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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 topical ointment containing metronidazole, 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 metronidazole are listed in tablet, capsule, suspension, injection, cream, gel and lotion forms, including gels for vaginal use. No finished metronidazole product of any kind is listed in ointment form.
Bases for this dose form are usually nonaqueous. 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.
Metronidazole is a nitroimidazole antimicrobial, manufactured as oral, topical, vaginal and injectable products, that compounding pharmacies prepare in topical, oral and other dosage forms.
Metronidazole is an antimicrobial in the nitroimidazole class. Inside anaerobic bacteria and certain parasites, the drug is chemically reduced into reactive forms that damage the organism's DNA; cells that use oxygen do not activate it the same way. Manufactured oral metronidazole (Flagyl and generics) is FDA-approved for trichomoniasis, amebiasis, and serious infections caused by susceptible anaerobic bacteria, including intra-abdominal, skin, gynecologic, bone and joint, central nervous system, lower respiratory tract and bloodstream infections. Manufactured topical metronidazole, such as the lotion, is FDA-approved for the inflammatory papules and pustules of rosacea. Prescribers may order metronidazole compounded when they want a strength or base that is not manufactured, a preparation without a specific excipient, or a combination with another ingredient. Compounded metronidazole is not FDA-approved and requires a prescription.
The manufactured oral product carries a boxed warning: metronidazole has caused cancer in mice and rats, so use should be limited to its labeled conditions. Do not take it with alcohol, or with products containing propylene glycol, during treatment and for at least three days after; the combination can cause nausea, vomiting, cramps, flushing and headache. It is contraindicated with disulfiram in the previous two weeks, in the first trimester of pregnancy for trichomoniasis, and in Cockayne syndrome. The label also warns of nerve damage in the hands and feet, seizures, confusion and severe skin reactions. It increases the effect of warfarin, raises lithium levels, and adds to QT prolongation. Common side effects are nausea, metallic taste, headache and diarrhea. Metronidazole passes into breast milk; LactMed reports topical use is acceptable while nursing. For numbness, tingling, confusion or spreading rash, talk to your prescriber or pharmacist.
Metronidazole is a nitroimidazole that is reduced within susceptible anaerobes and protozoa to intermediates and free radicals that damage DNA. Orally it is well absorbed, less than 20 percent protein-bound, distributed into cerebrospinal fluid, saliva and breast milk, metabolized hepatically by side-chain oxidation and glucuronidation, and excreted mainly in urine with an average half-life of about 8 hours; exposure rises in severe hepatic impairment and metabolites accumulate in end-stage renal disease. Cimetidine prolongs its half-life, while phenytoin and phenobarbital accelerate elimination. After topical application of the lotion, peak plasma levels were about 80 times lower than after a single oral tablet. Flagyl is labeled for trichomoniasis, amebiasis and serious anaerobic infections; topical metronidazole is labeled for inflammatory lesions of rosacea, and a published review of rosacea trials supports its role as maintenance therapy. Prescribers may order compounded topical metronidazole in strengths and bases that are not manufactured. Dosing and duration per prescriber. Monitoring per label: leukocyte counts before and after therapy, INR with warfarin, lithium and creatinine with lithium, prompt neurologic evaluation for abnormal signs, and QT risk with other QT-prolonging agents. Not a controlled substance.
Wash your hands. Apply a thin layer to the affected area and rub in gently as your label directs. Do not cover with a bandage or wrap unless your prescriber tells you to. Keep it out of your eyes. Do not apply to open wounds or broken skin unless told to. Wash your hands after applying.
Ointments are usually nonaqueous, so a USP <795> default beyond-use date of up to 180 days may apply when no other data exist. Store in the closed container at room temperature, away from heat and direct light, keep from freezing, and keep out of reach of children. Discard 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.
Apply topically to affected area(s)
