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Licensed to fill prescriptions for patients in RI, MA, CT, NJ, NH, FL, ME and PA. New York patients are served on a limited basis while nonresident registration is pending.
Prepared to a prescriber's order for one patient. Not FDA-approved.
This is a compounded suppository containing budesonide, prepared to a prescriber's order for one patient. Compounded preparations are not FDA-approved.
These listings cover every salt or ester form of each drug in the FDA National Drug Code Directory.
FDA-approved products containing budesonide are listed in suspension, aerosol, inhalant, capsule, spray and tablet forms. No finished budesonide product of any kind is listed in suppository form.
Suppository bases differ, and the base used decides how USP <795> classifies the preparation for beyond-use dating. The date printed on the label is the one to follow.
Budesonide is a corticosteroid with high first-pass metabolism that compounding pharmacies prepare by prescription as oral suspensions, sinus irrigations and other forms.
Budesonide is a potent glucocorticoid that binds glucocorticoid receptors and switches off inflammatory genes, reducing the activity of eosinophils, mast cells and other immune cells. Because 80% to 90% of an oral dose is removed on its first pass through the liver, little reaches the rest of the body. Eohilia oral suspension (Takeda) is FDA-approved for 12 weeks of treatment of eosinophilic esophagitis in patients 11 years and older. Other manufactured products include Pulmicort Respules for asthma in young children, Entocort EC capsules for Crohn disease, Uceris tablets and rectal foam for ulcerative colitis, and Tarpeyo capsules for IgA nephropathy. A prescriber may order budesonide compounded when a needed strength, vehicle or form, such as a sinus irrigation, is not manufactured. Compounded preparations are not FDA-approved and require a prescription.
Budesonide has no boxed warning. Do not use it if you are allergic to budesonide. Like other corticosteroids, it can cause signs of excess steroid, such as a rounded face, acne and stretch marks, and can suppress the adrenal glands. It lowers resistance to infection: chickenpox and measles can be serious, and thrush can develop in the mouth, throat or esophagus. Tell your prescriber about tuberculosis, hepatitis B, fungal or parasitic infections, or herpes infection of the eye. In children it may slow growth. Ketoconazole, itraconazole, ritonavir, erythromycin and grapefruit juice can raise budesonide levels and should be avoided. Studies of oral budesonide in pregnancy have not shown a drug-associated risk of birth defects, but infants exposed before birth can have low adrenal function. LactMed says amounts in milk are minute and considers inhaled, nasal, oral and rectal use acceptable. Talk to your prescriber or pharmacist about side effects.
Budesonide is a glucocorticoid receptor agonist with high hepatic clearance approaching liver blood flow. Per the Eohilia label, oral budesonide undergoes 80% to 90% first-pass metabolism, mainly by CYP3A4 to two major metabolites; plasma protein binding is 85% to 90%, and mean elimination half-life is 3.3 hours. LactMed cites oral bioavailability of about 9%. CYP3A4 inhibitors increase systemic exposure, and StatPearls notes systemic availability about 2.5-fold higher in cirrhosis. Labeled indications: Eohilia for 12 weeks of treatment of eosinophilic esophagitis; Pulmicort Respules for maintenance and prophylactic asthma treatment in children 12 months to 8 years; rectal foam for distal ulcerative colitis (StatPearls). StatPearls lists off-label sinonasal irrigation for chronic rhinosinusitis, oral viscous budesonide for eosinophilic esophagitis, microscopic colitis and autoimmune hepatitis without cirrhosis. Dosing is per prescriber. Monitor for hypercorticism and adrenal axis suppression, infection including oropharyngeal and esophageal candidiasis, growth in children, and bone and eye effects with long-term use (StatPearls). Budesonide is not a controlled substance.
Wash your hands. If the suppository is soft, chill it in its wrapper in the refrigerator or under cool water for a few minutes, then unwrap it. For rectal use, coat the tip with a water-soluble lubricant (not petroleum jelly), lie on your side with your upper knee bent, and insert it pointed end first past the muscle at the opening. For vaginal use, lie on your back with knees bent and insert it as far as it comfortably goes, by finger or applicator; bedtime use limits leakage, and a panty liner protects clothing. Stay lying down about 15 minutes. Wash your hands.
Suppositories are nonaqueous, so under USP <795> they can carry a beyond-use date of up to 180 days at controlled room temperature or in the refrigerator when no other stability data apply. Storage depends on the base: fatty bases can soften at room temperature and may be labeled for the refrigerator, while polyethylene glycol bases usually do not need refrigeration. Keep them cool so they do not melt, and refrigerate them if your label says to.
This formulation is compounded by Bayview Pharmacy on a prescriber's order for an individual patient. It is not an FDA-approved drug product, and the FDA has not evaluated it for safety, effectiveness, or manufacturing quality.
A valid prescription is required. Availability depends on Bayview's licensure in your state. This page is general information, not medical advice. Discuss your situation with a licensed healthcare provider.
Search by NCPDP 4106882, or by name and ZIP: Bayview Pharmacy, Warwick, RI 02886. Select it as the destination pharmacy and save it as a favorite. Click any value to copy it.
Compounded preparations have no NDC, so this formula will not appear in your EHR's drug search. Use your system's compound, non-formulary, or free-text prescription entry and name the preparation exactly as written in step 3. If your EHR forces you to pick a listed drug, pick the closest entry for the active ingredient and put the full formula in the prescription body (the Sig or directions field), not in Notes to Pharmacy.
Compounded preparations have no NDC and will not appear in your drug search. For EPCS to validate, select a drug entry your EHR recognizes as controlled, usually the bulk powder entry for the active ingredient (for example Ketamine (bulk) powder, not a branded product), then put the full formula from step 3 in the prescription body. A free-text entry that does not validate as controlled will be rejected by your EPCS module.
Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.
Transmit from your EHR. For this non-controlled preparation we also accept fax to (401) 284-4506 and phoned orders at (401) 284-4505. Order forms are on the formulation pages and in the prescriber portal.
Transmit with two-factor authentication through your EPCS-enabled EHR. No order form is offered for this preparation; e-prescribing guides for our controlled preparations are on the formulation pages.
Licensed to dispense in RI, MA, CT, NJ, NH, FL, ME, and PA; New York is served on a limited basis while nonresident registration is pending. Compounded preparations are not FDA-approved. A valid prescription is required. Full guide, including steps by EHR: How to e-prescribe to Bayview. Questions about this formula: call (401) 284-4505.
Insert 1 unwrapped suppository
