Dexamethasone Pho 4mg/ml Inj, 5ml

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
Corticosteroid
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Pharmacologic Class
Glucocorticoid
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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 similar to a natural hormone produced by your body. It's used to reduce inflammation (swelling and redness) and suppress the immune system. It can treat many conditions like severe allergies, arthritis, asthma, skin conditions, and certain cancers. For injection, it's given into a vein or muscle by a healthcare professional.
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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

  • Do not stop taking this medication suddenly, especially after long-term use, as it can lead to serious withdrawal symptoms. Your doctor will guide you on how to slowly reduce the dose.
  • Avoid exposure to people with infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection immediately.
  • Follow a diet low in sodium and high in potassium if advised by your doctor.
  • Monitor blood sugar levels if you have diabetes or are at risk.
  • Carry a steroid identification card if on long-term therapy.
  • Limit alcohol intake and avoid NSAIDs unless directed by your doctor, due to increased risk of stomach upset or bleeding.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. For anti-inflammatory/immunosuppressive: 0.75-9 mg/day IV/IM/PO in divided doses. For cerebral edema: Initial 10 mg IV, then 4 mg IV every 6 hours. For COVID-19: 6 mg IV/PO once daily for up to 10 days.
Dose Range: 0.75 - 24 mg

Condition-Specific Dosing:

Cerebral Edema: Initial 10 mg IV, then 4 mg IV every 6 hours for 2-4 days, then taper.
COVID-19 (severe): 6 mg IV/PO once daily for up to 10 days.
Anti-inflammatory/Immunosuppressive: 0.75-9 mg/day IV/IM/PO in divided doses.
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., bronchopulmonary dysplasia) may use 0.05-0.1 mg/kg/day IV/PO in divided doses.
Infant: 0.02-0.3 mg/kg/day IV/IM/PO in divided doses, depending on indication.
Child: 0.02-0.3 mg/kg/day IV/IM/PO in divided doses, depending on indication. Max 10 mg/day usually.
Adolescent: Generally adult dosing, 0.02-0.3 mg/kg/day IV/IM/PO in divided doses, depending on indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Not significantly dialyzable; no supplemental dose needed after dialysis. Monitor for fluid retention.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider dose reduction in severe hepatic impairment, as metabolism may be impaired. Monitor for increased side effects.
Severe: Consider dose reduction, monitor closely for adverse effects. Dexamethasone is primarily metabolized by the liver.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a glucocorticoid. It acts by binding to specific cytoplasmic glucocorticoid receptors, which then translocate to the nucleus and modulate gene expression. This leads to a wide range of effects, including potent anti-inflammatory and immunosuppressive actions by inhibiting the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes), suppressing immune cell function (e.g., lymphocytes, macrophages), and stabilizing lysosomal membranes. It also affects carbohydrate, protein, and fat metabolism, and maintains vascular integrity.
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Pharmacokinetics

Absorption:

Bioavailability: High (oral bioavailability is ~80-90% for dexamethasone base, phosphate ester is a prodrug)
Tmax: IV: immediate; IM: 8 hours (for phosphate ester); Oral: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect extent of absorption.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: 77% (to albumin)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

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

OnsetOfAction: IV: Rapid (minutes to hours); Oral: 1-2 hours
PeakEffect: IV: 1-2 hours; Oral: 8-12 hours (anti-inflammatory effect)
DurationOfAction: Biologic effect lasts 36-72 hours (due to prolonged tissue binding)

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 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 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 experience any of the following side effects, or if they bother you or don't go away, contact your doctor:

Nausea or vomiting
Trouble sleeping
Restlessness
Excessive sweating
Hair loss
Headache
Dizziness, fatigue, or weakness
Weight gain
Increased appetite
* Hiccups

This is not a complete 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 of hands, ankles, or feet
  • Extreme fatigue or weakness
  • Persistent headache or blurred vision
  • Increased thirst or urination
  • Muscle weakness or cramps
  • Black, tarry stools or severe stomach pain
  • Signs of infection (fever, chills, sore throat, body aches)
  • Slow wound healing
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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, other drugs, foods, or substances. Be sure to describe the allergic reaction and its symptoms.
The presence of any infection, such as bacterial, viral, or fungal infections, including:
+ 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 in 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 medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change 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. 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 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 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 while taking this medication; consult with your doctor for guidance.

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. 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 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 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 the body's natural production of steroids, which can affect your response to stress, such as fever, infection, surgery, or injury. In such situations, your doctor may recommend additional steroid doses.

If you have been taking this medication for an extended period, do not stop taking it without consulting your doctor, as this can lead to withdrawal symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness. In rare cases, long-term use of this medication can increase the risk of developing Kaposi's sarcoma, a type of cancer. Discuss this potential risk with your doctor.

Patients with cancer may be at higher risk for developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Inform your doctor if you have cancer. Older adults (65 years and older) may be more susceptible to side effects from this medication, so use it with caution.

This medication can 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.

Using this medication epidurally (into the spine) is not recommended, as it can cause severe and potentially life-threatening complications, including paralysis, loss of vision, stroke, and death. This medication can also lower sperm counts in men; discuss this potential side effect 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: fluid retention, hypertension, hyperglycemia, and electrolyte imbalances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection)
  • Mifepristone (decreased dexamethasone effect)
  • Aminoglutethimide (decreased dexamethasone effect)
  • Barbiturates (decreased dexamethasone effect)
  • Carbamazepine (decreased dexamethasone effect)
  • Phenytoin (decreased dexamethasone effect)
  • Rifampin (decreased dexamethasone effect)
  • Ketoconazole (increased dexamethasone effect)
  • Itraconazole (increased dexamethasone effect)
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin) (increased dexamethasone effect)
  • Non-depolarizing neuromuscular blockers (prolonged paralysis with high-dose corticosteroids)
  • Anticoagulants (warfarin) (altered anticoagulant effect, monitor INR)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide, loop) (increased risk of hypokalemia)
  • Antidiabetic agents (decreased glycemic control)
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Moderate Interactions

  • Cardiac glycosides (increased toxicity with hypokalemia)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Oral contraceptives (increased dexamethasone effect)
  • Fluoroquinolones (increased risk of tendon rupture, especially in elderly)
  • Cholestyramine (decreased dexamethasone absorption)
  • Antacids (decreased dexamethasone absorption)
  • Somatropin (decreased growth hormone effect)
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Minor Interactions

  • Grapefruit juice (potential for increased dexamethasone levels, but generally minor)

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

Weight

Rationale: Risk of fluid retention and weight gain.

Timing: Prior to initiation

Bone mineral density (for long-term use)

Rationale: Risk of osteoporosis.

Timing: Prior to initiation

Ophthalmic exam (for long-term use)

Rationale: Risk of cataracts and glaucoma.

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Daily to weekly (depending on dose/duration)

Target: Normal for patient

Action Threshold: Significant increase, consider antihypertensive or dose adjustment.

Serum electrolytes (Na, K)

Frequency: Weekly to monthly (depending on dose/duration)

Target: K: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L), consider potassium supplementation.

Blood glucose (fasting or random)

Frequency: Daily to weekly (especially in diabetics or high-dose therapy)

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

Action Threshold: Persistent hyperglycemia, consider antidiabetic therapy or dose adjustment.

Weight

Frequency: Weekly

Target: Stable

Action Threshold: Significant weight gain, assess for fluid retention.

Signs of infection

Frequency: Ongoing

Target: Absence of fever, localized pain, redness

Action Threshold: Fever, chills, new pain, or signs of infection, investigate promptly.

Adrenal function (ACTH stimulation test, cortisol levels)

Frequency: After prolonged therapy or during taper

Target: Normal adrenal response

Action Threshold: Evidence of adrenal suppression, slow taper or consider stress dose.

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Muscle weakness or pain
  • Swelling in ankles or feet
  • Unusual weight gain
  • Increased thirst or urination
  • Blurred vision or eye pain
  • Easy bruising or skin thinning
  • Slow wound healing
  • Signs of infection (fever, chills, sore throat, cough)
  • Stomach pain or black/tarry stools

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. Long-term use or high doses may lead to fetal growth restriction or adrenal suppression in the neonate.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless essential. Potential for increased risk of oral clefts (though data is conflicting and overall risk is low).
Second Trimester: Generally considered safer than first trimester if needed, but monitor for fetal growth.
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. Low doses are generally considered compatible with breastfeeding, but high doses or prolonged use may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production). Monitor infant for adverse effects.

Infant Risk: L3 (Moderate risk). Consider administering the dose immediately after breastfeeding and waiting 3-4 hours before the next feeding to minimize infant exposure, especially with higher doses.
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Pediatric Use

Children are more susceptible to growth retardation and adrenal suppression with long-term corticosteroid therapy. Monitor growth and development closely. Use the lowest effective dose for the shortest possible duration. Increased risk of intracranial hypertension in children.

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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. Lower doses may be appropriate.

Clinical Information

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Clinical Pearls

  • Dexamethasone has a long biological half-life (36-54 hours), allowing for once-daily dosing or alternate-day dosing for some indications.
  • It has minimal mineralocorticoid activity, making it less likely to cause significant sodium and water retention compared to other corticosteroids like hydrocortisone or prednisone.
  • Always taper the dose gradually after prolonged therapy (typically >2 weeks) to prevent adrenal insufficiency.
  • Administering the daily dose in the morning can help minimize sleep disturbances and mimic the body's natural cortisol rhythm.
  • Patients on long-term therapy should be advised to carry a steroid identification card.
  • Dexamethasone is often preferred for cerebral edema due to its good CNS penetration and potent anti-inflammatory effects.
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Alternative Therapies

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

Average Cost: Varies widely per 5ml vial
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 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 to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. 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, 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 amount, and the time it was taken to ensure prompt and effective treatment.