Fentanyl Cit 800mcg Oral Transmcsl

Fentanyl is a potent, synthetic opioid analgesic that acts primarily as an agonist at the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic effects 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 when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 abnormal heartbeat (fast or slow)
Seizures or depression
Difficulty controlling body movements
Swelling in the arms or legs
Changes in vision

Serotonin Syndrome: A Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening condition. Seek medical help immediately if you experience:

Agitation or changes in balance
Confusion or hallucinations
Fever or abnormal heartbeat
Flushing or muscle twitching or stiffness
Seizures or shivering/shaking
Excessive sweating or severe diarrhea, nausea, or vomiting
Severe headache

Adrenal Gland Problems: A Rare but Serious Condition

Taking an opioid medication like this one may lead to a rare but serious adrenal gland problem. Contact your doctor right away if you experience:

Extreme fatigue or weakness
Fainting or severe dizziness
Severe nausea, vomiting, or decreased appetite

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dizziness, drowsiness, tiredness, or weakness
Dry mouth or constipation
Diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Headache or feeling cold
Difficulty sleeping or excessive sweating
* Irritation at the site of administration

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. 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, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Kidney or liver disease
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as 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 enable them to verify the safety of taking this medication in conjunction with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

Important Warnings and Precautions

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. Be cautious 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, contact your doctor. Do not take more than the prescribed dose.

Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

Safe Use and Dosage
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 decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, contact your doctor.

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

Diabetes Considerations
If you have diabetes, inform your doctor, as some products may contain sugar.

Geriatric Use
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) or within 14 days of MAOI discontinuation (risk of severe, unpredictable reactions including serotonin syndrome or opioid toxicity).
• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, troleandomycin) in non-opioid tolerant patients (risk of fatal respiratory depression).
• Patients who are not opioid tolerant (risk of fatal respiratory depression).

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice) (increased fentanyl plasma concentrations, leading to increased opioid effects and respiratory depression).
• Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol) (additive CNS depression, profound sedation, respiratory depression, coma, death).
• 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 analgesic effect or precipitate withdrawal symptoms).

• Anticholinergic drugs (e.g., atropine, scopolamine) (increased risk of urinary retention and/or severe constipation).
• Diuretics (opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone).

• Not available

• Respiratory depression (slow, shallow breathing)
• Excessive sedation/somnolence
• Dizziness
• Nausea
• Vomiting
• Constipation
• Dry mouth
• Headache
• Pruritus
• Signs of opioid withdrawal (if abruptly discontinued)

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, 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 and respiratory depression. Monitor infants for increased sleepiness, difficulty breathing, or limpness.

Safety and efficacy not established in pediatric patients under 16 years of age. Contraindicated in opioid non-tolerant patients, including children. Accidental ingestion in children can be fatal.

Use with caution. Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Consider lower initial doses and slower titration. Monitor closely for adverse effects.

• Fentanyl lozenge is ONLY for opioid-tolerant cancer patients experiencing breakthrough pain. It is NOT for opioid-naïve patients or for acute pain management.
• Strict adherence to the titration schedule is crucial. Start with the lowest dose (200 mcg) and titrate upwards in increments until effective pain relief is achieved with tolerable side effects.
• Patients should be instructed to suck the lozenge, not chew or swallow it, to ensure proper transmucosal absorption.
• Due to the high risk of respiratory depression and accidental overdose, fentanyl lozenge is part of a strict REMS program. Prescribers, pharmacists, and patients must be enrolled.
• Emphasize safe storage and disposal. Unused or expired units must be flushed down the toilet immediately to prevent accidental exposure.
• Counsel patients on the signs of respiratory depression and the importance of seeking immediate medical attention or administering naloxone if available.

• Other short-acting opioids (e.g., oral morphine, oxycodone, hydromorphone) for breakthrough pain (though onset may be slower than TIRF products).
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain.
• Adjuvant analgesics (e.g., gabapentin, pregabalin, antidepressants) for neuropathic pain.
• Regional anesthesia or nerve blocks.
• Radiation therapy or chemotherapy for underlying cancer pain.

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. 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 immediately. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.