Dexamethasone 0.75mg Tablets

Dexamethasone is a synthetic adrenocortical steroid that is approximately 25 times more potent than hydrocortisone and 5-7 times more potent than prednisone. It exerts its effects by binding to specific cytoplasmic glucocorticoid receptors in target cells. This complex then translocates to the nucleus, where it modulates gene expression by binding to glucocorticoid response elements (GREs) in DNA. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortin) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses immune responses by inhibiting leukocyte migration, reducing capillary permeability, and stabilizing lysosomal membranes.

Serious 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 sputum production or change in sputum color, painful urination, mouth sores, or a wound that will not 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 or dizziness, fainting, or changes in vision.
Signs of a 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 belly, 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, significant weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow wound 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.
Unusual burning, numbness, or tingling sensations.
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 do not go away, 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 a comprehensive list of all 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
The presence of any infections, 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
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. Please inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you are experiencing

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety.

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 can interfere with certain laboratory tests, so be sure to notify all your healthcare providers and lab personnel that you are taking it. Additionally, this medication can cause high blood pressure, so your doctor will likely monitor your blood pressure regularly.

If you are scheduled to undergo allergy skin testing, inform your doctor and the lab personnel that you are taking this medication, as it may affect the test results. 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 also lead to osteoporosis (weak bones). Your doctor can help you determine if you are at higher risk of developing osteoporosis and answer any questions you may have. You may need to reduce your salt intake and increase your potassium consumption; consult with your doctor for personalized advice.

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 vaccinations, 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, notify 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. Inform your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. If you have a history of these infections, inform your doctor. 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, your doctor may recommend additional steroid doses.

If you have been taking this medication for an extended period, do not stop taking it without consulting your doctor, as this can lead to withdrawal symptoms. If you miss a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, notify your doctor.

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. Additionally, patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition; consult with your doctor to understand this risk.

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 in some individuals; if you have concerns, discuss them with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your 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, barbiturates): 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 GI ulceration and bleeding.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease), requiring close INR monitoring.
• Diuretics (thiazide, loop): Increased risk of hypokalemia.
• Digoxin: Increased risk of digoxin toxicity due to hypokalemia.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetic agents.
• Immunosuppressants (e.g., cyclosporine): Increased risk of seizures and other CNS effects with concurrent use; increased risk of infection.
• Cholestyramine, colestipol: May decrease absorption of dexamethasone.
• Aminoglutethimide: May decrease dexamethasone efficacy.

• Oral contraceptives/Estrogens: May increase dexamethasone effects by decreasing its metabolism.
• Fluoroquinolones: Increased risk of tendon rupture.
• Neuromuscular blockers: May prolong neuromuscular blockade.
• Vaccines (inactivated): Reduced immune response to vaccines.

• Not available

• Signs of infection (fever, sore throat, malaise, localized pain/redness)
• Mood changes (irritability, anxiety, depression, euphoria, psychosis)
• Sleep disturbances (insomnia)
• Fluid retention (swelling in ankles/feet, weight gain)
• Muscle weakness or pain
• Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
• Vision changes (blurred vision, eye pain)
• Increased thirst or urination (signs of hyperglycemia)
• Easy bruising or skin thinning
• Symptoms of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension, joint/muscle pain)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown teratogenic effects.

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 long-term use. Use with caution; consider delaying breastfeeding for 3-4 hours after a dose or using the lowest effective dose.

Corticosteroids can cause growth retardation in children. Long-term use should be carefully monitored. Adrenal suppression can occur, requiring careful tapering. Increased susceptibility to infections. Monitor for increased intracranial pressure in children.

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

• Always taper dexamethasone doses gradually after prolonged therapy (typically >7-10 days) to prevent adrenal insufficiency.
• Administer with food or milk to minimize gastrointestinal irritation.
• Dexamethasone has a long biological half-life, allowing for once-daily or alternate-day dosing for some indications, which can reduce side effects.
• Patients on long-term therapy should be advised to carry a steroid identification card.
• Be vigilant for signs of infection, as corticosteroids can mask symptoms.
• Consider bone protection (calcium, vitamin D, bisphosphonates) for patients on long-term therapy.
• Monitor blood glucose closely, especially in diabetic patients or those at risk for diabetes.

• Other systemic corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone)
• NSAIDs (for inflammatory conditions, if appropriate)
• Immunosuppressants (e.g., methotrexate, azathioprine, biologics for autoimmune diseases)
• Specific disease-modifying agents (e.g., for cancer, autoimmune diseases)

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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.