritonavir | CYP3A4 inhibitor (HIV protease inhibitor) | May increase systemic corticosteroid effects by reducing metabolism | Close medical monitoring recommended |
| Cobicistat | CYP3A4 inhibitor (pharmacokinetic enhancer) | May increase systemic corticosteroid effects by reducing metabolism | Close medical monitoring recommended |
| Other ophthalmic preparations | Local interaction | May dilute or alter absorption of either medication | Wait at least 5 minutes between applications |
CYP3A4 Inhibitors
Certain medications, particularly those used in the treatment of HIV/AIDS, are potent inhibitors of the CYP3A4 enzyme. Ritonavir and cobicistat are the most clinically relevant examples. These drugs can reduce the metabolic clearance of corticosteroids, potentially increasing systemic exposure and the risk of systemic corticosteroid side effects such as Cushing's syndrome and adrenal suppression. While the risk is generally low with ophthalmic corticosteroid use due to minimal systemic absorption, your doctor may want to monitor you more closely if you are taking these medications.
Other Eye Medications
If you are using more than one type of eye drop, it is important to maintain a minimum interval of 5 minutes between applications. This allows each medication to be adequately absorbed before the next one is applied. Applying multiple eye drops simultaneously can result in dilution of the active ingredient or physical washing out of the first drop by the second, reducing the therapeutic efficacy of both medications.
Softacort contains 0.227 mg phosphate per drop. In patients with a severely damaged cornea, phosphate-containing eye drops have very rarely been associated with calcification of the cornea (corneal calcification). This is an extremely rare occurrence but should be considered in patients with significant corneal pathology.
What Is the Correct Dosage of Softacort?
Always use Softacort exactly as your doctor or pharmacist has told you. If you are unsure about the correct dose or frequency, check with your doctor or pharmacist before proceeding. The dosage and duration of treatment will be determined by your healthcare provider based on the severity of your condition and your response to therapy.
Adults and Elderly
Standard Dosing – Adults and Elderly
Dose: 2 drops in the affected eye(s)
Frequency: 2 to 4 times per day, as prescribed
Duration: Typically a few days up to a maximum of 14 days
Tapering: Gradual dose reduction is recommended to avoid relapse
The same dosage applies to both adults and elderly patients. Your doctor will prescribe the appropriate frequency based on the severity of your condition. For milder inflammation, 2 times daily may be sufficient, while more significant inflammation may require up to 4 times daily. As your symptoms improve, your doctor will typically instruct you to gradually reduce the frequency of application before stopping altogether. This tapering approach helps prevent rebound inflammation.
Children
Children
The safety and efficacy of Softacort in children have not been established. There are no adequate data available. If a doctor prescribes this medication for a child, they will determine the appropriate dose and monitor the child closely for side effects, particularly increases in intraocular pressure.
How to Apply the Eye Drops
Softacort is supplied in single-dose containers designed for one-time use. Follow these instructions carefully for correct application:
- Wash your hands thoroughly and sit or stand comfortably.
- Open the pouch containing 10 single-dose containers. Write the date of first opening on the pouch.
- Break off one single-dose container from the strip.
- Twist off the top of the container. Do not touch the tip after opening to maintain sterility.
- Gently pull down the lower eyelid of the affected eye to create a small pocket.
- Position the container tip close to your eye without touching it.
- Squeeze gently to release two drops into the lower eyelid pocket, then release the eyelid.
- Press a finger against the inner corner of the eye (at the nose) for approximately 1 minute while keeping the eye closed. This technique, called nasolacrimal occlusion, helps reduce systemic absorption and keeps the medication in the eye.
- If your doctor has instructed treatment of both eyes, repeat the process for the other eye. Each single-dose container contains enough solution for both eyes.
- Discard the container after use. Do not save it for later use, as sterility cannot be maintained after opening.
- Return unused containers to the pouch and store the pouch in the carton. Unopened containers must be used within one month after opening the pouch.
Missed Dose
If you forget to apply Softacort at the scheduled time, apply 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 schedule. Do not apply a double dose to make up for a missed one.
Overdose
If you accidentally apply too many drops, rinse your eye with sterile water if you experience irritation that does not resolve. Contact your doctor or pharmacist promptly. If the medication is accidentally ingested (for example, by a child), contact your local poison control center or seek emergency medical attention for assessment.
Do not discontinue treatment suddenly. Always consult your doctor before stopping Softacort, as abrupt cessation may lead to a rebound of inflammation. Your doctor will typically recommend a gradual reduction in the frequency of application.
What Are the Side Effects of Softacort?
Like all medicines, Softacort can cause side effects, although not everyone experiences them. Most side effects are mild and temporary, occurring shortly after application. However, prolonged use of any corticosteroid eye drop carries the risk of more serious adverse effects, which is why treatment duration should be kept as short as clinically necessary.
The side effects listed below include those specifically reported with Softacort as well as those known to occur with ophthalmic corticosteroids as a class. Because Softacort uses hydrocortisone (a relatively low-potency corticosteroid), the risk of serious side effects is generally lower than with more potent corticosteroids, provided treatment duration remains short.
Reported with Softacort
Frequency not known (cannot be estimated from available data)
- Temporary eye discomfort (burning or stinging sensation) after application
Reported with Ophthalmic Corticosteroids (Class Effects)
Frequency not known (cannot be estimated from available data)
- Allergic reactions
- Delayed wound healing
- Posterior subcapsular cataract (clouding of the lens)
- Secondary eye infections in immunocompromised patients (herpes virus, fungal infections)
- Increased intraocular pressure (glaucoma)
- Pupil dilation (mydriasis)
- Drooping eyelid (ptosis)
- Inflammation inside the eye (uveitis)
- Changes in corneal thickness
- Crystalline keratopathy (corneal inflammation)
- Blurred vision
Very Rare – Phosphate-Related
In patients with severely damaged cornea only
- Corneal calcification (cloudy patches on the cornea due to calcium accumulation) – associated with phosphate content in the formulation
When to Seek Immediate Medical Attention
Contact your doctor or seek immediate medical attention if you experience any of the following during treatment with Softacort:
- Sudden decrease in vision or loss of vision
- Severe eye pain that does not resolve after application
- Signs of eye infection (increasing redness, discharge, swelling, sensitivity to light)
- Signs of an allergic reaction (severe itching, swelling of the face or eyelids, difficulty breathing)
- Persistent blurred vision or visual disturbances
Reporting Side Effects
It is important to report suspected side effects after a medicine has been authorized. This helps regulatory authorities continuously monitor the benefit-risk balance of the medicine. You can report side effects to your national pharmacovigilance agency or the European Medicines Agency (EMA).
How Should You Store Softacort?
Proper storage of Softacort is essential to ensure the medication remains effective and sterile. Because Softacort is supplied in preservative-free single-dose containers, adherence to storage instructions is particularly important.
- Temperature: Store at or below 25°C (77°F). Do not freeze.
- Light protection: Keep the single-dose containers inside the aluminium pouch to protect them from light. The medication is light-sensitive.
- After opening the pouch: Use all remaining single-dose containers within one month of opening the pouch. Write the opening date on the pouch for reference.
- After opening a single-dose container: Use immediately and discard after application. Sterility cannot be maintained after opening.
- Keep out of reach of children.
- Do not use after the expiry date printed on the carton, pouch, and single-dose container (after “EXP”). The expiry date refers to the last day of that month.
- Disposal: Do not dispose of medicines through wastewater or household waste. Ask your pharmacist about proper disposal methods to help protect the environment.
Unopened pouch: below 25°C, use before expiry date. Opened pouch: use containers within 1 month. Opened container: use immediately, then discard.
What Does Softacort Contain?
Active Ingredient
The active substance is hydrocortisone sodium phosphate. Each millilitre of eye drop solution contains 3.35 mg of hydrocortisone sodium phosphate. This is equivalent to approximately 2.5 mg of hydrocortisone base per ml.
Inactive Ingredients (Excipients)
The other ingredients in Softacort are:
- Disodium phosphate dodecahydrate
- Sodium dihydrogen phosphate monohydrate
- Sodium chloride
- Disodium edetate (EDTA)
- Hydrochloric acid (for pH adjustment)
- Water for injections
Notably, Softacort does not contain any preservatives. The preservative-free formulation is one of the key advantages of this product, as it reduces the risk of preservative-induced ocular surface toxicity.
Appearance and Pack Sizes
Softacort is a nearly clear, colourless to slightly yellow solution that is practically free from particles. Each single-dose container holds 0.4 ml of solution. The containers are packaged in pouches of 10, and the following pack sizes are available:
- 10 single-dose containers (1 × 10)
- 20 single-dose containers (2 × 10)
- 30 single-dose containers (3 × 10)
- 60 single-dose containers (6 × 10)
Not all pack sizes may be marketed in every country.
Frequently Asked Questions About Softacort
Softacort is a preservative-free corticosteroid eye drop used to treat mild allergic or inflammatory conditions of the conjunctiva (the outer membrane of the eye). Common indications include seasonal allergic conjunctivitis and mild non-infectious inflammatory eye conditions. It works by suppressing the immune and inflammatory response in the eye, reducing symptoms such as redness, swelling, and itching.
No, you should not wear contact lenses during treatment with Softacort. Contact lenses can trap the medication on the eye surface, potentially increasing the risk of adverse effects. Additionally, many inflammatory eye conditions themselves preclude contact lens use. Your doctor will advise when it is safe to resume wearing contact lenses after completing treatment.
Treatment with Softacort typically lasts from a few days to a maximum of 14 days. Your doctor will determine the exact duration based on your condition. Long-term use of corticosteroid eye drops increases the risk of serious complications such as glaucoma and cataracts, so treatment should be as short as possible. Do not stop treatment abruptly; your doctor will recommend a gradual dose reduction.
Softacort is formulated without preservatives because common eye drop preservatives, particularly benzalkonium chloride (BAK), can cause dose-dependent toxicity to the ocular surface. Preservative-free formulations are better tolerated, especially by patients with sensitive eyes, dry eye disease, or those using multiple eye medications. The single-dose container design eliminates the need for preservatives to maintain sterility.
Softacort is not recommended during pregnancy unless your doctor considers it absolutely necessary and treatment is carried out under strict medical supervision. While systemic absorption from eye drops is generally low, corticosteroids have been associated with potential risks to fetal development. If you are pregnant or planning to become pregnant, discuss all treatment options with your doctor.
If you accidentally apply more drops than prescribed, rinse your eye with sterile water or saline if you experience persistent irritation. A single overdose of eye drops is unlikely to cause serious harm. However, if you experience significant discomfort or if a child has accidentally swallowed the solution, contact your doctor, local emergency department, or poison control center for guidance.
References
- European Medicines Agency (EMA). Softacort – Summary of Product Characteristics. www.ema.europa.eu. Accessed January 2026.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List, 2023. Hydrocortisone listed as essential corticosteroid. www.who.int/publications.
- American Academy of Ophthalmology (AAO). Preferred Practice Pattern: Conjunctivitis, 2023. Guidelines for management of allergic conjunctivitis including topical corticosteroid use.
- National Institute for Health and Care Excellence (NICE). Clinical Knowledge Summaries: Allergic Conjunctivitis, 2024. Evidence-based guidance on treatment options. cks.nice.org.uk.
- Baudouin C, Labbé A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Progress in Retinal and Eye Research. 2010;29(4):312-334. doi:10.1016/j.preteyeres.2010.03.001
- McGhee CN, Dean S, Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Safety. 2002;25(1):33-55. doi:10.2165/00002018-200225010-00004
- Carnahan MC, Goldstein DA. Ocular complications of topical, peri-ocular, and systemic corticosteroids. Current Opinion in Ophthalmology. 2000;11(6):478-483.
- Bielory L, Friedlaender MH. Allergic conjunctivitis. Immunology and Allergy Clinics of North America. 2008;28(1):43-58. doi:10.1016/j.iac.2007.12.005
- British National Formulary (BNF). Hydrocortisone – ophthalmic preparations. bnf.nice.org.uk. Accessed January 2026.
Medical Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising specialist physicians in ophthalmology and clinical pharmacology with documented academic background and clinical experience.
All content follows the GRADE evidence framework and adheres to international guidelines from the WHO, EMA, AAO, and NICE. Our editorial process requires peer review by at least two independent medical specialists before publication.