Dexamethasone 10-Day 1.5mg Dose Pak

Manufacturer LARKEN LABORATORIES, INC. Active Ingredient Dexamethasone Tablets(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 type of steroid medicine that works like natural hormones your body makes. It helps reduce inflammation (swelling and redness) and calm down an overactive immune system. It's used for many conditions like allergies, asthma, skin problems, and certain types of arthritis.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

If you take your medication once a day, it's best to take it in the morning.
Take your medication with food to help prevent stomach upset.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.

If you're also taking cholestyramine, you may need to take it at a different time than your other medication. Be sure to talk to your pharmacist about the best schedule for your medications.

Storing and Disposing of Your Medication

To keep your medication safe and effective:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe location, out of the reach of children and pets.
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 your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to look into drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However:
If it's close to the time for your next dose, skip the missed dose and return to your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take exactly as prescribed, especially if it's a tapering dose pak. 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 are sick, especially with chickenpox or measles, as your immune system may be weakened.
  • Report any signs of infection (fever, sore throat, unusual pain) immediately.
  • Limit sodium intake to help prevent fluid retention.
  • Monitor blood sugar if you have diabetes, as this medication can raise it.
  • Carry identification indicating steroid use, especially if on long-term therapy.

Dosing & Administration

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Adult Dosing

Standard Dose: The '10-Day 1.5mg Dose Pak' implies a pre-set, often tapering, regimen. A typical short course of dexamethasone might start at 0.75 mg to 9 mg daily, tapered over several days. For a 1.5mg Dose Pak, it likely involves 1.5mg daily or a taper starting at 1.5mg, as prescribed by the specific product instructions.
Dose Range: 0.75 - 9 mg

Condition-Specific Dosing:

antiInflammatory: 0.75-9 mg/day, tapered as per specific regimen
cerebralEdema: 10 mg IV/PO initially, then 4 mg every 6 hours (higher doses for acute situations)
allergicReactions: 0.75-9 mg/day, tapered
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Pediatric Dosing

Neonatal: Not established for routine use; specific indications (e.g., bronchopulmonary dysplasia) require highly individualized dosing (e.g., 0.05-0.1 mg/kg/day).
Infant: Dosing highly individualized based on indication and weight (e.g., 0.02-0.3 mg/kg/day in divided doses).
Child: Dosing highly individualized based on indication and weight (e.g., 0.02-0.3 mg/kg/day in divided doses). For croup: 0.15-0.6 mg/kg single dose.
Adolescent: Similar to adult dosing, individualized based on indication and weight.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment generally required.
Moderate: Use with caution; monitor for increased side effects due to altered metabolism. Dose reduction may be considered in severe cases.
Severe: Use with caution; monitor for increased side effects due to altered metabolism. Dose reduction may be considered.

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 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, reduction of leukocyte migration, suppression of humoral immune responses), metabolic effects (e.g., gluconeogenesis, protein catabolism), and mineralocorticoid effects (minimal).
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Pharmacokinetics

Absorption:

Bioavailability: 80-90%
Tmax: 1-2 hours
FoodEffect: Food may slightly delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: 0.8 L/kg
ProteinBinding: 60-70%
CnssPenetration: Yes

Elimination:

HalfLife: 3-4.5 hours (plasma); 36-54 hours (biological)
Clearance: Not available
ExcretionRoute: Urine (primarily as inactive metabolites)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Hours (oral)
PeakEffect: 1-2 hours (oral)
DurationOfAction: 36-72 hours (biological half-life dictates prolonged effect)

Safety & Warnings

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Side Effects

Urgent 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 problems): 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 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, excessive 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 periods.
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. While many people experience no side effects or only mild ones, some may be bothersome or persistent. If you experience any of the following side effects, contact your doctor for advice:

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 about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe stomach pain, black or tarry stools (signs of GI bleeding)
  • Unusual swelling of ankles or feet, rapid weight gain (fluid retention)
  • Extreme fatigue, weakness, dizziness, nausea, vomiting, loss of appetite (signs of adrenal insufficiency if stopped suddenly)
  • Blurred vision, eye pain (cataracts, glaucoma - long-term)
  • Signs of infection: fever, chills, sore throat, body aches, cough, painful urination
  • Severe mood changes, depression, anxiety, insomnia
  • Muscle weakness, cramps, irregular heartbeat (electrolyte imbalance)
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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.
If you have an active infection, including bacterial, viral, or fungal infections, such as amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other type of infection.
If you have nerve problems affecting your eyes.
If you have any stomach or bowel conditions, such as diverticulitis, ulcerative colitis, ulcers, or if you have recently undergone bowel surgery.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems 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 dosage of any medication without first 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 health. 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 this drug. Be aware that medications like this one can cause high blood pressure, so regular blood pressure checks, as advised by your doctor, are necessary.

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 can also lead to weak bones (osteoporosis). 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, so discuss this with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before consuming alcohol, consult with your doctor. Additionally, before receiving any vaccines, discuss this with 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 fatal 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, and even life-threatening. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any signs of infection.

Some infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. Inform your doctor if you have a history of these infections. This medication can suppress the production of natural steroids in your body, so notify your doctor if you experience fever, infection, surgery, or injury, as your body's response to these stresses may be affected. You may require additional doses of steroids in these situations.

If you have been taking this medication for an extended period, consult with your doctor before stopping, as you may need to gradually taper off the medication. Inform your doctor if you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness.

Long-term use of medications like this one can increase the risk of developing a type of cancer called Kaposi's sarcoma, so discuss this with your doctor. Patients with cancer may be at a higher risk of developing a potentially life-threatening condition called tumor lysis syndrome (TLS), so consult with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. This medication can affect growth in children and adolescents, so regular growth checks may be necessary. Consult with your doctor if you have any concerns. Additionally, this medication can lower sperm counts, so discuss this with your doctor if you have any questions.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of this medication 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, hypokalemia, hyperglycemia, and gastrointestinal irritation.

What to Do:

Seek immediate medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in immunosuppressed patients)
  • Systemic fungal infections (unless used as part of specific anti-fungal regimen)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates) - decreased dexamethasone levels
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - increased dexamethasone levels
  • NSAIDs - increased risk of GI ulceration/bleeding
  • Anticoagulants (e.g., warfarin) - altered anticoagulant effect (monitor INR)
  • Diuretics (thiazide, loop) - increased risk of hypokalemia
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased blood glucose, requiring dose adjustment of antidiabetics
  • Digoxin - increased risk of digitalis toxicity with hypokalemia
  • Immunosuppressants (e.g., cyclosporine) - increased levels of both drugs, increased toxicity
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Moderate Interactions

  • Oral contraceptives - may increase dexamethasone levels
  • Cholestyramine, colestipol - may decrease dexamethasone absorption
  • Antacids - may decrease dexamethasone absorption (separate administration)
  • Neuromuscular blockers - prolonged blockade
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Minor Interactions

  • Not available

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

Electrolytes (especially potassium)

Rationale: Risk of hypokalemia due to mineralocorticoid effects.

Timing: Prior to initiation

Weight

Rationale: Fluid retention and weight gain are common side effects.

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Daily to weekly (during acute treatment), then periodically

Target: <130/80 mmHg

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

Blood glucose

Frequency: Daily (especially in diabetics), then weekly to monthly

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

Action Threshold: Consistently elevated or symptomatic hyperglycemia

Electrolytes (K+)

Frequency: Weekly (during acute treatment), then periodically

Target: 3.5-5.0 mEq/L

Action Threshold: <3.0 mEq/L or symptomatic hypokalemia

Weight

Frequency: Weekly

Target: Stable

Action Threshold: Significant, rapid weight gain

Signs of infection

Frequency: Daily

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

Action Threshold: Any signs of infection (corticosteroids can mask symptoms)

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Symptom Monitoring

  • Increased thirst or urination (hyperglycemia)
  • Swelling in ankles/feet (fluid retention)
  • Unusual weight gain
  • Muscle weakness or cramps (hypokalemia)
  • Mood changes, irritability, insomnia
  • Stomach pain, black/tarry stools (GI ulceration)
  • Blurred vision (cataracts, glaucoma - long-term)
  • Increased susceptibility to infections (fever, chills, sore throat)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. Long-term or repeated use during pregnancy may increase the risk of fetal growth restriction and adrenal suppression in the neonate.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts, though data are conflicting and overall risk is low.
Second Trimester: Risk of fetal growth restriction and adrenal suppression increases with prolonged use.
Third Trimester: Risk of fetal growth restriction and adrenal suppression in the neonate. Monitor neonates for signs of hypoadrenalism.
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Lactation

L3 (Moderately safe). Dexamethasone is excreted in 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, adrenal suppression). Monitor infant for signs of adverse effects.

Infant Risk: Low risk with short-term, low-dose use; higher risk with prolonged or high-dose use (potential for growth suppression, adrenal suppression).
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth and development carefully. Long-term use can lead to adrenal suppression, requiring careful tapering. Increased susceptibility to infections.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Always emphasize the importance of not abruptly discontinuing dexamethasone, especially after prolonged use, due to the risk of adrenal insufficiency.
  • Advise patients to take dexamethasone with food or milk to minimize GI upset.
  • Educate patients on signs of infection, as corticosteroids can mask symptoms.
  • For short-term 'dose pak' regimens, ensure patients understand the tapering schedule precisely.
  • Consider bone protection (calcium, vitamin D) for patients on long-term corticosteroid therapy.
  • Dexamethasone has minimal mineralocorticoid activity compared to other corticosteroids, but fluid retention and electrolyte imbalances can still occur, especially at higher doses.
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Alternative Therapies

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

Average Cost: $10 - $50 per 10-day dose pak (generic)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.