Hydrocortisone G.L. Pharma
Oral corticosteroid for adrenal insufficiency and cortisol replacement therapy
Quick Facts About Hydrocortisone G.L. Pharma
Key Takeaways About Hydrocortisone G.L. Pharma
- Essential replacement therapy: Hydrocortisone G.L. Pharma replaces cortisol in patients whose adrenal glands cannot produce enough of this vital hormone
- Never stop suddenly: Abrupt discontinuation can trigger a life-threatening adrenal crisis — always taper under medical supervision
- Carry a steroid card: All patients on long-term hydrocortisone should carry a steroid emergency card and wear a medical alert identification
- Dose adjustments needed during illness: Increase your dose during fever, infection, surgery, or significant physical stress (sick day rules)
- Mimic natural cortisol rhythm: Typically taken in divided doses, with the largest dose in the morning and a smaller dose in the afternoon
What Is Hydrocortisone G.L. Pharma and What Is It Used For?
Hydrocortisone G.L. Pharma is a prescription oral corticosteroid containing hydrocortisone (synthetic cortisol) in 10 mg tablets. It is primarily used as hormone replacement therapy in patients with adrenal insufficiency, including Addison's disease, congenital adrenal hyperplasia, and post-surgical adrenal deficiency.
Hydrocortisone is the pharmaceutical name for cortisol, often referred to as the "stress hormone." Cortisol is a glucocorticoid hormone naturally produced by the adrenal glands, two small glands located on top of the kidneys. It plays a critical role in numerous physiological processes, including the regulation of blood sugar levels, blood pressure maintenance, immune system modulation, and the body's response to physical and emotional stress. Without adequate cortisol, the body cannot maintain normal metabolic function, and life-threatening complications can develop.
Hydrocortisone G.L. Pharma, manufactured by G.L. Pharma, provides exogenous hydrocortisone to replace deficient endogenous cortisol. The 10 mg tablet strength allows for flexible dosing that can be tailored to individual patient requirements. Unlike more potent synthetic glucocorticoids such as prednisolone or dexamethasone, hydrocortisone has both glucocorticoid (anti-inflammatory) and mineralocorticoid (salt-retaining) properties, making it particularly suitable for physiological replacement therapy.
The primary indications for Hydrocortisone G.L. Pharma include:
- Primary adrenal insufficiency (Addison's disease): An autoimmune or infectious condition where the adrenal glands fail to produce sufficient cortisol and aldosterone
- Secondary adrenal insufficiency: Caused by inadequate production of adrenocorticotropic hormone (ACTH) from the pituitary gland, often resulting from pituitary surgery, tumors, or prolonged exogenous corticosteroid use
- Congenital adrenal hyperplasia (CAH): A genetic condition in which enzyme deficiencies impair cortisol production, leading to excess androgen production
- Post-adrenalectomy replacement: Following surgical removal of one or both adrenal glands
- Post-hypophysectomy replacement: After surgical removal of the pituitary gland
In the context of adrenal insufficiency, hydrocortisone is considered the gold standard for replacement therapy, as recommended by the Endocrine Society and the European Society of Endocrinology. Its pharmacokinetic profile closely mimics the body's natural cortisol production pattern, with rapid absorption and a relatively short duration of action that allows for physiological dosing schedules.
Hydrocortisone used as hormone replacement therapy in adrenal insufficiency is fundamentally different from high-dose corticosteroid therapy used to treat inflammatory conditions. Replacement doses (typically 15–25 mg daily) are much lower than anti-inflammatory doses and are intended to restore normal cortisol levels, not suppress the immune system.
What Should You Know Before Taking Hydrocortisone G.L. Pharma?
Before starting Hydrocortisone G.L. Pharma, inform your doctor about all medical conditions, current medications, recent vaccinations, and any history of infections. Key considerations include diabetes management, bone health, mental health history, and pregnancy status.
Contraindications
Hydrocortisone G.L. Pharma should not be used in patients with a known hypersensitivity to hydrocortisone or any of the excipients contained in the tablet. While there are very few absolute contraindications for replacement therapy in adrenal insufficiency (since the medication is life-sustaining), pharmacological doses of hydrocortisone are generally contraindicated in the following situations:
- Systemic fungal infections: Corticosteroids can worsen fungal infections by suppressing the immune response needed to control fungal proliferation
- Live or live-attenuated vaccines: Patients receiving immunosuppressive doses of corticosteroids should not receive live vaccines (e.g., MMR, varicella, yellow fever) due to the risk of disseminated infection. However, patients on physiological replacement doses may be vaccinated following specialist advice
- Known hypersensitivity: To hydrocortisone or any component of the formulation
It is crucial to understand that in patients with confirmed adrenal insufficiency, hydrocortisone is a life-saving medication. Even in the presence of relative contraindications, treatment must generally continue with appropriate monitoring and management of concurrent conditions.
Warnings and Precautions
Several important precautions apply to patients taking Hydrocortisone G.L. Pharma. Your prescribing physician should be informed about the following conditions before treatment begins, and ongoing monitoring may be required:
- Diabetes mellitus: Hydrocortisone can increase blood glucose levels. Patients with diabetes may require adjustment of their insulin or oral hypoglycemic medication doses
- Osteoporosis: Long-term corticosteroid use, even at replacement doses, may reduce bone mineral density. Calcium and vitamin D supplementation, along with bone density monitoring, may be recommended
- Peptic ulcer disease: Corticosteroids can exacerbate existing gastrointestinal ulcers and increase the risk of perforation, particularly when combined with nonsteroidal anti-inflammatory drugs (NSAIDs)
- Infections: Corticosteroids may mask signs and symptoms of infection and reduce resistance to new infections. Particular vigilance is needed regarding tuberculosis, varicella (chickenpox), and measles exposure
- Mental health disorders: Corticosteroids can cause or exacerbate psychiatric disturbances including euphoria, insomnia, mood swings, personality changes, severe depression, and psychotic manifestations
- Cardiovascular disease: Hydrocortisone may cause fluid retention and hypertension, requiring careful monitoring in patients with heart failure or hypertension
- Glaucoma and cataracts: Prolonged use may increase intraocular pressure and the risk of posterior subcapsular cataracts. Regular ophthalmological examinations are advisable
- Hepatic or renal impairment: Dose adjustments may be necessary, as hydrocortisone is metabolized primarily in the liver
- Hypothyroidism: Thyroid dysfunction can alter cortisol metabolism, potentially requiring dose adjustment of hydrocortisone
Never stop taking hydrocortisone suddenly. Abrupt withdrawal can cause a life-threatening adrenal crisis, characterized by severe hypotension, dehydration, hypoglycemia, confusion, and circulatory collapse. If your dose needs to be reduced, your doctor will implement a gradual tapering schedule over weeks to months. All patients on long-term hydrocortisone should carry a steroid emergency card and consider wearing a medical alert bracelet or necklace.
Pregnancy and Breastfeeding
Hydrocortisone is generally considered the corticosteroid of choice during pregnancy when cortisol replacement is medically necessary. The placenta contains the enzyme 11β-hydroxysteroid dehydrogenase type 2 (11β-HSD2), which converts active cortisol (hydrocortisone) to inactive cortisone, providing a degree of fetal protection from excessive glucocorticoid exposure. This enzymatic barrier means that approximately 80–90% of maternal hydrocortisone is inactivated before reaching the fetus.
Women with adrenal insufficiency must continue their hydrocortisone replacement therapy throughout pregnancy. Dose increases are commonly required, particularly during the second and third trimesters, as the body's cortisol requirements increase during pregnancy. Close monitoring by both an endocrinologist and an obstetrician is essential. Stress dosing (increased doses) is recommended during labor and delivery to prevent adrenal crisis.
Hydrocortisone is excreted in breast milk in small quantities. At physiological replacement doses, the amount of hydrocortisone in breast milk is unlikely to have clinically significant effects on the infant. The benefits of breastfeeding generally outweigh the minimal risk. However, infants should be monitored for signs of adrenal suppression if the mother is taking higher-than-replacement doses.
How Does Hydrocortisone G.L. Pharma Interact with Other Drugs?
Hydrocortisone interacts with numerous medications, particularly those affecting liver enzyme CYP3A4 activity, anticoagulants, antidiabetic drugs, and certain antibiotics. Always inform your doctor and pharmacist about all medications you are taking, including over-the-counter products and herbal supplements.
Drug interactions with hydrocortisone can be clinically significant and may require dose adjustments, increased monitoring, or avoidance of certain combinations. The primary mechanisms of interaction involve induction or inhibition of cytochrome P450 3A4 (CYP3A4) — the main hepatic enzyme responsible for hydrocortisone metabolism — as well as pharmacodynamic interactions that amplify or counteract the effects of corticosteroids.
Major Interactions
| Drug / Class | Mechanism | Clinical Effect | Action Required |
|---|---|---|---|
| Rifampicin | Potent CYP3A4 inducer | Reduces hydrocortisone levels by up to 50% | Double hydrocortisone dose; monitor closely |
| Phenytoin | CYP3A4 inducer | Accelerated hydrocortisone metabolism | Increase hydrocortisone dose; monitor symptoms |
| Carbamazepine | CYP3A4 inducer | Reduced corticosteroid efficacy | Increase hydrocortisone dose; clinical monitoring |
| Phenobarbital | CYP3A4 inducer | Decreased hydrocortisone plasma concentration | Dose increase likely needed |
| Ketoconazole / Itraconazole | Potent CYP3A4 inhibitor | Increased hydrocortisone levels; risk of Cushing-like side effects | Reduce hydrocortisone dose; monitor for hypercortisolism |
| Ritonavir | Strong CYP3A4 inhibitor | Markedly increased corticosteroid exposure | Avoid combination or reduce dose significantly |
| Warfarin / Anticoagulants | Altered coagulation factor synthesis | Both increased and decreased anticoagulant effect reported | Monitor INR frequently; adjust anticoagulant dose |
Minor Interactions and Other Considerations
| Drug / Class | Clinical Effect | Recommendation |
|---|---|---|
| NSAIDs (Ibuprofen, Naproxen) | Increased risk of gastrointestinal bleeding and ulceration | Use with caution; consider gastroprotection |
| Insulin / Oral antidiabetics | Increased blood glucose levels | Monitor blood glucose; adjust diabetes medications |
| Diuretics (Thiazide, Loop) | Enhanced potassium loss; risk of hypokalemia | Monitor potassium levels regularly |
| Cardiac glycosides (Digoxin) | Hypokalemia increases digoxin toxicity risk | Monitor potassium and digoxin levels |
| Antihypertensives | Reduced antihypertensive efficacy due to fluid retention | Monitor blood pressure; adjust doses as needed |
| Oral contraceptives / Estrogens | May increase cortisol-binding globulin, altering free cortisol levels | Monitor clinically; dose adjustment may be needed |
In addition to prescription medications, patients should be aware that certain herbal products can interact with hydrocortisone. St. John's Wort (Hypericum perforatum) is a CYP3A4 inducer and may reduce hydrocortisone efficacy. Licorice root (Glycyrrhiza glabra) inhibits 11β-HSD2, potentially increasing the mineralocorticoid effects of hydrocortisone, leading to fluid retention, hypertension, and hypokalemia. Grapefruit juice may modestly inhibit CYP3A4, increasing hydrocortisone levels.
What Is the Correct Dosage of Hydrocortisone G.L. Pharma?
The typical replacement dose for adults with adrenal insufficiency is 15–25 mg daily, divided into two or three doses. The largest dose is usually taken in the morning upon waking to mimic the body's natural cortisol peak, with smaller doses in the afternoon.
Dosing of Hydrocortisone G.L. Pharma must be individualized based on the underlying condition, disease severity, patient weight, and clinical response. For adrenal insufficiency, the goal is to mimic the physiological cortisol secretion pattern, which peaks in the early morning and declines throughout the day. Over-replacement can lead to Cushingoid features, weight gain, and metabolic complications, while under-replacement risks adrenal crisis.
Adults
Adrenal Insufficiency (Replacement Therapy)
Total daily dose: 15–25 mg, divided into 2–3 doses
Typical regimen (two-dose): 10–15 mg upon waking + 5–10 mg in early afternoon (around 14:00–16:00)
Typical regimen (three-dose): 10 mg upon waking + 5 mg at midday + 5 mg in late afternoon
The largest proportion of the daily dose should be given in the morning to replicate the physiological cortisol peak. The last dose should generally be taken no later than 16:00–17:00 to avoid insomnia.
Congenital Adrenal Hyperplasia (CAH)
Total daily dose: 15–25 mg/m²/day in adults, divided into 2–3 doses
In CAH, the dosing strategy aims to suppress excess adrenal androgen production while avoiding over-replacement. Monitoring involves measurement of 17-hydroxyprogesterone, androstenedione, and testosterone levels.
Stress Dosing (Sick Day Rules)
Minor illness (e.g., fever, cold): Double the usual daily dose for the duration of the illness
Moderate illness (e.g., vomiting, unable to take oral medication): Intramuscular hydrocortisone 100 mg; seek medical attention
Major stress (surgery, trauma): Intravenous hydrocortisone 100 mg followed by 50 mg every 6–8 hours, tapered over 1–3 days as clinical condition improves
Children
Pediatric Adrenal Insufficiency
Typical dose: 8–10 mg/m²/day, divided into 3 doses
Hydrocortisone is the preferred corticosteroid for replacement therapy in children, as it allows weight-based dose adjustments and has the shortest duration of action, minimizing growth suppression. Growth velocity should be monitored regularly, as excessive dosing can impair linear growth. The Endocrine Society recommends the lowest effective dose to maintain normal growth.
Elderly
Elderly patients may require lower replacement doses, as cortisol clearance decreases with age. Starting at the lower end of the dosing range (15 mg daily) and titrating based on clinical response is generally recommended. Elderly patients are at higher risk for corticosteroid-related side effects including osteoporosis, glucose intolerance, hypertension, and skin fragility. Bone density monitoring and calcium/vitamin D supplementation should be considered as standard of care.
Missed Dose
If you miss a dose of Hydrocortisone G.L. Pharma, take it as soon as you remember. If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to compensate. If you have missed multiple doses or are experiencing symptoms of cortisol deficiency (fatigue, dizziness, nausea, muscle weakness), contact your healthcare provider immediately.
Overdose
Acute overdose of oral hydrocortisone is rarely life-threatening. Symptoms of acute overdose may include nausea, vomiting, hyperglycemia, and electrolyte imbalances. Chronic overdose (taking too much over an extended period) is more clinically significant and can manifest as Cushing's syndrome, with symptoms including weight gain (particularly central obesity and moon face), skin thinning and easy bruising, muscle weakness, hypertension, and glucose intolerance.
If an overdose is suspected, contact your local poison control center or seek emergency medical attention. Treatment is generally supportive, with dose reduction or temporary discontinuation under medical supervision. In cases of severe acute overdose, gastric lavage may be considered if the patient presents within one hour of ingestion.
What Are the Side Effects of Hydrocortisone G.L. Pharma?
Side effects of hydrocortisone depend largely on dose and duration of treatment. At physiological replacement doses (15–25 mg/day), side effects are generally minimal. Higher doses or prolonged use beyond replacement needs can cause significant adverse effects including weight gain, glucose intolerance, osteoporosis, and adrenal suppression.
It is important to distinguish between side effects at physiological replacement doses and those associated with pharmacological (supra-physiological) doses. Patients receiving hydrocortisone solely for adrenal insufficiency replacement at appropriate doses are less likely to experience the classic corticosteroid side effects. However, even slight over-replacement over extended periods can lead to cumulative adverse effects. The following frequency classifications are based on pharmacovigilance data and clinical trial reports.
Very Common (affects more than 1 in 10 patients)
Primarily at doses above physiological replacement
- Increased appetite and weight gain
- Fluid retention (peripheral edema)
- Insomnia (particularly if taken too late in the day)
- Mood changes (irritability, anxiety)
Common (affects 1 in 10 to 1 in 100 patients)
May occur at replacement or higher doses
- Hyperglycemia (elevated blood sugar)
- Dyspepsia (indigestion) and gastric discomfort
- Increased susceptibility to infections
- Skin thinning and easy bruising
- Muscle weakness (proximal myopathy)
- Redistribution of body fat (truncal obesity)
- Acne
- Menstrual irregularities
Uncommon (affects 1 in 100 to 1 in 1,000 patients)
Usually associated with prolonged supra-physiological doses
- Osteoporosis and increased fracture risk
- Peptic ulceration and gastrointestinal hemorrhage
- Posterior subcapsular cataracts
- Glaucoma (increased intraocular pressure)
- Hypertension
- Hypokalemia (low potassium)
- Growth retardation in children
- Avascular necrosis of bone (particularly femoral head)
Rare (affects fewer than 1 in 1,000 patients)
Reported in post-marketing surveillance
- Psychotic episodes (hallucinations, severe paranoia)
- Tendon rupture
- Pancreatitis
- Allergic reactions (paradoxical hypersensitivity)
- Pseudotumor cerebri (benign intracranial hypertension)
- Adrenal crisis upon abrupt withdrawal
Seek immediate medical attention if you experience signs of adrenal crisis (severe fatigue, vomiting, abdominal pain, low blood pressure, confusion), signs of infection with high fever, sudden visual changes, severe mood disturbances, or unexplained muscle weakness. For non-urgent side effects, discuss these at your next scheduled appointment so your dose can be reviewed.
How Should You Store Hydrocortisone G.L. Pharma?
Store Hydrocortisone G.L. Pharma at room temperature below 25°C (77°F) in the original packaging to protect from moisture and light. Keep out of reach and sight of children.
Proper storage of Hydrocortisone G.L. Pharma is essential to maintain the medication's stability and efficacy throughout its shelf life. The following storage guidelines should be observed:
- Temperature: Store below 25°C (77°F). Do not refrigerate or freeze
- Light: Keep in the original blister pack or container to protect from light exposure, which can degrade the active ingredient
- Moisture: Store in a dry place. Avoid storing in bathrooms or other humid environments
- Children: Keep the medication out of the reach and sight of children at all times
- Expiry date: Do not use after the expiry date printed on the packaging. Check the expiry date regularly, particularly for emergency supplies
- Disposal: Do not dispose of unused medication via household waste or wastewater. Return expired or unused tablets to your pharmacy for safe disposal
Patients with adrenal insufficiency are advised to maintain an adequate supply of hydrocortisone at all times, including when traveling. It is recommended to carry at least a two-week supply of medication, along with a steroid emergency injection kit for situations where oral medication cannot be taken. When traveling across time zones, consult your endocrinologist about temporary dose schedule adjustments.
What Does Hydrocortisone G.L. Pharma Contain?
Each Hydrocortisone G.L. Pharma tablet contains 10 mg of hydrocortisone as the active ingredient, along with standard pharmaceutical excipients including lactose monohydrate and magnesium stearate.
The active substance in Hydrocortisone G.L. Pharma is hydrocortisone (also known as cortisol). Each tablet contains precisely 10 mg of hydrocortisone. Hydrocortisone is a white to practically white, odorless, crystalline powder with the molecular formula C21H30O5 and a molecular weight of 362.46 g/mol.
The inactive ingredients (excipients) typically found in hydrocortisone tablet formulations include:
- Lactose monohydrate: Filler/diluent — patients with lactose intolerance should discuss this with their doctor
- Maize starch: Binder and disintegrant
- Magnesium stearate: Lubricant to facilitate tablet manufacture
- Microcrystalline cellulose: Filler and binder
- Colloidal anhydrous silica: Glidant to improve powder flow during manufacturing
Patients with known allergies to any of these excipients should inform their prescribing physician. The lactose content is typically small but may be relevant for patients with severe lactose intolerance or galactose malabsorption.
The 10 mg tablets are designed to be scored or divisible where possible, allowing for dose adjustments in increments smaller than 10 mg. However, patients should confirm with their pharmacist whether their specific tablet formulation is suitable for splitting, as not all tablet designs maintain dose accuracy when divided.
Frequently Asked Questions About Hydrocortisone G.L. Pharma
Hydrocortisone G.L. Pharma 10 mg tablets are primarily used as replacement therapy for patients with adrenal insufficiency, including Addison's disease, congenital adrenal hyperplasia (CAH), and secondary adrenal insufficiency caused by pituitary disorders. The medication replaces the cortisol that the body's adrenal glands cannot produce in sufficient quantities. It may also be prescribed following surgical removal of the adrenal glands (adrenalectomy) or pituitary gland (hypophysectomy). Cortisol is essential for survival, regulating blood pressure, blood sugar, immune function, and the stress response.
No, you must never stop taking hydrocortisone abruptly without medical guidance. Sudden discontinuation can trigger a potentially fatal adrenal crisis, characterized by severe low blood pressure, dehydration, shock, hypoglycemia, and loss of consciousness. If your doctor determines that you no longer need the medication, they will gradually reduce your dose over several weeks or months. Patients with permanent adrenal insufficiency will generally need hydrocortisone replacement for life.
If you miss a dose, take it as soon as you remember. If it is nearly time for your next dose, skip the missed dose and continue your regular schedule. Never take a double dose. If you miss multiple doses or cannot keep your medication down due to vomiting, this is a medical situation requiring prompt attention — contact your doctor or go to an emergency department, as you may need an intramuscular hydrocortisone injection to prevent adrenal crisis.
Weight gain is possible with hydrocortisone, particularly at doses above physiological replacement levels. At standard replacement doses (15–25 mg daily for adrenal insufficiency), weight changes are generally modest. Hydrocortisone can increase appetite and cause fluid retention, both of which contribute to weight gain. If you notice significant weight changes, discuss this with your doctor, as it may indicate that your dose needs adjustment. Maintaining a balanced diet and regular physical activity can help manage weight during treatment.
Moderate alcohol consumption is generally acceptable while taking hydrocortisone at replacement doses, but caution is advised. Alcohol can irritate the stomach lining, and when combined with hydrocortisone, may increase the risk of gastrointestinal problems including gastritis and peptic ulcers. Alcohol also affects blood sugar regulation, which can be problematic since hydrocortisone also influences glucose metabolism. Discuss your alcohol intake with your doctor for personalized guidance.
Hydrocortisone is the active form of the hormone cortisol, produced naturally by the adrenal glands. Cortisone is an inactive prodrug that must be converted to cortisol (hydrocortisone) by an enzyme in the liver (11β-HSD1). Because hydrocortisone does not require hepatic activation, it provides more reliable and predictable cortisol levels, making it the preferred choice for replacement therapy. The terms "cortisol" and "hydrocortisone" are used interchangeably in medical literature.
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Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, comprising specialist physicians with expertise in endocrinology and clinical pharmacology. Our team follows international guidelines from the Endocrine Society, European Medicines Agency (EMA), British National Formulary (BNF), and the World Health Organization (WHO).
iMedic Medical Editorial Team — Specialists in endocrinology, internal medicine, and clinical pharmacology with documented academic credentials and clinical experience.
iMedic Medical Review Board — Independent panel of board-certified physicians who verify medical accuracy, evidence quality, and adherence to current international treatment guidelines.
Evidence framework: All medical claims in this article are supported by Level 1A evidence (systematic reviews and meta-analyses of randomized controlled trials) or established clinical practice guidelines from recognized international medical organizations. This article contains no commercial funding and has no conflicts of interest.