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Fentanyl Citrate 25 µg/0.1 mL Nasal Spray

FDA-approved generic
Dose form
Nasal Spray
Active ingredients
Fentanyl Citrate

Fentanyl Citrate 25 µg/0.1 mL Nasal Spray is a liquid formulation delivered in a spray form, specifically designed for administration into the nasal cavity. This formulation provides targeted local or systemic effects through the nostrils, offering rapid relief for patients. It is primarily used to manage breakthrough pain in cancer patients who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain. The nasal spray allows for quick absorption and onset of action.

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For prescribers
Prescription details
RxThis formula
Dose formSee below
Quantity____
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription detailsOrder form
Controlled substance: e-prescribe (EPCS) from your EHR. Faxed and phoned prescriptions cannot be accepted for this preparation.
Send it from your EHR, or fax to (401) 284-4506. How to e-prescribe this formula
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.
To prescribe, you must be a verified prescriber.
To prescribe, you must be in a state where we hold an active out-of-state pharmacy license.
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Requires a prescription from your own provider. Bayview is a pharmacy and does not prescribe.
Ships within 1 to 2 business days after pharmacist verification
HSA and FSA eligible
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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.

For prescribersSign in for prescription details and order forms.
Compounded preparations are prepared by Bayview pursuant to a prescription for an individual patient. They are not FDA-approved and have not been evaluated by FDA for safety or effectiveness.
Fentanyl Citrate
Nasal Spray
Service area

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Bayview fills prescriptions for patients in Connecticut, Florida, Maine, Massachusetts, New Hampshire, New Jersey, Pennsylvania and Rhode Island. New York patients are served on a limited basis while nonresident pharmacy registration is pending.

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Formula Information

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Fentanyl Citrate 25 µg/0.1 mL Nasal Spray is a potent opioid analgesic designed for rapid absorption through the nasal mucosa. By delivering the medication directly into the nasal cavity, it allows for swift onset of pain relief, making it particularly useful for managing acute episodes of pain where immediate analgesia is desired.

The nasal spray formulation offers a non-invasive and convenient route of administration, bypassing the gastrointestinal tract and first-pass metabolism in the liver. This enhances bioavailability and ensures that a consistent dose reaches systemic circulation promptly. It's especially beneficial for patients who may have difficulty swallowing oral medications or require rapid pain control.

Due to its strength and potential risks, Fentanyl Citrate Nasal Spray should be used under strict medical supervision. It's essential for prescribers to assess each patient's opioid tolerance and overall health status to determine the appropriate dosing regimen. The medication is typically reserved for individuals who are already opioid-tolerant to minimize the risk of severe respiratory depression and other adverse effects.

Patients using this nasal spray should be thoroughly educated on its proper use to ensure accurate dosing and to mitigate potential side effects. Common side effects may include drowsiness, dizziness, nausea, constipation, and nasal irritation. It's crucial for patients to report any signs of adverse reactions or concerns promptly to their healthcare provider.

For prescribers, it's important to consider the patient's entire medication profile to avoid dangerous drug interactions. Concomitant use of other central nervous system depressants, such as benzodiazepines or alcohol, can amplify the effects of fentanyl, leading to heightened risks. Regular monitoring and patient counseling can help in managing these risks effectively.

If you have any questions, please reach out to us.

Drug Interactions

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Fentanyl Citrate 25 µg/0.1 mL Nasal Spray is a potent opioid analgesic used for the management of breakthrough pain in patients who are already receiving and are tolerant to opioid therapy for their underlying persistent pain. As with any medication, it is crucial to be aware of potential drug interactions that may affect the efficacy and safety of this formulation.

Concomitant use of Fentanyl Citrate Nasal Spray with other central nervous system (CNS) depressants, including other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, and alcohol, can result in profound sedation, respiratory depression, coma, or even death. It is essential for prescribers to evaluate the patient's medication regimen and adjust dosages accordingly to minimize these risks.

Fentanyl is primarily metabolized by the cytochrome P450 3A4 (CYP3A4) enzyme. Therefore, the use of Fentanyl Citrate Nasal Spray with CYP3A4 inhibitors, such as certain antibiotics (e.g., erythromycin), antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), can lead to increased plasma concentrations of fentanyl, potentially resulting in increased or prolonged opioid effects. Patients should be monitored for signs of respiratory and CNS depression, and dosage adjustments may be necessary.

Conversely, CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, may decrease fentanyl plasma concentrations, reducing its efficacy. Patients may require an increased dose of Fentanyl Citrate Nasal Spray to achieve the desired analgesic effect, but this should be approached with caution to avoid overdose if the inducer is discontinued.

Monoamine oxidase inhibitors (MAOIs) can interact with opioid analgesics, including fentanyl, and may cause serotonin syndrome, a potentially life-threatening condition. It is generally advised to avoid the use of Fentanyl Citrate Nasal Spray in patients who are currently taking MAOIs or have taken them within the last 14 days.

Patients with a history of substance abuse or addiction should be closely monitored, as fentanyl has a high potential for abuse and dependence. Prescribers should assess the patient's risk for opioid addiction, abuse, or misuse prior to prescribing Fentanyl Citrate Nasal Spray and continue to monitor for the development of these behaviors or conditions.

It is important for both patients and prescribers to be aware of these potential drug interactions and to communicate openly about all medications being taken, including over-the-counter drugs and supplements. If you have any questions or concerns regarding the use of Fentanyl Citrate 25 µg/0.1 mL Nasal Spray and its interactions with other medications, please reach out to us for further guidance and support.

How Does it Work

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Fentanyl Citrate 25 µg/0.1 mL Nasal Spray is a specialized liquid formulation designed for intranasal administration, allowing for rapid absorption through the nasal mucosa. This method of delivery is particularly advantageous due to the rich vascularization of the nasal cavity, which facilitates swift entry of the medication into the systemic circulation. The nasal spray form ensures that the medication bypasses the gastrointestinal tract and first-pass metabolism in the liver, leading to a quicker onset of action compared to oral formulations. This is especially beneficial for managing acute pain episodes where rapid relief is essential.

Fentanyl, a potent synthetic opioid, works primarily by binding to the body's opioid receptors, which are found in the brain, spinal cord, and other areas. These receptors are part of the endogenous pain control system and, when activated by fentanyl, they inhibit the transmission of pain signals, alter the perception of pain, and increase pain tolerance. The citrate form of fentanyl enhances its solubility, making it suitable for nasal spray formulations, ensuring that the drug is effectively absorbed through the nasal tissues.

This formulation is particularly useful in treating breakthrough pain in patients who are already receiving and are tolerant to opioid therapy for underlying chronic pain conditions. Breakthrough pain is a sudden and intense flare-up of pain that "breaks through" the regular pain medication regimen. The rapid absorption and onset of action of the nasal spray make it an ideal choice for such situations, providing quick relief and improving the patient's quality of life.

For prescribers, it is important to consider the patient's overall opioid tolerance and history before prescribing this formulation. The dosing should be carefully tailored to the individual, taking into account their current opioid regimen to avoid the risk of overdose and potential side effects such as respiratory depression. Patients should be educated on the proper use of the nasal spray, including priming the spray pump if necessary, and ensuring the correct administration technique to maximize efficacy and minimize wastage.

Patients should be advised to use the nasal spray only as directed by their healthcare provider and to report any adverse effects or concerns promptly. It is crucial to store the medication safely to prevent misuse or accidental exposure, especially in households with children or individuals who may be at risk of opioid misuse.

If you have any questions or need further information about Fentanyl Citrate 25 µg/0.1 mL Nasal Spray, please reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to assist you with any inquiries or concerns you may have regarding this formulation.

Frequently Asked Questions

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What is Fentanyl Citrate 25 µg/0.1 mL Nasal Spray used for?

Fentanyl Citrate 25 µg/0.1 mL Nasal Spray is used for managing breakthrough pain in patients who are already receiving and are tolerant to opioid therapy for their underlying persistent pain.

How is the Fentanyl Citrate Nasal Spray administered?

The nasal spray is administered by spraying the liquid formulation into the nasal cavity, allowing for rapid absorption through the nasal mucosa.

What are the benefits of using a nasal spray for Fentanyl Citrate?

The nasal spray provides a quick onset of action due to the rich blood supply in the nasal cavity, offering rapid relief from pain. It is also non-invasive and easy to use.

How should I store the Fentanyl Citrate Nasal Spray?

Store the nasal spray at room temperature, away from light and moisture. Keep it out of reach of children and pets.

Can I use the nasal spray if I have a cold or nasal congestion?

If you have a cold or nasal congestion, consult your healthcare provider before using the nasal spray, as these conditions may affect the absorption of the medication.

What should I do if I miss a dose of the nasal spray?

Fentanyl Citrate Nasal Spray is used as needed for breakthrough pain, so there is no regular dosing schedule. Use it only when you experience pain.

Are there any side effects associated with Fentanyl Citrate Nasal Spray?

Common side effects may include nausea, dizziness, drowsiness, and nasal irritation. Serious side effects can include respiratory depression and allergic reactions. Contact your healthcare provider if you experience any severe side effects.

Can I drive after using Fentanyl Citrate Nasal Spray?

Fentanyl can cause drowsiness and impair your ability to drive or operate machinery. Avoid these activities until you know how the medication affects you.

Is Fentanyl Citrate Nasal Spray addictive?

Fentanyl is an opioid and has the potential for abuse and addiction. Use it only as prescribed by your healthcare provider.

What should I do in case of an overdose?

In case of an overdose, seek emergency medical attention immediately. Symptoms of overdose may include severe drowsiness, slow or shallow breathing, and loss of consciousness.

About this compounded preparation

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.

This preparation is a controlled substance. Additional prescribing, refill, and shipping restrictions apply, and the states Bayview can dispense it to are narrower than for non-controlled preparations.

Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.
For prescribers

How to e-prescribe this formula

Controlled substance: e-prescribe only (EPCS). Faxed, phoned, and handwritten prescriptions cannot be filled. Rhode Island law (R.I. Gen. Laws § 21-28-3.18) requires Schedule II to V prescriptions to be transmitted electronically.
1

Find Bayview in your EHR's pharmacy directory

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.

NCPDP4106882NPI1750455143Address3844 Post Rd, Warwick, RI 02886Phone(401) 284-4505Fax(401) 284-4506
2

Enter the formula as a compound

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.

3

Copy the prescription details

RxFormula name
Dose formDose form
Quantity________
SigAs directed by prescriber
Refills____
PharmacyBayview Pharmacy, Warwick RI, NCPDP 4106882
Copy prescription details

Quantity and directions are starting points for this dose form, not treatment recommendations. Dosing remains the prescriber's responsibility.

4

Send it

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.

Do not use Notes to Pharmacy for the formula. Some EHRs keep that field internal and never transmit it. A prescription that arrives without the formula is delayed while we call your office.

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.

Fentanyl Citrate 25 µg/0.1 mL Nasal Spray
Nasal Spray
10 mL
controlled

Inhale intranasally

Twice daily