eohilia
Eohilia (Budesonide) is a corticosteroid used to treat Perennial Allergic Rhinitis, Inflammatory Bowel Diseases.
Budesonide · by Takeda Pharms USA
Key facts
- Active ingredient
- Budesonide
- Drug class
- Corticosteroid
- Form
- Suspension
- Strength
- Budesonide 2MG/10ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Takeda Pharms USA
- Half-life
- about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) (how long it stays in your system)
- What the pharmacy pays
- ~$0.75 per ml — not your price
- FDA application
- NDA213976
What is Eohilia?
From the FDA label:EOHILIA (budesonide oral suspension) contains budesonide, a synthetic corticosteroid. Budesonide is designated chemically as (RS)-11β, 16α, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde. Budesonide is a mixture of two epimers (22 R and 22 S ). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.53. Its structural formula is: Budesonide is a white or almost-white, crystalline powder that is freely soluble in chloroform, sparingly soluble in alcohol and practically insoluble in water and heptane. EOHILIA (budesonide oral suspension) is a white to yellow, thixotropic, viscous suspension. Each 10 mL of EOHILIA contains 2 mg of budesonide. The oral suspension contains the following inactive ingredients: acesulfame potassium, ascorbic acid, Avicel ® RC-591, cherry flavor, citric acid, dextrose, disodium ethylenediaminetetraacetic acid (EDTA), glycerin, Magnasweet ® 110, maltodextrin, polysorbate 80, potassium sorbate, sodium ascorbate, sodium benzoate, sodium citrate, and purified water. Excipients contain no ingredient made from a gluten-containing grain (wheat, barley, or rye). Chemical Structure
How to use
Recommended dosage : 2 mg orally twice daily for 12 weeks. ( 2.1 ) See full prescribing information for preparation and important administration instructions. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage is 2 mg orally twice daily for 12 weeks. 2.2 Preparation and Important Administration Instructions Do NOT take EOHILIA with food or liquid at the time of ingestion. Wait for at least 30 minutes to eat or drink after taking EOHILIA. Administer EOHILIA as follows: Do NOT mix EOHILIA with food or liquid. Shake the EOHILIA packet for at least 10 seconds prior to opening . Squeeze the packet from the bottom to the top directly into the mouth. Repeat 2 to 3 times until the EOHILIA packet is empty . Swallow all the EOHILIA suspension. Do not eat or drink for 30 minutes after taking EOHILIA. After 30 minutes, rinse mouth with water and spit out the contents without swallowing [see Warnings and Precautions (5.2) ] . Avoid consumption of grapefruit juice for the duration of therapy with EOHILIA [see Drug Interactions (7.1) ] .
Side effects
The following serious adverse reactions are described in greater detail in other sections of the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] Immunosuppression and increased risk of infections [see Warnings and Precautions (5.2) ] Erosive esophagitis [see Warnings and Precautions (5.3) ] Effect on growth [see Warnings and Precautions (5.4) ] Symptoms of steroid withdrawal in those patients transferred from other systemic corticosteroids [see Warnings and Precautions (5.5) ] Other corticosteroid effects [see Warnings and Precautions (5.6) ] Kaposi’s sarcoma [see Warnings and Precautions (5.7) ] Most common adverse reactions (≥2%) are: respiratory tract infection, gastrointestinal mucosal candidiasis, headache, gastroenteritis, throat irritation, adrenal suppression, and erosive esophagitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EOHILIA in 410 adults and pediatric subjects 11 years of age and…
Warnings
Important safety information
Hypercorticism and Adrenal Axis Suppression : May occur with treatment; monitor for signs and symptoms and consider reducing the dosage. ( 5.1 , 8.6 ) Immunosuppression and Increased Risk of Infection : Increased risk of viral, bacterial, fungal, protozoan, and helminthic infections, including potentially fatal varicella and measles infection. Monitor patients for new or worsening localized or systemic infection, including oropharyngeal and esophageal candidiasis and consider drug discontinuation. Avoid use in patients with fungal infections, Strongyloides infestation, cerebral malaria, and ocular herpes simplex. Screen for hepatitis B infection. ( 5.2 ) Erosive Esophagitis : Advise patients or caregivers to report new or worsening signs or symptoms of erosive esophagitis; consider endoscopic evaluation as appropriate. ( 5.3 ) Effect on Growth : Use of corticosteroids may cause a reduction in growth velocity in pediatric patients; monitor growth during treatment. ( 5.4 ) Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids : Taper slowly from corticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). ( 5.5 ) Other Corticosteroid Effects : Monitor patients with concomitant conditions where corticosteroids may have unwanted effects (e.g., hypertension, diabetes mellitus). ( 5.6 ) Kaposi’s Sarcoma : Reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. ( 5.7 ) 5.1 Hypercorticism and Adrenal Axis Suppression Systemic effects such as hypercorticism and adrenal axis suppression may occur with use of corticosteroids, including EOHILIA. Monitor patients for signs and symptoms of hypercorticism and adrenal axis suppression and consider reducing the dosage of EOHILIA [see Adverse Reactions (6.1) , Clinical Pharmacology (12.2) ]. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure of oral budesonide. Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) and monitoring for signs and/or symptoms of hypercorticism is recommended in patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations (8.6) , Clinical Pharmacology (12.3) ]. Corticosteroids, including EOHILIA, can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to trauma, surgery, infection, or other stress situations, supplementation with a systemic corticosteroid is recommended. 5.2 Immunosuppression and Increased Risk of Infection Corticosteroids, including EOHILIA, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor patients for the development of infection and consider discontinuation of EOHILIA if the patient develops an infection while on treatment. Tuberculosis If corticosteroids are used in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation while receiving EOHILIA. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune pediatric and adult patients taking corticosteroids. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If an EOHILIA-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If an EOHILIA-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Prior to starting treatment with EOHILIA, for patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids may exacerbate systemic fungal infections; therefore, avoid EOHILIA use in the presence of such infections. Amebiasis Corticosteroids may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating EOHILIA in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Avoid EOHILIA in patients with known or suspected Strongyloides (threadworm) infection. Corticosteroid-induced immunosuppression may lead to Strongyloides superinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including EOHILIA, in patients with cerebral malaria. Ocular Herpes Simplex Avoid corticosteroids, including EOHILIA, in patients with active ocular herpes simplex. Localized Infections In clinical trials with EOHILIA, localized infections with Candida albicans occurred in the mouth, throat, and esophagus in some subjects [see Adverse Reactions (6.1) ] . Do not eat or drink for 30 minutes after taking EOHILIA. After 30 minutes, rinse mouth with water and spit without swallowing [see Dosage and Administration (2.2) ] . If oropharyngeal or esophageal candidiasis develops, treat with appropriate local or systemic antifungal therapy and consider discontinuing treatment with EOHILIA. 5.3 Erosive Esophagitis Erosive esophagitis occurred in subjects who received EOHILIA in a 12-week clinical trial. None of the subjects had erosions at baseline esophagogastroduodenoscopy (EGD), and most were receiving concomitant therapy with a proton pump inhibitor (PPI) during the trial [see Adverse Reactions (6.1) ] . Advise patients or caregivers to report new onset or worsening signs or symptoms of erosive esophagitis to their healthcare provider. Consider endoscopic evaluation as appropriate. 5.4 Effect on Growth Use of corticosteroids may cause a reduction of growth velocity in pediatric patients. Monitor the growth of pediatric patients on EOHILIA. The maximum recommended duration of treatment with EOHILIA is 12 weeks [see Dosage and Administration (2.1) ] . 5.5 Symptoms of Steroid Withdrawal in Patients Transferred from Other Systemic Corticosteroids Monitor patients who are transferred from corticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as EOHILIA, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal axis suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously. Replacement of systemic corticosteroids with EOHILIA may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug. 5.6 Other Corticosteroid Effects Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic…
Who should not take Eohilia
EOHILIA is contraindicated in patients with hypersensitivity to budesonide. Serious hypersensitivity reactions, including anaphylaxis, have occurred with oral budesonide products [see Adverse Reactions (6.2) ] . Hypersensitivity to budesonide. ( 4 )
Overdose — what happens if you take too much
Treatment of acute overdosage consists of immediate gastric lavage or emesis followed by supportive and symptomatic therapy. Use of corticosteroids, such as EOHILIA, at excessive doses or for prolonged periods, increases the risk of systemic corticosteroid effects such as hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): Can increase systemic budesonide concentrations. Avoid concomitant use. ( 2.2 , 7.1 ) 7.1 CYP3A4 Inhibitors Budesonide is a substrate for CYP3A4. Concomitant use of budesonide with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice) can increase systemic budesonide concentrations [see Clinical Pharmacology (12.3) ] . Avoid concomitant use of CYP3A4 inhibitors, including grapefruit juice, with EOHILIA [see Dosage and Administration (2.2) ] .
How long does Budesonide stay in your body?
The elimination half-life of budesonide is about 2 to 3.6 hours (terminal elimination half-life, measured after intravenous dosing) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label reports the true (terminal) plasma elimination half-life from IV dosing as 2 to 3.6 hours, the same in healthy adults and Crohn's disease patients. The APPARENT half-life after ORAL dosing is longer — mean 6.3 ± 1.6 hours (range 2 to 8 hours) after a single 9 mg dose in healthy fasted subjects — because absorption is slower than elimination (flip-flop kinetics), not because the drug lingers; use the ~2–3.6 h IV figure as the elimination half-life. Budesonide is NOT a prodrug and has NO longer-lasting active metabolite: its two major CYP3A4 metabolites (6β-hydroxy budesonide and 16α-hydroxy prednisolone) have negligible corticosteroid activity (<1/100 of the parent). Liver impairment: budesonide is a high-hepatic-clearance drug, so systemic exposure rises with impaired liver function — patients with moderate impairment (Child-Pugh B) had a 3.5-fold higher AUC than those with normal liver function, and the label says to avoid use in severe impairment (Child-Pugh C). Kidney impairment: the label gives no PK half-life change (budesonide is cleared hepatically, not renally). Older adults: the label states studies did not include enough patients aged 65+ to characterize any difference. This is an elimination half-life, not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Budesonide (oral) FDA label, §12.3 Pharmacokinetics — DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Eohilia ranks — best-rated corticosteroid for:
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Eohilia treat?
- Eohilia (Budesonide) may be used to treat perennial allergic rhinitis, inflammatory bowel diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Eohilia work?
- Eohilia is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How much does Eohilia cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.75 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Pred Forte — about $0.60 on the same basis.
- Is there a coupon or discount for Eohilia?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Eohilia. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Eohilia?
- Eohilia is marketed by Takeda Pharms USA. You can see Takeda Pharms USA's full profile, rating, and other products on pharmaranks.
- Is Eohilia a brand-name or generic drug?
- Eohilia is a brand-name product with the active ingredient Budesonide.
- Is Eohilia available over the counter?
- No. Eohilia is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Eohilia come in?
- Eohilia is currently marketed as suspension, per the FDA's National Drug Code Directory.
- What class of drug is Eohilia?
- Eohilia is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Eohilia FDA-registered?
- Eohilia is on record with the U.S. FDA under application number NDA213976. You can verify this on its official FDA label.
- Is Eohilia safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Eohilia. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Eohilia?
- Eohilia's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described in greater detail in other sections of the labeling: Hypercorticism and adrenal axis suppression [see Warnings and Precautions (5.1) ] Immunosuppression and increased risk of infections [see Warnings and Precautions (5.2) ] Erosive esophagitis [s… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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