Deflazacort 18mg 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 anti-inflammatory and immunosuppressive effects, including inhibition of prostaglandin and leukotriene synthesis, reduction of leukocyte migration, and suppression of humoral immune responses.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 changed sputum production, painful urination, mouth sores, or a wound that won't heal
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of adrenal gland problems: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of 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
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Changes in vision
Bone or joint pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
New or worsening mental, mood, or behavioral changes
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Signs of a blood clot: 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
A severe skin reaction (toxic epidermal necrolysis) may occur, causing serious health problems or even death. Seek medical help immediately if you experience: red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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, contact 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 problems, 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 HIV medications
+ Infection treatments
+ Seizure medications
+ Other medications that may interact with this drug

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not start, stop, or change the dose of any medication without consulting your doctor first.

Important Warnings and 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 will be necessary, as directed by your doctor. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Long-term Use Risks

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this with your doctor to understand the potential risks. Additionally, long-term use may cause weak bones (osteoporosis). Talk to your doctor to determine if you are at a higher risk or have any questions.

Blood Pressure and Sugar Monitoring

This medication may cause high blood pressure. Regular blood pressure checks will be necessary, as directed by your doctor. If you have diabetes, it is crucial to closely monitor your blood sugar levels. You may need to reduce your salt intake and take extra potassium. Consult your doctor for guidance.

Dietary Restrictions and Vaccine Precautions

Avoid consuming grapefruit and grapefruit juice while taking this medication. If you are not up to date with all your vaccines, discuss this with your doctor. You may need to receive certain vaccines 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. Consult your doctor before receiving any vaccines.

Infection Risks

If you have not had chickenpox or measles before, avoid being near anyone with these conditions. If you have been exposed to chickenpox or measles, inform your doctor immediately. Steroid medications like this one can increase the risk of infection, which can be severe or even life-threatening. Wash your hands frequently, avoid people with infections, colds, or flu, and report any signs of infection to your doctor.

Reactivation of Infections

In some cases, this medication may reactivate latent infections, such as tuberculosis or hepatitis B. Inform your doctor if you have a history of these infections.

Adrenal Insufficiency and Stress

This medication may lower your body's natural steroid production. If you experience a fever, infection, surgery, or injury, consult your doctor, as you may need additional oral steroids to help your body cope with stress. Carry a warning card indicating that you may require extra steroids in certain situations.

Rare but Serious Risks

Long-term use of this medication may lead to rare but serious 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, blood clots have been reported in people taking this medication. 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, particularly with long-term use. Consult your doctor to understand this risk.

Stopping the Medication

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 guide you on how to gradually taper off the dosage. If you have missed a dose or recently stopped taking this medication and experience symptoms such as fatigue, weakness, shakiness, fast heartbeat, confusion, sweating, or dizziness, inform your doctor.

Effects on Growth and Pregnancy

This medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss the potential risks. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the benefits and risks to you and your baby.

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

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, diltiazem, grapefruit juice) - may increase deflazacort levels and risk of adverse effects.
• CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - may decrease deflazacort levels and efficacy.
• Non-steroidal anti-inflammatory drugs (NSAIDs) - increased risk of gastrointestinal ulceration and bleeding.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics) - deflazacort may increase blood glucose, requiring dose adjustment of antidiabetics.

• Diuretics (e.g., thiazide, loop diuretics) - increased risk of hypokalemia.
• Warfarin - corticosteroids may alter anticoagulant effects (monitor INR).
• Cardiac glycosides (e.g., digoxin) - increased risk of toxicity if hypokalemia occurs.
• Cholestyramine, colestipol - may decrease absorption of deflazacort.
• Antacids - may decrease absorption of deflazacort.

• Oral contraceptives - may increase corticosteroid levels.

• Signs of infection (fever, chills, sore throat, unusual fatigue)
• Cushingoid features (moon face, buffalo hump, central obesity, striae)
• Mood changes (irritability, depression, euphoria, insomnia)
• Gastrointestinal upset (abdominal pain, nausea, vomiting, black/tarry stools)
• Muscle weakness or pain
• Swelling in ankles or feet
• Vision changes
• Increased thirst or urination
• Easy bruising or thinning skin
• Delayed wound healing

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids can cross the placenta and may be associated with fetal growth restriction, cleft palate, and adrenal suppression in the neonate.

Deflazacort and its active metabolite are excreted into breast milk. The amount is generally low, but potential for adverse effects in the infant (e.g., growth suppression, adrenal suppression) exists. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for deflazacort and any potential adverse effects on the breastfed infant.

Deflazacort is specifically indicated for Duchenne Muscular Dystrophy in patients 5 years of age and older. Long-term use in pediatric patients requires careful monitoring for growth suppression, bone mineral density changes, and ophthalmologic effects (cataracts, glaucoma).

Elderly patients may be at increased risk of adverse effects associated with corticosteroids, including osteoporosis, hypertension, diabetes, and fluid retention. Use with caution and monitor closely.

• Deflazacort is a prodrug; its active metabolite is 21-desacetyl deflazacort.
• Always taper the dose gradually when discontinuing to prevent adrenal insufficiency.
• Patients should be educated on the signs of infection and adrenal insufficiency.
• Bone health is a significant concern with long-term corticosteroid use; consider calcium, vitamin D, and bisphosphonate therapy as appropriate.
• Monitor blood glucose regularly, especially in patients with pre-existing diabetes or risk factors.
• Vaccination status should be reviewed; live vaccines are contraindicated during deflazacort therapy.
• Consider ophthalmologic exams annually due to the risk of cataracts and glaucoma.

• Prednisone (another corticosteroid used for DMD)
• Prednisolone (another corticosteroid used for DMD)
• Vamorolone (another corticosteroid for DMD, with potentially fewer side effects)
• Eteplirsen (Exondys 51, for DMD with specific exon 51 skipping mutation)
• Golodirsen (Vyondys 53, for DMD with specific exon 53 skipping mutation)
• Viltolarsen (Viltepso, for DMD with specific exon 53 skipping mutation)
• Casimersen (Amondys 45, for DMD with specific exon 45 skipping mutation)

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.