Cortisal

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Cortisal

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Cortisal

Property Description
Active Ingredients Prednisolone Acetate, Hydroxyethyl Salicylate
Primary Form Ophthalmic Suspension, Solution, or Ointment
Pharmacological Class Combination Anti-inflammatory and Analgesic Agent
General Purpose Symptomatic relief of irritation and pain
Origin Synthetic / Semi-synthetic

Cortisal is structurally defined as a combination pharmaceutical product, utilizing two distinct active ingredients to provide a dual-action therapeutic approach. This medicine is primarily classified as an Anti-inflammatory Agent, integrating a potent Glucocorticoid (corticosteroid) with a Salicylate derivative (a component similar to an NSAID). This formulation is typically optimized for Topical or Ophthalmic administration, a distinctive feature that sets it apart from products intended for systemic use.

The formulation combines Prednisolone Acetate and Hydroxyethyl Salicylate. Prednisolone Acetate is the corticosteroid component, recognized for its ability to suppress the body’s inflammatory cascade and reduce swelling. This mechanism means the medicine is effective at stopping the underlying biological process that causes redness and swelling.

Cortisal is specifically designed for localized delivery, often used for temporary relief in scenarios involving tissue irritation or inflammation. The combination strategy offers a focused approach to managing localized irritation, as combining these mechanisms can enhance local therapeutic efficacy against inflammation and pain. Therefore, the combination is specifically designed to reduce significant inflammation while simultaneously relieving tenderness and aching in the affected area. This specialized composition is distinct from single-component prednisolone products like Pred Mild or Pred Forte, as Cortisal uniquely integrates the analgesic benefits of the salicylate derivative.

What side effects are possible with Cortisal?

Possible Side Effects and Safety Information

The officially documented safety profile for Cortisal is primarily defined by the risks associated with its corticosteroid component, which can affect the structure and pressure within the eye. Adverse reactions are classified by regulatory agencies, with the most significant risks being tied to prolonged exposure.


Adverse Reaction Classification

Regulatory documents list three primary ocular risks in a decreasing order of frequency based on clinical reports:

  • Elevation of Intraocular Pressure (IOP), which may progress to glaucoma and damage to the optic nerve.
  • Posterior Subcapsular Cataract formation.
  • Delayed wound healing, particularly following ocular surgery.

Other commonly reported reactions include transient burning and stinging upon instillation and minor ocular irritation or foreign body sensation.


Serious Adverse Reactions and Safety Patterns

Adverse reactions classified as serious include glaucoma, the formation of cataracts, and the risk of perforation of the globe when the product is used in the presence of thin corneal or scleral tissue. Use of Cortisal is also associated with an increased hazard of developing secondary ocular infections (bacterial, fungal, or viral).

This risk profile requires a specific time-related safety note: if the medicine is used for 10 days or longer, routine monitoring of the IOP is necessary as stated in official labeling.


Population-Specific Notes and Constraints

The product is contraindicated in patients with active or suspected viral diseases (including Herpes Simplex Keratitis), fungal diseases, or mycobacterial infection of the eye, as the corticosteroid may mask or enhance these conditions. Safety information also notes that the use of corticosteroids during pregnancy should only occur if the potential benefit justifies the potential risk to the fetus, as animal studies have shown teratogenicity.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Cortisal is defined by the toxicological distinction between its intended route of administration and its active components. Over-application of the ophthalmic suspension is not ordinarily expected to cause acute toxic problems based on its formulation characteristics. However, due to the presence of a salicylate derivative, accidental systemic ingestion carries the risk of severe toxicity.

Documented Manifestations and Severe Outcomes

Accidental overdose may result in documented systemic manifestations such as tinnitus, nausea, hyperthermia, confusion, and convulsions. Officially documented severe outcomes include acid-base disturbances (respiratory alkalosis progressing to metabolic acidosis), pulmonary edema, and renal failure. Regulatory notes indicate that children face an increased risk of severe systemic toxicity from ingestion, and the elderly have a higher morbidity risk associated with chronic exposure.

Mandated Emergency Action

Regulatory authorities mandate that individuals seek immediate medical attention and contact emergency services immediately following any suspected accidental ingestion or the manifestation of systemic symptoms. As the official labeling states that no specific antidote is known, management is strictly limited to supportive and symptomatic treatment for complications like hypotension and respiratory depression. Hospital admission for monitoring is required for all symptomatic patients to observe vital signs and metabolic status.

Therapeutic Uses of Cortisal

What Cortisal Treats: Main Uses and Benefits

Cortisal, an ophthalmic combination product, is generally used in situations involving certain distressing symptoms and inflammatory states of the anterior eye. This class of medicine contributes to improved comfort during periods of heightened symptoms associated with acute ocular irritation.

It is commonly used across conditions presenting with acute episodes of inflammation, such as allergic conjunctivitis, postoperative irritation, and inflammation associated with thermal or radiation injury to the eye. It is relevant for managing symptoms related to inflammatory or irritative states, which may assist with easing distress during difficult episodes, including redness, swelling, stinging, and localized pain.

Key Therapeutic Indications

Cortisal is applied in clinical settings that involve acute or unstable symptom patterns of the front of the eye, including the conjunctiva, cornea, and anterior segment. It is used when groups of symptoms appear suddenly, requiring supportive management of inflammation and localized pain, which may assist with easing associated sensations like stinging and burning. This dual support provides supportive relief when symptoms interfere with routine activities.

Quick Fact: Relevant for managing symptoms of Inflammation and Localized Pain

Regulatory References

  1. NIH MedlinePlus overview of Ophthalmic Prednisolone

Eligibility and Restrictions for Use

Eligibility Scope and Contraindications

Cortisal (hydrocortisone) is allowed primarily for patients requiring replacement therapy for adrenocortical insufficiency or for adults needing pharmacological treatment for specific inflammatory, autoimmune, or hematologic conditions.

Populations for whom use is strictly contraindicated by official regulatory labeling include patients with Systemic Fungal Infections and those with a documented hypersensitivity to the drug or its components. It is also generally contraindicated for use with live or live, attenuated vaccines in patients receiving immunosuppressive doses due to the risk of a severe infection. Intrathecal administration is typically prohibited.

Restricted or Special Consideration Use

Use requires special consideration in patients with pre-existing conditions that may be worsened by the medicine, such as Hypertension, Diabetes Mellitus, Peptic Ulcer disease, Osteoporosis, and active ocular Herpes Simplex. The presence of latent Tuberculosis or Amoebiasis must be ruled out or carefully managed.

Age and Pregnancy Rules

Pediatric use requires caution as the drug may cause growth retardation; safety and efficacy are not established for certain oral formulations in children under 5 years. For pregnancy and lactation, use is generally allowed for replacement therapy, but the benefit must be weighed against the potential hazard, especially when high doses are administered.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Cortisal, an ophthalmic combination product containing a corticosteroid (Prednisolone Acetate), is primarily defined by two areas of official regulatory constraint: potential systemic exposure of the corticosteroid component and local co-administration rules for the eye.

Documented Interaction Restrictions

Classification Regulatory Statement and Constraint
Metabolic Interaction Co-administration with strong or moderate CYP3A4 inhibitors may increase the systemic exposure of the corticosteroid component, raising the risk of systemic effects. This combination should be avoided unless benefits outweigh risks.
Pharmacodynamic Interaction Concomitant use with other ophthalmic Nonsteroidal Anti-Inflammatory Agents (NSAIDs) may result in additive damage to ocular tissue, increasing the risk of impaired healing. This combination requires careful management.
Timing Restriction When using Cortisal with other topical ophthalmic solutions or suspensions, a minimum time interval (e.g., five minutes) must separate the administration of each product. This procedural rule prevents wash-out of the medicines from the ocular surface.

Official regulatory documents also classify use of the corticosteroid component as generally contraindicated in patients with active systemic fungal infections. No specific interactions with food, alcohol, or herbal products are explicitly documented in the regulatory labeling for this topical ophthalmic formulation.

Mechanism of Action

Intracellular Glucocorticoid Receptor (GR) Signaling

Cortisal's action begins by binding to the Glucocorticoid Receptor (GR) inside the cell, forming a complex that moves to the nucleus to regulate gene expression; this fundamental genomic mechanism dictates the drug's broad systemic physiological effects.

Master Regulation of Inflammatory Pathways

The activated Cortisal-GR complex effectively suppresses the immune system by physically blocking key pro-inflammatory transcription factors, like NF-smallkappaB, thereby halting the production of inflammatory mediators and reducing the expression of pro-inflammatory mediators throughout the body.

Systemic Modulation of Metabolic Homeostasis

By influencing gene transcription in the liver and muscle tissue, Cortisal promotes gluconeogenesis and catabolic processes (protein and fat breakdown); this mechanism mobilizes energy reserves, leading to an overall increase in blood glucose and contributing to the physiological changes characteristic of the stress response.

Dosage and Administration Information

Official Administration Guidelines for Cortisal (Oral Modified-Release)

Cortisal is an oral, modified-release hydrocortisone formulation intended for replacement therapy, administered strictly according to individualised physician guidance to mimic the body's natural cortisol rhythm. Dosage is highly individualised, but the total daily maintenance dose for adults is commonly 20 to 30 mg daily, adjusted based on the patient's clinical response and the underlying condition such as Adrenal Insufficiency.

Administration Scope Administration Instruction
Route Oral administration.
Preparation Capsules/Tablets must be swallowed whole with water. They must not be chewed, crushed, or divided, as this alters the modified-release profile.
Timing & Frequency The dose is typically taken once daily in the morning, at least 30 minutes before food, or split into two doses (e.g., evening/morning) depending on the specific product and clinical need.
Age-Specific Dosage for children and adolescents who have not completed growth is often determined based on body surface area (mg/m^2).
Missed Dose If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular schedule resumed. Do not double the dose to compensate for a forgotten one.
Special Conditions Patients must be instructed to administer an additional dose of immediate-release hydrocortisone during periods of excessive physical or mental stress, intercurrent illness (e.g., fever), or surgery. Oral administration must be replaced with parenteral (injectable) hydrocortisone in severe situations, such as gastroenteritis with vomiting or diarrhoea.

Procedural Summary

The treatment protocol strictly outlines the non-divisible nature of the oral form and the necessary timing in relation to meals to ensure proper drug release. The core procedural structure is the consistent daily intake combined with an explicit, physician-defined protocol for stress dosing (increasing the dose or switching to injection) during illness or high stress. These steps are utilized to prevent acute adrenal crisis.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cortisal

The research base for Cortisal, a medicine containing two active ingredients (Prednisolone Acetate and Hydroxyethyl Salicylate), primarily was studied for the anti-inflammatory component, Prednisolone Acetate, in the context of eye conditions. Findings from high-quality clinical trials, such as randomized controlled trials (RCTs), contributes to the literature base.


Evidence for use in Post-Surgical Ocular Inflammation

Research has studied the anti-inflammatory component of Cortisal in settings where researchers examined outcomes linked to inflammatory or irritative states and perceived discomfort following ocular procedures. These studies involved adult patients and typically used short-term RCTs, where research explored patterns observed with the main component versus a non-treatment (vehicle) or other agents.

In these trials, researchers examined patient-reported outcomes describing perceived discomfort, alongside clinical measurements of the eye's inflammatory state. Research describes the patterns observed in the studies related to outcomes linked to inflammatory or irritative states during the immediate post-surgical period.


What is Still Uncertain about Cortisal's Research Base

A key limitation noted in the research landscape is that the evidence supporting this medicine is drawn primarily from studies of the single anti-inflammatory ingredient (Prednisolone Acetate). Therefore, comparative evidence is lacking to fully define the specific therapeutic contribution of combining it with Hydroxyethyl Salicylate.

Furthermore, while the evidence provides insight into short-term changes, long-term effects are not fully established, and follow-up durations were limited in the primary trials. Data for certain groups, such as children (pediatric patients), remain insufficient in the current research base for the specific formulations relevant to this medicine. This research describes group patterns, not personal outcomes, and evidence highlights what is known — and what is still uncertain.

Key Studies & References

  1. Corticosteroids and non-steroidal anti-inflammatory drugs for treating postoperative inflammation and pain after cataract surgery (Cochrane Review)

Frequently Asked Questions (FAQ)

Common questions about Cortisal (FAQ)


Q: Is Cortisal a steroid?

A: Yes, Cortisal (hydrocortisone) is classified in official regulatory documents as a glucocorticoid. Glucocorticoids are a specific type of corticosteroid, and hydrocortisone is chemically identical to cortisol, the principal steroid hormone naturally produced by the body's adrenal glands.


Q: Is it safe to use Cortisal if I have a history of [common chronic condition, e.g., high cholesterol]?

A: Regulatory documents state that Cortisal requires special consideration in patients with certain pre-existing conditions. For example, conditions such as hypertension (high blood pressure), diabetes mellitus, peptic ulcer disease, or osteoporosis may require careful management by a healthcare provider while using this medicine.


Q: Can Cortisal be taken by teenagers?

A: Official information notes that corticosteroids may have the potential to suppress growth in children and adolescents. For certain oral formulations, safety and effectiveness have not been definitively established for children under 5 years of age. A healthcare provider determines the appropriate use and monitoring for teenagers.


Q: What is the regulatory status of Cortisal (e.g., approved by the FDA)?

A: Cortisal (hydrocortisone) is an FDA-approved and EMA-approved medicine. It is indicated for use in specific endocrine, rheumatic, and other conditions as described in its respective regulatory labeling across different jurisdictions.


Q: What if I experience stomach upset after taking Cortisal?

A: Gastrointestinal side effects are documented in official safety information, including indigestion or feeling sick. Taking immediate-release formulations with food may be advised for some patients, which can potentially help manage milder symptoms like indigestion.


Q: Does Cortisal affect my immune system?

A: Yes, the medicine's action involves the corticosteroid component, which suppresses the immune system to reduce inflammation. Regulatory warnings highlight that this effect may increase the risk of developing or worsening existing infections, including bacterial, fungal, or viral conditions.


Q: Can Cortisal be used by people with lactose intolerance?

A: Some commercially available oral formulations of Cortisal (hydrocortisone tablets) list lactose as an inactive ingredient. For individuals with lactose intolerance, it is important to confirm the inactive ingredients in their specific product with their pharmacist or prescriber.


Q: Does Cortisal work better if taken in the morning or evening?

A: Official product information describes the typical administration schedule as once daily in the morning, or sometimes split into two doses. This is generally aligned with the body’s natural cortisol pattern, where natural cortisol levels are typically highest in the early morning.


Q: Why is Cortisal often taken with food?

A: While the modified-release oral formulation is typically taken before food, some immediate-release hydrocortisone products may be instructed to be taken with food. The instruction to take certain hydrocortisone products with food is often provided to help mitigate the risk of gastrointestinal side effects like indigestion.


Q: Can Cortisal affect my sleep?

A: Official regulatory sources note that problems with sleep, specifically insomnia, are a documented potential adverse effect of corticosteroid treatment. These types of central nervous system effects are usually more noticeable when higher doses are used.


Q: Will Cortisal make me gain weight?

A: Weight gain is listed in regulatory safety documents as a potential side effect, particularly when used long-term at higher doses, and relates to possible changes in fluid retention and metabolism.


Q: Does Cortisal affect blood pressure?

A: Yes, the regulatory information on side effects indicates that Cortisal can cause changes in fluid and electrolyte balance, which may lead to an elevation of blood pressure (hypertension) and fluid retention.


Q: Is it normal to feel [vague emotional state] when starting Cortisal?

A: The official product information lists documented mood changes and psychiatric adverse reactions. These psychological effects are documented potential side effects that may occur, often relating to the dose used.


Q: Can Cortisal cause mood changes or depression?

A: Official regulatory sources explicitly list psychiatric adverse reactions, which include mood changes and the potential for depression. Patients are advised to be aware that these kinds of effects, including difficulty with thinking, are documented side effects.


Q: Is it safe to take Cortisal with alcohol (low-level general question)?

A: Official guidance indicates that alcohol consumption may worsen some documented side effects, such as feeling dizzy or weak, and its use is therefore generally discouraged during treatment.


Q: Do I need to change my diet while taking Cortisal?

A: Official warnings note that management of potential fluid and electrolyte changes may sometimes require specific dietary considerations, such as sodium restriction or potassium supplementation.


Q: Can Cortisal affect lab test results?

A: Yes, regulatory documents indicate that the medicine can affect various laboratory values. This includes the potential for an increase in liver enzymes and the effect on endocrine tests by causing a decrease in carbohydrate tolerance and potentially manifesting latent diabetes mellitus.


Q: Is Cortisal a controlled substance?

A: No, Cortisal (hydrocortisone) is a steroid replacement medicine and is not classified as a controlled substance in major regulatory jurisdictions, such as the United States.


Q: What is the difference between Cortisal and its active ingredient?

A: Cortisal is the brand name (or proprietary name) of the pharmaceutical product, which is often a capsule or tablet containing both active and inactive ingredients. The active ingredient is hydrocortisone, the chemical substance that produces the intended therapeutic effect in the body.


Q: How is Cortisal eliminated from the body?

A: Official regulatory information on pharmacokinetics indicates that hydrocortisone is eliminated from the body almost completely by metabolism in the liver and other tissues. The resulting degraded forms are then mainly excreted via the urine.

How should Cortisal be stored and disposed of?

How to Store and Dispose of Cortisal (Prednisolone Acetate Ophthalmic Suspension)

Storage Conditions

Cortisal must be stored at room temperature, typically between 15°C and 30°C (59°F and 86°F), and must not be frozen. The product should be kept in its original container with the bottle tightly closed and stored out of the sight and reach of children.

To ensure proper suspension of the active ingredients, the bottle must be shaken well before using.

Stability and Disposal

The in-use stability period requires the medicine to be discarded one month after opening the container. For disposal of unused or expired product, the official guidance directs patients to utilize a drug take-back program when available.

It is mandatory that Cortisal not be disposed of in wastewater or flushed down the toilet.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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