Cortef 20mg Tablets

Hydrocortisone is a naturally occurring glucocorticoid. It binds to specific intracellular glucocorticoid receptors in target tissues, forming a complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements), modulating gene transcription. This leads to synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). It also suppresses immune responses by inhibiting lymphocyte proliferation and function, and reduces capillary permeability.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Infection: Fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or a wound that won't heal.
High Blood Sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Low Potassium Levels: Muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Pancreatitis: Severe stomach pain, back pain, or nausea and vomiting.
High Blood Pressure: Severe headache, dizziness, fainting, or changes in vision.
Cushing's Syndrome: Weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Adrenal Insufficiency: Severe nausea and vomiting, dizziness, fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Other Serious Symptoms: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Skin Changes: Acne, stretch marks, slow healing, or excessive hair growth.
Skin Lesions: Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Musculoskeletal Pain: Bone or joint pain.
Menstrual Changes: Irregular periods.
Cardiovascular Symptoms: Chest pain or pressure.
Vision Changes: Blurred vision, eye pain, or severe eye irritation.
Behavioral Changes: Mood swings, depression, or hallucinations (seeing or hearing things that aren't there).
Seizures: Convulsions or fits.
Bleeding or Bruising: Unexplained bruising or bleeding.
Gastrointestinal Symptoms: Severe stomach pain, black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.

Common Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor if they bother you or persist:

Upset stomach or nausea
Difficulty sleeping
Restlessness
Excessive sweating
Increased appetite
* Weight gain

Reporting Side Effects

If you experience any side effects, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have an active infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
If you have nerve problems in your eye, as this may affect your treatment.

Additionally, it is crucial to discuss all of your medications, including:

Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins

with your doctor and pharmacist to ensure safe use. This is not an exhaustive list of potential interactions, and you must verify that it is safe to take this medication with all of your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor will likely recommend regular blood tests to monitor your condition. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

This medication may interfere with allergy skin tests, so be sure to notify your doctor and laboratory personnel that you are taking it. Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so discuss this with your doctor. Additionally, prolonged use may lead to weak bones (osteoporosis), so talk to your doctor about your individual risk factors and any concerns you may have.

You may need to reduce your salt intake and take potassium supplements, so consult with your doctor about making these changes. If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, discuss the potential risks with your doctor. If you regularly drink grapefruit juice or eat grapefruit, inform your doctor, as this may interact with the medication.

Do not exceed the prescribed dose, as taking more than recommended may increase the risk of severe side effects. Before receiving any vaccinations, consult with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

If you have not had chickenpox or measles before, avoid close contact with anyone who has these conditions, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, notify your doctor immediately.

Steroid medications, including this one, can increase the risk of infection, which can be mild or severe, and even life-threatening. The risk of infection is higher with higher doses of steroids. To minimize this risk, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these conditions. This medication may also lower the levels of natural steroids in your body, so if you experience a fever, infection, surgery, or injury, consult with your doctor, as you may need additional oral steroids to help your body cope with these stresses. Carry a warning card indicating that you may require extra steroids in certain situations.

If you have been taking this medication for an extended period, do not stop suddenly without consulting your doctor, as this may lead to withdrawal symptoms. If you experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness after missing a dose or stopping the medication, notify your doctor promptly.

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor. If you have or may have a condition called pheochromocytoma, inform your doctor, as this medication can have severe and potentially life-threatening effects in people with this condition.

Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your doctor. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

This medication may affect growth in children and adolescents, so regular growth checks may be necessary. If you are a premature infant, inform your doctor, as this medication has been associated with a specific heart problem in this population.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor. If you took this medication during pregnancy, inform your baby's doctor. If you have poor adrenal function, be aware that stopping this medication, taking too low of a dose, or switching between different forms of this medication can lead to severe and potentially life-threatening adrenal gland problems. Consult with your doctor if you have any questions or concerns.

• Live or live attenuated vaccines (in patients receiving immunosuppressive doses of corticosteroids)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase hydrocortisone levels and effects.
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates): May decrease hydrocortisone levels and effects.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease INR).
• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
• Diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetic agents.

• Cardiac glycosides (e.g., digoxin): Increased risk of toxicity if hypokalemia occurs.
• Cholestyramine, colestipol: May decrease absorption of hydrocortisone.
• Cyclosporine: May increase levels of both hydrocortisone and cyclosporine.
• Estrogens/Oral Contraceptives: May increase hydrocortisone levels and effects.
• Fluoroquinolones: Increased risk of tendon rupture.

• Antacids: May decrease absorption (separate administration time).

• Signs of infection (fever, sore throat, malaise, localized pain/swelling)
• Fluid retention (swelling in ankles/feet, weight gain)
• Mood changes (irritability, anxiety, depression, euphoria)
• Sleep disturbances
• Muscle weakness or pain
• Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
• Vision changes
• Increased thirst or urination (signs of hyperglycemia)
• Easy bruising or thinning skin
• Delayed wound healing

Hydrocortisone is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Hydrocortisone is excreted in breast milk. Low doses are generally considered compatible with breastfeeding, but caution is advised. High doses or prolonged use may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production). Monitor the infant for signs of adrenal suppression.

Corticosteroids can cause growth retardation in children. Growth and development should be carefully monitored. Long-term use can also lead to adrenal suppression, requiring careful tapering. Pediatric patients may be more susceptible to adverse effects such as intracranial hypertension.

Elderly patients may be at increased risk for adverse effects such as osteoporosis, fluid retention, hypertension, and diabetes. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

• Always taper corticosteroids gradually when discontinuing, especially after prolonged use, to prevent adrenal insufficiency crisis.
• Administer hydrocortisone in divided doses, mimicking the body's natural diurnal rhythm (e.g., 2/3 in the morning, 1/3 in the afternoon) for adrenal insufficiency.
• Patients on long-term corticosteroids should be advised to carry a steroid card or wear medical alert identification.
• Corticosteroids can mask signs of infection; monitor patients closely for any new symptoms.
• Consider bone protection (calcium, vitamin D, bisphosphonates) for patients on long-term corticosteroid therapy.
• Patients should be educated on potential mood changes and report severe symptoms to their healthcare provider.

• Prednisone (oral)
• Methylprednisolone (oral)
• Dexamethasone (oral)
• Other systemic corticosteroids depending on indication and potency requirements.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.