BUDEZ Enema 115ml

INTRODUCTION

BUDEZ contains Budesonide which belongs to theroup of medicines called Corticosteroids. It is used to treat ulcers and inflammation of the large intestine (distal ulcerative colitis).

Distal ulcerative colitis (also known as left-sided ulcerative colitis) is a type of ulcerative colitis characterized by inflammation of the innermost layers of the large intestines, colon, and the rectum. It typically originates in the rectum and extends up to descending colon and sigmoid colon (left part of the colon).

Budesonide is a steroid medication. It works by suppressing the release of certain chemical mediators in the body that causes inflammation and swelling. This reduces the inflammation of the digestive tract.

Before using BUDEZ inform your doctor if you have any problems in your liver or kidneys. You must also inform your doctor if you have diabetes, stomach ulcers, weak bones, mental illness, or any upcoming eye surgery.

BUDEZ is not recommended for use in patients with blockage or perforations in theut. It should be used in pregnant or breastfeeding women only if considered necessary by the physician. The most common side effects of using BUDEZ are depression, heart burn, stomach pain or diarrhea. Consult your doctor if any of these side effect worsens.

USES OF BUDEZ
Treats distal ulcerative colitis (inflammation of the rectum, sigmoid colon and descending colon)
HOW BUDEZ WORKS

BUDEZ controls inflammation of the bowel lining where budesonide acts by blocking the production of certain chemical mediators that causes inflammation of the digestive tract. As a result, it helps in the control of inflammatory bowel diseases affecting the colon, or the rectum.

DIRECTIONS FOR USE

Always use BUDEZ as directed by the physician. It is for rectal use only. Add the medicine in the enema bottle. Close the bottle and shake vigorously for 10-15 seconds until the medicine completely dissolves in the liquid present in the bottle.

Lie down on one side or in any comfortable position. Carefully insert the tip of the nozzle into the rectum.ently squeeze the bottle in such a way that it pushes most of the liquid into the back passage. However, you may not be able to empty the whole bottle. Push the liquid as far as your bowel can hold.

After administration, lie on your stomach and stay still for 5 minutes. This will prevent any liquid from coming back. Try to retain the enema in the bowel for the maximum hours possible as it can improve the healing of ulcers. To achieve this, your doctor willenerally prescribe BUDEZ during the nighttime. Continue to use BUDEZ as instructed by your doctor to achieve better results.

SIDE EFFECTS OF BUDEZ
COMMON
Feeling depressed
Nausea, flatulence, diarrhea, stomach pain, heartburn
UNCOMMON
Difficulty in sleeping
Feeling anxious, agitated, restless
Unintentional body movements with muscle spasms or twitching
Stomach or duodenal ulcer
RARE
Glaucoma (increased pressure in the eye)
Blurred or cloudy vision
Discoloration of the skin caused due to bleeding under the skin
Destruction of bone tissues
Inflamed pancreas (associated with pain in upper abdomen and back with nausea)

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

Severe allergic reactions (such as skin rash, itching, raised lumps on your skin, or swelling of the face, lips, mouth, tongue, or throat which may cause difficulty in breathing)
Blurred vision or any other visual changes
HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Hydrate yourself by drinking plenty of fluids, such as water or fruit juices. Consuming ORS can also be beneficial. Do not self-treat diarrhea on your own. Consult your doctor if your diarrhea becomes uncontrollable.

Blurred vision:

Close your eyes and relax. Do not strain your eyes by looking at mobile phones, laptops, or television. Avoid driving or operating any heavy tools or machines while your vision is blur. Consult your doctor if you experience blurred vision for a prolonged period.

WARNING & PRECAUTIONS
PREGNANCY

BUDEZ should be used in pregnant women only if considered necessary by the physician. Therefore, consult your doctor before using it.

BREASTFEEDING

BUDEZ should be used with caution in breastfeeding women. Therefore, consult your doctor before using it.

DRIVING AND USING MACHINES

BUDEZ is unlikely to affect your ability to drive or operate any heavy tools or machinery.

KIDNEY

BUDEZ should be used with caution in patients with kidney diseases. Therefore, consult your doctor before taking it.

LIVER

BUDEZ should be used with caution in patients who have or ever had any liver problems (such as liver cirrhosis). Therefore, consult your doctor before using it.

ALLERGY

Do not use BUDEZ if you are allergic to Budesonide.

OTHERS

BUDEZ is not recommended for use if you:

Have any bacterial, viral, or fungal infections in the body
Have active tuberculosis
Have any blockage or perforations in theastrointestinal tract
Have an abscess (pus) or wounds in theut
Recently had any surgery in theut

Before using BUDEZ, inform your physician if you:

Have ever hadlaucoma (increased pressure in the eye) or cataracts
Have diabetes
Have ever had brittle or weak bones (osteoporosis)
Had or have a stomach ulcer
Have any mental illness or have a family history of mental problems
Areoing to have diagnostic tests for pituitaryland
Have taken other corticosteroids within the past few days

Use in pediatrics:

BUDEZ is not recommended for use in children and in adolescents (below 18 years) due to lack of safety data. Therefore, consult your doctor before using it.

Use ineriatrics:

BUDEZ should be used with caution in elderly patients. Therefore, consult your doctor before using it.

INTERACTIONS

A. Drug-Drug Interaction:

Before using BUDEZ, inform your doctor if you are taking any of the following medicines such as:

Medicines used to treat fungal infections (Ex. ketoconazole, itraconazole, miconazole or fluconazole)
Other corticosteroids such as prednisolone or dexamethasone (used to treat inflammatory conditions)
Medicines containing estrogens such as hormone replacement therapy or birth control pills (Ex. ethinyl estradiol)
Erythromycin, troleandomycin (used to treat bacterial infection)
Ritonavir, cobicistat (used to treat HIV infection)
Cimetidine, omeprazole (used to neutralize stomach acid)
Cyclosporin (a medicine used to preventraft rejection)

Overdosage:

If you or anyone else accidentally used more BUDEZ, contact your doctor for advice.

SYNOPSIS
Drug :

Budesonide

Pharmacological Category :

Corticosteroids

Therapeutic Indication :   Distal Ulcerative colitis
Dosage Forms :   Tablet, Capsule, Enema, Respules, Plumules, Smartules, Rotacaps, Resicap, Nasal spray, Inhaler
MORE INFORMATION
Keep BUDEZ out of reach from children
Store BUDEZ at room temperature
FAQs ABOUT BUDEZ

Can I stop using BUDEZ once my symptoms subside?

No. Do not stop using BUDEZ without consulting your doctor. Continue to use BUDEZ for the stipulated duration mentioned by your doctor, although if your symptom subsides.

Can BUDEZ be used to treat stomach ulcer?

No. BUDEZ is only used to treat distal ulcerative colitis affecting the left side of the colon (such as sigmoid colon, descending colon) and the rectum. It should be used with caution in patients having stomach ulcers. Therefore, consult your doctor before using BUDEZ as a precaution.

Can BUDEZ be used in children?

BUDEZ is not recommended for use in children and adolescents (below 18 years). However, consult your doctor before using it.

Is BUDEZ safe for use in patients with diabetes?

BUDEZ should be used with caution in diabetic patients and in patients who has a family history of diabetes, because BUDEZ may increase the blood sugar levels. Your doctor may regularly monitor your blood sugar levels and eye pressure while using BUDEZ to avoid the risk of unwanted side effects. However, if you experience any unusual symptoms such as blurred vision or excessive urination, thirst, or hunger, after using BUDEZ consult your doctor for advice.

Can BUDEZ cause bone loss?

BUDEZ may rarely decrease bone density and may cause bone fracture. It happens particularly if taken at higher doses. Take BUDEZ as advised by your physician to avoid unwanted bone related side effects.

Can the use of BUDEZ weaken your immune system?

Yes. BUDEZ may suppress or weaken your immune system. To protect yourself against serious infections, avoid contact with people who have contagious infections like chickenpox or measles while using BUDEZ, as there are increased chances for you toet infected.

What kind of medications must be avoided while using BUDEZ?

While taking BUDEZ, avoid taking medicines that can further decrease your immune functions such as immunosuppressants (Ex. ciclosporin or tacrolimus). As you may already have a weak immune system, it may further reduce your immune functions and make you more prone to infections. Also, consult your doctor if you are taking any antibiotics (Ex. erythromycin), anti-viral (Ex. ritonavir, cobicistat) or anti-fungal medicines (Ex. ketoconazole, miconazole) as a precaution.

How long should I take BUDEZ?

BUDEZ should be used as recommended by the physician. Your doctor will usually prescribe BUDEZ for at least 4 weeks. However, the therapy canet extended until 8 weeks if required. Therefore, continue to use BUDEZ for the stipulated duration mentioned by your doctor to achieve better results.

Can BUDEZ cause psychological problems?

BUDEZ may make you feel sad or depressed. Consult your doctor for advice if you experience such symptoms.

Is it safe to drive a vehicle after taking BUDEZ?

BUDEZ is unlikely to affect your ability to drive or operate any machinery. However, if you experience any abnormal symptoms that can affect your ability to drive or operate heavy tools after using BUDEZ, consult your doctor.

Is BUDEZ safe for use in patients with cataracts?

BUDEZ should be used with caution in patients with cataract in the eye, as it may worsen the existing condition of your eye. Therefore, consult your doctor for advice before using.

What if I forgot to take a dose of BUDEZ?

If you forget to take a dose of BUDEZ take it as soon as you remember. However, if it is time for the next dose of BUDEZ, skip the missed dose and take the next one at the regular time. Do not take a double dose of BUDEZ to compensate the missed dose.

What are the common side effects of BUDEZ?

The most common side effects of using BUDEZ are depression, heart burn, stomach pain, flatulence, or diarrhea. Consult your doctor if any of these side effect worsens.

How to use BUDEZ?

BUDEZ is for rectal use only. Dissolve the medicine completely in the liquid present in the enema bottle before administration. Lie down on one side or in any comfortable position. Carefully insert the tip of the nozzle into the rectum.ently squeeze the bottle in such a way that it pushes most of the liquid into the back passage. However, you may not be able to empty the whole bottle. Push the liquid as far as your bowel can hold. After administration, lie on your stomach and stay still for 5 minutes.

REFERENCES

1. K.D. Tripathi. Drugs for cough and bronchial asthma. Essentials of medical pharmacology. 8th Edition. 2019. Page – 250-251.

2. Makoto Naganuma, Nobuo Aoyama, Yasuo Suzuki, Haruo Nishino, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, and Toshifumi Hibi. Twice-daily Budesonide 2-mg Foam Induces Complete Mucosal Healing in Patients with Distal Ulcerative Colitis. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC PubMed Central. July 2016. [Accessed on 27th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955911/

3. Abhijit A. Date,ilad Halpert, Taarika Babu, Jairo Ortiz, Pranjali Kanvinde, Peter Dimitrion, Janani Narayan, Hannah Zierden, Kalpana Betageri, Olivia Musmanno, Helen Wiegand, Xinglu Huang, Sanjeevumber, Justin Hanes, and Laura M. Ensign. Mucus-penetrating budesonide nanosuspension enema for local treatment of inflammatory bowel disease. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC PubMed Central. December 2018. [Accessed on 28th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6193453/

4. Tillotts Pharma UK Limited. Electronic Medicines Compendium (EMC). [Revised in November 2020] [Accessed on 27th May 2022] https://www.medicines.org.uk/emc/files/pil.873.pdf

5. Tillotts PharmambH. Budesonide enema 0.02 mg/ml. [Revised in February 2018] [Accessed on 27th May 2022] https://pdf.hres.ca/dpd_pm/00044077.PDF

PRODUCT DETAILS
Net Qty
1 N
Item Weight
25
Ingredient
BUDESONIDE 2.3 MG
Hsn Code
30049099
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