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Budesonide - (Enteric Coated) (Budesonide)

Trade Name : Budesonide

Teva Pharmaceuticals USA, Inc.

CAPSULE, DELAYED RELEASE PELLETS

Strength 3 mg/1

BUDESONIDE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Budesonide - (Enteric Coated) (Budesonide) which is also known as Budesonide and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 3 mg/1 per ml. Read more

Budesonide - (Enteric Coated) (Budesonide) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Budesonide capsules (enteric coated) are a corticosteroid indicated for:
  • Treatment of mild to moderate active Crohnu2019s disease involving the ileum and/or the ascending colon. ()
  • Maintenance of clinical remission of mild to moderate Crohnu2019s disease involving the ileum and/or the ascending colon for up to 3 months in adults. ()
  • Recommended Dosage:
  • Mild to moderate active Crohnu2019s disease ():
  • Maintenance of clinical remission of mild to moderate Crohnu2019s disease ():
  • Hepatic Impairment:
  • Capsules: 3 mg elongated, two-piece hard gelatin capsules with dark peach opaque cap and white opaque body, filled with white to off-white pellets, imprinted with u201cTEVA 7445u201d in black ink, containing 3 mg budesonide.
  • Capsules: 3 mg ()
  • Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred n
  • Hypersensitivity to budesonide or any of the ingredients in budesonide capsules (enteric coated). ()
  • No data
  • Hypercorticism and Adrenal Axis Suppression:
  • Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids:
  • Increased Risk of Infection, including Serious and Fatal Chicken Pox and Measles:
  • Other Corticosteroid Effects:
  • The following clinically significant adverse reactions are described elsewhere in labeling:
  • Most common adverse reactions (u22655%) in adults are: headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, and pain. ()
  • Budesonide is a substrate for CYP3A4. Avoid use with CYP3A4 inhibitors. Concomitant oral administration of a strong CYP3A4 inhibitor (ketoconazole) caused an eight-fold increase of the systemic exposure to oral budesonide. Inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine) can increase systemic budesonide concentrations n
  • Grapefruit Juice
  • Avoid ingestion of grapefruit juice with budesonide. Intake of grapefruit juice which inhibits CYP3A4 activity with budesonide can increase the systemic exposure for budesonide n
  • CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice)
  • Pregnancy
  • Pediatric use information is approved for Perrigo Pharma International DACu2019s ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DACu2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Reports of acute toxicity and/or death following overdosage of glucocorticoids are rare. Treatment consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy.
  • If corticosteroids are used at excessive doses for prolonged periods, systemic corticosteroid effects such as hypercorticism and adrenal axis suppression may occur. For chronic overdosage in the case of severe disease requiring continuous steroid therapy, the dosage may be reduced temporarily.
  • Single oral doses of 200 and 400 mg/kg were lethal in female and male mice, respectively. The signs of acute toxicity were decreased motor activity, piloerection and generalized edema.
  • Budesonide, USP, the active ingredient of budesonide capsules (enteric coated), is a synthetic corticosteroid. Budesonide, USP is designated chemically as (RS)-11u03b2, 16u03b1, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide, USP is provided as a mixture of two epimers (22R and 22S). Its structural formula is:
  • CHO M.W. 430.5
  • Budesonide, USP is a white to off-white crystalline, tasteless, odorless powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10 ionic strength 0.01.
  • Budesonide Capsules (Enteric Coated) are formulated as hard gelatin capsules filled with enteric-coated granules that dissolve at pH greater than 5.5. Each capsule for oral administration contains 3 mg of micronized budesonide, USP with the following inactive ingredients: acetyltributyl citrate, ethylcellulose aqueous dispersion, glacial acetic acid, lactose monohydrate, methacrylic acid copolymer dispersion, polysorbate 80, simethicone, sodium hydroxide, sugar spheres, talc and triethyl citrate. The ingredients in the capsule shell are FD&C yellow no. 6, FD&C red no. 40, gelatin and titanium dioxide. The ingredients in the imprinting ink are D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, shellac glaze, black iron oxide and propylene glycol.
  • No data
  • Carcinogenicity studies with budesonide were conducted in rats and mice. In a two-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In addition, there were increased incidences of primary hepatocellular tumors in male rats at 25 mcg/kg (approximately 0.023 times the maximum recommended human dose on a body surface area basis) and above. No tumorigenicity was seen in female rats at oral doses up to 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In an additional two-year study in male Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). However, it caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) showed similar findings. In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately 0.1 times the maximum recommended human dose on a body surface area basis).
  • Budesonide was not genotoxic in the Ames test, the mouse lymphoma cell forward gene mutation (TK ) test, the human lymphocyte chromosome aberration test, the sex-linked recessive lethality test, the rat hepatocyte UDS test and the mouse micronucleus test.
  • In rats, budesonide had no effect on fertility at subcutaneous doses up to 80 mcg/kg (approximately 0.07 times the maximum recommended human dose on a body surface area basis). However, it caused a decrease in prenatal viability and viability in pups at birth and during lactation, along with a decrease in maternal body-weight gain, at subcutaneous doses of 20 mcg/kg (approximately 0.02 times the maximum recommended human dose on a body surface area basis) and above. No such effects were noted at 5 mcg/kg (approximately 0.005 times the maximum recommended human dose on a body surface area basis).
  • No data
  • No data
  • Budesonide Capsules (Enteric Coated), 3 mg are available as elongated, two-piece hard gelatin capsules with dark peach opaque cap and white opaque body, filled with white to off-white pellets, imprinted with u201cTEVA 7445u201d in black ink, containing 3 mg budesonide, USP, packaged in bottles of 100 capsules (NDC: 0093-7445-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise Patients to read the FDA-Approved patient labeling (Patient Information).
  • Hypercorticism and Adrenal Axis Suppression
  • Advise patients that budesonide capsules (enteric coated) may cause hypercorticism and adrenal axis suppression and to follow a taper schedule, as instructed by their healthcare provider if transferring to budesonide capsules (enteric coated) from systemic corticosteroids Advise patients that replacement of systemic corticosteroids with budesonide capsules (enteric coated) 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 n
  • Pregnancy
  • Advise female patients that budesonide capsules (enteric coated) may cause fetal harm and to inform their healthcare provider with a known or suspected pregnancy n
  • Administration
  • Advise patients to:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. C 11/2017
  • PATIENT INFORMATION
  • Budesonide (bue desu2019 oh nide)
  • Capsules (Enteric Coated)
  • Read this Patient Information before you start taking budesonide capsules (enteric coated) 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 are budesonide capsules (enteric coated)?
  • Budesonide capsules (enteric coated) are a prescription corticosteroid medicine used to treat mild to moderate Crohnu2019s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):
  • It is not known if budesonide capsules (enteric coated) are safe and effective in children under 8 years of age.
  • Pediatric use information is approved for Perrigo Pharma International DACu2019s ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DACu2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • Who should not take budesonide capsules (enteric coated)?
  • Do not take budesonide capsules (enteric coated) if:
  • What should I tell my healthcare provider before taking budesonide capsules (enteric coated)?
  • Before you take budesonide capsules (enteric coated) tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • How should I take budesonide capsules (enteric coated)?
  • What are the possible side effects of budesonide capsules (enteric coated)?
  • Budesonide capsules (enteric coated) may cause serious side effects, including:
  • u25cb fever u25cb chills
  • u25cb pain u25cb feeling tired
  • u25cb aches u25cb nausea and vomiting
  • The most common side effects of budesonide capsules (enteric coated) in adults include:
  • u25cf headache u25cf stomach area (abdominal) pain
  • u25cf infection in your air passages (respiratory infection) u25cf gas
  • u25cf nausea u25cf vomiting
  • u25cf back pain u25cf tiredness
  • u25cf indigestion u25cf pain
  • u25cf dizziness
  • 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 (enteric coated). 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 Teva at 1-888-838-2872.
  • How should I store budesonide capsules (enteric coated)?
  • Keep budesonide capsules (enteric coated) and all medicines out of the reach of children.
  • General information about the safe and effective use of budesonide capsules (enteric coated)
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use budesonide capsules (enteric coated) for a condition for which they were not prescribed. Do not give budesonide capsules (enteric coated) to other people, even if they have the same symptoms you have. They may harm them. You can ask your healthcare provider or pharmacist for information about budesonide capsules (enteric coated) that is written for health professionals.
  • What are the ingredients in budesonide capsules (enteric coated)?
  • Active ingredient:
  • Inactive ingredients:
  • Pediatric use information is approved for Perrigo Pharma International DACu2019s ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DACu2019s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. B 11/2017
  • No data

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