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Fentanyl Citrate 800 mcg Oral Troches

Fentanyl Citrate 800 mcg Oral Troches are square-shaped solid dosage forms intended for buccal administration. These troches are designed to dissolve slowly in the mouth, facilitating the absorption of the active ingredient, fentanyl citrate, through the oral mucosa. This delivery method allows for targeted local or systemic effects. Fentanyl is a potent opioid analgesic, and these troches are typically used in the management of severe chronic pain in patients who require continuous opioid analgesia and are already tolerant to opioid therapy. They may also be employed in the treatment of breakthrough cancer pain in patients who are already receiving and who are tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.

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Fentanyl Citrate
Troches
6564c274e34f1a18e235d2c9
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Formula Information

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Fentanyl Citrate 800 mcg Oral Troches are square-shaped solid dosage forms specifically compounded to provide pain relief through the mucosal tissues of the mouth. These troches are designed to dissolve slowly, allowing for the gradual release and absorption of fentanyl citrate, a potent opioid analgesic, directly into the bloodstream. This method of delivery is particularly beneficial for patients who may have difficulty swallowing or require rapid onset of pain relief without the gastrointestinal side effects associated with oral tablet ingestion.

The fentanyl in these troches acts on the central nervous system to relieve pain by binding to opioid receptors, which can alter the perception and response to pain. The 800 mcg dosage is carefully calculated to provide effective pain management for patients with severe chronic pain, such as that associated with cancer, or for breakthrough pain where other medications have not been sufficient. Due to the high potency of fentanyl, these troches should only be used in patients who are opioid-tolerant and under strict medical supervision.

It is crucial for both patients and prescribers to understand the potential risks associated with fentanyl, including respiratory depression, addiction, and misuse. Prescribers must closely monitor patients for signs of opioid addiction and overdose. Patients should be advised to use the troches exactly as prescribed and to keep them out of reach of children and individuals for whom they are not intended. Additionally, patients should be informed about the potential for serious interactions with other CNS depressants and alcohol.

For those considering Fentanyl Citrate 800 mcg Oral Troches for pain management, it is essential to have a comprehensive understanding of the patient's medical history, current medications, and potential risk factors for opioid misuse. Bayview Pharmacy's team of compounding pharmacists is available to answer any questions and provide detailed information to ensure safe and effective use of this formulation. If you have any questions or require further assistance, please do not hesitate to reach out to us.

Drug Interactions

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Fentanyl citrate is a potent synthetic opioid analgesic that is used for managing severe pain, such as that experienced by cancer patients, when other pain treatments are not effective. It is important to note that due to its high potency and potential for abuse, fentanyl should only be used by patients who are already tolerant to opioid therapy. The oral troche formulation allows for the medication to be absorbed through the oral mucosa, providing a rapid onset of pain relief.

When considering the use of fentanyl citrate oral troches, it is crucial to be aware of potential drug interactions that may occur. Fentanyl is metabolized primarily by the cytochrome P450 3A4 (CYP3A4) enzyme system. Therefore, concomitant use with agents that affect CYP3A4 activity can lead to significant alterations in fentanyl plasma concentrations. Inhibitors of CYP3A4 such as ketoconazole, erythromycin, and ritonavir may increase fentanyl levels, leading to enhanced or prolonged opioid effects, including potentially fatal respiratory depression. Conversely, inducers of CYP3A4 such as rifampin, carbamazepine, and phenytoin may decrease fentanyl levels, reducing its efficacy.

Additionally, fentanyl should be used with caution when combined with central nervous system (CNS) depressants, including other opioids, benzodiazepines, muscle relaxants, sedatives, hypnotics, or general anesthetics. These combinations can result in additive CNS depression, hypotension, profound sedation, or coma. The use of fentanyl with serotonergic drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase inhibitors (MAOIs), can increase the risk of serotonin syndrome, a potentially life-threatening condition.

Patients taking fentanyl should also avoid consuming grapefruit or grapefruit juice, as these can inhibit CYP3A4 and increase fentanyl levels. Alcohol consumption should be avoided as well, due to the risk of exacerbated CNS depression and respiratory failure. Additionally, caution is advised when fentanyl is prescribed to patients taking anticholinergic medications, as the combination may lead to urinary retention and constipation.

It is also important to consider the potential for fentanyl to interact with antihypertensive medications and diuretics, as opioid-induced release of vasopressin can lead to altered blood pressure control. Patients with cardiovascular disease should be monitored closely when initiating or adjusting fentanyl therapy.

Given the complexity and seriousness of these potential drug interactions, it is imperative that prescribers carefully evaluate a patient's current medication regimen before prescribing fentanyl citrate oral troches. Patients should be instructed to inform their healthcare provider of all medications they are taking, including over-the-counter drugs and herbal supplements. For any questions or concerns regarding drug interactions with fentanyl citrate oral troches, please reach out to us at Bayview Pharmacy for professional advice and guidance.

How Does it Work

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Fentanyl Citrate 800 mcg Oral Troches are square-shaped solid dosage forms that are specifically designed to dissolve slowly when placed in the mouth. The active ingredient, fentanyl citrate, is a potent opioid analgesic that provides pain relief. When a troche is placed in the oral cavity, it gradually dissolves, releasing the medication. The fentanyl is then absorbed through the oral mucosa, the mucous membrane lining the inside of the mouth. This route of administration 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.

The absorption through the oral mucosa also provides a more consistent plasma concentration of the drug, which can be beneficial for managing pain. Fentanyl works by binding to the body's opioid receptors, which are found in the brain, spinal cord, and other organs. By attaching to these receptors, fentanyl can block the transmission of pain signals in the nervous system, providing relief to the patient. This makes fentanyl oral troches particularly useful for managing breakthrough pain in cancer patients, which is a sudden flare of pain that "breaks through" the regular pain medication.

It is important to note that due to its potency and the risk of addiction, abuse, and misuse, fentanyl citrate should only be used in patients who are already receiving opioid therapy and are tolerant to its effects. This formulation is not intended for use in opioid-naive patients. Fentanyl troches are also used in chronic pain management when other pain relief methods are not effective. The 800 mcg dose is specifically tailored for patients with a high opioid tolerance and should be prescribed and monitored by a healthcare professional experienced in the use of potent opioids for the management of chronic pain.

For patients and prescribers considering the use of Fentanyl Citrate 800 mcg Oral Troches, it is crucial to understand the potential risks and to adhere strictly to the prescribed dosing regimen to minimize the risk of overdose and other serious complications. If you have any questions or require further information about this formulation and its appropriate use, 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 needed to ensure safe and effective treatment with this medication.

Other Uses

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Fentanyl citrate 800 mcg oral troches are primarily indicated for the management of severe, chronic pain in patients who require long-term opioid treatment and are already tolerant to opioid therapy. Such patients typically have cancer-related pain or other persistent pain conditions that have not responded to less potent analgesics. However, the unique delivery system of this formulation can be advantageous in other scenarios. For instance, fentanyl oral troches may be considered for use in breakthrough pain, a transient exacerbation of pain that occurs despite stable and adequately managed chronic pain. The rapid mucosal absorption can provide quick relief without the need for intravenous access.

Furthermore, in palliative care settings where ease of administration is crucial, these troches may offer an alternative route for patients with swallowing difficulties or those who cannot tolerate oral medications due to nausea or vomiting. In any case, since fentanyl is a potent opioid, the prescriber must assess the patient's previous opioid use, typical dosage, and level of tolerance before considering fentanyl citrate troches for alternative indications to ensure safety and prevent overdose risks.

It's also worth mentioning that there has been some interest in the use of these troches for procedural sedation or premedication prior to stressful events such as surgery or invasive diagnostic procedures, thanks to the troche's ability to absorb directly into the bloodstream through the oral mucosa. However, these would be considered off-label uses and should only be pursued with careful consideration of the patient's overall health status, potential drug interactions, and the safety of such an approach under close medical supervision.

As compounding pharmacists, we are mindful of the potential for misuse and abuse of fentanyl-containing products. Consequently, it is essential that both patients and prescribers are well-informed about the proper use, potential side effects, and safety measures associated with fentanyl citrate troches. They should be dispensed and utilized with a high level of caution and always stored securely to prevent accidental ingestion or misuse. Given the complexity and risks associated with opioid formulations, we invite any questions you may have about the use of fentanyl citrate 800 mcg oral troches. Please don't hesitate to reach out to us for further clarification or guidance.

Frequently Asked Questions

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What are Fentanyl Citrate 800 mcg Oral Troches?

Fentanyl Citrate 800 mcg Oral Troches are square-shaped solid dosage forms that contain 800 micrograms of Fentanyl Citrate. They are designed to dissolve slowly in the patient's mouth, with the medication being absorbed through the oral mucosa for targeted local or systemic effects, depending on the formulation and purpose.

How do I use Fentanyl Citrate Oral Troches?

To use Fentanyl Citrate Oral Troches, place one troche in your mouth, usually between the gum and cheek or under the tongue, and allow it to dissolve completely. Do not chew or swallow the troche, as the medication is intended to be absorbed through the tissues in your mouth.

How long does it take for a Fentanyl Citrate Oral Troche to dissolve?

The time it takes for a Fentanyl Citrate Oral Troche to dissolve can vary, but it is formulated to dissolve slowly, allowing for gradual absorption over a period. It's important to allow the troche to dissolve fully without chewing or swallowing for proper medication absorption.

What are the potential side effects of Fentanyl Citrate Oral Troches?

Possible side effects can include nausea, constipation, dizziness, drowsiness, dry mouth, headache or sweating. Like any opioid medication, Fentanyl Citrate also carries a risk of addiction, abuse, and misuse, which can lead to overdose and death. Severe respiratory depression may also occur. Always report side effects to your healthcare provider.

Can I eat or drink after using a Fentanyl Citrate Oral Troche?

It is generally advised to avoid eating or drinking until the troche has completely dissolved and the medication has been absorbed. Eating or drinking too soon may reduce the effectiveness of the medication and increase the likelihood of swallowing the medication, which should be avoided.

How should I store Fentanyl Citrate Oral Troches?

Store Fentanyl Citrate Oral Troches at room temperature, away from light and moisture. Keep them out of reach of children and pets due to the high risk of fatal overdose from accidental ingestion.

What should I do if I miss a dose or overdose on Fentanyl Citrate Oral Troches?

If you miss a dose, take it as soon as you remember if it is within a certain timeframe. If it's nearly time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double up to make up for a missed dose. If an overdose is suspected, seek emergency medical attention immediately, as it can be life-threatening.

Are there any medications or foods that interact with Fentanyl Citrate Oral Troches?

Yes, some medications can interact with Fentanyl Citrate, including other opioids, sedatives, tranquilizers, muscle relaxants, and medications for anxiety or seizures. Certain herbal products and alcohol may also interact. Consult with your healthcare provider for a complete list of interactions.

Can I drive or operate machinery after using a Fentanyl Citrate Oral Troche?

No, Fentanyl Citrate can impair your thinking and reaction time. It is advised not to drive or operate heavy machinery until you know how the medication affects you and are sure you can perform such activities safely.

Is Fentanyl Citrate Oral Troche suitable for everyone?

Fentanyl Citrate Oral Troches are not suitable for everyone. Specifically, they should not be used in opioid-non-tolerant patients, patients with acute or severe bronchial asthma, or those with a known hypersensitivity to fentanyl or any components of the troche. A thorough medical history and consultation with a healthcare provider are necessary to determine if it is suitable for an individual.

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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.