Dexamethasone 6-Day 1.5mg Dose Pack

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 (first trimester), Category D (prolonged use or high doses in third trimester)
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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 by reducing inflammation (swelling and redness) and calming down your body's 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 secure 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 explore 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 scheduled dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, especially following the tapering schedule of a dose pack. Do not stop abruptly without consulting your doctor.
  • Take with food or milk to reduce stomach upset.
  • Avoid contact with people who are sick or have infections, as this medicine can weaken your immune system.
  • Report any unusual side effects immediately, such as severe mood changes, vision problems, or signs of infection.
  • Limit salt intake to help prevent fluid retention.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Carry identification indicating steroid use if on prolonged therapy, in case of emergency.

Dosing & Administration

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Adult Dosing

Standard Dose: Typical 6-day tapering regimen (e.g., DexPak 6-Day): Day 1: 6 tablets (9 mg) once daily; Day 2: 5 tablets (7.5 mg) once daily; Day 3: 4 tablets (6 mg) once daily; Day 4: 3 tablets (4.5 mg) once daily; Day 5: 2 tablets (3 mg) once daily; Day 6: 1 tablet (1.5 mg) once daily. Tablets are typically 1.5 mg each.
Dose Range: 1.5 - 9 mg

Condition-Specific Dosing:

acuteinflammation: Initial dose 0.75-9 mg/day depending on condition, then tapered.
cerebraledema: 10 mg IV initially, then 4 mg IM/IV every 6 hours until symptoms subside. Oral tapering follows.
allergicreactions: 4-8 mg/day initially, then tapered.
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Pediatric Dosing

Neonatal: Not established for routine use; specific conditions (e.g., bronchopulmonary dysplasia) may use 0.05-0.2 mg/kg/day in divided doses, tapered.
Infant: 0.02-0.3 mg/kg/day in 3-4 divided doses, depending on condition and response.
Child: 0.02-0.3 mg/kg/day in 3-4 divided doses, depending on condition and response. Max 10 mg/day.
Adolescent: Similar to adult dosing, but may be weight-based (0.02-0.3 mg/kg/day) for some conditions.
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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.
Dialysis: Not significantly dialyzable; no supplemental dose needed post-dialysis. Monitor for fluid retention and electrolyte imbalances.

Hepatic Impairment:

Mild: No specific adjustment.
Moderate: Use with caution; monitor for increased side effects due to altered metabolism. Dose reduction may be considered in severe impairment.
Severe: Use with caution; monitor for increased side effects. 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, forming a complex that translocates to the nucleus. This complex then binds to glucocorticoid response elements (GREs) on DNA, modulating gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) 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: 80-90% (oral)
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: 77% (primarily to albumin, less to transcortin than other corticosteroids)
CnssPenetration: Yes (readily crosses blood-brain barrier)

Elimination:

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

OnsetOfAction: Hours (for anti-inflammatory effects)
PeakEffect: Within 24 hours
DurationOfAction: 36-72 hours (biologic half-life)

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 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 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, 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.
Burning, numbness, or tingling sensations that are not normal.
Unexplained bruising or bleeding.
Severe stomach pain.
Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.

Other Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they don't go away, contact your doctor:

Nausea or vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Hair thinning.
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, talk to 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/tarry stools, or vomiting blood (signs of GI bleeding)
  • Swelling in your face, hands, or ankles; rapid weight gain (fluid retention)
  • Extreme tiredness, weakness, dizziness, nausea, vomiting, or loss of appetite (signs of adrenal insufficiency, especially if stopping abruptly)
  • Increased thirst, increased urination, blurred vision (signs of high blood sugar)
  • Fever, chills, body aches, flu symptoms (signs of infection)
  • Muscle weakness or pain
  • Changes in mood or behavior (depression, anxiety, euphoria, insomnia)
  • Blurred vision, eye pain, or seeing halos around lights (signs of glaucoma or cataracts)
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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 disclose all your health conditions and medications to 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 adjust the dosage 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 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 workers that you are taking it. Be aware that drugs 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 your doctor to determine if you are at a higher risk of developing weak bones or if you have any questions. You may need to reduce your salt intake and take potassium supplements, so discuss this with your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before consuming alcohol, consult 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 deadly 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 steroid doses in these situations.

If you have been taking this medication for an extended period, consult your doctor before stopping or reducing the dose, as this may need to be done gradually. If you miss a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform your doctor.

Long-term use of this medication has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this with your doctor. Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition, so inform your doctor if you have cancer.

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. Additionally, this medication can lower sperm counts, so discuss this with your doctor if you have concerns.

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: nausea, vomiting, stomach upset, weakness, fluid retention, high blood pressure, 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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Contraindicated Interactions

  • Live or live attenuated vaccines (during immunosuppressive doses of corticosteroids)
  • Systemic fungal infections
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates): May decrease dexamethasone levels and efficacy.
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase dexamethasone levels and side effects.
  • Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease).
  • NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI ulceration/bleeding.
  • Diuretics (thiazide or loop): Increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, metformin): May increase blood glucose, requiring dose adjustment of antidiabetics.
  • Cholestyramine, colestipol: May decrease dexamethasone absorption.
  • Digoxin: Increased risk of digitalis toxicity due to hypokalemia.
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Moderate Interactions

  • Oral contraceptives/estrogens: May increase dexamethasone effects.
  • Cyclosporine: Increased risk of seizures and other CNS effects for both drugs.
  • Fluoroquinolones: Increased risk of tendon rupture.
  • Muscle relaxants (non-depolarizing): May prolong or antagonize neuromuscular blockade.
  • Vaccines (inactivated): Reduced immune response.
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Minor Interactions

  • Antacids: May decrease dexamethasone absorption (separate administration).

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 (especially potassium)

Rationale: Risk of hypokalemia and fluid retention.

Timing: Prior to initiation

Weight

Rationale: Monitor for fluid retention and weight gain.

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 during acute treatment, then periodically.

Target: Individualized, typically <130/80 mmHg

Action Threshold: Sustained elevation requiring intervention.

Blood glucose

Frequency: Daily during acute treatment, then periodically (e.g., weekly/monthly) or as needed.

Target: Fasting <126 mg/dL, Postprandial <200 mg/dL

Action Threshold: Persistent hyperglycemia requiring antidiabetic therapy or dose adjustment.

Serum electrolytes (Na, K)

Frequency: Weekly during acute treatment, then periodically.

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

Action Threshold: Significant hypokalemia or hypernatremia.

Weight

Frequency: Weekly

Target: Stable

Action Threshold: Significant, rapid weight gain (e.g., >2 kg in a week).

Signs of infection

Frequency: Ongoing clinical assessment

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

Action Threshold: Development of new or worsening signs of infection.

Adrenal suppression (for prolonged use)

Frequency: Clinical assessment, consider ACTH stimulation test if withdrawal symptoms occur.

Target: Not applicable

Action Threshold: Symptoms of adrenal insufficiency upon tapering/discontinuation.

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Increased appetite/weight gain
  • Muscle weakness or pain
  • Vision changes (blurred vision, cataracts, glaucoma)
  • Easy bruising or thinning skin
  • Increased thirst or urination (signs of hyperglycemia)
  • Signs of infection (fever, sore throat, cough, painful urination)
  • Stomach pain or black/tarry stools (GI bleeding)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. Prolonged or high-dose use, especially in the third trimester, may lead to fetal growth restriction, adrenal suppression in the neonate, and increased risk of cleft palate (though data are conflicting).

Trimester-Specific Risks:

First Trimester: Category C. Potential increased risk of oral clefts, though overall risk is low and data are inconsistent.
Second Trimester: Category C. Generally considered safer than first or third trimester, but still use with caution.
Third Trimester: Category D (for prolonged or high-dose use). 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. While generally considered compatible with breastfeeding at low doses, high doses or prolonged use may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production). Monitor the infant for signs of adrenal suppression or other adverse effects. Consider administering the dose immediately after feeding to minimize infant exposure.

Infant Risk: Low to Moderate (L3). Risk increases with higher doses and longer duration of therapy.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth and development carefully. Adrenal suppression can occur, especially with prolonged use; gradual tapering is crucial. Increased susceptibility to infections. Use the lowest effective dose for the shortest possible duration.

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Geriatric Use

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

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 conditions.
  • Always emphasize the importance of following the tapering schedule precisely, especially with dose packs, to prevent adrenal insufficiency.
  • Advise patients to take dexamethasone in the morning to minimize sleep disturbances.
  • Patients on long-term therapy should be advised about bone health (calcium, vitamin D, weight-bearing exercise) and regular eye exams.
  • Immunosuppressive effects mean patients are at increased risk of infection; advise avoiding sick contacts and reporting any signs of infection promptly.
  • Dexamethasone is a potent glucocorticoid with minimal mineralocorticoid activity, meaning less fluid retention compared to hydrocortisone or prednisone at equivalent anti-inflammatory doses.
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Alternative Therapies

  • Prednisone
  • Methylprednisolone
  • Hydrocortisone
  • Betamethasone
  • Triamcinolone
  • NSAIDs (for inflammatory conditions where corticosteroids are not required or as an alternative)
  • Specific immunomodulators/biologics (for autoimmune conditions)
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Cost & Coverage

Average Cost: $10 - $50 per 6-day dose pack (e.g., 21 x 1.5mg tablets)
Generic Available: Yes
Insurance Coverage: Tier 1 (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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 overdose, including the medication taken, the amount, and the time it occurred.