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Budez CR Capsule 10'S

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    Introduction About BUDEZ CR CAPSULE

    BUDEZ CR CAPSULE contains Budesonide, which belongs to the group of medicines called Corticosteroids. It is used to manage ulcerative colitis, Crohn’s disease, and microscopic colitis. Ulcerative colitis is an inflammatory bowel disease characterized by inflammation of the innermost layers of the large intestines, colon, and rectum. It typically originates in the rectum and large intestine and can spread to the colon if left unmanaged. Microscopic colitis is a type of chronic inflammatory bowel disease that affects the large intestine. Unlike ulcerative colitis, it cannot be diagnosed using any normal diagnostic techniques (like colonoscopy). Inflammation can be detected only under a microscope, hence the name microscopic colitis. It is characterized by chronic watery diarrhea with rectal bleeding, stomach pain, weight loss, and anemia. Crohn’s disease is also a bowel disease characterized by inflammation of the lower part of the small intestines or the entire digestive tract.

    Budesonide is a steroid medication that works by suppressing the release of certain chemical mediators in the body that cause inflammation and swelling.

    Before taking BUDEZ CR CAPSULE, inform your doctor if you have stomach ulcers, any forms of infections, or if you are about to receive any vaccination. Avoid drinking grapefruit juice while taking BUDEZ CR CAPSULE, as it can increase the risk of side effects. It is important to inform your doctor about the previous use of potent corticosteroids (like prednisone or prednisolone) before taking BUDEZ CR CAPSULE as a precaution. BUDEZ CR CAPSULE should be used in pregnant or breastfeeding women only if prescribed by the physician. BUDEZ CR CAPSULE works by suppressing the immune system, and therefore it may increase the risk of infections. Consult your doctor immediately if you experience any signs of infection. Other most common side effects of taking BUDEZ CR CAPSULE are headache, stomach pain, muscle pain, and depression. Consult your doctor if any of the symptoms bother you.

    Uses Of BUDEZ CR CAPSULE

    • Manages ulcerative colitis, Crohn’s disease, and microscopic colitis

    How BUDEZ CR CAPSULE Works

    BUDEZ CR CAPSULE controls inflammation of the bowel lining, where budesonide acts by blocking the production of certain chemical mediators that are involved in causing inflammation of the digestive tract. As a result, it helps in the control and maintenance of inflammatory bowel diseases affecting the large intestine, colon, and rectum.

    How to use BUDEZ CR CAPSULE

    Always take BUDEZ CR CAPSULE as directed by your physician. Swallow the medicine with a glass of water and do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending on your age, body weight, and disease condition. Do not stop taking BUDEZ CR CAPSULE without consulting your doctor, as sudden withdrawal of the therapy may make you feel ill.

    Side Effects Of BUDEZ CR CAPSULE

    Common

    • signs of Cushing syndrome (such as a weight gain, round face, acne, increased bruising tendency)
    • signs of low potassium levels in the blood (such as muscle weakness or fatigue, thirst, or a tingling sensation)
    • feeling nervous, difficulty sleeping
    • mood swings
    • feeling depressed
    • headache
    • rapid heartbeat
    • nausea, stomach pain, bloating, indigestion
    • dry mouth
    • skin rash or itching
    • acne
    • muscle pain or cramps
    • heavy or irregular menstrual periods
    • feeling extremely tired

    Uncommon

    • flu-like symptoms
    • restlessness, anxiety
    • feeling dizzy or shaky
    • back pain
    • swelling of the legs

    Rare

    • glaucoma (increased pressure in the eye)
    • blurred vision, cataract
    • purple or bluish black spots on the skin

    Stop taking BUDEZ CR CAPSULE and contact your doctor immediately if you experience any of the following side effects:

    • signs of severe allergic reactions (such as skin rash, itching, swelling of the face, lips, mouth, tongue, and throat, which causes difficulty in breathing)
    • severe depression, being violent, and having suicidal thoughts
    • blurred vision or any other visual changes

    How To Manage Side Effects

    Dizziness Or Drowsiness

    Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines while you are feeling dizzy. Consult your doctor if the dizziness worsens.

    Headache

    Take a rest and get adequate sleep. Apply a pain-relieving balm on the forehead if required. Consult your doctor if the headache worsens.

    Nausea And Vomiting

    Take BUDEZ CR CAPSULE with, or just after meals. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the nausea persists.

    Skin rash Or Itching

    Avoid hot showers because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing while going outdoors. Regularly moisturize your skin. Consult your doctor if the skin rash worsens.

    Warning & Precautions

    Pregnancy

    Monitoring required

    BUDEZ CR CAPSULE should be used in pregnant women only if it is considered necessary by your doctor, as it may harm the unborn baby. Inform your doctor immediately if you become pregnant or think you may be pregnant while taking BUDEZ CR CAPSULE.

    Breastfeeding

    Consult your doctor

    It is not known whether BUDEZ CR CAPSULE can pass through breast milk and affect the breastfeeding infant. Therefore, consult your doctor before taking it.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate any machines if you feel dizzy or weak after taking BUDEZ CR CAPSULE.

    Kidney

    Use with Caution

    BUDEZ CR CAPSULE should be taken with caution in patients with kidney problems. Consult your doctor for advice before taking it.

    Liver

    Use with Caution

    BUDEZ CR CAPSULE should be used with caution in patients suffering from liver function impairment or active liver diseases. Consult your doctor for advice.

    Allergy

    Contraindicated

    Do not take BUDEZ CR CAPSULE if you are allergic to Budesonide.

    Heart Disease

    Use with Caution

    BUDEZ CR CAPSULE should be used with caution in patients who have ever had high blood pressure. Kindly consult your doctor for advice before taking it.

    Use In Pediatrics

    Contraindicated

    BUDEZ CR CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor for advice before taking it.

    Use In Geriatrics

    Use with Caution

    BUDEZ CR CAPSULE should be used with caution in elderly patients. Consult your doctor for advice before taking it.

    Others

    Before taking BUDEZ CR CAPSULE, inform your physician if you:

    • have any type of bacterial, fungal, or viral infection
    • have diabetes
    • had weak or brittle bones (osteoporosis)
    • ever had a stomach ulcer in the past
    • ever had glaucoma (increased pressure in the eye) or gray cataract
    • are previously managed with any strong corticosteroid or suddenly shifted from another corticosteroid therapy (Ex. prednisone) to BUDEZ CR CAPSULE
    • are scheduled for any vaccination
    • are scheduled for any upcoming surgery or any other form of procedure that can cause physical stress
    • have any mental problems or a family history of mental illnesses

    Interactions

    A. Drug-Drug interactions:

    Before taking BUDEZ CR CAPSULE, inform your doctor if you are taking any of the following:

    • medicines used to manage fungal infections (Ex. ketoconazole or itraconazole)
    • medicines used to manage viral infections (Ex. ritonavir, nelfinavir, cobicistat-containing dose regimen)
    • other corticosteroids such as prednisolone or dexamethasone (used to manage inflammatory conditions)
    • carbamazepine (used to manage epilepsy)
    • cardiac glycosides (used to manage abnormal heart rhythm) Ex. digoxin
    • diuretics (used to increase urine output and to reduce blood pressure) Ex. furosemide, hydrochlorothiazide
    • medicines containing estrogens, such as hormone replacement therapy or birth control pills (Ex. ethinyl estradiol)
    • cholestyramine (a medicine used to reduce blood cholesterol levels)
    • antacids (used to neutralize stomach acids) Ex. aluminum hydroxide, magnesium hydroxide, simethicone
    • cimetidine (used to manage stomach ulcers)

    B. Drug-Food interaction:

    Avoid drinking grapefruit juice while taking BUDEZ CR CAPSULE, as it may increase the risk of side effects.

    Overdosage:

    If you or anyone else accidentally took more of BUDEZ CR CAPSULE, contact your doctor immediately or go to a hospital straight away.

    Synopsis

    Drug :   Budesonide
    Pharmacological Category :   Corticosteroids
    Therapeutic Indication :   Ulcerative colitis, microscopic colitis, Crohn’s disease
    Dosage Forms :   Tablet, Capsule, Enema, Respules, Plumules, Smartules, Rotacaps, Resicap, Nasal Spray, Inhaler

    More Information

    Storage

    • Keep BUDEZ CR CAPSULE out of reach of children
    • Store at room temperature

    FAQs About BUDEZ CR CAPSULE

    Q: Can I stop taking BUDEZ CR CAPSULE once my symptoms subside?

    A: No. Do not stop taking BUDEZ CR CAPSULE without consulting your doctor, as sudden withdrawal of the therapy may make you feel ill. Continue to take BUDEZ CR CAPSULE although the symptom subsides. Your doctor will carefully reduce the dose according to your condition before completely stopping the medication.

    Q: Can BUDEZ CR CAPSULE be used to manage stomach ulcers?

    A: No. BUDEZ CR CAPSULE is only used to manage inflammatory bowel conditions like ulcerative colitis, microscopic colitis, and Crohn’s disease. Consult your doctor before taking BUDEZ CR CAPSULE if you have stomach ulcers.

    Q: Can BUDEZ CR CAPSULE be used in children?

    A: BUDEZ CR CAPSULE is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking it.

    Q: Is BUDEZ CR CAPSULE safe for use in patients with diabetes?

    A: BUDEZ CR CAPSULE should be used with caution in diabetic patients or among patients who have a family history of diabetes, because BUDEZ CR CAPSULE can increase the blood sugar level. Your doctor may also advise regular monitoring of your blood sugar level and eye pressure. Consult your doctor for advice.

    Q: Can BUDEZ CR CAPSULE cause bone loss?

    A: BUDEZ CR CAPSULE can decrease bone density and cause bone fracture. It happens particularly if taken at higher doses. Take BUDEZ CR CAPSULE as advised by your physician to avoid unwanted bone-related side effects.

    Q: Can the use of BUDEZ CR CAPSULE weaken your immune system?

    A: Yes. BUDEZ CR CAPSULE can suppress or weaken your immune system. Avoid contact with people who have contagious infections like chickenpox or measles while taking BUDEZ CR CAPSULE, as there are increased chances for you to get infected.

    Q: Is BUDEZ CR CAPSULE safe for use in patients taking immune suppressant medicine?

    A: BUDEZ CR CAPSULE should be used with caution in patients taking immune suppressant medicines (Ex. tacrolimus). As the immune system is already compromised in these patients, they are more prone to viral diseases (such as chickenpox, measles, etc.), bacterial (tuberculosis, etc.), parasitic, or fungal infections.

    Q: How long should I take BUDEZ CR CAPSULE?

    A: BUDEZ CR CAPSULE should be used as recommended by your doctor. Your doctor will decide the dose, duration, and frequency of therapy for use depending upon your age, body weight, and disease condition.

    Q: Can BUDEZ CR CAPSULE cause dizziness?

    A: Dizziness is one of the most common side effects of taking BUDEZ CR CAPSULE. Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines if you are feeling dizzy after taking BUDEZ CR CAPSULE. Consult your doctor immediately if the symptom worsens or persists.

    Q: Can BUDEZ CR CAPSULE cause psychological problems?

    A: BUDEZ CR CAPSULE can cause side effects like psychological problems such as altered behavior, nervousness, mood swings, being violent, depression or suicidal thoughts or behavior, etc. Consult your doctor immediately when the symptoms occur or worsen.

    Q: Is it safe to drive a vehicle after taking BUDEZ CR CAPSULE?

    A: Do not drive or operate any tools or machines if you are feeling dizzy, severe tiredness, or body weakness after taking BUDEZ CR CAPSULE. Dizziness is one of the most common side effects of taking BUDEZ CR CAPSULE. Try to rest and relax. Get enough sleep. If the symptoms worsen or persist, consult your doctor immediately.

    Q: Is BUDEZ CR CAPSULE safe for use in patients with cataracts?

    A: BUDEZ CR CAPSULE should be used with caution in patients with cataracts in the eye, as this medicine may worsen the existing condition of the eye. Consult your doctor for advice.

    Q: What if I forgot to take a dose of BUDEZ CR CAPSULE?

    A: If you forget to take a dose of BUDEZ CR CAPSULE, take it as soon as you remember. However, skip the missing dose if it’s time for the next dose. Do not take a double dose to make up for a missed dose.

    References

    1. KD. Tripathi. Drugs for cough and bronchial asthma. Essentials of Medical Pharmacology. 8th Edition. 2019. Page – 250-251.

    2. Laurence Brunton, Bruce Chabner, Bjorn Knollman. Pharmacotherapy of inflammatory bowel diseases. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th Edition. 2006. Page- 1356- 1358.

    3. Giovanni Maconi, Deborah Camatta, Rosanna Cannatelli, Francesca Ferretti, Anna Carvalhas Gabrielli, and Sandro Ardizzone. National Library of Medicine (NIH). Budesonide MMX in the Management of Ulcerative Colitis: Current Perspectives on Efficacy and Safety. April 2021. [Accessed on 21st August 2024] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8039041/

    4. Ferring Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 21st August 2024] https://www.medicines.org.uk/emc/files/pil.1895.pdf

    5. AstraZeneca. Electronic Medicines Compendium (EMC). [Revised in October 2019] [Accessed on 21st August 2024] https://www.medicines.org.uk/emc/files/pil.872.pdf

    6. Golden State Medical Supply, Inc., National Library of Medicine, DailyMed. BUDESONIDE- budesonide capsule, delayed-release. [Revised in December 2021] [Accessed on 21st August 2024] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5868e960-73ca-4219-b122-11893dedfdcf&type=display#section-9

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    Author Details

    Written By Dr. N. Sai Swaroop - Pharm.D
    Reviewed For Accuracy By Dr. Rajnikant - MBBS, MD (Physiology)
    Last updated on 26 Aug 2024 | 12:17 PM(IST)
    Lab updated