Budesonide (Page 5 of 6)

15 REFERENCES

1. Best WR, Becktel JM, Singleton JW, Kern F: Development of a Crohn’s Disease Activity Index, National Cooperative Crohn’s Disease Study. Gastroenterology 1976; 70(3): 439-444.

16 HOW SUPPLIED/STORAGE AND HANDLING

BUDESONIDE Capsules, 3 mg are hard gelatin capsules size “0” light grey opaque body and pink opaque cap imprinted with black ink “AC” on Cap and “520” on body filled with white to off white Pellets. BUDESONIDE Capsules, 3 mg are supplied as follows:

NDC 64980-255-01 Bottles of 100

Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP Controlled Room Temperature].

Keep container tightly closed.

17 PATIENT COUNSELING INFORMATION

Advise Patients to read the FDA-Approved patient labeling (Patient Information).

Hypercorticism and Adrenal Axis Suppression

Advise patients that BUDESONIDE Capsules may cause hypercorticism and adrenal axis suppression and to follow a taper schedule, as instructed by their healthcare provider if transferring to BUDESONIDE Capsules from systemic corticosteroids [see Warnings and Precautions (5.1),(5.2)]. Advise patients that replacement of systemic corticosteroids with BUDESONIDE Capsules may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.

Increased Risk of Infection

Advise patients to avoid exposure to people with chicken pox or measles and, if exposed, to consult their healthcare provider immediately. Inform patients that they are at increased risk of developing a variety of infections; including worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections or ocular herpes simplex and to contact their healthcare provider if they develop any symptoms of infection [see Warnings and Precautions (5.3)].

Pregnancy

Advise female patients that BUDESONIDE Capsules may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Administration

Advise patients to:

  • Take BUDESONIDE Capsules once daily in the morning.
  • Swallow BUDESONIDE Capsules whole. Do not chew or crush.
  • Avoid consumption of grapefruit juice for the duration of their BUDESONIDE Capsules therapy [see Drug Interactions (7.1)].

ENTOCORT is a registered trademark of the Elan Pharma International Limited, a Perrigo Company.

Manufactured By:
Appco Pharma LLC
Piscataway, New Jersey 08854
Distributed By:
Rising Pharmaceuticals, Inc.
Saddle Brook, New Jersey 07633
Revised: 07/2018
200300

Patient Information

BUDESONIDE Capsules
(bue-DES-oh-nide kæpˌsjul)

Read this Patient Information before you start taking Budesonide Capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is BUDESONIDE Capsules?

BUDESONIDE Capsules, is a prescription corticosteroid medicine used to treat mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):

  • in people with active Crohn’s disease
  • in adults to help keep symptoms from coming back for up to 3 months

It is not known if Budesonide Capsules is safe and effective in children under 8 years of age

Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Who should not take BUDESONIDE Capsules?
Do not take BUDESONIDE Capsules, if:

  • You are allergic to budesonide or any of the ingredients in BUDESONIDE Capsules. See the end of this leaflet for a complete list of ingredients in BUDESONIDE Capsules.

What should I tell my healthcare provider before taking BUDESONIDE Capsules?
Before you take BUDESONIDE Capsules, tells your healthcare provider if you:

  • have liver problems
  • are planning to have surgery
  • have chicken pox or measles or have recently been near anyone with chicken pox or measles
  • have an infection
  • have diabetes or glaucoma or have a family history of diabetes or glaucoma
  • have cataracts
  • have or had tuberculosis
  • have high blood pressure (hypertension)
  • have decreased bone mineral density (osteoporosis)
  • have stomach ulcers
  • have any other medical condition
  • are pregnant or plan to become pregnant. BUDESONIDE Capsules may harm your unborn baby. Talk to your healthcare provider about the possible risk to your unborn baby if you take BUDESONIDE Capsules when you are pregnant. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during your treatment with BUDESONIDE Capsules.
  • are breastfeeding or plan to breastfeed. It is not known if BUDESONIDE Capsules passes into your breast milk or if it will affect your baby. Talk to your healthcare provider about the best way to feed your baby if you take BUDESONIDE Capsules.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. BUDESONIDE Capsules and other medicines may affect each other causing side effects.

How should I take BUDESONIDE Capsules?

  • Take BUDESONIDE Capsules exactly as your healthcare provider tells you.
  • Your healthcare provider will tell you how many BUDESONIDE Capsules to take. Your healthcare provider may change your dose if needed.
  • Take BUDESONIDE Capsules 1 time each day in the morning.
  • Take BUDESONIDE Capsules whole. Do not chew or crush BUDESONIDE Capsules before swallowing.
  • If you take too much BUDESONIDE Capsules call your healthcare provider right away or go to the nearest hospital emergency room.

What should I avoid while taking BUDESONIDE Capsules?

  • Do not drink grapefruit juice during your treatment with BUDESONIDE Capsules. Drinking grapefruit juice can increase the level of BUDESONIDE in your blood.

What are the possible side effects of BUDESONIDE Capsules?
BUDESONIDE Capsules may cause serious side effects, including:

  • Effects of having too much corticosteroid medicine in your blood (hypercorticism). Long-time use of BUDESONIDE Capsules can cause you to have too much corticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:
    • acne
    • bruise easily
    • rounding of your face (moon face)
    • ankle swelling
    • thicker or more hair on your body and face
    • a fatty pad or hump between your shoulders (buffalo hump)
    • pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms
  • Adrenal suppression. When BUDESONIDE Capsules, is taken for a long period of time (chronic use), adrenal suppression can happen. This is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal suppression include: tiredness, weakness, nausea and vomiting and low blood pressure. Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with BUDESONIDE Capsules.
  • Worsening of allergies. If you take certain other corticosteroid medicines to treat allergies, switching to BUDESONIDE Capsules may cause your allergies to come back. These allergies may include a skin condition called eczema or inflammation inside your nose (rhinitis). Tell your healthcare provider if any of your allergies become worse while taking BUDESONIDE Capsules.
  • Increased risk of infection. BUDESONIDE Capsules weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases, such as chicken pox or measles, while taking BUDESONIDE Capsules. Tell your healthcare provider right away if you come in contact with anyone who has chicken pox or measles.

Tell your healthcare provider about any signs or symptoms of infection during treatment with BUDESONIDE Capsules, including:

  • Fever • chills
  • pain • feeling tired
  • aches • nausea and vomiting

The most common side effects of BUDESONIDE Capsules, include:

  • headache
  • infection in your air passages (respiratory infection)
  • nausea
  • back pain
  • indigestion
  • dizziness
  • stomach area (abdominal) pain
  • gas
  • vomiting
  • tiredness
  • pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BUDESONIDE Capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Rising Pharmaceuticals, Inc at 1-866-562-4597.

How should I store BUDESONIDE Capsules?

  • Store BUDESONIDE Capsules, at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep BUDESONIDE Capsules, in a tightly closed container.

Keep BUDESONIDE Capsules, and all medicines out of the reach from children.

General information about BUDESONIDE Capsules.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. Do not use BUDESONIDE Capsules for a condition for which it was not prescribed. Do not give BUDESONIDE Capsules to other people, even if they have the same symptoms you have. It may harm them.You can ask your healthcare provider or pharmacist for information about BUDESONIDE Capsules that is written for health professionals.

What are the ingredients in BUDESONIDE Capsules?

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, lactose monohydrate, methacrylic acid copolymer dispersion, triethyl citrate, sodium hydroxide, talc and sugar spheres.

The capsule shell contains: gelatin, iron oxide red, iron oxide black, iron oxide yellow and titanium dioxide

Sugar Spheres contains the following inactive ingredients; Sucrose and corn starch.

The imprinting ink contains the following nonvolatile components; black iron oxide, potassium hydroxide and shellac.

Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

ENTOCORT is a registered trademark of the Elan Pharma International Limited, a Perrigo Company.

Manufactured By:
Appco Pharma LLC
Piscataway, New Jersey 08854
Distributed By:
Rising Pharmaceuticals, Inc.
Saddle Brook, New Jersey 07633
Revised: 07/2018
200300

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