Dexamethasone Phos 120mg/30ml Inj

Manufacturer MYLAN INSTITUTIONAL 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 agent; Immunosuppressant
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Pharmacologic Class
Corticosteroid
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Pregnancy Category
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 helps reduce inflammation (swelling and redness) and calm down an overactive immune system. It's used for many conditions like allergies, asthma, arthritis, skin problems, and certain cancers.
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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.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Take exactly as prescribed; do not stop suddenly without consulting your doctor, as this can lead to serious withdrawal symptoms.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection immediately (fever, sore throat, unusual pain).
  • Follow a diet low in sodium and high in potassium, and ensure adequate calcium and vitamin D intake to protect bone health.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Carry a steroid warning card if on long-term therapy.
  • Limit alcohol intake, as it can increase the risk of stomach irritation.

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, often divided. For cerebral edema: Initial 10 mg IV, then 4 mg IM/IV every 6 hours. For COVID-19: 6 mg IV/PO once daily for up to 10 days.
Dose Range: 0.75 - 40 mg

Condition-Specific Dosing:

Anti-inflammatory/Immunosuppressive: 0.75 mg to 9 mg daily, often divided
Cerebral Edema: Initial 10 mg IV, then 4 mg IM/IV every 6 hours
Chemotherapy-induced Nausea/Vomiting (CINV): 8 mg to 20 mg IV/PO prior to chemotherapy
COVID-19 (severe): 6 mg IV/PO once daily for up to 10 days
Multiple Myeloma: 40 mg PO/IV once weekly or 20 mg PO/IV twice weekly
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., bronchopulmonary dysplasia) may use 0.05-0.2 mg/kg/day divided.
Infant: Highly variable by indication and weight. Anti-inflammatory: 0.02-0.3 mg/kg/day divided every 6-12 hours.
Child: Highly variable by indication and weight. Anti-inflammatory: 0.02-0.3 mg/kg/day divided every 6-12 hours. Cerebral edema: Initial 0.5-1.5 mg/kg IV, then 0.25 mg/kg every 6 hours.
Adolescent: Dosing similar to adult based on weight and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed.
Severe: No specific adjustment generally needed.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis.

Hepatic Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed.
Severe: Monitor for increased effects; dose reduction may be considered in severe cirrhosis due to altered metabolism and protein binding, but no specific guidelines.
Confidence: Medium

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a glucocorticoid. It binds to specific cytoplasmic glucocorticoid receptors in target tissues, forming a complex that translocates to the nucleus. This complex then interacts with DNA (glucocorticoid response elements), modulating gene transcription. 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.
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Pharmacokinetics

Absorption:

Bioavailability: High (nearly 100% after oral, rapid after IM/IV)
Tmax: IV: immediate; IM: 8 hours (dexamethasone acetate); Oral: 1-2 hours
FoodEffect: Minimal effect on absorption, but may reduce GI upset.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: Approximately 77% (primarily to albumin)
CnssPenetration: Limited, but sufficient for therapeutic effects in cerebral edema due to specific mechanisms (e.g., reducing capillary permeability).

Elimination:

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

OnsetOfAction: IV: Rapid (minutes); IM: 1-2 hours; Oral: 1-2 hours
PeakEffect: IV: 1 hour; IM: 8 hours (dexamethasone acetate); Oral: 2-3 hours
DurationOfAction: Biologic effects can last 36-72 hours due to long biologic 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 immediately or seek emergency 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, 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, 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, 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 period
Bone or joint pain
Muscle pain or weakness
Changes in vision
Changes in behavior or mood
Seizures
Unusual burning, numbness, or tingling sensations
Unexplained bruising or bleeding
Severe stomach pain
Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

Nausea and 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, 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, sore throat, cough, painful urination)
  • Severe stomach pain, black/tarry stools, or vomiting blood (signs of GI bleeding)
  • Unusual swelling in hands, ankles, or feet; rapid weight gain
  • Extreme tiredness, weakness, nausea, vomiting, dizziness, or loss of appetite (signs of adrenal insufficiency upon withdrawal)
  • Blurred vision, eye pain, or seeing halos around lights
  • Increased thirst or urination (signs of high blood sugar)
  • Mood changes (severe depression, euphoria, anxiety, confusion)
  • Muscle weakness or cramps
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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. 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
+ Any other type of infection
Nerve problems affecting the eye
Stomach or bowel problems, such as:
+ Diverticulitis
+ Ulcerative colitis
+ Ulcers
+ Recent bowel surgery

This list is not exhaustive, and it is crucial to discuss all your health conditions and medications with your doctor. Provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have

Verify with your doctor that it is safe to take this medication with all your other medications and health conditions. Do not initiate, stop, or modify the dosage of any medication without 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 it is crucial to notify all your healthcare providers and lab workers that you are taking it. Additionally, be aware that this medication can cause high blood pressure, so your doctor may recommend regular blood pressure checks.

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 interfere with 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). Your doctor can help you determine if you are at higher risk of developing osteoporosis or if you have any questions. You may need to reduce your salt intake and take potassium supplements, so consult with your doctor about this.

If you have diabetes, it is vital to monitor your blood sugar levels closely while taking this medication. Before consuming alcohol, talk to your doctor, and before receiving any vaccines, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

Be cautious when interacting with individuals who have chickenpox or measles, as these infections can be severe or even fatal in people taking steroid medications like this one. If you have not had these infections before, avoid close contact with anyone who has them, and if you have been exposed, 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, 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 this medication, so inform your doctor if you have a history of these infections.

This medication can suppress the production of natural steroids in your body, which can affect your response to stress, such as fever, infection, surgery, or injury. Inform your doctor if you experience any of these conditions, as you may require additional steroid doses.

If you have been taking this medication for an extended period, do not stop taking it abruptly. Instead, consult with your doctor about gradually tapering off the medication. 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 developing Kaposi's sarcoma, a type of cancer. Discuss this risk with your doctor. Additionally, patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition, 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 they may require regular growth checks. Inform your doctor if you have any concerns.

If you are allergic to sulfites, notify your doctor, as some products may contain sulfites. Be aware that administering this medication into the spine (epidural) has been associated with severe health problems, including paralysis, loss of vision, stroke, and death, although it is not an approved use for this medication.

This medication may lower sperm counts, so if you have concerns, discuss them with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby. If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: increased fluid retention, hypertension, hyperglycemia, muscle weakness, and psychiatric disturbances (e.g., agitation, depression, psychosis).

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. Contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in immunosuppressed patients)
  • Systemic fungal infections (unless used as life-saving therapy)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates): May decrease dexamethasone levels, requiring dose increase.
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase dexamethasone levels, requiring dose decrease.
  • NSAIDs: Increased risk of GI ulceration/bleeding.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (monitor INR).
  • Diuretics (thiazide, loop): Increased risk of hypokalemia.
  • Digoxin: Increased risk of digoxin toxicity due to hypokalemia.
  • Antidiabetic agents (insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetics.
  • Neuromuscular blockers: Prolonged neuromuscular blockade (especially with non-depolarizing agents).
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Moderate Interactions

  • Oral contraceptives/estrogens: May increase dexamethasone levels.
  • Cyclosporine: Increased risk of seizures and other CNS effects.
  • Fluoroquinolones: Increased risk of tendon rupture.
  • Vaccines (inactivated): Reduced immune response to vaccines.
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Minor Interactions

  • Antacids: May decrease dexamethasone absorption (separate administration).

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Risk of 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

Weight

Rationale: Risk of fluid retention

Timing: Prior to initiation

Ophthalmic exam (if long-term use anticipated)

Rationale: Risk of cataracts, glaucoma

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Regularly (e.g., weekly to monthly, depending on duration/dose)

Target: Individualized, typically <140/90 mmHg

Action Threshold: Sustained elevation requiring intervention

Serum electrolytes (especially K)

Frequency: Periodically (e.g., every 1-3 months for chronic use)

Target: K: 3.5-5.0 mEq/L

Action Threshold: K <3.5 mEq/L

Blood glucose (fasting or HbA1c)

Frequency: Regularly (e.g., weekly to monthly, depending on duration/dose)

Target: Fasting: <100 mg/dL; HbA1c: <7%

Action Threshold: Sustained elevation, new-onset diabetes

Weight

Frequency: Weekly to monthly

Target: Stable

Action Threshold: Significant, rapid weight gain

Growth (in pediatric patients)

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

Target: Normal growth curve

Action Threshold: Growth retardation

Signs/symptoms of infection

Frequency: Ongoing

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

Action Threshold: Any signs of infection

Adrenal function (e.g., morning cortisol) if tapering

Frequency: As clinically indicated during and after taper

Target: Normal adrenal response

Action Threshold: Signs of adrenal insufficiency

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Symptom Monitoring

  • Signs of infection (fever, sore throat, unusual fatigue, localized pain/redness)
  • Symptoms of hyperglycemia (increased thirst, urination, hunger)
  • Fluid retention (swelling in ankles/feet, rapid weight gain)
  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances
  • Muscle weakness or pain
  • Stomach pain or black/tarry stools (GI bleeding)
  • Vision changes (blurred vision, eye pain)
  • Easy bruising or thinning skin
  • Symptoms of adrenal insufficiency upon withdrawal (severe fatigue, weakness, nausea, vomiting, dizziness)

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. Prolonged or repeated use during pregnancy may lead to fetal growth restriction or adrenal suppression in the neonate.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless clearly indicated.
Second Trimester: May be used for specific indications (e.g., preterm labor to promote fetal lung maturity), but monitor for fetal growth restriction.
Third Trimester: Risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
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Lactation

Dexamethasone is excreted into breast milk. While the amount is generally small, 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 the lowest effective dose.

Infant Risk: Low to moderate risk, depending on dose and duration. Monitor infant for signs of adrenal suppression (e.g., poor weight gain, irritability).
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Pediatric Use

Corticosteroids can cause growth retardation in children. Long-term use requires careful monitoring of growth and development. Adrenal suppression can occur, especially with prolonged use, requiring slow tapering. Increased susceptibility to infections. Bone density should be monitored with chronic use.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, hypertension, diabetes, and fluid retention. Use the lowest effective dose for the shortest possible duration. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Always taper dexamethasone slowly after prolonged therapy to prevent adrenal insufficiency. The rate of taper depends on the dose and duration of therapy.
  • Administer oral doses with food or milk to minimize GI upset.
  • Patients on long-term therapy should carry a steroid warning card.
  • Dexamethasone has a long biologic half-life, allowing for once-daily dosing or even alternate-day dosing for some indications.
  • Consider prophylactic measures for bone health (calcium, vitamin D, bisphosphonates) in patients on long-term corticosteroid therapy.
  • Monitor for signs of infection, as corticosteroids can mask symptoms.
  • For cerebral edema, dexamethasone is effective due to its ability to stabilize cell membranes and reduce capillary permeability, not primarily due to CNS penetration.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone)
  • NSAIDs (for inflammatory conditions, if appropriate)
  • Immunosuppressants (e.g., methotrexate, azathioprine, biologics for autoimmune diseases)
  • Antiemetics (for CINV, e.g., ondansetron, aprepitant)
  • Diuretics (for cerebral edema, e.g., mannitol, hypertonic saline, if appropriate)
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Cost & Coverage

Average Cost: Varies widely by formulation, strength, and quantity. For 120mg/30ml (4mg/ml) vial, typically $20-$100+ per vial. per 30ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, 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 information about the medication taken, the quantity, and the time of the incident.