Dexamethasone Intensol 1mg/ml Soln

Manufacturer ROXANE Active Ingredient Dexamethasone Oral Drops(deks a METH a sone) Pronunciation deks-a-METH-a-sone
It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Glucocorticoid, Anti-inflammatory, Immunosuppressant
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Pharmacologic Class
Corticosteroid
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Pregnancy Category
C
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FDA Approved
May 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Dexamethasone is a powerful 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, including allergies, asthma, skin conditions, arthritis, and certain cancers. Intensol is a concentrated liquid form that allows for precise dosing.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
If you take your medication once a day, take it in the morning.
To minimize the risk of an upset stomach, take your medication with food.
It's essential to use the correct liquid strength, as there are multiple strengths available. Measure your liquid dose carefully using the measuring device provided with your medication. If you don't have a measuring device, ask your pharmacist for one.
Only use the measuring device that comes with your medication to ensure accurate dosing.
Before taking your medication, mix the liquid with water, juice, soda, applesauce, or pudding. Take your dose immediately after mixing, and do not store the mixture for future use.
Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

Important Interaction

If you're taking cholestyramine, you may need to take it at a different time than your current medication. Consult with your pharmacist to determine the best schedule for your medications.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, avoiding the bathroom.
Do not freeze your medication.
Discard any unused medication 90 days after opening.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses.
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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.
  • Take with food or milk to reduce stomach upset.
  • Avoid contact with people who have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat) immediately.
  • Monitor blood sugar if you have diabetes, as this medication can raise it.
  • Limit sodium intake to help prevent fluid retention.
  • Ensure adequate calcium and vitamin D intake, especially with long-term use, to protect bone health.
  • Carry a medical alert card or bracelet if on long-term therapy, indicating you are taking a corticosteroid.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication. For anti-inflammatory/immunosuppressive effects: 0.75 mg to 9 mg daily 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. Oral dosing may follow.
Anti-inflammatory/Immunosuppressive: 0.75 mg to 9 mg daily, adjusted based on patient response and disease severity.
Multiple Myeloma: 40 mg orally once weekly (often in combination regimens).
COVID-19 (severe): 6 mg orally or IV once daily for up to 10 days.
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., bronchopulmonary dysplasia) may warrant use under strict medical supervision. Dosing is highly individualized (e.g., 0.05-0.2 mg/kg/day).
Infant: Highly individualized based on condition. For anti-inflammatory/immunosuppressive: 0.02-0.3 mg/kg/day in 3-4 divided doses.
Child: Highly individualized based on condition. For anti-inflammatory/immunosuppressive: 0.02-0.3 mg/kg/day in 3-4 divided doses. For croup: 0.15-0.6 mg/kg single dose (max 10 mg).
Adolescent: Similar to adult dosing, adjusted for weight and condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Dexamethasone is not significantly removed by dialysis. No supplemental dose needed post-dialysis.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: Use with caution; monitor for increased effects due to decreased metabolism. Dose adjustment may be necessary in severe impairment.
Severe: Use with caution; monitor for increased effects due to decreased metabolism. Dose reduction may be necessary.

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a potent glucocorticoid. It binds to specific cytoplasmic glucocorticoid receptors in target cells, forming a steroid-receptor complex that translocates into the nucleus. This complex then interacts with specific DNA sequences (glucocorticoid response elements), modulating the transcription of various genes. 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: Approximately 80-90% (oral)
Tmax: 1-2 hours (oral)
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 2 L/kg
ProteinBinding: Approximately 77% (primarily to albumin)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 3-4.5 hours (plasma); 36-54 hours (biological)
Clearance: Approximately 0.125 L/hr/kg
ExcretionRoute: Renal (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Hours to days (depending on effect and route)
PeakEffect: Variable, depending on indication (e.g., anti-inflammatory effects may take days)
DurationOfAction: Long-acting; biological half-life of 36-54 hours allows for once-daily dosing.

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 abnormal 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, excessive 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
Abnormal sensations: burning, numbness, or tingling
Unexplained bruising or bleeding
Severe stomach pain
Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material

Other Possible 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 or seek medical attention:

Nausea or vomiting
Insomnia or 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 stomach pain or black, tarry stools (signs of GI bleeding)
  • Unusual swelling of ankles, feet, or hands (fluid retention)
  • Extreme fatigue, weakness, dizziness, nausea, vomiting, or loss of appetite (signs of adrenal insufficiency, especially if stopping suddenly)
  • Blurred vision, eye pain, or halos around lights (signs of glaucoma or cataracts)
  • Increased thirst or urination (high blood sugar)
  • Muscle weakness or cramps (electrolyte imbalance)
  • Mood changes (severe depression, euphoria, psychosis)
  • Signs of infection (fever, chills, persistent cough, painful urination)
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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
+ Other types of infections
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 your existing medications and health conditions. Do not initiate, stop, or modify the dose 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. 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 workers that you are taking it. There is a risk of developing high blood pressure while taking this medication, and your doctor will need to monitor your blood pressure regularly.

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 to understand the potential risks.

Prolonged use of this medication can also lead to osteoporosis (weak bones). Consult with your doctor to determine if you are at a higher risk of developing osteoporosis or if you have any concerns. You may need to reduce your salt intake and increase your potassium consumption; discuss this with your doctor to determine the best course of action.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication. Before consuming alcohol, consult with your doctor to discuss any potential risks. Additionally, before receiving any vaccinations, inform your doctor, 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, notify your doctor immediately. Steroid medications, including this one, can increase the risk of infection, which can be mild or severe. To minimize the risk of infection, practice good hygiene by washing your hands frequently, and avoid close contact with individuals who have infections, colds, or flu. Inform your doctor if you experience any signs of infection.

In some cases, this medication can reactivate latent infections, such as tuberculosis or hepatitis B. If your child has a history of these infections, inform your doctor. This medication can also suppress the body's natural production of steroids, which can affect the body's 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 dosage, as this can lead to withdrawal symptoms. If you experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness after stopping or missing a dose, inform your doctor immediately.

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 to understand this risk.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can also affect growth in children and adolescents, and regular growth checks may be necessary; discuss this with your doctor. Furthermore, this medication can lower sperm counts in some individuals; if you have concerns, consult with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as this medication can affect the fetus or baby. If you took this medication during pregnancy, inform your baby's doctor, as they may need to monitor the baby's health.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: increased blood pressure, fluid retention, hypokalemia, hyperglycemia, and psychiatric disturbances.

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Major Interactions

  • Live vaccines (increased risk of infection)
  • Mifepristone (antagonizes corticosteroid effect)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital - decreased dexamethasone levels)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin - increased dexamethasone levels)
  • Warfarin (may alter anticoagulant effect, monitor INR)
  • NSAIDs (increased risk of GI ulceration/bleeding)
  • Diuretics (thiazide and loop - increased risk of hypokalemia)
  • Antidiabetic agents (may increase blood glucose, requiring dose adjustment of antidiabetics)
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Moderate Interactions

  • Cardiac glycosides (e.g., digoxin - increased risk of toxicity with hypokalemia)
  • Fluoroquinolones (increased risk of tendon rupture, especially in elderly)
  • Immunosuppressants (additive immunosuppression)
  • Cholestyramine, colestipol (may decrease dexamethasone absorption)
  • Oral contraceptives/estrogens (may increase dexamethasone effects)
  • Anticholinesterases (e.g., neostigmine, pyridostigmine - severe weakness in myasthenia gravis patients)
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Minor Interactions

  • Grapefruit juice (mild CYP3A4 inhibition, potential for slight increase in dexamethasone levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation

Blood Glucose

Rationale: Corticosteroids can induce hyperglycemia.

Timing: Prior to initiation

Serum Electrolytes (Na, K, Ca)

Rationale: Risk of fluid retention, hypokalemia, and hypocalcemia.

Timing: Prior to initiation

Bone Mineral Density (DEXA scan)

Rationale: For long-term therapy, to assess osteoporosis risk.

Timing: Prior to initiation (if long-term therapy anticipated)

Ophthalmologic Exam (intraocular pressure)

Rationale: Risk of glaucoma and cataracts with prolonged use.

Timing: Prior to initiation (if long-term therapy anticipated)

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Routine Monitoring

Blood Pressure

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

Target: <130/80 mmHg

Action Threshold: >140/90 mmHg or significant increase from baseline

Blood Glucose (fasting or HbA1c)

Frequency: Regularly (e.g., weekly to monthly, more frequently if diabetic)

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

Action Threshold: Fasting >126 mg/dL or HbA1c >7%

Serum Potassium

Frequency: Regularly (e.g., monthly, more frequently if on diuretics)

Target: 3.5-5.0 mEq/L

Action Threshold: <3.5 mEq/L

Weight and Fluid Balance

Frequency: Regularly (e.g., weekly)

Target: Stable weight, no significant edema

Action Threshold: Significant weight gain or edema

Growth (pediatric patients)

Frequency: Every 3-6 months

Target: Normal growth velocity for age

Action Threshold: Growth retardation

Signs of Infection

Frequency: Ongoing clinical assessment

Target: Absence of fever, localized infection, or systemic symptoms

Action Threshold: Presence of fever, malaise, or signs of infection

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Symptom Monitoring

  • Signs of infection (fever, sore throat, malaise, localized pain/redness)
  • Fluid retention (swelling, weight gain)
  • Mood changes (irritability, depression, euphoria)
  • Sleep disturbances
  • Muscle weakness or pain
  • Gastrointestinal upset (heartburn, abdominal pain, black/tarry stools)
  • Vision changes (blurred vision, halos around lights)
  • 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. Category C.

Trimester-Specific Risks:

First Trimester: Limited data, but generally avoided unless essential. Potential for increased risk of oral clefts (though data are conflicting and overall risk is low).
Second Trimester: Generally considered safer than first trimester if needed, but still used with caution.
Third Trimester: May be used for fetal lung maturation (e.g., in preterm labor). Prolonged use near term may lead to fetal adrenal suppression, requiring monitoring of the neonate.
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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 (Moderately safe)
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Pediatric Use

Corticosteroids can cause growth retardation in children. Long-term therapy requires careful monitoring of growth and development. Increased susceptibility to infections. Adrenal suppression is a significant concern, especially with prolonged use or abrupt discontinuation.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects, including osteoporosis, fluid retention, hypertension, and diabetes. Use the lowest effective dose for the shortest duration possible. Monitor closely for side effects.

Clinical Information

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Clinical Pearls

  • Dexamethasone Intensol is a highly concentrated oral solution (1 mg/mL), allowing for precise dosing, especially useful in pediatric or oncology settings where small, accurate doses are critical.
  • Due to its long biological half-life, dexamethasone can often be given once daily, even for conditions requiring continuous corticosteroid effect.
  • Always taper the dose gradually when discontinuing prolonged corticosteroid therapy to prevent adrenal insufficiency.
  • Patients on long-term dexamethasone should be advised about the risk of osteoporosis and counselled on calcium/vitamin D supplementation and weight-bearing exercise.
  • Immunosuppressive effects mean patients are at increased risk of infection; advise prompt reporting of any signs of illness.
  • Can cause significant mood changes, including euphoria, depression, or psychosis; counsel patients and caregivers to report these symptoms.
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Alternative Therapies

  • Prednisone
  • Methylprednisolone
  • Hydrocortisone
  • Betamethasone
  • Triamcinolone
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Cost & Coverage

Average Cost: Not available per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.