Dexamethasone 4mg Tablets

Manufacturer ANI PHARMACEUTICALS Active Ingredient Dexamethasone Tablets(deks a METH a sone) Pronunciation deks-a-METH-a-sone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Corticosteroid, Anti-inflammatory, Immunosuppressant
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Pharmacologic Class
Glucocorticoid receptor agonist
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Dexamethasone is a type of steroid medicine that works by reducing inflammation (swelling and redness) and calming down your body's immune system. It's used for many conditions like allergies, asthma, skin problems, and certain cancers.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

If you take your medication once a day, it's best to take it in the morning.
Take your medication with food to help prevent stomach upset.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

If you're also taking cholestyramine, you may need to take it at a different time than your other medication. Be sure to talk to your pharmacist about the best schedule for your medications.

Storing and Disposing of Your Medication

To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However:
If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take with food or milk to reduce stomach upset.
  • Do not stop taking this medicine suddenly, especially if you've been on it for a long time. Your doctor will tell you how to slowly reduce the dose.
  • Avoid contact with people who are sick or have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Carry a medical alert card or bracelet if you are on long-term therapy, indicating you are taking a steroid.
  • Limit sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake to protect bone health, especially with long-term use.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on condition; typically 0.75 mg to 9 mg daily, in single or divided doses.
Dose Range: 0.75 - 9 mg

Condition-Specific Dosing:

anti-inflammatory/immunosuppressive: 0.75-9 mg/day orally in single or divided doses
cerebralEdema: 10 mg IV/PO initially, then 4 mg every 6 hours until symptoms subside
multipleMyeloma: 40 mg orally once weekly (often with other agents)
COVID-19 (severe): 6 mg orally or IV once daily for up to 10 days
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., bronchopulmonary dysplasia) may use 0.05-0.1 mg/kg/day in divided doses.
Infant: 0.02-0.3 mg/kg/day orally in 1-4 divided doses, depending on condition.
Child: 0.02-0.3 mg/kg/day orally in 1-4 divided doses, depending on condition (e.g., croup: 0.6 mg/kg single dose, max 16 mg).
Adolescent: Similar to adult dosing, 0.02-0.3 mg/kg/day orally in 1-4 divided doses, depending on condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Monitor for increased side effects; dose reduction may be considered in severe cases.
Severe: Monitor closely; dose reduction may be necessary due to impaired metabolism and clearance.

Pharmacology

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Mechanism of Action

Dexamethasone is a potent synthetic glucocorticoid. It exerts its anti-inflammatory and immunosuppressive effects by binding to cytoplasmic glucocorticoid receptors, which then translocate to the nucleus. This complex modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) and inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins, leukotrienes) by inhibiting phospholipase A2 and cyclooxygenase-2. It also suppresses the immune system by inhibiting lymphocyte proliferation and function.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90% (oral)
Tmax: 1-2 hours (oral)
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 2 L/kg
ProteinBinding: Approximately 77% (primarily to albumin, less to transcortin than hydrocortisone)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: Plasma half-life: 3-4.5 hours; Biological half-life: 36-54 hours
Clearance: Approximately 0.125 L/hr/kg
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Hours (anti-inflammatory effects), minutes (IV for acute effects)
PeakEffect: Variable, depending on condition and route; typically 1-2 hours for peak plasma levels, but clinical effects may take longer.
DurationOfAction: 36-72 hours (due to long biological half-life)
Confidence: Medium

Safety & Warnings

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Side Effects

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 notice 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 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, unusual 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 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
Abnormal sensations (burning, numbness, or tingling)
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 may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Nausea and vomiting
Trouble sleeping
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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Signs of infection: fever, chills, sore throat, body aches, unusual tiredness, cough, painful urination.
  • Signs of adrenal insufficiency (if stopping too quickly): severe fatigue, weakness, nausea, vomiting, dizziness, joint pain.
  • Severe stomach pain, black/tarry stools, or vomiting blood.
  • Swelling in your hands or feet, rapid weight gain.
  • Blurred vision, eye pain, or seeing halos around lights.
  • Severe mood changes, depression, or unusual thoughts/behavior.
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Before Using This Medicine

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 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
Nerve problems affecting the eye
Stomach or bowel problems, including:
+ 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

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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Precautions & Cautions

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 affect the results of certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication.

There is a risk of developing high blood pressure while taking this medication. Your doctor will monitor your blood pressure regularly, so it is crucial to follow their instructions for checking your blood pressure.

This medication may interfere with allergy skin tests. Inform your doctor and laboratory personnel that you are taking this medication to ensure accurate test results.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Prolonged use of this medication can also lead to osteoporosis (weak bones). Talk to your doctor to determine if you are at higher risk or if you have any questions about osteoporosis.

You may need to reduce your salt intake and increase your potassium consumption while taking this medication. Consult with your doctor to determine the best approach for your specific situation.

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, wash your hands frequently, avoid close contact with individuals 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 infections.

This medication can suppress the production of natural steroids in your body. If you experience fever, infection, surgery, or injury, notify your doctor, as your body's response to these stresses may be affected. You may require additional steroid doses in these situations.

If you have been taking this medication for an extended period, consult with your doctor before stopping or reducing the dosage. You may need to gradually taper off the medication to avoid adverse effects. If you have missed a dose or recently stopped taking this medication and experience fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, notify your doctor immediately.

Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this potential 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 affect growth in children and adolescents. Regular growth checks may be necessary to monitor this potential effect. Discuss this risk with your doctor.

This medication may also lower sperm counts in some individuals. If you have concerns, consult with your doctor.

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.

It is crucial to follow your doctor's instructions and attend all scheduled appointments to ensure safe and effective use of this medication.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: nausea, vomiting, stomach upset, fluid retention, electrolyte imbalances, and exacerbation of known side effects.

What to Do:

Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive and symptomatic.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (increased risk of infection)
  • Mifepristone (antagonism of corticosteroid effect)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates - decreased dexamethasone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased dexamethasone levels)
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Moderate Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • Anticoagulants (warfarin - altered anticoagulant effect, monitor INR)
  • Oral hypoglycemics/Insulin (may require increased dose of antidiabetic agents)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs)
  • Fluoroquinolones (increased risk of tendon rupture, especially in elderly)
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Minor Interactions

  • Antacids (may reduce absorption, separate administration)
  • Cholestyramine (may reduce absorption)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood glucose

Rationale: Corticosteroids can induce hyperglycemia.

Timing: Prior to initiation

Serum electrolytes (Na, K)

Rationale: Risk of fluid retention and hypokalemia.

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: For long-term therapy, risk of osteoporosis.

Timing: Prior to initiation (if long-term therapy anticipated)

Ophthalmic exam (intraocular pressure)

Rationale: Risk of glaucoma and cataracts with long-term use.

Timing: Prior to initiation (if long-term therapy anticipated)

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during initiation and dose changes.

Target: Normal for patient

Action Threshold: Sustained elevation requiring intervention.

Blood glucose (fasting or HbA1c)

Frequency: Regularly, more frequently in diabetics or those at risk.

Target: Normal for patient or individualized glycemic targets.

Action Threshold: Persistent hyperglycemia requiring antidiabetic medication adjustment.

Serum electrolytes (Na, K)

Frequency: Periodically, especially with concomitant diuretics or cardiac conditions.

Target: Normal range

Action Threshold: Significant hypokalemia or hypernatremia.

Growth and development (pediatric)

Frequency: Regularly (e.g., every 3-6 months) for long-term therapy.

Target: Normal growth curve

Action Threshold: Growth retardation.

Signs of infection

Frequency: Ongoing clinical assessment.

Target: Absence of fever, localized infection signs.

Action Threshold: Development of fever, malaise, or localized infection.

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, unusual pain)
  • Adrenal insufficiency (fatigue, weakness, nausea, vomiting, hypotension, joint pain upon withdrawal)
  • Hyperglycemia (increased thirst, urination, hunger)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Gastrointestinal upset (stomach pain, black/tarry stools)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Skin changes (thinning, bruising, acne)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. There is a potential for fetal growth restriction and adrenal suppression with prolonged or high-dose use.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless essential. Potential for increased risk of oral clefts (though data is conflicting and less clear for dexamethasone than other corticosteroids).
Second Trimester: Risk of fetal growth restriction and adrenal suppression increases with prolonged use.
Third Trimester: Risk of fetal growth restriction and adrenal suppression. Neonates should be monitored for signs of hypoadrenalism.
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Lactation

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

Infant Risk: Low risk with short-term or low-dose use; moderate risk with high-dose or prolonged use.
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Pediatric Use

Long-term use can cause growth retardation and suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Children are more susceptible to systemic side effects. Monitor growth and development closely. Alternate day therapy may reduce growth suppression.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects, including osteoporosis, fluid retention, hypertension, and diabetes. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Always taper the dose gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
  • Administer with food or milk to minimize gastrointestinal irritation.
  • Patients on long-term therapy should be monitored for bone density, blood glucose, blood pressure, and ophthalmic changes.
  • Immunosuppression increases the risk of infection; advise patients to report any signs of infection promptly.
  • Dexamethasone has a long biological half-life, allowing for once-daily or alternate-day dosing for many conditions.
  • Consider calcium and vitamin D supplementation for patients on long-term therapy to mitigate bone loss.
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Alternative Therapies

  • Other corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone, betamethasone) depending on potency and duration of action required.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions where corticosteroids are not indicated or as an adjunct.
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for chronic inflammatory/autoimmune conditions.
  • Immunosuppressants (e.g., azathioprine, methotrexate, cyclosporine) for conditions requiring long-term immune modulation.
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, 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 details. 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 reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.