Deflazacort 30mg Tablets

Deflazacort is a prodrug that is rapidly converted to its active metabolite, 21-desacetyl deflazacort. This active metabolite is a corticosteroid that binds to glucocorticoid receptors, modulating gene expression. This leads to a wide range of physiological effects, including potent anti-inflammatory and immunosuppressive actions. It inhibits the release of inflammatory mediators, suppresses the migration of leukocytes, and reverses increased capillary permeability.

Serious Side Effects: Seek Medical Help Immediately

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 or seek medical attention right away:

Allergic reactions: 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.
Infections: Fever, chills, severe sore throat, ear or sinus pain, cough, increased sputum production or change in sputum color, painful urination, mouth sores, or wounds that won't heal.
High blood sugar: Confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Cushing's syndrome: Weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Adrenal gland problems: Severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
High blood pressure: Severe headache or dizziness, fainting, or changes in vision.
Electrolyte imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea or vomiting.
Respiratory problems: Shortness of breath, significant weight gain, or swelling in the arms or legs.
Skin changes: Acne, stretch marks, slow healing, or excessive hair growth.
Vision changes: Changes in eyesight.
Musculoskeletal problems: Bone or joint pain.
Gastrointestinal problems: Black, tarry, or bloody stools, or vomiting blood or coffee ground-like material.
Mental health changes: New or worsening mental, mood, or behavioral changes.
Skin discoloration: Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Blood clots: Chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Severe skin reactions (toxic epidermal necrolysis): Red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes. This condition can lead to serious health problems and even death. Seek medical help immediately if you experience any of these symptoms.

Other Side Effects

Most people experience no side effects or only mild side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Weight gain
Increased appetite
Common cold symptoms
Nose and throat irritation
Frequent urination
Stomach pain
Constipation
Back pain
Upset stomach
Headache

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. Be sure to describe the allergic reaction and its symptoms.
The presence of any infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
Certain health conditions, including:
+ Diverticulitis
+ Hole in the gastrointestinal (GI) tract
+ Stomach or bowel infection
+ Ulcers
Recent stomach or bowel surgery
* Any medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as some may interact with this medication. Specifically, inform your doctor about:
+ Certain drugs used to treat HIV, infections, seizures, and other conditions
+ Any other medications that may interact with this drug

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications and health conditions with your doctor and pharmacist to ensure safe treatment. Do not start, stop, or change the dose 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. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Long-term use of this medication may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this with your doctor. Additionally, prolonged use may lead to weak bones (osteoporosis). Your doctor can help determine if you are at a higher risk of developing osteoporosis and answer any questions you may have.

This medication may cause high blood pressure. Regular blood pressure checks, as advised by your doctor, are necessary to monitor your condition. If you have diabetes, it is vital to closely monitor your blood sugar levels. You may need to reduce your salt intake and take extra potassium supplements; consult with your doctor for guidance.

Avoid consuming grapefruit and grapefruit juice while taking this medication. If you are not up to date with all your vaccinations, discuss this with your doctor. You may need to receive certain vaccinations before starting treatment with this medication. However, some vaccines may not be effective or may increase the risk of infection when taken with this medication, so it is essential to consult with your doctor before receiving any vaccinations.

If you have not had chickenpox or measles before, it is crucial to avoid close contact with anyone who has these conditions, as they 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, and even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize the risk of infection, wash your hands frequently, avoid close contact with people who have infections, colds, or flu, and 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 may also lower the levels of natural steroids in your body. If you experience a fever, infection, undergo surgery, or are injured, consult with your doctor, as you may need additional oral steroid doses to help your body cope with these stresses. It is recommended to carry a warning card indicating that you may require extra steroids in certain situations.

Long-term use of this medication can lead to severe and potentially life-threatening health problems, including changes in adrenal gland function and the development of a tumor on the adrenal gland (pheochromocytoma). Discuss these risks with your doctor. Additionally, this medication may increase the risk of blood clots; inform your doctor if you have a history of blood clots.

There is also a risk of developing a type of cancer called Kaposi's sarcoma with long-term use of this medication. Discuss this risk with your doctor.

Do not stop taking this medication abruptly without consulting your doctor, as this may increase the risk of side effects. If you need to stop taking this medication, your doctor will advise you on how to gradually discontinue it. 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, inform your doctor.

This medication may affect growth in children and teenagers; regular growth checks may be necessary. Discuss this with your doctor. If you are pregnant, plan to become pregnant, or are breastfeeding, it is essential to discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Live or live-attenuated vaccines (due to immunosuppression)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit juice) - may significantly increase deflazacort levels, increasing risk of adverse effects. Dose reduction of deflazacort may be necessary.
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may significantly decrease deflazacort levels, reducing efficacy. Dose increase of deflazacort may be necessary.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - increased risk of gastrointestinal ulceration and bleeding.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics) - deflazacort can increase blood glucose, requiring dose adjustment of antidiabetics.
• Diuretics (e.g., thiazide, loop diuretics) - increased risk of hypokalemia.
• Warfarin - may alter anticoagulant effect (monitor INR).

• Cardiac glycosides (e.g., digoxin) - increased risk of toxicity if hypokalemia occurs.
• Neuromuscular blocking agents - prolonged neuromuscular blockade.
• Cholestyramine - may decrease absorption of deflazacort.
• Antacids - may decrease absorption of deflazacort (separate administration).

• Not available

• Signs of infection (fever, chills, sore throat, unusual fatigue)
• Hyperglycemia (increased thirst, urination, hunger)
• Fluid retention (swelling in ankles/feet, weight gain)
• Mood changes (irritability, anxiety, depression, euphoria)
• Gastrointestinal upset (stomach pain, black/tarry stools)
• Muscle weakness or pain
• Vision changes (blurred vision, eye pain)
• Skin changes (thinning, bruising, acne)
• Signs of adrenal insufficiency (severe fatigue, weakness, dizziness, nausea, vomiting, loss of appetite, weight loss) upon dose reduction or discontinuation

Deflazacort is classified as Pregnancy Category C. Animal studies have shown adverse effects on fetal development (e.g., cleft palate, skeletal abnormalities, growth restriction). Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Monitor neonates exposed to corticosteroids in utero for signs of hypoadrenalism.

Deflazacort and its active metabolite are excreted into human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for deflazacort and any potential adverse effects on the breastfed infant from deflazacort or from the underlying maternal condition. Monitor breastfed infants for signs of adrenal suppression (e.g., poor weight gain, delayed growth).

Deflazacort is indicated for Duchenne Muscular Dystrophy in patients 2 years of age and older. Long-term corticosteroid use in children can cause growth suppression, bone demineralization, and other systemic adverse effects. Close monitoring of growth, bone health, and overall development is essential.

Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Elderly patients may be at increased risk of adverse effects associated with corticosteroids, including osteoporosis, hypertension, diabetes, and fluid retention. Use with caution, generally starting at the lower end of the dosing range.

• Deflazacort is a prodrug; its active metabolite (21-desacetyl deflazacort) is responsible for its therapeutic effects.
• It is crucial to taper deflazacort slowly when discontinuing or reducing the dose to prevent acute adrenal insufficiency.
• Patients on deflazacort are at increased risk of infection, especially opportunistic infections. Advise patients to report any signs of infection immediately.
• Monitor for common corticosteroid side effects including weight gain, Cushingoid features, hyperglycemia, hypertension, bone demineralization, and behavioral changes.
• Regular ophthalmologic exams are recommended for long-term users due to the risk of cataracts and glaucoma.
• Calcium and Vitamin D supplementation should be considered to mitigate bone loss, especially in pediatric patients.
• Avoid live or live-attenuated vaccines during deflazacort therapy due to immunosuppression.

• Prednisone (another corticosteroid commonly used in DMD, though deflazacort may have a better side effect profile regarding bone health and weight gain in some patients)
• Prednisolone
• Other glucocorticoids (e.g., methylprednisolone)
• Exon-skipping therapies (e.g., eteplirsen, golodirsen, viltolarsen, casimersen) for specific DMD mutations
• Gene therapy (e.g., delandistrogene moxeparvovec) for DMD

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 overdose, including the medication taken, the amount, and the time it occurred.