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Formulas

Fentanyl Citrate 2 mg Oral Troches

The Fentanyl Citrate 2 mg Oral Troches are square-shaped solid dosage forms intended for buccal administration. These troches are specifically formulated to dissolve slowly in the mouth, allowing for the medication to be absorbed through the oral mucosa. This method of delivery is designed to provide targeted local or systemic effects. Fentanyl, the active ingredient, is a potent opioid analgesic used to manage severe pain that requires continuous, around-the-clock treatment not controlled by other medications. It is commonly prescribed for patients with cancer-related pain, as well as for other chronic pain conditions where opioid therapy is deemed appropriate by a healthcare provider.

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Troches
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Formula Information

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Fentanyl Citrate 2 mg Oral Troches are square-shaped solid dosage forms meticulously crafted to dissolve gradually when placed in the mouth. This unique delivery system is designed to facilitate the absorption of medication through the oral mucosa, leading to either targeted local relief or systemic therapeutic effects. Fentanyl, the active ingredient in these troches, is a potent opioid analgesic that provides significant pain relief and is commonly used in the management of severe chronic pain that requires long-term opioid treatment, such as cancer-related pain, and may also be employed in certain cases of non-malignant chronic pain where alternative treatment options are inadequate.

The formulation of Fentanyl Citrate 2 mg Oral Troches allows for a controlled and steady release of the medication, which can be advantageous for patients who require consistent plasma levels of fentanyl for prolonged periods. The troches bypass the gastrointestinal tract, reducing the potential for first-pass metabolism and ensuring more of the drug reaches systemic circulation. This can be particularly beneficial for patients with gastrointestinal issues that may interfere with the absorption of oral medications. Additionally, the use of troches can provide a more convenient and discreet method of administration compared to other dosage forms, such as injections or transdermal patches, enhancing patient compliance.

It is crucial for both patients and prescribers to understand that fentanyl is a highly potent opioid and its use must be approached with caution. Appropriate dosing, vigilant monitoring for signs of opioid toxicity, and adherence to guidelines for opioid prescribing are essential to minimize the risks of overdose and dependency. Patients should be thoroughly assessed for their pain management needs and their ability to safely use opioid therapy before initiating treatment with Fentanyl Citrate 2 mg Oral Troches. Additionally, patients should be counseled on the proper use of the troches, including the importance of not chewing or swallowing the dosage form to ensure the intended pharmacokinetic profile is maintained.

For those considering Fentanyl Citrate 2 mg Oral Troches for pain management, it is imperative to consult with a healthcare professional to determine if this formulation is appropriate for the individual's specific medical condition and pain management needs. Our team at Bayview Pharmacy is equipped with the expertise to provide guidance on the use of this formulation and to answer any questions regarding its indications, administration, and potential side effects. If you have any questions or require further information, please do not hesitate to reach out to us for professional advice and support.

Drug Interactions

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Fentanyl citrate is a potent synthetic opioid analgesic used for managing severe pain or for anesthesia. When formulated as a 2 mg oral troche, it is designed to be dissolved slowly in the mouth, allowing for the medication to be absorbed through the oral mucosa. This route of administration can provide targeted local or systemic effects. However, due to its potency and pharmacological profile, fentanyl can interact with a variety of substances, which may lead to serious adverse effects or reduced 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 should be advised to avoid or limit the use of alcohol and consult their healthcare provider before taking any CNS depressants.

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 may enhance the effects of fentanyl, increasing the risk of serotonin syndrome, a potentially life-threatening condition. Patients should inform their healthcare provider if they are taking or have recently taken MAOIs.

Medications that inhibit the cytochrome P450 3A4 (CYP3A4) enzyme can also interact with fentanyl. These include certain antifungals (such as ketoconazole and itraconazole), macrolide antibiotics (such as erythromycin and clarithromycin), and protease inhibitors used to treat HIV. Inhibitors of CYP3A4 can lead to increased fentanyl plasma concentrations, potentially causing an overdose or increased side effects. Conversely, inducers of CYP3A4, such as rifampin, carbamazepine, and phenytoin, can decrease fentanyl plasma concentrations, potentially leading to reduced efficacy.

Patients taking serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and triptans, should be monitored for signs of serotonin syndrome, especially when starting fentanyl or increasing the dose.

Additionally, fentanyl may interact with other opioid agonists and antagonists, muscle relaxants, anticholinergic drugs, and blood thinners (anticoagulants). These interactions can lead to increased effects of these drugs or increased risk of bleeding in the case of anticoagulants.

Given the complexity and potential severity of drug interactions with fentanyl, it is crucial for patients to provide a complete list of all medications, including over-the-counter drugs and herbal supplements, to their healthcare provider. Prescribers should carefully consider the patient's current medication regimen before prescribing fentanyl troches and monitor for any signs of adverse interactions. Dose adjustments or alternative therapies may be necessary to ensure patient safety.

If you have any questions or require further information regarding drug interactions with fentanyl citrate oral troches, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide guidance and support to both patients and prescribers.

How Does it Work

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Fentanyl Citrate 2 mg Oral Troches are square-shaped solid dosage forms that are specifically designed to be placed in the mouth, where they dissolve slowly over time. The active ingredient, fentanyl citrate, is a potent opioid analgesic that provides pain relief. When a troche is placed in the mouth, the fentanyl is gradually released and absorbed through the oral mucosa, the mucous membrane lining the inside of the mouth. This method of delivery allows for the medication to enter the bloodstream directly, bypassing the gastrointestinal tract and first-pass metabolism in the liver, which can lead to a more rapid onset of action compared to oral tablets that are swallowed.

The fentanyl in the troches binds to opioid receptors in the central nervous system, altering the perception of and response to pain. It is particularly effective in managing 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. The formulation is also used in other chronic pain conditions where patients require opioid analgesia. The design of the troche allows for the patient to have some control over the rate of absorption; the troche can be moved around the mouth and the rate of dissolution can be somewhat controlled by the amount of saliva produced and the movements of the mouth.

It is important for both patients and prescribers to understand that fentanyl is a very powerful opioid and its use must be carefully monitored to avoid the risk of overdose and addiction. The troches should only be used by patients who are opioid-tolerant and should not be used for acute or postoperative pain. Prescribers must ensure that patients are given clear instructions on how to use the troches safely and are aware of the potential side effects, which can include nausea, dizziness, constipation, and respiratory depression. Due to the risk of serious adverse events, fentanyl troches are typically reserved for use in a controlled setting under the guidance of a healthcare professional experienced in the use of potent opioids for the management of chronic pain.

If you have any questions about Fentanyl Citrate 2 mg Oral Troches or their appropriate use, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is here to provide the necessary information and support to ensure the safe and effective use of this medication.

Other Uses

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Fentanyl Citrate 2 mg Oral Troches are primarily utilized for their potent analgesic effects in managing severe pain that requires continuous, around-the-clock opioid analgesia and for which alternative treatments are inadequate. The specific design as a square-shaped solid troche allows for slow dissolution and direct absorption through the oral mucosa, providing a rapid onset of analgesia while minimizing gastrointestinal side effects. While its primary use is in the management of pain, there may be investigational or off-label applications for this formulation.

In some instances, these troches might be used off-label for the management of breakthrough pain in patients already on chronic opioid therapy. This requires close monitoring and a clear understanding of the patient's tolerance to opioids. It’s important to note that fentanyl troches should not be used for the treatment of acute or postoperative pain or for those individuals who are not opioid-tolerant. Besides pain management, research into alternative applications for fentanyl, including the use of troches for the sedation of ventilated patients or in palliative care settings to alleviate dyspnea, is ongoing. However, these uses are less established and should be approached with caution, under the guidance of a healthcare provider.

The pharmacokinetics profile of fentanyl delivered via oral transmucosal dosage forms may also make them suitable for specific patient populations who require non-invasive delivery methods, such as those who have difficulties swallowing or those who have gastrointestinal issues that would interfere with the absorption of orally ingested medications. Regardless of the use, due to the high potential for abuse, addiction, and serious side effects, it is imperative that prescribers adhere to strict guidelines and that patients are closely monitored. Given the risks associated with the powerful opioid contained in these troches, clinicians should assess individual patient risk for opioid abuse or misuse prior to prescribing and while treating with fentanyl citrate troches.

Lastly, because of the nuanced and potentially high-risk nature of this medication, we at Bayview Pharmacy place a strong emphasis on thorough and open communication with our patients and prescribing healthcare providers. If there are any questions regarding the use of Fentanyl Citrate 2 mg Oral Troches, or if healthcare providers are considering this formulation for alternative applications, we encourage them to reach out to us for detailed information, guidance, and collaboration to ensure patient safety and optimal therapeutic outcomes.

Frequently Asked Questions

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What are Fentanyl Citrate 2 mg Oral Troches?

Fentanyl Citrate 2 mg Oral Troches are square-shaped solid dosage forms containing fentanyl citrate, a strong opioid pain medication. They are designed to dissolve slowly in the mouth, allowing the medication to be absorbed through the oral mucosa for either targeted local relief or systemic effects to manage pain.

How do I use Fentanyl Citrate Oral Troches?

To use the Fentanyl Citrate Oral Troches, place the troche in your mouth and allow it to dissolve slowly. Do not chew or swallow the troche, as it is intended to be absorbed through the lining of your mouth for effectiveness.

How long does it take for Fentanyl Citrate Oral Troches to work?

The onset of action for Fentanyl Citrate Oral Troches can vary, but you may begin to feel pain relief soon after the troche starts to dissolve in your mouth, typically within 15 to 30 minutes. However, individual response times can vary.

Can I eat or drink while using Fentanyl Citrate Oral Troches?

It's best to avoid eating or drinking while the troche is dissolving in your mouth, as this could interfere with the absorption of the medication.

What should I do if I accidentally swallow the Fentanyl Citrate Troche?

If you swallow the troche, you may not receive the intended dose as the medication is designed to be absorbed through the mouth's mucosa. Contact your healthcare provider for guidance, but do not take another troche without medical advice.

Are there any potential side effects of using Fentanyl Citrate Oral Troches?

As with any medication, there are potential side effects. Common ones include nausea, dizziness, drowsiness, constipation, and headaches. Serious side effects can occur as well and should be reported to your doctor immediately. These include difficulty breathing, extreme drowsiness, or signs of an allergic reaction.

What should I do if I miss a dose?

If you miss a dose, use the troche as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a missed one.

How should Fentanyl Citrate Oral Troches be stored?

Store the troches at room temperature, away from direct light and moisture. Keep them in the original packaging until ready for use, and always out of reach of children and pets.

Is it possible to overdose on Fentanyl Citrate Oral Troches?

Yes, it is possible to overdose on fentanyl, as it is a potent opioid medication. An overdose can be life-threatening and requires immediate medical attention. Symptoms of an overdose may include slow breathing, extreme drowsiness, or loss of consciousness.

Can I drive or operate heavy machinery while using Fentanyl Citrate Oral Troches?

Because fentanyl can cause drowsiness, dizziness, or impaired thinking, you should not drive or operate heavy machinery until you know how the medication affects you and are certain you can perform such activities safely.

How should I dispose of unused or expired Fentanyl Citrate Oral Troches?

Unused or expired Fentanyl Citrate Oral Troches should be disposed of promptly and properly due to the risk of misuse, abuse, or accidental exposure. Contact your pharmacy or local waste disposal company for specific instructions on medication disposal in your area.

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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.