Dexamethasone 1mg Tablets

Manufacturer VIONA 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
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
C
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FDA Approved
May 1958
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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 like a natural hormone your body makes. It's used to treat many conditions, including inflammation, allergies, and certain types of cancer. It helps reduce swelling, redness, itching, and allergic reactions, and can suppress your immune system.
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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 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, 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.
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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 or at high doses. Your doctor will tell you how to slowly reduce your dose to prevent withdrawal symptoms.
  • Avoid contact with people who are sick or have infections (like chickenpox or measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat) immediately.
  • Carry a steroid identification card or wear medical alert jewelry if you are on long-term therapy, in case of emergency.
  • Limit salt intake and eat foods rich in potassium (e.g., bananas, oranges) as advised by your doctor.
  • Regular exercise and calcium/vitamin D supplementation may be recommended for long-term use to protect bone health.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. For anti-inflammatory/immunosuppressive: 0.75 mg to 9 mg daily in single or divided doses.
Dose Range: 0.75 - 9 mg

Condition-Specific Dosing:

antiInflammatoryImmunosuppressive: 0.75 mg to 9 mg daily
cerebralEdema: 10 mg IV initially, then 4 mg IM/IV every 6 hours until symptoms subside. Oral maintenance 1-3 mg TID.
multipleMyeloma: 40 mg orally once weekly (often combined with other agents)
antiemetic: 8-20 mg IV/oral prior to chemotherapy
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Pediatric Dosing

Neonatal: Not established for routine use; used in specific conditions like bronchopulmonary dysplasia (0.1-0.2 mg/kg/day divided q12-24h for 3-7 days).
Infant: Highly variable based on indication (e.g., anti-inflammatory: 0.02-0.3 mg/kg/day divided q6-12h).
Child: Highly variable based on indication (e.g., anti-inflammatory: 0.02-0.3 mg/kg/day divided q6-12h; Croup: 0.6 mg/kg single dose, max 16 mg).
Adolescent: Dosing similar to adult, adjusted for weight/surface area and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Not significantly removed by dialysis; no dose adjustment needed.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in severe hepatic impairment, as metabolism may be impaired.
Severe: Consider dose reduction, monitor for increased side effects.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is approximately 25 times more potent than hydrocortisone and 5-10 times more potent than prednisone. It binds to specific cytoplasmic glucocorticoid receptors in target tissues, forming a steroid-receptor complex that translocates into the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating the transcription of various genes. This leads to altered protein synthesis, resulting in anti-inflammatory, immunosuppressive, and metabolic effects. It inhibits the release of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppresses immune cell function (e.g., lymphocytes, macrophages), and affects carbohydrate, protein, and fat metabolism.
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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: 0.8 L/kg
ProteinBinding: 77% (primarily to albumin, less to corticosteroid-binding globulin)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 3-4.5 hours (plasma); 36-54 hours (biological)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Hours (anti-inflammatory effects); Minutes to hours (IV for acute effects)
PeakEffect: 1-2 hours (oral); 4-8 hours (anti-inflammatory effects)
DurationOfAction: 36-72 hours (biological half-life, allowing for once-daily dosing)

Safety & Warnings

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Side Effects

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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of pancreatitis (pancreas problems), including:
+ Severe stomach pain
+ Severe back pain
+ Severe nausea or vomiting
Signs of high blood pressure, such as:
+ Severe headache
+ Dizziness or fainting
+ Changes in vision
Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow wound healing
Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ 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 cycle
Bone or joint pain
Muscle pain or weakness
Changes in vision
Changes in behavior
Depression or mood changes
Seizures
Burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Severe stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material

Other Possible Side Effects

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

Upset stomach or nausea
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.
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Seek Immediate Medical Attention If You Experience:

  • Signs of infection (fever, chills, body aches, cough, sore throat)
  • Severe mood changes (depression, anxiety, irritability, thoughts of self-harm)
  • Unusual swelling in your hands or feet, rapid weight gain
  • Muscle weakness or severe fatigue
  • Black, tarry, or bloody stools; severe stomach pain
  • Blurred vision or eye pain
  • Increased thirst or urination
  • Easy bruising or unusual bleeding
  • New or worsening high blood pressure (severe headache, blurred vision)
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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 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, 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. 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 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 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). Consult with your doctor to determine if you are at a higher risk of developing weak bones or if you have any questions. You may need to reduce your salt intake and take extra potassium, so discuss this with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before consuming alcohol, consult with your doctor. Additionally, before receiving any vaccines, discuss this with your doctor, as some vaccines may not work as effectively 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 deadly 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, and even life-threatening. To minimize the risk of infection, 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 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 doses of steroids, 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 this medication has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this 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 if you have concerns, discuss this with your doctor.

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 taking this medication. If you took this medication during pregnancy, notify your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: nausea, vomiting, stomach upset, weakness, fluid retention, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, obesity, skin thinning, muscle weakness).

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection)
  • Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital - decreased dexamethasone efficacy)
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased dexamethasone levels/toxicity)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Anticoagulants (e.g., warfarin - altered anticoagulant effect, monitor INR)
  • Diuretics (especially thiazide and loop diuretics - increased risk of hypokalemia)
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics - increased blood glucose, require dose adjustment)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia)
  • Mifepristone (antagonizes glucocorticoid effects)
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Moderate Interactions

  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Fluoroquinolones (increased risk of tendon rupture, especially in elderly)
  • Cholestyramine, colestipol (may decrease dexamethasone absorption)
  • Oral contraceptives (may increase dexamethasone levels)
  • Aminoglutethimide (may decrease dexamethasone efficacy)
  • Neuromuscular blockers (prolonged weakness/myopathy with long-term concomitant use)
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Minor Interactions

  • Antacids (may decrease absorption, separate administration)
  • Grapefruit juice (potential for minor increase in dexamethasone levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Serum Electrolytes (Na, K)

Rationale: Risk of sodium retention and potassium depletion.

Timing: Prior to initiation

Blood Glucose

Rationale: Risk of hyperglycemia, especially in predisposed individuals.

Timing: Prior to initiation

Weight

Rationale: Fluid retention and metabolic changes.

Timing: Prior to initiation

Ophthalmologic Exam

Rationale: Long-term use can cause cataracts or glaucoma.

Timing: Prior to initiation for anticipated long-term therapy

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially during initiation and dose changes; weekly to monthly for chronic use.

Target: Normal for patient

Action Threshold: Sustained elevation requiring intervention

Serum Electrolytes (Na, K)

Frequency: Weekly initially, then monthly for chronic use.

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

Action Threshold: K < 3.0 mEq/L or symptomatic hypokalemia; Na > 145 mEq/L with edema

Blood Glucose (Fasting or HbA1c)

Frequency: Weekly initially, then monthly to quarterly for chronic use.

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

Action Threshold: Sustained hyperglycemia requiring intervention (e.g., >126 mg/dL fasting)

Weight

Frequency: Weekly to monthly.

Target: Stable

Action Threshold: Significant, unexplained weight gain

Bone Mineral Density (DEXA scan)

Frequency: Baseline, then annually for chronic use (>3 months) or high doses.

Target: T-score > -2.5

Action Threshold: Osteopenia/osteoporosis requiring intervention

Growth (in children)

Frequency: Regularly (e.g., every 3-6 months) for chronic use.

Target: Normal growth velocity

Action Threshold: Growth retardation

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise)
  • Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, hypotension) upon withdrawal
  • Signs of Cushingoid features (moon face, buffalo hump, striae, acne)
  • Mood changes (irritability, depression, euphoria, psychosis)
  • Gastrointestinal symptoms (abdominal pain, black/tarry stools, vomiting blood)
  • Muscle weakness or pain
  • Vision changes (blurred vision, eye pain)
  • Swelling in ankles/feet
  • Unusual bruising or bleeding
  • Increased thirst or urination

Special Patient Groups

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Pregnancy

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 with first-trimester use, though this risk is low and controversial. Neonates exposed to corticosteroids in utero should be observed for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Potential, but low and controversial, increased risk of oral clefts.
Second Trimester: Risk of fetal growth restriction, adrenal suppression.
Third Trimester: Risk of fetal growth restriction, adrenal suppression, premature delivery.
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Lactation

Dexamethasone is excreted into breast milk. While the amount is generally low, long-term or high-dose use may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production). Use with caution; consider delaying breastfeeding for 3-4 hours after a dose or using an alternative if high doses are required.

Infant Risk: Low to moderate risk, especially with high doses or prolonged use. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability).
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Pediatric Use

Children are more susceptible to the adverse effects of corticosteroids, including growth retardation, adrenal suppression, and increased intracranial pressure. Use the lowest effective dose for the shortest possible duration. Monitor growth and development closely.

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Geriatric Use

Elderly patients may be at increased risk for adverse reactions, including osteoporosis, fluid retention, hypertension, diabetes, and cataracts. Use the lowest effective dose and monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Dexamethasone has a long biological half-life, allowing for once-daily dosing, which can improve adherence.
  • Due to its potent anti-inflammatory and immunosuppressive effects, it is crucial to taper the dose gradually after prolonged therapy to prevent adrenal insufficiency.
  • Patients on long-term dexamethasone should be advised about the risk of infection and to report any signs of illness promptly.
  • Consider bone protection strategies (calcium, vitamin D, bisphosphonates) for patients on chronic corticosteroid therapy.
  • Dexamethasone is often preferred over other corticosteroids in conditions requiring CNS penetration (e.g., cerebral edema, spinal cord compression) due to its good blood-brain barrier penetration.
  • Administering dexamethasone in the morning (before 9 AM) can help minimize disruption of the hypothalamic-pituitary-adrenal (HPA) axis.
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Alternative Therapies

  • Prednisone (oral corticosteroid, intermediate-acting)
  • Methylprednisolone (oral/IV corticosteroid, intermediate-acting)
  • Hydrocortisone (oral/IV corticosteroid, short-acting)
  • Betamethasone (oral corticosteroid, long-acting, similar to dexamethasone)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent)
  • Immunosuppressants (e.g., methotrexate, azathioprine, biologics) for chronic inflammatory/autoimmune diseases (often used as steroid-sparing agents)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (1mg)
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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.