Deflazacort 6mg Tablets

Deflazacort is a glucocorticoid, a prodrug that is rapidly converted to its active metabolite, 21-desacetyl deflazacort. It exerts its anti-inflammatory and immunosuppressive effects by binding to intracellular glucocorticoid receptors, which then translocate to the nucleus and modulate gene expression. This leads to the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, prostaglandins) and promotion of anti-inflammatory proteins, thereby reducing inflammation and immune responses.

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:

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 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 insufficiency: severe nausea or vomiting, extreme 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

If you experience any of the following symptoms, seek medical help immediately:

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
Toxic epidermal necrolysis: a severe skin reaction that can cause serious health problems or death. Seek medical help if you have 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. If you're concerned about any of the following side effects or if they persist, contact your doctor:

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, 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 infections (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 Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Regular Health Checks

Your doctor will need to monitor your blood work regularly. Additionally, if you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Potential Risks and Side Effects

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

High blood pressure has been reported in some individuals taking this medication. Your doctor will need to monitor your blood pressure regularly. If you have diabetes, it is essential to closely monitor your blood sugar levels. You may need to reduce your salt intake and increase your potassium consumption; consult with 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 on all recommended 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 your risk of infection when taken with this medication. Your doctor will advise you on the best course of action.

Infection Risks and Precautions

If you have not had chickenpox or measles before, avoid exposure to these illnesses, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If you have been exposed, notify your doctor immediately.

Steroid medications, including this one, can increase your risk of infection, which can be mild, severe, or even life-threatening. The risk of infection is typically higher with higher doses of steroids. To minimize your risk, wash your hands frequently, avoid close contact with individuals who have infections, colds, or flu, and notify 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.

Adrenal Insufficiency and Stress Response

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

Rare but Serious Side Effects

Long-term use of this medication can 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.

Blood clots have been reported in individuals taking this medication. Inform your doctor if you have a history of blood clots. Additionally, long-term use of this medication has been associated with an increased risk of a type of cancer called Kaposi's sarcoma; discuss this risk with your doctor.

Stopping Treatment and Missed Doses

Do not stop taking this medication abruptly without consulting your doctor, as this can increase your risk of side effects. If you need to stop treatment, your doctor will guide you on how to gradually taper off the medication. 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.

Special Considerations for Children, Teens, and Pregnant or Breastfeeding Women

This medication may affect growth in children and teens; regular growth checks may be necessary. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication to you and your baby.

• Live or live-attenuated vaccines (during immunosuppressive doses)

• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): 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.
• Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of gastrointestinal ulceration and bleeding.
• Antidiabetic agents (e.g., insulin, oral hypoglycemics): Deflazacort can increase blood glucose levels, requiring adjustment of antidiabetic therapy.
• Warfarin: May alter anticoagulant effects (either increase or decrease INR). Close INR monitoring is required.
• Diuretics (thiazide or loop diuretics): Increased risk of hypokalemia.

• Cardiac glycosides (e.g., digoxin): Increased risk of digitalis toxicity if hypokalemia occurs.
• Neuromuscular blocking agents: May prolong or antagonize neuromuscular blockade.
• Oral contraceptives: May increase deflazacort levels.
• Anticholinesterase agents (e.g., pyridostigmine): May cause severe weakness in patients with myasthenia gravis.
• Cyclosporine: Increased risk of seizures.

• Antacids: May reduce absorption of deflazacort (administer separately).
• Cholestyramine: May reduce absorption of deflazacort.

• Signs of infection (fever, chills, sore throat, cough, unusual fatigue)
• Hyperglycemia (increased thirst, frequent urination, blurred vision)
• Hypertension (headache, dizziness)
• Mood changes (irritability, anxiety, depression, euphoria, insomnia)
• Gastrointestinal upset (stomach pain, heartburn, black/tarry stools)
• Muscle weakness or pain
• Swelling (edema) in ankles or feet
• Vision changes
• Unusual bruising or bleeding
• Changes in menstrual cycle
• Weight gain (especially in face, neck, trunk)

Deflazacort is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

Deflazacort and its active metabolite are excreted into human milk. The amount is generally low, but potential for adverse effects on the breastfed infant (e.g., growth suppression, interference with endogenous corticosteroid production) 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 approved for Duchenne muscular dystrophy in patients 2 years of age and older. Corticosteroids can cause growth suppression in children; monitor growth velocity closely. Pediatric patients are also at increased risk for other corticosteroid-related adverse effects such as cataracts, glaucoma, and bone density changes.

Elderly patients may be at increased risk for common corticosteroid adverse effects, including osteoporosis, diabetes, hypertension, and fluid retention. Use with caution and monitor closely for adverse reactions.

• Deflazacort is a prodrug; its active metabolite is 21-desacetyl deflazacort.
• Unlike some other corticosteroids, deflazacort is considered to have a more favorable bone safety profile in some studies, but osteoporosis remains a significant risk with long-term use.
• Always taper the dose gradually when discontinuing deflazacort to prevent adrenal insufficiency.
• Patients should be educated on the signs of infection and instructed to report them immediately, as corticosteroids can mask symptoms of infection.
• Monitor blood glucose levels regularly, especially in patients with diabetes or those at risk, as corticosteroids can cause hyperglycemia.
• Consider calcium and vitamin D supplementation, and potentially bisphosphonates, for patients on long-term therapy to mitigate bone loss.
• Psychiatric disturbances (e.g., mood swings, insomnia, depression, euphoria) are common and should be discussed with patients and caregivers.

• Other corticosteroids (e.g., Prednisone, Methylprednisolone, Dexamethasone)
• For Duchenne Muscular Dystrophy: Eteplirsen, Golodirsen, Viltolarsen, Casimersen (exon-skipping therapies); Ataluren (for nonsense mutations); Vamorolone (another corticosteroid-like drug with potentially fewer side effects).

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 this medication, don't 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 details about the medication taken, the amount, and the time it happened.