Dexamethasone 0.5mg Tablets

Dexamethasone is a synthetic adrenocortical steroid that is approximately 25 times more potent than hydrocortisone and 5 times more potent than prednisone. It binds to specific intracellular glucocorticoid receptors in target tissues, forming a steroid-receptor complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements), modulating gene transcription. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1, which inhibits phospholipase A2) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, adhesion molecules, prostaglandins, leukotrienes). It also suppresses immune responses by inhibiting the function of lymphocytes and macrophages.

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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an abnormal heartbeat.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache, dizziness, fainting, or changes in vision.
Signs of adrenal insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Abnormal heartbeat (fast, slow, or irregular).
Chest pain or pressure.
Swelling, warmth, numbness, color changes, or pain in a leg or arm.
Changes in menstrual period.
Bone or joint pain.
Muscle pain or weakness.
Changes in vision.
Changes in behavior or mood.
Seizures.
Burning, numbness, or tingling sensations that are not normal.
Unexplained bruising or bleeding.
Severe stomach pain.
Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or persist, contact your doctor or seek medical attention:

Nausea and vomiting.
Insomnia.
Restlessness.
Excessive sweating.
Hair thinning.
Headache.
Dizziness, fatigue, or weakness.
Weight gain.
Increased appetite.
Hiccups.

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
The presence of any 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
+ Other types of infections
Nerve problems affecting the eye
Stomach or bowel problems, such as:
+ Diverticulitis
+ Ulcerative colitis
+ Ulcers
+ Recent bowel surgery

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Your doctor will assess the safety of taking this medication with your existing health conditions and medications. Do not start, stop, or change the dose of any medication without consulting your doctor first.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Additionally, if you are taking this medication long-term, you may need to undergo eye pressure and bone density checks.

This medication can interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and lab personnel that you are taking this drug. Be aware that medications like this one can cause high blood pressure, so regular blood pressure checks, as advised by your doctor, are necessary.

This medication may also affect the results of allergy skin tests, so be sure to inform your doctor and lab workers that you are taking this medication. Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so discuss this with your doctor.

Prolonged use of this medication can lead to weak bones (osteoporosis), so talk to your doctor about your risk factors and any concerns you may have. You may need to reduce your salt intake and increase your potassium consumption, 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. Additionally, consult with your doctor before receiving any vaccines, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

It is essential to avoid close contact with individuals who have chickenpox or measles, as these infections can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. To minimize this risk, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. Notify your doctor if you experience any signs of infection.

In some cases, medications like this one can reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections. This medication can also suppress your body's natural production of steroids, which can affect your response to stress, such as fever, infection, surgery, or injury. In such situations, you may require additional steroid doses, so notify your doctor.

If you have been taking this medication for an extended period, consult with your doctor before stopping or reducing the dosage, as this can cause withdrawal symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness.

Long-term use of medications like this one has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor. Additionally, patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition, so inform your doctor if you have cancer.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can also affect growth in children and adolescents, so regular growth checks may be necessary. Furthermore, this medication can lower sperm counts, so discuss any concerns with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as this medication can affect the fetus or baby. If you took this medication during pregnancy, notify your baby's doctor.

• Live or live attenuated vaccines (during immunosuppressive doses of corticosteroids)
• Systemic fungal infections (unless used as part of specific anti-fungal regimen)

• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital): May decrease dexamethasone levels, requiring dose increase.
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase dexamethasone levels, requiring dose reduction.
• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effect (either increase or decrease), requiring close INR monitoring.
• Diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics): Dexamethasone can increase blood glucose, requiring increased doses of antidiabetic agents.
• Cholestyramine, colestipol: May decrease absorption of dexamethasone.
• Digoxin: Increased risk of digitalis toxicity due to hypokalemia.
• Neuromuscular blockers (e.g., pancuronium, vecuronium): Prolonged neuromuscular blockade, especially with high-dose corticosteroids.
• Immunosuppressants (e.g., cyclosporine): Increased risk of seizures and other CNS effects with concomitant use.

• Oral contraceptives/estrogens: May increase dexamethasone levels.
• Aspirin (high dose): Increased risk of GI side effects; corticosteroids may decrease salicylate levels.
• Vaccines (inactivated): Reduced immune response to vaccines.
• Aminoglutethimide: May decrease dexamethasone efficacy.
• Isoniazid: Decreased isoniazid levels.

• Grapefruit juice: May slightly increase dexamethasone levels (CYP3A4 inhibition).

• Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia) upon withdrawal
• Signs of Cushing's syndrome (moon face, buffalo hump, central obesity, striae, muscle weakness) with long-term use
• Mood changes (insomnia, anxiety, depression, euphoria, psychosis)
• Gastrointestinal upset, abdominal pain, black/tarry stools (GI bleeding)
• Muscle weakness, pain
• Blurred vision, eye pain (glaucoma, cataracts)
• Increased thirst, urination (hyperglycemia)
• Increased susceptibility to infection (fever, chills, sore throat, unusual fatigue)
• Swelling of ankles/feet (fluid retention)

Category C. Dexamethasone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects. Human data are limited but suggest a potential for increased risk of oral clefts, especially with first-trimester exposure, though this risk is debated and likely small.

Dexamethasone is excreted into breast milk. The amount is generally low, but potential for adverse effects on the infant (e.g., growth suppression, interference with endogenous corticosteroid production) exists, especially with high doses or prolonged use. Use with caution. Monitor infant for adverse effects.

Corticosteroids can cause growth retardation in children. Long-term use requires careful monitoring of growth and development. Adrenal suppression can occur, especially with abrupt withdrawal. Increased susceptibility to infections. Use the lowest effective dose for the shortest possible duration.

Elderly patients may be at increased risk for adverse effects, including osteoporosis, fluid retention, hypertension, diabetes, and skin thinning. Close monitoring is recommended. Use the lowest effective dose.

• Dexamethasone has a long biological half-life, allowing for once-daily dosing or alternate-day dosing for some indications.
• Always taper the dose gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
• Patients on long-term dexamethasone should be advised to carry a steroid warning card.
• Monitor for signs of infection, as corticosteroids can mask symptoms.
• Consider bone protection (calcium, vitamin D, bisphosphonates) for patients on long-term therapy.
• Administer with food to minimize gastrointestinal irritation.
• Dexamethasone is often preferred over other corticosteroids for cerebral edema due to its good CNS penetration and minimal mineralocorticoid activity.

• Other corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone) for inflammatory or immunosuppressive conditions.
• NSAIDs (e.g., ibuprofen, naproxen) for mild to moderate inflammation and pain (less potent than corticosteroids).
• Disease-modifying antirheumatic drugs (DMARDs) or biologics for chronic autoimmune conditions (often used in conjunction with or as an alternative to long-term corticosteroids).
• Specific therapies for underlying conditions (e.g., chemotherapy for cancer, antibiotics for infection).

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.