Dexamethasone 0.5mg/5ml Oral Soln

Dexamethasone is a synthetic adrenocortical steroid that is a potent glucocorticoid. It acts by binding to specific 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, stabilization of lysosomal membranes), metabolic effects (e.g., gluconeogenesis, protein catabolism), and mineralocorticoid effects (though minimal compared to other corticosteroids).

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, 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 discolored sputum, 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, 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 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, discoloration, 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.
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 notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

Nausea and vomiting.
Trouble 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.

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 medications (prescription, over-the-counter, natural products, and 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 consulting your doctor first.

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 laboratory personnel that you are taking this drug. There is a risk of developing high blood pressure with this medication, and your doctor will monitor your blood pressure accordingly.

If you are scheduled to undergo allergy skin tests, inform your doctor and laboratory personnel 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 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. Before consuming alcohol, consult your doctor to understand the potential risks. Additionally, discuss any upcoming vaccinations 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, inform 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. Inform your doctor if you have a history of these infections. This medication can also suppress the production of natural steroids in your body, which can affect your 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 your doctor before stopping or reducing the dosage, as this can lead to withdrawal symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness. A rare type of cancer called Kaposi's sarcoma has been associated with long-term use of medications like this one; discuss this risk with your doctor. Patients with cancer may be at a higher risk of developing a life-threatening condition called tumor lysis syndrome (TLS); consult your doctor to understand this risk.

If you are 65 years 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; regular growth checks may be necessary. Additionally, this medication can lower sperm counts in some individuals; consult your doctor if you have concerns.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform 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 to ensure the best possible care for your child.

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

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

• Oral contraceptives/estrogens: May increase dexamethasone levels.
• Fluoroquinolones: Increased risk of tendon rupture.
• Muscle relaxants (non-depolarizing): May prolong or antagonize neuromuscular blockade.
• Vaccines (inactivated): Reduced immune response.
• Aprepitant, fosaprepitant: May increase dexamethasone levels.

• Not available

• Signs of infection (fever, sore throat, unusual fatigue, non-healing wounds)
• Hyperglycemia (increased thirst, urination, hunger, blurred vision)
• Fluid retention/edema (swelling in ankles/feet, weight gain)
• Mood changes (irritability, anxiety, depression, euphoria, insomnia)
• Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
• Muscle weakness or pain
• Bone pain or fractures
• Vision changes (blurred vision, halos around lights)
• Skin changes (thinning, bruising, acne)
• Adrenal insufficiency symptoms upon withdrawal (severe fatigue, weakness, dizziness, nausea, vomiting, loss of appetite)

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Dexamethasone crosses the placenta. It is often used in specific situations (e.g., fetal lung maturation in preterm labor) where benefits outweigh risks.

Dexamethasone is excreted into breast milk. Use with caution. The amount excreted is generally low, but potential for adverse effects on the infant (e.g., growth suppression, interference with endogenous corticosteroid production) exists, especially with high doses or prolonged use.

Children are more susceptible to growth suppression and adrenal suppression with long-term corticosteroid use. Monitor growth velocity carefully. Dosing should be individualized and the lowest effective dose used for the shortest duration possible. Increased risk of intracranial hypertension in children.

Elderly patients may be at increased risk for adverse effects, including osteoporosis, fluid retention, hypertension, diabetes, and cataracts. Use the lowest effective dose and monitor closely for side effects.

• Dexamethasone has a long biologic half-life (36-54 hours), allowing for once-daily or alternate-day dosing for some indications.
• Always taper the dose gradually after prolonged therapy (typically > 2-3 weeks) to prevent adrenal insufficiency.
• Patients on long-term dexamethasone may require 'stress doses' during periods of severe illness, surgery, or trauma.
• Oral solution is useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
• Educate patients about signs of infection and to report them immediately, as corticosteroids can mask symptoms of infection.
• Consider bone protection (calcium, vitamin D, bisphosphonates) for patients on long-term therapy.

• Prednisone (oral)
• Methylprednisolone (oral, IV)
• Hydrocortisone (oral, IV)
• Betamethasone (oral)
• Triamcinolone (oral)
• For specific conditions, non-steroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), biologics, or other immunosuppressants may be alternatives or adjunctive therapies.

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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.