Entocort Enema (Budesonide Enema)

Prescription medicineOnly Available By Prescription

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Strength Pack Size Qty
Strength
2mg/115ml
Pack Size
Qty
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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

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Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Entocort Enema is a medicine used to treat active ulcerative colitis in the lower part of the large intestine, including the rectum, sigmoid colon, and descending colon. It is given as an enema, which is placed directly against the inflamed bowel lining. Its active ingredient, budesonide, is a corticosteroid that reduces inflammation. Most of the medicine is broken down by the liver before it can circulate through the rest of the body, reducing the risk of steroid-related effects elsewhere. Each kit contains a 2.3 mg tablet and a 115 mL bottle of liquid that are mixed to make one 2 mg enema. Packs contain seven doses.

Fact Table

Formula

C25H34O6

License

Health Canada (DIN 02052431)

Bioavailability

15 ± 12% systemic availability after rectal administration

Legal status

Rx only

Chemical Name

11ß,21-Dihydroxy-16a,17a-[butane-1,1-diylbis(oxy)]pregna-1,4-diene-3,20-dione (Budesonide)

Elimination half-life

2–3 hours in adults

Dosage (Strength)

0.02mg/mL (2mg/100mL) after reconstitution; 2.3mg dispersible tablet with 115mL solution; one enema nightly for 4 weeks, may be extended to 8 weeks if necessary

Pregnancy

Use during pregnancy only when the benefit to the mother outweighs the potential risk to the fetus

Brands

Entocort Enema, Entocort, Budenofalk, Uceris, Pulmicort, Rhinocort

Protein binding

88%

PubChem CID

5281004

MedlinePlus

a608007

ChEBI

3207

ATC code

A07EA06

DrugBank

DB01222

KEGG

D00246

Routes of administration

Rectal

Directions

Prepare the enema just before use. Put one dissolvable tablet into the bottle and shake firmly for at least 15 seconds until it has fully dissolved. The liquid will turn slightly yellow when it is ready.

Use one enema each night at bedtime for four weeks. Your prescriber may extend treatment to eight weeks if needed. If possible, empty your bowels first, lie on your left side, insert the nozzle, and squeeze the bottle until empty. Remain lying down afterward to help keep the medicine in place. If you miss a dose, skip it and use the next dose as scheduled. Do not use two doses at once.

Ingredients

The active ingredient in Entocort Enema is budesonide. The dispersible tablet contains crospovidone, lactose, anhydrous lactose, magnesium stearate, riboflavin-5-phosphate sodium, and silicon dioxide. The liquid vehicle contains methylparaben, propylparaben, sodium chloride, and purified water.

Cautions

  • Before using this medication, you may want to consult a healthcare provider about the following:
    • Any existing health conditions
    • Any allergies
    • A list of all medications currently being taken
  • Tell your healthcare provider if you are coming off steroid tablets such as prednisone. The previous steroid dosage has to be decreased slowly, since switching too fast can leave your adrenal glands unable to respond.
  • Watch for signs of infection and report them, since steroids can mask the usual symptoms.
  • Avoid exposure to chickenpox or measles if you have never had them or are not vaccinated, and call your healthcare provider the same day if you are exposed.
  • Consult a healthcare provider if you have liver cirrhosis or an underactive thyroid, since either condition can increase how much budesonide lingers in your system.
  • Have your eyes examined if your vision blurs or changes, and ask about a referral to an eye specialist, since corticosteroids can bring on cataracts and glaucoma.
  • Skip grapefruit juice, and tell your pharmacist about ketoconazole, itraconazole, clarithromycin, ritonavir, or anything similar, since these slow budesonide’s breakdown and can increase its levels.
  • Budesonide crosses the placenta, so treatment during pregnancy should be avoided unless there is a compelling reason. Consult a healthcare provider about breastfeeding.
  • Report trouble sleeping, agitation, anxiety, or low mood, all of which can surface on corticosteroids.
  • Use this product rectally only, and never swallow it.

Contraindications

Avoid taking or using this medication if any of the following apply:

  • A potential bowel perforation, obstruction, abscess, or other pus-forming infection
  • Fresh surgical joins in the intestine, extensive fistulas, or sinus tracts
  • A bacterial, fungal, or viral infection, whether local or throughout the body
  • Hypersensitivity to budesonide or to any other ingredient in the tablet, the vehicle, or the container

Side Effects

Common side effects of Entocort Enema include:

  • Gas
  • Nausea
  • Diarrhea
  • Abdominal discomfort
  • Trouble sleeping, or drowsiness
  • Agitation, anxiety, or low mood
  • Rash, or red spots that burn, itch, or sting

Stop the enema and get emergency help if hives spread, your face or throat swells, or you have trouble breathing. Call your healthcare provider the same day about a fever, chills, or any other hint of infection. Report abdominal pain that worsens, a swollen, tender belly, or bleeding, since those can mean the colitis is worsening. Let your healthcare provider know about unusual tiredness, dizziness when you stand, or weakness, especially after a long course or a switch from oral steroid tablets.

References

Entocort Enema Product Monograph. Rheinfelden, Germany: Tillotts Pharma GmbH; 2023.

Entocort Enema Product Monograph. Burlington, ON: C.R.I.; 2021.




IMPORTANT NOTE: The information provided above is for general awareness and educational purposes only. It is not intended to diagnose, treat, or replace professional medical or veterinary advice. Always consult your physician, pharmacist, or veterinarian regarding the safety, suitability, and proper use of any medication for yourself or your pet.

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