Dexamethasone Sod Phos 10mg/ml Inj

Manufacturer WEST-WARD 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
Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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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 powerful medicine that belongs to a group of drugs called corticosteroids. It works by reducing inflammation (swelling and irritation) and suppressing the immune system. It's used for many conditions like severe allergies, asthma, arthritis, skin conditions, and certain cancers. It can also help reduce swelling in the brain.
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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 follow all instructions 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 method.

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

  • Take exactly as prescribed; do not stop abruptly, especially after long-term use, as this can lead to serious withdrawal symptoms.
  • Report any signs of infection immediately, as this medication can mask symptoms and increase susceptibility.
  • Monitor blood sugar if you have diabetes, as this medication can raise blood glucose levels.
  • Limit sodium intake to help manage fluid retention and high blood pressure.
  • Ensure adequate calcium and vitamin D intake, and discuss bone health with your doctor, especially for long-term use.
  • Avoid live vaccines while on this medication without consulting your doctor.
  • Carry a steroid identification card if on long-term therapy.

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, IV/IM/PO, in single or divided doses.
Dose Range: 0.75 - 9 mg

Condition-Specific Dosing:

Cerebral Edema: 10 mg IV initially, then 4 mg IM/IV every 6 hours until symptoms subside.
Allergic Reactions: 4-8 mg IV/IM, then tapered.
Antiemetic (chemotherapy-induced): 8-20 mg IV prior to chemotherapy.
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Pediatric Dosing

Neonatal: Respiratory Distress Syndrome (prevention): 0.25 mg/kg/dose IM, 4 doses every 12 hours. Bronchopulmonary Dysplasia: 0.5 mg/kg/day divided q12h for 3-7 days, then tapered.
Infant: Anti-inflammatory/Immunosuppressive: 0.02-0.3 mg/kg/day divided q6-12h. Croup: 0.6 mg/kg IM/PO single dose (max 10 mg).
Child: Anti-inflammatory/Immunosuppressive: 0.02-0.3 mg/kg/day divided q6-12h. Croup: 0.6 mg/kg IM/PO single dose (max 10 mg). Bacterial Meningitis (adjunctive): 0.15 mg/kg IV every 6 hours for 2-4 days.
Adolescent: Dosing similar to adult, adjusted for weight/surface area for specific indications.
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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 dialyzable. No specific adjustment needed, but monitor for fluid retention and electrolyte imbalances.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for increased effects due to decreased metabolism.
Severe: No specific adjustment needed, but monitor for increased effects due to decreased metabolism.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a potent glucocorticoid. It binds to specific intracellular glucocorticoid receptors in target tissues, forming a steroid-receptor 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., cytokines, prostaglandins, leukotrienes), resulting in potent anti-inflammatory, immunosuppressive, and metabolic effects.
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Pharmacokinetics

Absorption:

Bioavailability: High (nearly 100% orally, rapid and complete after IM/IV)
Tmax: IV: immediate; IM: 8 hours; Oral: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect bioavailability.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: 60-70% (primarily to albumin, less to corticosteroid-binding globulin than hydrocortisone)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

HalfLife: Plasma half-life: 1.8-3.5 hours; Biologic half-life: 36-54 hours
Clearance: Not available (variable)
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: IV: within minutes; IM: 1-2 hours; Oral: 1-2 hours
PeakEffect: IV: 1 hour; IM: 8-12 hours; Oral: 2-8 hours
DurationOfAction: Biologic effects persist for 36-72 hours (due to prolonged tissue binding and genomic 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 experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an 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 a weak adrenal gland: severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or belly, moon face, severe headache, or slow wound healing
Signs of high blood sugar: confusion, drowsiness, 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 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

Most medications can cause side effects, but many people experience none or only mild symptoms. If you experience any of the following side effects or any other symptoms that bother you or don't go away, contact your doctor or seek medical attention:

Nausea and vomiting
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:

  • Severe mood changes (depression, euphoria, psychosis)
  • Unusual swelling in hands, ankles, or feet
  • Significant weight gain
  • Blurred vision or eye pain
  • Increased thirst or urination
  • Muscle weakness or pain
  • Black, tarry stools or severe stomach pain
  • Signs of infection (fever, chills, sore throat, body aches)
  • Slow wound healing
  • New or worsening skin problems (acne, thinning skin, easy bruising)
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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 medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose 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 condition. 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 personnel that you are taking it. There is a risk of developing high blood pressure with this medication, and your doctor will monitor your blood pressure accordingly.

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 cataracts or glaucoma; discuss this with your doctor.

Prolonged use of this medication can also lead to osteoporosis (weak bones). Your doctor will assess your risk factors and address any concerns you may have. You may need to reduce your salt intake and increase your potassium consumption; consult with your doctor for personalized advice.

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

It is crucial to avoid close contact 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 been exposed to these infections or have a history of them, 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, such as frequent handwashing, and avoid close contact with individuals 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, injury, or surgery. Your doctor may prescribe additional steroid doses in these situations.

If you have been taking this medication for an extended period, do not stop abruptly. Consult with your doctor, as you may need to gradually taper off the medication. If you experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness after missing a dose or stopping the medication, 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 risk with your doctor. Additionally, patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition; consult with your doctor about this risk.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children and adolescents, this medication can affect growth; 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) can lead to severe and potentially life-threatening complications, including paralysis, loss of vision, stroke, and death. This route of administration is not approved, and you should discuss the risks with your doctor.

This medication may affect sperm count; 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, notify your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare and usually does not cause life-threatening symptoms.
  • Symptoms may include: increased blood pressure, fluid retention, hypokalemia, hyperglycemia, and exacerbation of known side effects.

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is generally supportive and symptomatic. Long-term high-dose exposure can lead to Cushing's syndrome.

Drug Interactions

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Major Interactions

  • Live or live-attenuated vaccines (risk of disseminated infection)
  • Mifepristone (antagonizes corticosteroid effects)
  • Barbiturates (e.g., Phenobarbital - decreased dexamethasone effect)
  • Phenytoin (decreased dexamethasone effect)
  • Rifampin (decreased dexamethasone effect)
  • Ketoconazole (increased dexamethasone effect)
  • Non-depolarizing neuromuscular blockers (prolonged weakness/myopathy with high-dose corticosteroids)
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Moderate Interactions

  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide, loop - increased risk of hypokalemia)
  • Warfarin (variable effect on INR, monitor closely)
  • Insulin/Oral Hypoglycemics (increased blood glucose, may require dose adjustment)
  • Digoxin (increased risk of toxicity with hypokalemia)
  • CYP3A4 inhibitors (e.g., Azole antifungals, Macrolide antibiotics - increased dexamethasone levels)
  • CYP3A4 inducers (e.g., Carbamazepine, St. John's Wort - decreased dexamethasone levels)
  • Oral Contraceptives (increased dexamethasone levels)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
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Minor Interactions

  • Antacids (may decrease absorption of oral dexamethasone)
  • Cholestyramine (may decrease absorption of oral dexamethasone)

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, especially in diabetics.

Timing: Prior to initiation

Weight

Rationale: Fluid retention, metabolic effects.

Timing: Prior to initiation

Bone Mineral Density (for long-term use)

Rationale: Risk of osteoporosis.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

Frequency: Daily to weekly, then periodically

Target: Individualized, within normal limits

Action Threshold: Significant elevation (e.g., >140/90 mmHg) or symptomatic hypertension

Serum Electrolytes (Na, K)

Frequency: Weekly initially, then periodically for long-term use

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

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

Blood Glucose

Frequency: Daily to weekly, then periodically; more frequently in diabetics

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

Action Threshold: Persistent hyperglycemia (>180 mg/dL) or symptomatic hyperglycemia

Weight

Frequency: Weekly

Target: Stable

Action Threshold: Significant weight gain (>2 kg/week) due to fluid retention

Signs of Infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Fever, chills, new pain, redness, or other signs of infection

Growth (in children)

Frequency: Every 3-6 months for long-term use

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Ophthalmic Exam (for long-term use)

Frequency: Annually

Target: Absence of cataracts or glaucoma

Action Threshold: Development of cataracts or increased intraocular pressure

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Muscle weakness or pain
  • Increased thirst or urination (signs of hyperglycemia)
  • Swelling in ankles, feet, or hands (fluid retention)
  • Unusual bruising or skin thinning
  • Vision changes
  • Stomach pain or black/tarry stools (GI ulceration)
  • Signs of infection (fever, chills, sore throat, cough, painful urination)
  • Fatigue, weakness, dizziness (adrenal insufficiency upon withdrawal)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. Prolonged or repeated use during pregnancy may lead to fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless critical. Potential for increased risk of oral clefts (though data is conflicting and overall risk is low).
Second Trimester: Risk of fetal adrenal suppression increases with prolonged use.
Third Trimester: Risk of fetal adrenal suppression increases with prolonged use. Used for fetal lung maturation (preterm labor).
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Lactation

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

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid use. Monitor growth and development closely. Use the lowest effective dose for the shortest duration possible. Adrenal suppression may occur even after discontinuation, requiring stress-dose steroids during illness or surgery.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects such as osteoporosis, fluid retention, hypertension, and diabetes. Use with caution and monitor closely for these effects. Lower doses may be appropriate.

Clinical Information

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Clinical Pearls

  • Always taper dexamethasone doses gradually after prolonged therapy to prevent adrenal insufficiency.
  • Administer oral doses with food or milk to minimize GI upset.
  • Dexamethasone is a potent antiemetic, often used in chemotherapy regimens.
  • It has minimal mineralocorticoid activity, making it less likely to cause significant fluid retention compared to hydrocortisone or prednisone.
  • Patients on long-term therapy should carry a steroid identification card.
  • Monitor for signs of infection, as corticosteroids can mask symptoms.
  • Consider prophylactic bone protection (calcium, vitamin D, bisphosphonates) for long-term use.
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Alternative Therapies

  • Prednisone (oral, IV)
  • Methylprednisolone (oral, IV, IM)
  • Hydrocortisone (oral, IV, IM)
  • Betamethasone (oral, IM)
  • Triamcinolone (oral, IM)
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Cost & Coverage

Average Cost: Varies widely by dose, formulation, and pharmacy. Typically low cost for generic. per vial/tablet
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 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. 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 a healthcare professional. 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 emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.