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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 capsule containing itraconazole hydrochloride, 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 itraconazole are listed in capsule and solution forms.
This is a solid, nonaqueous dose form. Under USP <795>, nonaqueous preparations carry longer default beyond-use dates than water-containing ones. The date printed on the label is the one to follow.
Itraconazole is a broad-spectrum triazole antifungal, commonly compounded into oral suspensions and liquids at strengths not sold commercially.
Itraconazole is a triazole antifungal. It blocks the fungal enzyme 14-alpha-demethylase, which stops the fungus from making ergosterol for its cell membrane; the leaky membrane that results halts growth. Its main metabolite, hydroxy-itraconazole, is about as active as the parent drug. Manufactured Sporanox capsules (itraconazole) and generics are FDA-approved for blastomycosis, histoplasmosis, aspergillosis in patients who cannot take or did not respond to amphotericin B, and dermatophyte onychomycosis of the toenail or fingernail in non-immunocompromised patients. Sporanox oral solution and other brands such as Tolsura also exist, and the label states capsules and solution are not interchangeable. Prescribers order itraconazole compounded when they want an oral liquid at a strength not sold or a vehicle free of a particular excipient. Compounded preparations are not FDA-approved and require a prescription.
The Sporanox label carries a boxed warning on two points: itraconazole can cause or worsen congestive heart failure and must not be used for nail fungus in anyone with ventricular dysfunction or a history of heart failure, and it is a strong CYP3A4 inhibitor, so many drugs are contraindicated with it because raised levels can cause dangerous heart rhythm changes. Contraindicated partners include methadone, quinidine, pimozide, triazolam, lovastatin, simvastatin and ticagrelor, among others. Rare serious liver injury, sometimes fatal, has occurred; stop and talk to your prescriber or pharmacist about yellow skin, dark urine or unusual tiredness. Hearing loss and nerve damage have also been reported. Antacids and acid reducers lower capsule absorption, so take it with a full meal. Pregnancy: do not use for onychomycosis if pregnant or planning pregnancy; use contraception during and for two months after. Breastfeeding: milk levels are low; an alternative may be preferred for newborns. Common side effects are nausea, diarrhea, stomach pain, headache and rash.
Itraconazole inhibits fungal CYP-dependent 14-alpha-demethylase. Oral bioavailability from capsules is about 55 percent, highest after a full meal and reduced by gastric acid suppression; peak levels occur at 2 to 5 hours. It is over 99.8 percent protein bound, mainly to albumin, metabolized primarily by hepatic CYP3A4 to active hydroxy-itraconazole, with a half-life of 16 to 28 hours after a single dose rising to 34 to 42 hours at steady state, reached in about 15 days. Itraconazole and its metabolite are potent inhibitors of CYP3A4, P-glycoprotein and BCRP. Labeled indications (Sporanox capsules): blastomycosis, histoplasmosis, aspergillosis refractory to or intolerant of amphotericin B, and dermatophyte onychomycosis. StatPearls lists off-label use in coccidioidomycosis, paracoccidioidomycosis, superficial mycoses, sporotrichosis and pulse-dosed seborrheic dermatitis. Prescribers have ordered compounded oral itraconazole suspensions; a 2010 IJPC dissolution study found four of five published extemporaneous suspensions released drug too early or insufficiently and one behaved like commercial capsules, which is a formulation-selection point for the pharmacist. Dosing is per prescriber. Monitoring: trough levels after about a week and with interacting drugs, liver enzymes at baseline and periodically beyond one month, blood pressure and potassium for pseudoaldosteronism, and signs of heart failure. Not a controlled substance.
Swallow each capsule whole with a glass of water, unless your label says otherwise. Do not crush, chew or open the capsule unless your pharmacist tells you it is safe to do so. Take it at the times shown on your prescription label. If you miss a dose or are unsure how to take it, call the pharmacy.
Capsules are nonaqueous, so under USP <795> they usually carry a beyond-use date of up to 180 days when no other stability data apply. Keep the vial tightly closed at room temperature, away from heat, moisture and direct light, and out of reach of children. Discard any capsules left after the beyond-use date on the label.
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 1 capsule by mouth
