Budez Od Tablet (15 Tab)

BUDEZ OD TABLET (15 TAB) by SUN PHARMA LABORATORIES LTD.

Budez OD Tablet is a medication prescribed to manage inflammatory bowel diseases. Manufactured by SUN PHARMA LABORATORIES LTD., it is available in a 15-tablet pack.

• Name:

  • Brand Name: Budez OD Tablet
  • Common Name: Budesonide (as an extended-release or "OD" once-daily formulation)

• Composition:

  • Active Ingredient: Budesonide 9 mg. This is a synthetic glucocorticoid (corticosteroid) medication.

• Uses: Budez OD Tablet is primarily used to treat inflammatory bowel diseases by reducing inflammation in the digestive tract. Specific conditions include:

  • Active, mild to moderate ulcerative colitis
  • Crohn's disease
  • Microscopic colitis It may also be used for eosinophilic esophagitis and to reduce protein in the urine in patients with Primary Immunoglobulin A Nephropathy (IgAN).

• Dosage and Administration: Budez OD Tablet should be taken orally as directed by a healthcare professional.

  • Swallow the tablet whole with a glass of water; do not chew, crush, or break it.
  • It can be taken with or without food.
  • The typical frequency is once daily, usually for a course duration of approximately 8 weeks, as advised by the physician.
  • Do not exceed the recommended dose or stop the medication abruptly without consulting your doctor.

• Side Effects: Most side effects are temporary and often resolve with continued use.

  • Common Side Effects: Headache, nausea, abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia (joint pain), constipation, dizziness, vomiting, stuffy nose, sneezing, and sore throat.
  • Serious Side Effects: Signs of Cushing syndrome (e.g., weight gain, round face, acne), signs of low potassium, severe depression or suicidal thoughts, blurred vision or other visual changes, and severe allergic reactions (e.g., skin rash, swelling of the face/lips/tongue, difficulty breathing).

• Precautions:

  • Allergies: Contraindicated in patients with known hypersensitivity to budesonide or any of its excipients.
  • Pregnancy and Breastfeeding: Use with caution and only if prescribed by a physician, as it may be unsafe during pregnancy and may pass into breast milk.
  • Alcohol: Avoid consuming alcohol as it may worsen side effects.
  • Liver/Kidney Conditions: Use with caution in patients with liver or kidney problems, and dose adjustments may be needed.
  • Medical History: Inform your doctor if you have active infections (viral, bacterial, fungal, tuberculosis), diabetes, hypertension, osteoporosis, glaucoma, cataracts, stomach ulcers, heart disease, or a weak immune system.
  • Interactions: Avoid grapefruit juice as it can increase the risk of side effects. Inform your doctor about all other medications, including antifungals (e.g., ketoconazole), antivirals (e.g., ritonavir), other corticosteroids, carbamazepine, cardiac glycosides, diuretics, estrogen-containing medications, cholestyramine, antacids, and cimetidine.
  • Driving and Operating Machinery: Avoid driving or operating machinery if you experience dizziness or weakness.
  • Children and Elderly: Generally not recommended for children under 12 years of age unless advised by a doctor. Older patients should be monitored due to increased susceptibility to side effects.

• Storage: Store Budez OD Tablet in a tightly closed container at room temperature, ideally below 25°C or between 10ºC to 25ºC or below 30ºC. Keep the medicine away from light, moisture, and out of reach of children. Always check the expiry date.

BUDEZ OD TABLET (15 TAB) by SUN PHARMA LABORATORIES LTD. contains budesonide, a corticosteroid primarily used to treat inflammatory bowel diseases.

What is BUDEZ OD Tablet used for?

BUDEZ OD Tablet is primarily used to manage active, mild to moderate ulcerative colitis, a chronic inflammatory bowel disease affecting the large intestine and rectum. It is also used to treat Crohn's disease and microscopic colitis, which are other types of inflammatory bowel diseases. Additionally, it may be used for eosinophilic esophagitis and to reduce protein in the urine for primary IgA nephropathy (IgAN).

How does BUDEZ OD Tablet work?

BUDEZ OD Tablet contains budesonide, a type of corticosteroid. It works by reducing inflammation in the intestines. It achieves this by suppressing the production of pro-inflammatory mediators and calming the body's overactive immune response within the digestive tract. This action helps to alleviate symptoms such as pain, swelling, irritation, and diarrhea.

What is the usual dosage for BUDEZ OD Tablet?

The typical dosage is 9 milligrams (mg) once a day, usually in the morning, for up to 8 weeks, as directed by your doctor. The tablet should be swallowed whole with a glass of water and not chewed, crushed, or broken. It can be taken with or without food. Always adhere to the prescribed dosage and do not exceed it without consulting your doctor.

What are the possible side effects of BUDEZ OD Tablet?

Common side effects may include headache, nausea, abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia (joint pain), and constipation. Other potential side effects include dizziness, sore throat, cough, hoarseness, and mood changes like depression or anxiety. More serious, though less common, side effects can involve signs of Cushing syndrome, low potassium levels, increased risk of infection, high blood sugar levels, decreased adrenal gland function, and bone loss with long-term, high-dose use. Most common side effects are temporary and often resolve as your body adjusts to the medication.

Is BUDEZ OD Tablet safe during pregnancy or breastfeeding?

Caution is advised during pregnancy. BUDEZ OD Tablet should only be used if your doctor deems it necessary, as it may potentially harm the unborn baby. If you are breastfeeding, it is generally considered unsafe as the drug may pass into breast milk and could harm the baby. It is crucial to consult your doctor to discuss the potential risks and benefits before taking this medication while pregnant or breastfeeding.

Can BUDEZ OD Tablet be taken with other medications?

BUDEZ OD Tablet can interact with various medications. It is important to inform your doctor about all prescription, over-the-counter, vitamin, and herbal supplements you are taking. Specific interactions include:

• CYP3A4 Inhibitors: Medicines like ketoconazole, itraconazole, ritonavir, clarithromycin, and certain antivirals can increase the systemic exposure to budesonide, potentially increasing side effects.
• Other Corticosteroids: Such as prednisolone or dexamethasone.
• Cardiac Glycosides: Like digoxin.
• Diuretics: Such as furosemide and hydrochlorothiazide.
• Medicines containing estrogens: Including hormone replacement therapy or birth control pills.
• Cholestyramine.
• Antacids.
• Cimetidine.
• Carbamazepine. Additionally, avoid consuming grapefruit juice as it can increase the risk of side effects.

What precautions should be taken while taking BUDEZ OD Tablet?

Before taking BUDEZ OD Tablet, inform your doctor if you have any allergies to the medicine or its ingredients, or if you have any active infections (viral, bacterial, fungal, or tuberculosis). Also, disclose any history of diabetes, high blood pressure, osteoporosis, glaucoma, cataracts, stomach ulcers, liver or kidney problems, or a weakened immune system. You should avoid alcohol consumption. Do not stop taking the medicine abruptly, as this can worsen your symptoms. If you experience dizziness, avoid driving or operating machinery.

What happens if a dose of BUDEZ OD Tablet is missed?

If you miss a dose of BUDEZ OD Tablet, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one, as this may increase the chances of side effects.

How should BUDEZ OD Tablet be stored?

BUDEZ OD Tablet should be stored in a tightly closed container at room temperature, ideally below 25°C or below 30°C. Keep the medicine away from light and moisture, and ensure it is out of the reach of children. Always check the expiry date and do not use the tablet after this date.