Dexamethasone Sod Phos Inj, 10ml

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
Adrenocortical steroid
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Pregnancy Category
Category C (first trimester), Category D (second/third trimester or prolonged use)
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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 called corticosteroids. It works by reducing inflammation (swelling and redness) and calming down your body's immune system. It's used for many conditions like severe allergies, asthma, arthritis, and certain cancers. It's given as an injection, often into a vein or muscle.
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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 immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Follow your doctor's instructions carefully, especially regarding dose and duration. Do not stop taking this medication suddenly without consulting your doctor, as it 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 (fever, sore throat, unusual pain) to your doctor immediately.
  • Monitor your blood sugar if you are diabetic, as this medication can raise blood sugar levels.
  • Maintain a balanced diet, potentially low in sodium and high in potassium, as advised by your doctor.
  • Discuss any vaccinations with your doctor before receiving them, especially live vaccines.
  • Carry a steroid identification card or wear medical alert jewelry if you are on long-term therapy, indicating your need for corticosteroids in emergencies.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication. Typical anti-inflammatory/immunosuppressive dose: 0.75-9 mg/day IV/IM, often divided. Cerebral edema: 10 mg IV initially, then 4 mg IV every 6 hours.
Dose Range: 0.75 - 24 mg

Condition-Specific Dosing:

anti-inflammatory/immunosuppressive: 0.75-9 mg/day IV/IM, often divided
cerebral_edema: 10 mg IV initially, then 4 mg IV every 6 hours (for 2-4 days, then tapered)
multiple_myeloma: 40 mg IV/PO weekly (as part of combination therapy)
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., bronchopulmonary dysplasia prevention) require specialized dosing (e.g., 0.1-0.25 mg/kg/day divided).
Infant: 0.02-0.3 mg/kg/day IV/IM divided every 6-12 hours, depending on indication.
Child: 0.02-0.3 mg/kg/day IV/IM divided every 6-12 hours, depending on indication. Max 10 mg/day for anti-inflammatory.
Adolescent: Similar to adult dosing, often weight-based or indication-specific.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Dexamethasone is not significantly removed by hemodialysis. No supplemental dose needed post-dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Use with caution; monitor for increased effects due to decreased metabolism. Dose adjustment may be considered based on clinical response.
Severe: Use with caution; monitor for increased effects due to decreased metabolism. Dose adjustment may be considered based on clinical response.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid (glucocorticoid) that is approximately 25 times more potent than hydrocortisone and 5-7 times more potent than prednisone. It exerts its effects by binding to specific intracellular glucocorticoid receptors, forming a complex that translocates to the nucleus and modulates gene expression. This leads to widespread effects including potent anti-inflammatory and immunosuppressive actions (e.g., inhibition of prostaglandin and leukotriene synthesis, suppression of immune cell function), metabolic effects (e.g., gluconeogenesis, protein catabolism), and mineralocorticoid effects (minimal).
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV/IM); Oral bioavailability is high (approx. 80-90%).
Tmax: 1-2 hours (oral); Immediate (IV)
FoodEffect: Food may slightly delay absorption but does not significantly affect extent of absorption.

Distribution:

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

Elimination:

HalfLife: Plasma half-life: 3-4.5 hours; Biologic half-life: 36-72 hours (due to prolonged tissue effects)
Clearance: Not readily available as a single rate, but primarily hepatic metabolism.
ExcretionRoute: Urine (as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Rapid (IV); Within hours (oral)
PeakEffect: Variable, depending on indication and route. Anti-inflammatory effects may take hours to days.
DurationOfAction: Prolonged (biologic half-life of 36-72 hours), allowing for once-daily dosing or less frequent administration.

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 spots 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 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 Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Nausea and vomiting.
Difficulty sleeping.
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, sore throat, cough, painful urination)
  • Severe stomach pain, black or tarry stools, or vomiting blood (signs of GI bleeding)
  • Unusual swelling in your hands, ankles, or feet (fluid retention)
  • Extreme tiredness, weakness, nausea, vomiting, dizziness, or fainting (signs of adrenal insufficiency, especially if stopping suddenly)
  • Blurred vision or eye pain
  • Severe mood changes (depression, anxiety, euphoria, confusion)
  • Muscle weakness or cramps
  • Unusual bruising or bleeding
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
The presence of any infection, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
Nerve problems affecting the eye
Stomach or bowel problems, 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

Important Warnings and Cautions

It is crucial 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 necessary 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 may interfere with certain laboratory tests, so it is essential to notify all your healthcare providers and lab workers that you are taking it. Be aware that high blood pressure has been reported in patients taking similar medications, 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 developing cataracts or glaucoma, so discuss this with your doctor.

Prolonged use of this medication may also lead to weak bones (osteoporosis), so talk to your doctor about your individual risk factors and any concerns you may have. You may need to reduce your salt intake and take potassium supplements, so consult with your doctor about any necessary dietary changes.

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 vaccines, 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 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 by washing your hands frequently, 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 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, consult with your doctor before stopping or reducing the dose, as this can lead to 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 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.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication may also affect growth in children and adolescents, so regular growth checks may be necessary.

If you have a sulfite allergy, inform your doctor, as some products contain sulfites. Be aware 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 may lower sperm counts, so discuss any concerns 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 blood pressure, fluid retention, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity, skin thinning).

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally 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)
  • Mifepristone (antagonizes glucocorticoid effect)
  • CYP3A4 inducers (e.g., Phenytoin, Phenobarbital, Rifampin, Carbamazepine - decrease dexamethasone levels)
  • CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin - increase dexamethasone levels)
  • Anticoagulants (e.g., Warfarin - may alter anticoagulant effect, requiring INR monitoring)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • Antidiabetic agents (insulin, oral hypoglycemics - increased blood glucose, requiring dose adjustment)
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Moderate Interactions

  • Cardiac glycosides (e.g., Digoxin - increased toxicity risk with hypokalemia)
  • Neuromuscular blockers (prolonged blockade with high-dose corticosteroids)
  • Cholestyramine (may decrease dexamethasone absorption)
  • Oral contraceptives (may increase dexamethasone levels)
  • Cyclosporine (increased risk of seizures and other CNS effects)
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Minor Interactions

  • Antacids (may decrease dexamethasone absorption if taken concurrently)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Serum glucose

Rationale: Corticosteroids can induce hyperglycemia.

Timing: Prior to initiation

Serum electrolytes (especially potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects (though minimal for dexamethasone) or concomitant diuretic use.

Timing: Prior to initiation

Weight

Rationale: Fluid retention and metabolic changes.

Timing: Prior to initiation

Bone mineral density (for long-term use)

Rationale: Risk of osteoporosis.

Timing: Prior to initiation if long-term use anticipated

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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 glucose

Frequency: Daily to weekly initially, then periodically (more frequent for diabetics)

Target: Individualized, typically <180 mg/dL postprandial

Action Threshold: Persistent hyperglycemia (>200 mg/dL) requiring intervention

Serum electrolytes (especially potassium)

Frequency: Weekly initially, then periodically (especially with concomitant diuretics)

Target: Potassium 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L) or other electrolyte imbalances

Weight

Frequency: Weekly

Target: Stable or as desired

Action Threshold: Significant weight gain (>2 kg/week) or edema

Signs/symptoms of infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Any signs of infection, especially in immunocompromised patients

Growth (pediatric patients)

Frequency: Periodically (e.g., every 3-6 months for long-term use)

Target: Normal growth velocity for age

Action Threshold: Growth retardation

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Symptom Monitoring

  • Signs of infection (fever, sore throat, cough, unusual pain)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Mood changes (irritability, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Muscle weakness or pain
  • Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
  • Vision changes (blurred vision, cataracts)
  • Skin changes (thinning, bruising, acne)
  • Signs of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)

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. Risk of fetal adrenal suppression, especially with prolonged use or high doses in the third trimester. Increased risk of cleft palate in animal studies, though human data is less clear.

Trimester-Specific Risks:

First Trimester: Potential increased risk of oral clefts (animal data, human data inconclusive). Generally Category C.
Second Trimester: Risk of fetal growth restriction and adrenal suppression with prolonged use. Generally Category D if prolonged use.
Third Trimester: Significant risk of fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism. Generally Category D if prolonged use.
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Lactation

Dexamethasone is excreted into breast milk. Short-term, low-dose use is generally considered compatible with breastfeeding, but caution is advised. 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 adverse effects.

Infant Risk: Low to Moderate (L3). Potential for growth suppression, adrenal suppression, or other adverse effects with high doses or prolonged use.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Long-term use should be carefully monitored. Adrenal suppression can occur. Use the lowest effective dose for the shortest possible duration. Increased susceptibility to infections.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects of corticosteroids, including osteoporosis, fluid retention, hypertension, and diabetes. Use with caution and monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Dexamethasone has a long biologic half-life (36-72 hours), allowing for once-daily or alternate-day dosing for many indications.
  • It has minimal mineralocorticoid activity, making it less likely to cause significant fluid retention or hypokalemia compared to hydrocortisone or prednisone, but these can still occur.
  • Abrupt discontinuation after prolonged therapy can lead to adrenal insufficiency (steroid withdrawal syndrome). Doses should be tapered gradually.
  • Patients on long-term therapy should be advised to carry a steroid identification card.
  • Immunosuppression is a significant concern; patients should be advised to avoid exposure to infections and report any signs of illness.
  • Can cause psychiatric disturbances (mood swings, insomnia, psychosis), especially at higher doses.
  • Administer IV injections slowly to avoid perineal itching or burning, which can occur with rapid administration.
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Alternative Therapies

  • Other corticosteroids (e.g., Prednisone, Methylprednisolone, Hydrocortisone, Betamethasone) depending on potency, duration, and route of administration.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions (less potent, different mechanism).
  • Immunosuppressants (e.g., Methotrexate, Azathioprine, Cyclosporine) for autoimmune diseases (different mechanisms, often used for steroid-sparing effect).
  • Biologic agents for specific inflammatory or autoimmune conditions.
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Cost & Coverage

Average Cost: $10 - $50 per 10ml vial (4mg/ml or 10mg/ml)
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 evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional or pharmacist, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.

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 emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time of ingestion, to ensure prompt and effective treatment.