Dexamethason 13-Day Tab

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
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 a natural hormone your body makes. It's used to treat many conditions by reducing inflammation (swelling and redness) and calming down an overactive immune system. This can help with allergies, asthma, arthritis, skin conditions, and certain cancers.
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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 of your medication:
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 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 if it's a tapering dose (like a 13-day pack). 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 or have infections, as this medicine can weaken your immune system.
  • Report any signs of infection (fever, chills, sore throat) immediately.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Maintain a diet rich in calcium and vitamin D, and engage in weight-bearing exercise to help protect bone health, especially with long-term use.
  • Limit sodium intake to help prevent fluid retention and high blood pressure.
  • Carry a steroid warning card if on long-term therapy, indicating your need for increased doses during stress (e.g., surgery, severe illness).

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication; common starting doses range from 0.75 mg to 9 mg daily, often tapered.
Dose Range: 0.75 - 16 mg

Condition-Specific Dosing:

antiInflammatory: 0.75 mg to 9 mg daily, in single or divided doses. For acute conditions, higher doses may be used initially, followed by tapering.
cerebralEdema: Initial 10 mg IV, then 4 mg IM/IV every 6 hours until symptoms subside. Oral taper may follow.
multipleMyeloma: 40 mg orally once weekly (often in combination with other agents).
dexamethasoneSuppressionTest: 1 mg orally at 11 PM, blood sample at 8 AM the next morning.
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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 divided every 12-24 hours, often tapered.
Infant: 0.02-0.3 mg/kg/day orally or IV in 1-4 divided doses, depending on indication and severity.
Child: 0.02-0.3 mg/kg/day orally or IV in 1-4 divided doses, depending on indication and severity. Max 10 mg/day for most indications, but higher for acute severe conditions (e.g., croup: 0.6 mg/kg single dose).
Adolescent: Similar to adult dosing, adjusted for weight and indication.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Not significantly dialyzable; no supplemental dose needed post-dialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Dexamethasone is a synthetic adrenocortical steroid that is a potent 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 physiological effects, including potent anti-inflammatory and immunosuppressive actions (e.g., inhibition of prostaglandin and leukotriene synthesis, reduction of leukocyte migration, stabilization of lysosomal membranes), metabolic effects (e.g., gluconeogenesis, protein catabolism, fat redistribution), and mineralocorticoid effects (minimal).
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Pharmacokinetics

Absorption:

Bioavailability: 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, less to corticosteroid-binding globulin)
CnssPenetration: Yes (readily crosses the blood-brain barrier)

Elimination:

HalfLife: 3-4.5 hours (plasma half-life); 36-54 hours (biological half-life)
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 indication and route)
PeakEffect: Variable, often within 1-2 days for anti-inflammatory effects.
DurationOfAction: Biological half-life of 36-54 hours allows for once-daily dosing for many indications.

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 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, 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
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 notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Nausea and vomiting
Difficulty sleeping
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, 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 mood changes (depression, euphoria, psychosis)
  • Signs of infection (fever, chills, persistent sore throat, unusual fatigue, painful urination)
  • Unusual weight gain or swelling in hands/ankles/feet
  • Increased thirst or urination (signs of high blood sugar)
  • Muscle weakness or cramps
  • Black, tarry stools or severe stomach pain (signs of GI bleeding)
  • Blurred vision or eye pain
  • Shortness of breath
  • Severe dizziness or fainting
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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 in 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 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 existing treatments and health conditions. Do not initiate, discontinue, 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 health. 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. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this medication. Additionally, high blood pressure has been associated with medications like this one, so it is crucial to have your blood pressure checked as directed by your doctor.

If you are scheduled to undergo allergy skin testing, inform your doctor and laboratory personnel 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; 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 questions. You may need to reduce your salt intake and increase your potassium consumption; 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 vaccinations, discuss the potential risks 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 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 you have a history of these infections, inform your doctor. This medication can also suppress the production of natural steroids in your body. If you experience fever, infection, surgery, or injury, notify your doctor, as your body's response to these stresses may be affected, and 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 may need to be done gradually. 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, notify 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 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 about 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; regular growth checks may be necessary. Furthermore, this medication can lower sperm counts in some individuals; if you have concerns, discuss them with your doctor.

If you are pregnant, plan to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks to you and your baby. If you took this medication during pregnancy, inform your baby's doctor.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is generally not life-threatening but may cause increased side effects such as fluid retention, high blood pressure, hyperglycemia, and psychiatric disturbances. Chronic overdose leads to Cushingoid features (moon face, buffalo hump, central obesity).

What to Do:

Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. There is no specific antidote. Long-term overdose requires gradual withdrawal of the drug under medical supervision.

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (in immunosuppressed patients)
  • Systemic fungal infections (unless used for specific indications like adrenal insufficiency)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates) - may decrease dexamethasone levels.
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may increase dexamethasone levels.
  • NSAIDs - increased risk of gastrointestinal ulceration and bleeding.
  • Anticoagulants (e.g., warfarin) - may alter anticoagulant effect (monitor INR).
  • Diuretics (thiazide and loop) - increased risk of hypokalemia.
  • Digoxin - increased risk of digitalis toxicity due to hypokalemia.
  • Immunosuppressants (e.g., cyclosporine) - increased risk of seizures with cyclosporine; increased toxicity of both drugs.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics) - may increase blood glucose, requiring dose adjustment of antidiabetic agents.
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Moderate Interactions

  • Cholestyramine, colestipol - may decrease dexamethasone absorption.
  • Oral contraceptives - may increase dexamethasone levels.
  • Fluoroquinolones - increased risk of tendon rupture.
  • Neuromuscular blockers - prolonged neuromuscular blockade.
  • Vaccines (inactivated) - diminished antibody 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 or worsen existing diabetes.

Timing: Prior to initiation

Serum electrolytes (especially potassium)

Rationale: Risk of hypokalemia, especially with concomitant diuretics.

Timing: Prior to initiation

Bone mineral density (DEXA scan)

Rationale: For patients anticipated to be on long-term therapy (>3 months) due to risk of osteoporosis.

Timing: Prior to initiation

Ophthalmic exam (intraocular pressure)

Rationale: For patients anticipated to be on long-term therapy (>6 weeks) due to risk of glaucoma and cataracts.

Timing: Prior to initiation

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during initial therapy and dose changes.

Target: Within patient's normal range or target.

Action Threshold: Significant elevation; consider antihypertensive therapy or dose adjustment.

Blood glucose (fasting or HbA1c)

Frequency: Regularly, more frequently in diabetics or those at risk.

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

Action Threshold: Persistent hyperglycemia; consider antidiabetic agents or dose adjustment.

Serum electrolytes (potassium)

Frequency: Periodically, especially with concomitant diuretics.

Target: 3.5-5.0 mEq/L.

Action Threshold: Hypokalemia; consider potassium supplementation or dose adjustment.

Weight and fluid balance

Frequency: Regularly.

Target: Stable weight, no significant edema.

Action Threshold: Significant weight gain or edema; consider fluid restriction or diuretic.

Signs of infection

Frequency: Continuously.

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

Action Threshold: Any signs of infection; prompt evaluation and treatment.

Adrenal function (e.g., morning cortisol)

Frequency: If tapering after prolonged therapy or suspecting adrenal insufficiency.

Target: Normal cortisol response.

Action Threshold: Signs of adrenal suppression; slow taper or consider stress dosing.

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Symptom Monitoring

  • Mood changes (irritability, anxiety, depression, euphoria)
  • Sleep disturbances (insomnia)
  • Increased appetite and weight gain
  • Fluid retention (swelling in ankles, feet)
  • Muscle weakness or pain
  • Easy bruising or thinning skin
  • Delayed wound healing
  • Increased thirst or urination (signs of hyperglycemia)
  • Signs of infection (fever, chills, sore throat, cough, painful urination)
  • Gastrointestinal upset (heartburn, abdominal pain)
  • Visual disturbances

Special Patient Groups

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Pregnancy

Category C. Dexamethasone crosses the placenta. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. There is a potential for fetal growth restriction and adrenal suppression, especially with prolonged use.

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 increases with prolonged use. Neonates exposed in utero should be observed for signs of hypoadrenalism.
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Lactation

Dexamethasone is excreted into breast milk. Low doses are generally considered compatible with breastfeeding, but higher or prolonged doses may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production) or decrease milk supply. Use with caution.

Infant Risk: Low risk with short-term, low-dose use. Higher doses or prolonged use may lead to growth suppression, adrenal suppression, or other adverse effects in the infant. Monitor infant for unusual weight gain/loss, developmental milestones, and signs of infection.
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Pediatric Use

Children are more susceptible to the adverse effects of corticosteroids, including growth suppression, adrenal suppression, and increased intracranial pressure. Long-term use should be carefully monitored for growth and development. Dosage should be individualized and the lowest effective dose used for the shortest duration possible.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, fluid retention, hypertension, diabetes, and cataracts. Close monitoring is recommended. Use the lowest effective dose for the shortest duration.

Clinical Information

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Clinical Pearls

  • Dexamethasone is a potent glucocorticoid with minimal mineralocorticoid activity, making it suitable for conditions where fluid retention is undesirable.
  • The '13-Day Tab' or similar pre-packaged taper kits are designed to facilitate gradual withdrawal of corticosteroids, minimizing the risk of adrenal insufficiency and rebound symptoms.
  • Always emphasize the importance of not abruptly stopping dexamethasone, especially after prolonged therapy, due to the risk of adrenal crisis.
  • Patients on long-term therapy should be advised to carry a steroid warning card.
  • Consider prophylactic measures for bone health (calcium, vitamin D, bisphosphonates) in patients on long-term corticosteroid therapy.
  • Educate patients about the signs of infection, as corticosteroids can mask symptoms and increase susceptibility.
  • Monitor for psychiatric side effects, which can range from mood swings to psychosis.
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Alternative Therapies

  • Other systemic corticosteroids (e.g., prednisone, methylprednisolone, hydrocortisone)
  • NSAIDs (for inflammatory conditions, if appropriate)
  • Immunosuppressants (e.g., methotrexate, azathioprine, biologics for autoimmune diseases)
  • Specific disease-modifying agents depending on the underlying condition (e.g., bronchodilators for asthma, chemotherapy for cancer)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 0.5mg-4mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.