Dexamethasone Pho 4mg/ml Injection

Manufacturer FRESENIUS KABI Active Ingredient Dexamethasone Injection Solution(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
Glucocorticoid; Anti-inflammatory; Immunosuppressant
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Pharmacologic Class
Corticosteroid
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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 powerful steroid medication used to reduce inflammation and suppress the immune system. It can treat many conditions like severe allergies, asthma, arthritis, skin conditions, and certain cancers. It works by reducing swelling and redness in the body.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and adhere to all guidelines provided. This medication is administered via injection.

For proper storage and disposal, consult with your doctor, nurse, or pharmacist to determine the best approach if you need to store this medication at home.

If you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid contact with people who are sick or have infections, as this medication can weaken your immune system.
  • Report any signs of infection (fever, chills, sore throat) immediately.
  • Follow a diet rich in calcium and vitamin D, and engage in weight-bearing exercise to help protect bone health, especially with long-term use.
  • Limit sodium intake to help prevent fluid retention.
  • Monitor blood sugar levels regularly, especially if you have diabetes.
  • Do not stop this medication suddenly, especially after prolonged use, as it can lead to withdrawal symptoms. Your doctor will provide a tapering schedule.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. Typical initial doses range from 0.75 mg to 9 mg daily, administered IM or IV, often in divided doses.
Dose Range: 0.75 - 40 mg

Condition-Specific Dosing:

Cerebral Edema: 10 mg IV initially, then 4 mg IM/IV every 6 hours until symptoms subside. Taper over 5-7 days.
Anti-inflammatory/Immunosuppressive: 0.75 mg to 9 mg daily, IM or IV, in single or divided doses.
Antiemetic (Chemotherapy-induced nausea and vomiting): 8 mg to 20 mg IV prior to chemotherapy, then 8 mg IV daily for 2-4 days.
COVID-19 (severe): 6 mg IV or PO once daily for up to 10 days or until discharge.
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., bronchopulmonary dysplasia) may use 0.05-0.1 mg/kg/day divided every 12-24 hours, with caution.
Infant: Dosing highly individualized based on indication. For anti-inflammatory: 0.02-0.3 mg/kg/day divided every 6-12 hours.
Child: Dosing highly individualized based on indication. For anti-inflammatory: 0.02-0.3 mg/kg/day divided every 6-12 hours. For croup: 0.6 mg/kg IM/PO single dose (max 10 mg).
Adolescent: Generally follows adult dosing guidelines, individualized based on indication and weight.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: Use with caution; dose reduction may be considered in severe impairment due to decreased metabolism and clearance.
Severe: Use with caution; dose reduction may be considered due to decreased metabolism and clearance. Monitor for increased adverse 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 exerts its effects by binding to specific cytoplasmic glucocorticoid receptors in target cells. The activated receptor-steroid 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-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 the function of lymphocytes and macrophages.
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Pharmacokinetics

Absorption:

Bioavailability: High (nearly 100% after IM/IV administration)
Tmax: IV: immediate; IM: 8 hours (for phosphate ester, rapid hydrolysis to active dexamethasone)
FoodEffect: Not applicable for injection; oral absorption is not significantly affected by food.

Distribution:

Vd: Approximately 2 L/kg
ProteinBinding: Approximately 77% (primarily to albumin, less to corticosteroid-binding globulin)
CnssPenetration: Limited (but effective for cerebral edema due to specific mechanisms and high potency)

Elimination:

HalfLife: Plasma half-life: 3-4.5 hours; Biologic half-life: 36-54 hours (due to prolonged tissue effects)
Clearance: Approximately 0.125 L/hr/kg
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: IV: Rapid (within minutes to hours, depending on effect); IM: within hours
PeakEffect: IV: 1-2 hours; IM: 8-24 hours
DurationOfAction: Biologic effects persist for 36-72 hours after a single dose due to prolonged tissue effects.

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 immediately or seek medical attention:

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 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 gland problems: 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 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.
Irritation at the injection site.

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 persist, contact your doctor:

Nausea or vomiting.
Sleep disturbances.
Restlessness.
Excessive sweating.
Hair loss.
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, 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, body aches, flu symptoms, sores in mouth/throat)
  • Unusual bruising or bleeding
  • Severe stomach pain, black/tarry stools, vomiting blood
  • Swelling in your hands or feet, rapid weight gain
  • Shortness of breath
  • Severe depression, unusual thoughts or behavior
  • Blurred vision, eye pain, or seeing halos around lights
  • Muscle weakness or pain
  • Increased thirst or urination (signs of high blood sugar)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have an active 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, cerebral malaria, threadworm infestation, or any other type of infection.
If you have nerve problems affecting your eyes.
If you have any stomach or bowel issues, such as diverticulitis, ulcerative colitis, ulcers, or if you have recently undergone bowel surgery.

It is crucial to note that this list is not exhaustive, and you should discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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, so be sure to notify all your healthcare providers and lab workers 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 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 osteoporosis (weak bones). Your doctor can help determine if you are at higher risk for osteoporosis or if you have any questions about this potential side effect. You may need to reduce your salt intake and take potassium supplements; consult with your doctor about this.

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. You should also 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, 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 people who have infections, colds, or flu. 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. Your doctor may need to prescribe additional steroid medication in these situations.

If you have been taking this medication for an extended period, do not stop taking it abruptly. Your doctor may recommend a gradual tapering of the dosage to minimize potential side effects. If you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor promptly.

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 for developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Your doctor can provide more information about 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. Inform your doctor if you have any concerns.

If you are allergic to sulfites, notify your doctor, as some formulations of this medication may contain sulfites. It is essential to note that administering this medication into the spine (epidural) has been associated with severe and potentially life-threatening complications, including paralysis, loss of vision, stroke, and death. This medication is not approved for epidural use, and you should discuss the potential risks with your doctor.

This medication may lower sperm counts in some individuals. If you have concerns about fertility, 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 of 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: increased fluid retention, hypertension, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushingoid features.

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 (increased risk of infection)
  • Mifepristone (decreased dexamethasone effect)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates - decreased dexamethasone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased dexamethasone levels)
  • Anticoagulants (e.g., warfarin - altered anticoagulant effect, monitor INR)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (e.g., thiazides, loop diuretics - enhanced potassium depletion)
  • Antidiabetics (e.g., insulin, oral hypoglycemics - increased blood glucose, require dose adjustment)
  • Digoxin (increased risk of digitalis toxicity due to hypokalemia)
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Moderate Interactions

  • Cyclosporine (increased levels of both drugs)
  • Oral contraceptives (increased dexamethasone levels)
  • Fluoroquinolones (increased risk of tendon rupture, especially in elderly)
  • Neuromuscular blockers (prolonged weakness/myopathy with long-term high-dose corticosteroids)
  • Cholestyramine, colestipol (may decrease dexamethasone absorption if given orally)
  • Aminoglutethimide (may decrease dexamethasone effect)
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Minor Interactions

  • Antacids (may decrease oral absorption, not relevant for injection)
  • 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, Cl)

Rationale: Risk of fluid retention, hypokalemia.

Timing: Prior to initiation

Blood glucose

Rationale: Risk of hyperglycemia.

Timing: Prior to initiation

Signs of infection

Rationale: Corticosteroids are immunosuppressive.

Timing: Prior to initiation

Weight

Rationale: Fluid retention.

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Daily to weekly, then periodically during long-term therapy

Target: Normal for patient

Action Threshold: Significant increase or sustained hypertension

Serum electrolytes (Na, K)

Frequency: Weekly initially, then periodically during long-term therapy

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

Action Threshold: Hypokalemia (<3.5 mEq/L) or significant fluid retention

Blood glucose

Frequency: Daily to weekly initially, then periodically during long-term therapy (more frequent in diabetics)

Target: Fasting: <100 mg/dL; Postprandial: <140 mg/dL

Action Threshold: Sustained hyperglycemia (>180 mg/dL) or new-onset diabetes

Signs/symptoms of infection

Frequency: Continuously

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

Action Threshold: Fever, chills, new or worsening pain, purulent discharge

Growth (pediatric patients)

Frequency: Every 3-6 months during long-term therapy

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Bone mineral density (long-term therapy)

Frequency: Baseline, then annually or biennially

Target: T-score > -1.0

Action Threshold: Osteopenia or osteoporosis

Ophthalmic exam (long-term therapy)

Frequency: Annually

Target: Absence of cataracts or glaucoma

Action Threshold: Development of cataracts or increased intraocular pressure

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, cough, painful urination)
  • Hyperglycemia (increased thirst, urination, hunger)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Muscle weakness or pain
  • Vision changes
  • Difficulty sleeping
  • Easy bruising or thinning skin

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. It crosses the placenta. High doses or prolonged use may lead to fetal growth restriction or adrenal suppression in the neonate.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts, though data are conflicting and overall risk is low.
Second Trimester: Risk of fetal growth restriction and adrenal suppression increases with prolonged use.
Third Trimester: Risk of fetal growth restriction and adrenal suppression in the neonate. Monitor neonates for signs of hypoadrenalism.
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Lactation

Dexamethasone is excreted into breast milk. While generally considered compatible with breastfeeding at low doses, caution is advised. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, delayed development) or other adverse effects.

Infant Risk: Low to moderate risk, especially with high doses or prolonged use. 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. Long-term use should be carefully monitored for growth velocity. Adrenal suppression can occur, requiring careful tapering. Increased susceptibility to infections. Monitor for increased intracranial pressure in children.

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Geriatric Use

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. Monitor closely for adverse reactions.

Clinical Information

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Clinical Pearls

  • Dexamethasone has a long biological half-life (36-54 hours), allowing for once-daily dosing in many indications, even though its plasma half-life is shorter.
  • It has minimal mineralocorticoid activity, making it less likely to cause significant fluid retention compared to other corticosteroids like hydrocortisone.
  • Always taper the dose gradually after prolonged therapy (typically >2-3 weeks) to prevent adrenal insufficiency.
  • Administering the dose in the morning can help minimize sleep disturbances.
  • Patients on long-term therapy should carry a steroid identification card.
  • Consider prophylactic measures for bone health (calcium, vitamin D, bisphosphonates) in patients on long-term high-dose therapy.
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Alternative Therapies

  • Other corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone)
  • NSAIDs (for anti-inflammatory effects, less potent)
  • Immunosuppressants (e.g., methotrexate, azathioprine, biologics - for specific autoimmune conditions)
  • Antihistamines (for allergic reactions, less potent)
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Cost & Coverage

Average Cost: Varies widely, typically low for generic per 4mg/ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unused medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it occurred, to ensure prompt and effective treatment.