Fentanyl Cit 1600mcg Oral Transmcsl

Fentanyl is a potent, synthetic opioid analgesic that acts primarily as a mu-opioid receptor agonist. Its principal therapeutic action is analgesia. Other pharmacological effects include respiratory depression, miosis, bradycardia, 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
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Chest pain
Abnormal heartbeat (fast or slow)
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Changes in eyesight

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
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, 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. Seek medical help immediately if you experience:

Extreme fatigue or weakness
Fainting
Severe dizziness
Severe stomach upset
Vomiting
Decreased appetite

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Dizziness, sleepiness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
Headache
Feeling cold
Trouble sleeping
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 should be discussed 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 consulting your doctor.

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 down 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. 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 become more sensitive to pain, or experience 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 can 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
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Concomitant use with benzodiazepines or other CNS depressants (including alcohol) in patients for whom alternatives are inadequate, due to risk of profound sedation, respiratory depression, coma, and death.
• Concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, nelfinavir, saquinavir, diltiazem, verapamil, grapefruit juice) due to increased fentanyl plasma concentrations and risk of serious adverse events, including fatal respiratory depression.
• Patients who are not opioid tolerant.

• Other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, tricyclic antidepressants): Increased risk of respiratory depression, hypotension, profound sedation, coma, and death.
• Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid): Risk of serotonin syndrome.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May decrease fentanyl plasma concentrations, leading to reduced efficacy and potential withdrawal symptoms.

• Anticholinergics: Increased risk of urinary retention and/or severe constipation.
• Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.

• Not available

• Respiratory depression (slow, shallow breathing, difficulty breathing)
• Excessive sedation/somnolence
• Dizziness/lightheadedness
• Nausea/vomiting
• Constipation
• Confusion
• Miosis (pinpoint pupils)
• Signs of opioid withdrawal (if abruptly discontinued or dose reduced too quickly)

Category C. Use during pregnancy 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. Due to the potential for serious adverse reactions in breastfed infants (e.g., respiratory depression, sedation), breastfeeding is not recommended during treatment with fentanyl. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.

Safety and effectiveness have not been established in pediatric patients under 16 years of age. Accidental ingestion in children can be fatal. This product is not for use in opioid non-tolerant pediatric patients.

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. Consider age-related decreases in renal and hepatic function.

• Fentanyl oral transmucosal lozenge is for opioid-tolerant patients only for breakthrough cancer pain. It is NOT for opioid-naive patients or for acute pain management.
• Strict adherence to the TIRF REMS program is mandatory for prescribing, dispensing, and patient enrollment.
• Titration is crucial. Patients must be started on the lowest dose (200 mcg) and titrated upwards under medical supervision until an effective dose is found.
• Instruct patients and caregivers on proper administration (suck, do not chew/swallow), safe storage, and disposal of unused lozenges.
• Emphasize the risk of accidental exposure, especially to children, and the importance of immediate medical attention if ingested.
• Warn patients about the dangers of concomitant use with CNS depressants (including alcohol) and CYP3A4 inhibitors.
• Patients should only use one lozenge per breakthrough pain episode and wait at least 4 hours before treating another episode.

• Other short-acting opioids (e.g., immediate-release oxycodone, hydromorphone, morphine) for breakthrough pain (though onset may be slower)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild-moderate pain (not typically sufficient for BTCP)
• Adjuvant analgesics (e.g., gabapentin, pregabalin, antidepressants) for neuropathic pain components
• Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
• Radiation therapy or chemotherapy for underlying cancer pain

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.

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