Dexamethasone 1.5mg Tablets

Manufacturer HIKMA /ROXANE 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
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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 helps reduce inflammation (swelling and pain) and suppress the immune system. It's used for many conditions like allergies, asthma, arthritis, skin conditions, 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're feeling 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 secure 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 of your medication:
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 one.
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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 dose needs to be gradually reduced by your doctor to prevent withdrawal symptoms.
  • 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 wear a bracelet stating you are taking a steroid, especially if you are on long-term therapy.
  • Limit salt intake to help prevent fluid retention.
  • Discuss vaccinations with your doctor before receiving them, as some vaccines may not be safe or effective while on dexamethasone.
  • Report any unusual stress (e.g., surgery, illness, injury) to your doctor, as your dose may need adjustment.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication; 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 mg to 9 mg daily, adjusted based on patient response and disease severity.
Cerebral Edema: Initial 10 mg IV, then 4 mg IM/IV every 6 hours until symptoms subside. Oral therapy may follow.
Multiple Myeloma: 40 mg orally once weekly (often in combination regimens).
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.
Infant: Dosing highly individualized based on condition and weight; e.g., 0.02-0.3 mg/kg/day in 3-4 divided doses for anti-inflammatory.
Child: Dosing highly individualized based on condition and weight; e.g., 0.02-0.3 mg/kg/day in 3-4 divided doses for anti-inflammatory.
Adolescent: Similar to adult dosing, individualized based on condition and weight.
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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.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in severe hepatic impairment due to decreased metabolism and clearance.
Severe: Dose reduction may be necessary; monitor for increased side effects.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a potent glucocorticoid. It binds to specific cytoplasmic glucocorticoid receptors, forming a complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements), modulating gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortin-1) 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 lymphocyte proliferation and function, and reducing the activity of macrophages and other immune cells.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 0.8 L/kg
ProteinBinding: 77% (primarily to albumin, less than other corticosteroids)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: Plasma half-life: 3-4.5 hours; Biological half-life: 36-54 hours
Clearance: Not readily available, but primarily hepatic metabolism followed by renal excretion.
ExcretionRoute: Renal (metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Oral: within hours; IV: minutes to hours
PeakEffect: Oral: 1-2 hours; IV: 1 hour
DurationOfAction: Biological effects can last 36-72 hours due to long biological half-life.

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, difficulty 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 irregular 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 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, 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 periods.
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 Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor or seek medical attention:

Nausea or vomiting.
Difficulty 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of infection: fever, chills, sore throat, body aches, flu-like symptoms, unusual pain or redness.
  • Severe mood changes: depression, euphoria, insomnia, anxiety, confusion.
  • Gastrointestinal bleeding: black, tarry stools; severe stomach pain; vomiting blood.
  • Fluid retention: significant swelling in hands, ankles, or feet; unusual weight gain.
  • High blood sugar: increased thirst, increased urination, blurred vision.
  • Muscle weakness or severe fatigue.
  • Vision problems: blurred vision, eye pain, halos around lights.
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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, such as:
+ Diverticulitis
+ Ulcerative colitis
+ Ulcers
+ Recent bowel surgery

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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. Regular blood tests, as directed by your doctor, are crucial to monitor your health. Additionally, if you are taking this medication long-term, you may need to have your eye pressure and bone density checked.

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

If you are scheduled to undergo allergy skin tests, inform your doctor and lab workers 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 weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk or if you have any concerns. You may need to reduce your salt intake and take extra potassium, so consult with your doctor about this. If you have diabetes, it is crucial to closely monitor your blood sugar levels.

Before consuming alcohol, discuss it with your doctor. Additionally, consult with your doctor before receiving any vaccines, as some vaccines may not work as well or may increase the risk of infection when taken with this medication.

It is essential to be aware that chickenpox and measles can be severe or even life-threatening in people taking steroid medications like this one. Avoid close contact with anyone who has chickenpox or measles if you have not had these illnesses before. 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, and even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize the 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.

Some infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. 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, inform your doctor, as your body's response to these stresses may be affected, and you may require additional steroid doses.

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

Long-term use of this medication has been associated with an increased risk of a type of cancer called Kaposi's sarcoma. Discuss this with your doctor. Patients with cancer may be at a higher risk of developing a potentially life-threatening condition called tumor lysis syndrome (TLS), 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 affect growth in children and teenagers, so regular growth checks may be necessary. Additionally, this medication can lower sperm counts, so discuss this with your doctor if you have concerns.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of this medication to you and your baby. If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: severe nausea, vomiting, stomach pain, weakness, drowsiness, confusion, fluid retention, high blood pressure, and electrolyte imbalances.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Long-term overdose can lead to Cushing's syndrome.

Drug Interactions

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Contraindicated Interactions

  • Live or live-attenuated vaccines (during immunosuppressive doses)
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Major Interactions

  • CYP3A4 inducers (e.g., Phenytoin, Carbamazepine, Rifampin, Barbiturates): Decreased dexamethasone efficacy.
  • CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin): Increased dexamethasone levels and toxicity.
  • NSAIDs (e.g., Ibuprofen, Naproxen): Increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., Warfarin): May alter anticoagulant effect (monitor INR).
  • Diuretics (e.g., Thiazides, Loop diuretics): Increased risk of hypokalemia.
  • Antidiabetics (e.g., Insulin, Metformin): May increase blood glucose, requiring dose adjustment of antidiabetics.
  • Digoxin: Increased risk of digitalis toxicity due to hypokalemia.
  • Cholestyramine, Colestipol: May decrease dexamethasone absorption.
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Moderate Interactions

  • Oral contraceptives/Estrogens: May increase dexamethasone effects.
  • Cyclosporine: Increased levels of both drugs, increased risk of seizures.
  • Fluoroquinolones: Increased risk of tendon rupture.
  • Vaccines (inactivated): Reduced immune response to vaccines.
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Minor Interactions

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

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Before initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia or worsen existing diabetes.

Timing: Before initiation

Serum Electrolytes (especially Potassium)

Rationale: Risk of hypokalemia and fluid/electrolyte imbalance.

Timing: Before initiation

Bone Mineral Density (DEXA scan)

Rationale: For patients anticipated to be on long-term therapy (>3 months) due to risk of osteoporosis.

Timing: Before initiation

Ophthalmic Exam (intraocular pressure)

Rationale: For patients anticipated to be on long-term therapy (>6 weeks) due to risk of glaucoma/cataracts.

Timing: Before initiation

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during dose adjustments or long-term therapy.

Target: Individualized, typically <130/80 mmHg

Action Threshold: Sustained elevation requiring intervention.

Blood Glucose (fasting or HbA1c)

Frequency: Weekly initially, then monthly or as clinically indicated for long-term therapy.

Target: Fasting <100 mg/dL; HbA1c <6.5%

Action Threshold: Persistent hyperglycemia requiring antidiabetic medication or dose adjustment.

Serum Electrolytes (Na, K)

Frequency: Periodically, especially during initial therapy or with concomitant diuretics.

Target: Na: 135-145 mEq/L; K: 3.5-5.0 mEq/L

Action Threshold: Significant hypokalemia or hypernatremia.

Weight and Fluid Balance

Frequency: Regularly

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain or edema.

Signs of Infection

Frequency: Continuously

Target: Absence of fever, localized pain, redness, swelling

Action Threshold: Any signs of infection (corticosteroids can mask symptoms).

Growth (pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth velocity for age

Action Threshold: Growth retardation.

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, localized pain/redness)
  • Mood changes (irritability, anxiety, depression, euphoria, insomnia)
  • Gastrointestinal upset (heartburn, indigestion, abdominal pain, black/tarry stools)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Skin changes (thinning, bruising, acne)
  • Increased thirst or urination (signs of hyperglycemia)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. There is a potential for fetal growth restriction, adrenal suppression, and cleft palate (especially with first-trimester exposure, though data are conflicting).

Trimester-Specific Risks:

First Trimester: Potential increased risk of oral clefts (conflicting data), fetal adrenal suppression.
Second Trimester: Risk of fetal growth restriction, adrenal suppression.
Third Trimester: Risk of fetal growth restriction, adrenal suppression in the neonate (monitor neonate for signs of hypoadrenalism).
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Lactation

L3 (Moderately safe). Dexamethasone is excreted into breast milk in small amounts. Low doses are generally considered compatible with breastfeeding. High doses or prolonged use may cause adverse effects in the infant (e.g., growth suppression, adrenal suppression).

Infant Risk: Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability) or other adverse effects. Consider administering the dose immediately after a feeding to minimize infant exposure.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth velocity carefully. Use the lowest effective dose for the shortest possible duration. Increased risk of intracranial hypertension in children.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects, including osteoporosis, hypertension, diabetes, and fluid retention. Use with caution and the lowest effective dose.

Clinical Information

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Clinical Pearls

  • Always taper the dose of dexamethasone gradually when discontinuing, especially after prolonged therapy, to prevent adrenal insufficiency.
  • Take dexamethasone with food or milk to minimize gastrointestinal irritation.
  • Patients on long-term therapy should be advised to carry a steroid identification card.
  • Dexamethasone has a long biological half-life, allowing for once-daily dosing or alternate-day therapy for some conditions.
  • Be vigilant for signs of infection, as corticosteroids can mask inflammatory responses.
  • Monitor blood glucose levels, especially in diabetic or pre-diabetic patients, as corticosteroids can elevate blood sugar.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., Prednisone, Methylprednisolone, Hydrocortisone) - choice depends on potency, duration, and specific indication.
  • NSAIDs (for inflammatory conditions, if appropriate and less severe)
  • Immunosuppressants (e.g., Methotrexate, Azathioprine, Cyclosporine - for autoimmune diseases)
  • Biologic agents (for specific inflammatory or autoimmune conditions)
  • Antihistamines (for allergic reactions)
  • Bronchodilators (for asthma exacerbations)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (1.5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

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 your 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 medication taken, the amount, and the time it occurred.