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Fentanyl 80 mg/0.1 mL Nasal Spray

The Fentanyl 80 mg/0.1 mL Nasal Spray is a high-potency, liquid medication formulated for intranasal delivery. This spray is designed to deliver a precise dose of fentanyl, a powerful opioid analgesic, directly into the nasal cavity for rapid absorption into the systemic circulation. The formulation is intended for use in managing severe pain in patients who are already tolerant to opioid therapy, particularly in cancer-related pain management. It may also be utilized for breakthrough pain, which is a sudden flare-up of pain that occurs even when a patient is regularly taking pain medication. The nasal spray form allows for quick onset of pain relief, which is essential in acute pain situations. Due to the potency of fentanyl, this formulation is typically reserved for use in a controlled medical setting under the guidance of a healthcare professional.

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Fentanyl Citrate
Nasal Spray
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Formula Information

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Fentanyl 80 mg/0.1 mL Nasal Spray is a highly potent opioid analgesic formulation intended for the management of severe pain in patients who are already tolerant to opioid therapy. This liquid formulation is designed to be delivered as a nasal spray, allowing for rapid absorption through the nasal mucosa and quick onset of action. The nasal route of administration is particularly useful for patients who may have difficulty swallowing or where intravenous access is not available. It is also beneficial for breakthrough pain, which requires a fast-acting medication.

The concentration of fentanyl in this formulation is very high, at 80 mg per 0.1 mL, indicating that it is intended for use in a controlled medical setting under strict supervision by healthcare professionals. Fentanyl is a synthetic opioid that is 50-100 times more potent than morphine, and its use must be carefully titrated to avoid respiratory depression and other serious adverse effects. The small volume of 0.1 mL per spray allows for precise dosing, which is critical given the potency of the drug.

This nasal spray is used in the treatment of severe chronic pain, such as that associated with cancer, where the patient has developed tolerance to other opioids. It is not intended for use in opioid-naïve patients due to the risk of life-threatening respiratory depression. The rapid onset of action provided by the nasal spray formulation makes it an effective option for the management of acute episodes of pain that break through the patient's regular pain control regimen.

Patients and prescribers should be aware that due to the high risk of addiction, abuse, and misuse with opioids, even at recommended doses, fentanyl nasal spray should only be used in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. It is essential that patients are monitored closely for signs of addiction, abuse, and misuse. Furthermore, patients should be educated on the proper use of the nasal spray, including how to administer the medication and the importance of not exceeding the prescribed dose.

For healthcare providers, it is crucial to understand the pharmacokinetics and pharmacodynamics of fentanyl when prescribing this medication. Prescribers must be familiar with opioid equivalency conversions when switching patients from other opioids to fentanyl nasal spray to avoid accidental overdose. Additionally, prescribers should be prepared to provide necessary guidance on titration and monitoring for adverse effects, particularly respiratory depression.

If you have any questions or require further information about the Fentanyl 80 mg/0.1 mL Nasal Spray formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing support and guidance to ensure the safe and effective use of this medication.

Drug Interactions

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Fentanyl is a potent synthetic opioid analgesic with a rapid onset and short duration of action. It is primarily used for managing acute and chronic pain, including breakthrough pain in cancer patients. When administered as a nasal spray, fentanyl provides quick pain relief by being absorbed through the nasal mucosa directly into the bloodstream. However, due to its potency and pharmacological effects, fentanyl can interact with a variety of substances, which can lead to serious adverse effects or diminished therapeutic efficacy.

One of the most significant interactions is with central nervous system (CNS) depressants, such as benzodiazepines, barbiturates, anxiolytics, hypnotics, sedatives, and alcohol. Concurrent use of these substances with fentanyl can result in additive CNS depression, leading to increased risk of respiratory depression, hypotension, profound sedation, or even coma. Patients and prescribers should exercise caution and consider dose adjustments or monitoring when these agents are used together.

Another important interaction is with monoamine oxidase inhibitors (MAOIs). The use of fentanyl with MAOIs or within 14 days of stopping treatment with an MAOI can lead to serotonin syndrome, a potentially life-threatening condition, or opioid toxicity. Symptoms of serotonin syndrome may include mental status changes, autonomic instability, neuromuscular aberrations, and gastrointestinal symptoms. Prescribers should avoid concomitant use and seek alternative pain management strategies in patients taking MAOIs.

Additionally, fentanyl's metabolism is primarily mediated by the cytochrome P450 3A4 (CYP3A4) enzyme system. Drugs that inhibit CYP3A4, such as ketoconazole, erythromycin, and ritonavir, can lead to increased fentanyl plasma concentrations, resulting in enhanced or prolonged opioid effects. Conversely, CYP3A4 inducers, such as rifampin, carbamazepine, and phenytoin, can decrease fentanyl plasma levels, potentially leading to inadequate analgesia. Careful consideration and monitoring are advised when fentanyl is co-administered with CYP3A4 inhibitors or inducers.

Patients using fentanyl nasal spray should also be cautioned about the potential for interaction with serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and triptans. These combinations can increase the risk of serotonin syndrome, especially when fentanyl is initiated, when doses are increased, or when another serotonergic drug is added.

Lastly, partial agonist/antagonist and antagonist opioid analgesics, such as buprenorphine, nalbuphine, and naltrexone, may reduce the analgesic effect of fentanyl or precipitate withdrawal symptoms in patients who are opioid-dependent. These medications should be avoided in patients receiving fentanyl unless under the supervision of a healthcare provider with expertise in opioid detoxification and withdrawal management.

Given the complexity of these interactions and the high potency of fentanyl, it is crucial for prescribers to thoroughly review a patient's medication history and for patients to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements. If you have any questions or require further information regarding the safe use of fentanyl nasal spray, please reach out to us at Bayview Pharmacy for assistance.

How Does it Work

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The Fentanyl 80 mg/0.1 mL Nasal Spray is a potent opioid analgesic formulation intended for the management of severe pain in patients who are already tolerant to opioid therapy. This high-concentration liquid solution is designed to be administered as a fine mist directly into the nasal cavity, where the drug can be rapidly absorbed through the nasal mucosa.

Upon administration, the fentanyl nasal spray delivers a precise dose of the medication. Fentanyl, the active ingredient, is a synthetic opioid that is similar to morphine but is 50 to 100 times more potent. It works by binding to the body's opioid receptors, which are found in areas of the brain that control pain and emotions. When fentanyl attaches to these receptors, it can decrease the feeling of pain and increase feelings of relaxation and euphoria. This can provide significant pain relief to patients experiencing severe pain.

The nasal cavity's rich vascular supply allows for the rapid onset of action, as the drug is quickly absorbed into the bloodstream and then transported to the central nervous system. This mode of delivery is particularly useful for patients who require immediate pain relief or for those who may have difficulties with oral administration due to vomiting, oral mucositis, or other conditions that impair oral intake.

It is important to note that due to its high potency and the risk of serious adverse effects, including respiratory depression and addiction, fentanyl nasal spray should only be used in patients who are opioid-tolerant and under the strict supervision of a healthcare professional. This formulation is typically reserved for the treatment of breakthrough pain in cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

Patients and prescribers must be aware of the potential for abuse, misuse, and addiction associated with opioid analgesics, even at prescribed doses. Therefore, the use of fentanyl nasal spray should be accompanied by appropriate monitoring, patient education, and adherence to prescribing guidelines to minimize these risks.

If you have any questions or require further information about the Fentanyl 80 mg/0.1 mL Nasal Spray, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the support and guidance necessary for the safe and effective use of this medication.

Other Uses

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While Fentanyl 80 mg/0.1 mL Nasal Spray is often prescribed primarily for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain, it is important to note that the use of fentanyl nasal spray may extend to other applications as permitted within clinical guidelines and under the discretion of a healthcare provider. An off-label yet notable use of this formulation is in the management of acute pain episodes in patients who have a high opioid tolerance due to other chronic pain conditions or prior opioid exposure. The rapid onset of action of fentanyl via the nasal route can be advantageous in these circumstances, though strict monitoring is required due to the potency of fentanyl and the potential for serious adverse effects.

Additionally, in controlled clinical settings, fentanyl nasal spray has been utilized for its sedative properties during certain medical procedures that require analgesia and sedation. Again, due to the high potency and risk for respiratory depression, this must be done with appropriate expertise and in environments where resuscitation equipment is readily available. In emergency medicine, fentanyl nasal spray may sometimes be considered as an alternative to intravenous opioid administration, particularly when intravenous access is challenging or in pre-hospital care contexts, although this is less common and must be approached with caution.

It should be emphasized that fentanyl is a potent opioid and should only be used in patients who are opioid-tolerant to minimize the risk of opioid-induced respiratory depression, which can be fatal. Close monitoring and adherence to dosing recommendations are crucial. Before considering fentanyl nasal spray for any off-label use, it is essential to thoroughly assess the patient's past medical history, current medication profile, and their potential for opioid abuse or misuse. Healthcare providers must weigh the benefits against the risks and ensure that use is in line with robust clinical evidence or practice guidelines. Furthermore, patients and prescribes should engage in a detailed conversation about the indications, potential off-label uses, and the risks associated with such potent opioid therapy. If you have any questions or require additional information about the appropriate use of Fentanyl 80 mg/0.1 mL Nasal Spray for conditions beyond those for which it is commonly prescribed, please reach out to us at Bayview Pharmacy. We are here to provide the necessary guidance and support to optimize patient care with this highly potent dosage form.

Frequently Asked Questions

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What is Fentanyl 80 mg/0.1 mL Nasal Spray?

Fentanyl 80 mg/0.1 mL Nasal Spray is a strong prescription medication used to manage pain in patients who are opioid-tolerant. It delivers a liquid formulation of fentanyl, a potent opioid analgesic, in a spray form designed for administration through the nostrils, either for targeting local pain relief or systemic effects.

How is Fentanyl Nasal Spray administered?

The nasal spray should be used as directed by a healthcare provider. It is administered by gently inserting the nozzle into a nostril and pressing the pump to release a spray of the medication. Patients should not exceed the prescribed dose.

What are the systemic effects of using Fentanyl Nasal Spray?

As an opioid, fentanyl can provide significant pain relief by acting on the central nervous system. Systemic effects include analgesia, sedation, and a sense of relaxation, but can also include unwanted effects such as respiratory depression, altered mental states, and potential for abuse.

Is Fentanyl Nasal Spray suitable for everyone?

No, Fentanyl Nasal Spray is only suitable for patients who are already opioid-tolerant and who require continuous, around-the-clock pain relief that they cannot achieve with other medications. It is not suitable for treating pain that is not constant or for those who are opioid-naive.

Can Fentanyl Nasal Spray be used for acute pain relief?

Fentanyl Nasal Spray is not indicated for the relief of acute or postoperative pain, or for any pain that is mild or not expected to persist for an extended period. Only patients with chronic pain who require long-term opioid treatment and are opioid-tolerant should use this medication.

What should I do if I miss a dose of Fentanyl Nasal Spray?

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed one and do not increase the frequency of doses without consulting your healthcare provider.

What are the possible side effects of Fentanyl Nasal Spray?

Common side effects include drowsiness, dizziness, nausea, vomiting, constipation, and headaches. Serious side effects can include breathing difficulties, low blood pressure, confusion, tolerance, addiction, and overdose. Promptly seek medical attention if you experience any concerning or severe side effects.

Can I drive or operate machinery while using Fentanyl Nasal Spray?

No, fentanyl can impair your thinking and physical abilities. Patients using this medication should not drive or operate heavy machinery until they know how it affects them. It is important to avoid any tasks that would require you to be alert until you are sure you can perform them safely.

How should Fentanyl Nasal Spray be stored?

The nasal spray should be stored at room temperature and kept away from children, pets, and individuals who should not have access to the medication. To prevent misuse or accidental exposure, the nasal spray should also be stored in a locked place when not in use.

What should I do in the case of an overdose?

An overdose of fentanyl can be fatal, especially to someone who is not opioid-tolerant. Signs of overdose include extreme drowsiness, confusion, limp muscles, cold and clammy skin, slow heart rate, trouble breathing, or coma. If an overdose is suspected, seek emergency medical attention or call 911 immediately. Naloxone is an antidote for a fentanyl overdose and should be administered by a healthcare provider or a trained individual, if available.

Can Fentanyl Nasal Spray lead to drug dependency or abuse?

Yes, fentanyl is a highly potent opioid which can lead to dependency and abuse, even at prescribed doses. It is important to use the medication exactly as prescribed by your healthcare provider and to discuss any concerns regarding dependency or substance use disorder with them.

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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.