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INTRODUCTION
BUDEZ CR contains Budesonide which belongs to the group of medicines called Corticosteroids. It is used to treat 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 the rectum. It typically originates in the rectum and large intestine and can spread to colon if left untreated. 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). The inflammation can be detected only under a microscope and 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 lower part of small intestines or the entire digestive tract.
Budesonide is a steroid medication which works by suppressing the release of certain chemical mediators in the body that causes inflammation and swelling.
Before taking BUDEZ CR, 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 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 as a precaution. BUDEZ CR should be used in pregnant or breastfeeding women only if prescribed by the physician. BUDEZ CR 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 infections. Other most common side effects of taking BUDEZ CR are headache, stomach pain, muscle pain and depression. Consult your doctor if any of the symptom bothers you.
USES OF BUDEZ CR
- Treats Ulcerative colitis, Crohn’s disease and Microscopic colitis
HOW BUDEZ CR WORKS
BUDEZ CR controls inflammation of the bowel lining where budesonide acts by blocking the production of certain chemical mediators which 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 the rectum.
DIRECTIONS FOR USE
Always take BUDEZ CR 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 without consulting your doctor as sudden withdrawal of the therapy may make you feel ill.
SIDE EFFECTS OF BUDEZ CR
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 in 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 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
Nausea:
Take BUDEZ CR with, or just after meals. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom worsens.
Headache:
Take rest and get adequate sleep. Apply a pain-relieving balm on the forehead if required. Consult your doctor if the symptom worsens.
Skin rash:
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 symptom worsens.
Dizziness:
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 symptom worsens.
WARNING & PRECAUTIONS
PREGNANCY
BUDEZ CR 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.
BREASTFEEDING
It is not known whether BUDEZ CR can pass through breast milk and affect the breastfeeding infant. Therefore, consult your doctor before taking.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy or weak after taking BUDEZ CR.
KIDNEY
BUDEZ CR should be taken with caution in patients with kidney problems. Consult your doctor for advice before taking.
LIVER
BUDEZ CR should be used with caution in patients who ever had any liver problems. Consult your doctor for advice before taking.
ALLERGY
Do not take BUDEZ CR if you are allergic to Budesonide.
HEART DISEASE
BUDEZ CR should be used with caution in patients who have ever had high blood pressure. Kindly consult your doctor for advice before taking.
OTHERS
Before taking BUDEZ CR, inform your physician if you:
- have any type of bacterial, fungal, or viral infections
- 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 grey cataract
- are previously treated with any strong corticosteroid or suddenly shifted from another corticosteroid therapy (Ex. prednisone) to BUDEZ CR
- are schedule for any vaccination
- are scheduled for any upcoming surgery or any other form of procedures that can cause physical stress
- have any mental problems or a family history of mental illnesses
Use in pediatrics:
- BUDEZ CR is not recommended for use in children and adolescents (below 18 years). Consult your doctor for advice before taking.
Use in geriatrics:
- BUDEZ CR should be used with caution in elderly patients. Consult your doctor for advice before taking.
INTERACTIONS
A. Drug-Drug interactions:
Before taking BUDEZ CR, inform your doctor if you are taking any of the following:
- medicines used to treat fungal infections (Ex. ketoconazole or itraconazole)
- medicines used to treat viral infections (Ex. ritonavir, nelfinavir, cobicistat-containing dose regimen)
- other corticosteroids such as prednisolone or dexamethasone (used to treat inflammatory conditions)
- carbamazepine (used to treat epilepsy)
- cardiac glycosides (used to treat 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 treat stomach ulcers)
B. Drug-Food interaction:
Avoid drinking grapefruit juice while taking BUDEZ CR as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more of BUDEZ CR, 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
- Keep BUDEZ CR out of reach from children
- Store at room temperature
FAQs ABOUT BUDEZ CR
Can I stop taking BUDEZ CR once my symptoms subside?
No. Do not stop taking BUDEZ CR without consulting your doctor as sudden withdrawal of the therapy may make you feel ill. Continue to take BUDEZ CR although if the symptom subsides. Your doctor will carefully reduce the dose according to your condition before completely stopping the medication.
Can BUDEZ CR be used to treat stomach ulcer?
No. BUDEZ CR is only used to treat inflammatory bowel conditions like Ulcerative colitis, microscopic colitis, and Crohn’s disease. Consult your doctor before taking BUDEZ CR if you have stomach ulcers.
Can BUDEZ CR be used in children?
BUDEZ CR is not recommended for use in children and adolescents (below 18 years). Consult your doctor before taking.
Is BUDEZ CR safe for use in patients with diabetes?
BUDEZ CR should be used with caution in diabetic patients or among patients who has a family history of diabetes, because BUDEZ CR 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.
Can BUDEZ CR cause bone loss?
BUDEZ CR can decrease bone density and cause bone fracture. It happens particularly of taken at higher doses. Take BUDEZ CR as advised by your physician to avoid unwanted bone related side effects.
Can the use of BUDEZ CR weaken your immune system?
Yes. BUDEZ CR can suppress or weakens your immune system. Avoid contact with people who have contagious infections like chickenpox or measles while taking BUDEZ CR, as there are increased chances for you to get infected.
Is BUDEZ CR safe for use in patients taking immune suppressant medicine?
BUDEZ CR 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 (such as chickenpox, measles etc.), bacterial (tuberculosis etc.), parasitic or fungal infections.
How long should I take BUDEZ CR?
BUDEZ CR 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.
Can BUDEZ CR cause dizziness?
Dizziness is one of the most common side effects of taking BUDEZ CR. 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. Consult your doctor immediately if the symptom worsens or persists.
Can BUDEZ CR cause psychological problems?
BUDEZ CR 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.
Is it safe to drive a vehicle after taking BUDEZ CR?
Do not drive or operate any tools/machines if you are feeling dizzy, severe tiredness or body weakness after taking BUDEZ CR, Dizziness is one of the most common side effects of taking BUDEZ CR. Try to rest and relax. Get enough sleep. If the symptoms worsen or persist consult your doctor immediately.
Is BUDEZ CR safe for use in patients with cataracts?
BUDEZ CR should be used with caution in patients with cataract in the eye, as this medicine may worsen the existing condition of the eye. Consult your doctor for advice.
What if I forgot to take a dose of BUDEZ CR?
If you forget to take a dose of BUDEZ CR 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 Treatment of Ulcerative Colitis: Current Perspectives on Efficacy and Safety. April 2021. [Accessed on 26th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8039041/
4. Ferring Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2020] [Accessed on 26th May 2022] https://www.medicines.org.uk/emc/files/pil.1895.pdf
5. AstraZeneca. Electronic Medicines Compendium (EMC). [Revised in October 2019] [Accessed on 26th May 2022] 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 26th May 2022] https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5868e960-73ca-4219-b122-11893dedfdcf&type=display#section-9
PRODUCT DETAILS
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