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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 oral liquid containing ketoconazole, 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 ketoconazole are listed in cream, shampoo, tablet and aerosol forms. No FDA-approved ketoconazole product is listed in liquid form; liquid products containing it are filed as over-the-counter monograph drugs.
Liquid bases can be aqueous or nonaqueous, and USP <795> classifies the preparation by its water activity. Aqueous preparations carry shorter default beyond-use dates than nonaqueous ones. The date printed on the label is the one to follow.
Ketoconazole is an imidazole antifungal, most often compounded into topical creams, gels, foams, shampoos and solutions for the skin and scalp.
Ketoconazole is an imidazole antifungal. It binds fungal cytochrome P450 enzymes and blocks the production of ergosterol, a building block of the fungal cell membrane, which stops dermatophytes and yeasts such as Candida and Malassezia from growing. Manufactured products include ketoconazole tablets, FDA-approved for certain systemic fungal infections (blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis and paracoccidioidomycosis) only when other antifungal therapy is not available or tolerated, and ketoconazole 2% cream, approved for tinea corporis, tinea cruris, tinea pedis, tinea versicolor, cutaneous candidiasis and seborrheic dermatitis. Ketoconazole 2% shampoo is manufactured by prescription for tinea versicolor, and a 1% ketoconazole shampoo (Nizoral) is sold over the counter for dandruff. A prescriber might order ketoconazole compounded when a patient needs a strength, vehicle or allergen-free base that is not manufactured, or a combination with another topical ingredient in one preparation. Compounded preparations are not FDA-approved and require a prescription.
Ketoconazole tablets carry an FDA boxed warning: they are to be used only when other antifungal therapy is not available or tolerated and are not for nail, skin or Candida infections; they can cause serious liver injury, including deaths and liver transplants; and they cause QT prolongation, a dangerous heart rhythm change, when combined with certain drugs. The cream label notes negligible absorption through skin, with no liver or hormonal effects seen from topical use. Oral ketoconazole strongly inhibits CYP3A4 and must not be combined with drugs such as dofetilide, quinidine, pimozide, cisapride, methadone, simvastatin, lovastatin, triazolam or oral midazolam. Antacids and acid reducers lower its absorption; alcohol raises liver risk. People with liver disease or a ketoconazole allergy should not take it. It passes into breast milk; LactMed says other agents are preferred for oral use, while topical use away from the breast poses little to no risk. Topical side effects include irritation, itching and stinging. For yellow skin or eyes, dark urine, palpitations, fainting or any worrying side effect, talk to your prescriber or pharmacist.
Ketoconazole inhibits fungal cytochrome P450-dependent lanosterol demethylation, depleting ergosterol in the fungal membrane. It is active against dermatophytes, Candida and Malassezia. Oral absorption is pH-dependent: the drug is a weak dibase and requires gastric acidity to dissolve, so acid-suppressing drugs and antacids reduce bioavailability. It is about 99% protein bound, metabolized hepatically by CYP3A4 to inactive metabolites, and has a biphasic half-life of roughly 2 hours initially and 8 hours terminally, with negligible CSF penetration. Systemic absorption after topical application of the 2% cream was undetectable in volunteers. Labeled indications: ketoconazole tablets for refractory blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis and paracoccidioidomycosis; ketoconazole 2% cream for tinea corporis, cruris and pedis, tinea versicolor, cutaneous candidiasis and seborrheic dermatitis; ketoconazole 2% shampoo for tinea versicolor; ketoconazole 2% foam for seborrheic dermatitis in patients 12 and older. The tablet boxed warning states the tablets are not indicated for onychomycosis, cutaneous dermatophyte infections or Candida infections. Dosing is per prescriber. For oral therapy the label calls for baseline liver panel and viral hepatitis testing, weekly ALT during treatment, and adrenal function monitoring in at-risk patients; higher oral doses suppress adrenal corticosteroid secretion. Ketoconazole is not a controlled substance.
Shake the bottle if your label says to. Measure each dose with the oral syringe or dosing cup the pharmacy gave you, never a kitchen spoon. Give the liquid slowly into the mouth. Rinse the syringe with water after each use. Call the pharmacy if you are unsure how to measure.
Storage depends on the vehicle. Water-based liquids with a preservative usually carry a USP <795> beyond-use date of up to 35 days; without a preservative they are kept refrigerated for up to 14 days. Oil-based (nonaqueous) oral liquids may carry up to 90 days. Your label states whether to refrigerate and the beyond-use date. Keep out of reach of children and discard after that date.
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.
Take orally
