Fentanyl Cit 400mcg Oral Transmcsl

Fentanyl is a potent, synthetic opioid agonist that primarily interacts with mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic actions are analgesia and sedation. It also produces respiratory depression, miosis, euphoria, and physical dependence.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness or lightheadedness
+ Headache or feeling sleepy
+ Weakness, shaking, or a rapid heartbeat
+ Confusion, hunger, or excessive sweating
Severe dizziness or fainting
Confusion or disorientation
Severe constipation or stomach pain, which may indicate a serious bowel problem
Breathing difficulties, such as:
+ Slow or shallow breathing
+ Noisy breathing or breathing problems during sleep (sleep apnea)
Chest pain or an irregular heartbeat (fast or slow)
Seizures or depression
Difficulty controlling body movements
Swelling in the arms or legs
Changes in vision
Serotonin syndrome, a potentially life-threatening condition that may occur when taking this medication with certain other drugs. Symptoms include:
+ Agitation or changes in balance
+ Confusion, hallucinations, or fever
+ Rapid or abnormal heartbeat, flushing, or muscle twitching or stiffness
+ Seizures, shivering or shaking, or excessive sweating
+ Severe diarrhea, stomach upset, or vomiting, or a severe headache
Adrenal gland problems, a rare but serious condition that may occur when taking opioid medications like this one. Symptoms include:
+ Extreme fatigue or weakness
+ Fainting or severe dizziness
+ Severe stomach upset, vomiting, or decreased appetite

Other Possible Side Effects

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:

Dizziness, drowsiness, fatigue, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, or decreased appetite
Headache or feeling cold
Difficulty sleeping or excessive sweating
* Irritation at the site of administration

If you experience any of these side effects or have concerns about others, consult your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Presence of mouth sores, which may require discussion with your doctor

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dose of any medication without consulting your doctor first.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.

Additionally, regular use of opioid medications like this one can result in dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions carefully. Monitor for signs of withdrawal, increased pain, mood changes, suicidal thoughts, or other adverse effects, and report them to your doctor.

Safe Use
Do not exceed the prescribed dose, frequency, or duration of treatment, as this may increase the risk of severe side effects. Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.

If your pain worsens, you experience increased sensitivity to pain, or you develop new pain, contact your doctor immediately. Do not take more than the prescribed dose.

Interactions and Contraindications
If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor. Do not take this medication with alcohol or products containing alcohol, as this may lead to unsafe and potentially fatal effects.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

Hormonal Effects
Long-term use of opioid medications may lead to decreased sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.

Dental Care
Maintain good oral hygiene and schedule regular dental check-ups.

Diabetes Considerations
If you have high blood sugar (diabetes), consult your doctor, as some products may contain sugar.

Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

Breastfeeding
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe CNS depression)
• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, troleandomycin) in patients not already receiving fentanyl (risk of fatal respiratory depression)

• Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
• Strong CYP3A4 inhibitors (in patients already on fentanyl): Increased fentanyl plasma concentrations, leading to increased opioid effects and potentially fatal respiratory depression.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine): May reduce fentanyl's analgesic effect or precipitate withdrawal symptoms.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole): Increased fentanyl exposure, requiring close monitoring and potential dose reduction.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, potentially leading to reduced efficacy or withdrawal symptoms.
• Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation.

• Not available (most interactions are significant due to fentanyl's potency and narrow therapeutic index)

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness
• Nausea
• Vomiting
• Constipation
• Confusion
• Itching
• Pinpoint pupils
• Cold, clammy skin

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated.

Fentanyl is excreted into breast milk. It is generally not recommended for use during breastfeeding due to the risk of serious adverse reactions in the infant, including sedation, respiratory depression, and death. If use is unavoidable, monitor the infant closely for signs of sedation and respiratory depression.

Safety and efficacy have not been established in pediatric patients for breakthrough cancer pain. Use is generally not recommended. Accidental ingestion in children can be fatal.

Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially respiratory depression and sedation.

• Fentanyl lozenge is ONLY for opioid-tolerant patients experiencing breakthrough cancer pain. It is NOT for opioid-naive patients or for acute pain.
• Dosing is highly individualized and requires careful titration to find the effective dose for each breakthrough pain episode.
• Patients must be instructed on proper administration: place in mouth, allow to dissolve slowly over 15 minutes, do not chew or swallow whole.
• Emphasize the critical importance of secure storage and proper disposal to prevent accidental exposure, which can be fatal, especially in children.
• Educate patients and caregivers about the signs of respiratory depression and the availability of naloxone.
• Avoid concomitant use with strong CYP3A4 inhibitors or other CNS depressants due to the risk of life-threatening respiratory depression.

• Other rapid-acting transmucosal/intranasal fentanyl formulations (e.g., fentanyl buccal tablet, fentanyl sublingual tablet, fentanyl nasal spray)
• Other short-acting oral opioids (e.g., immediate-release morphine, oxycodone, hydromorphone) for breakthrough pain, though onset may be slower.

If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Carefully read this guide when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide the following information: the substance involved, the quantity taken, and the time of the incident.