Fentanyl Cit 1200mcg 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 actions are analgesia and sedation. It produces its analgesic effects by binding to and activating mu-opioid receptors, which are G-protein coupled receptors that inhibit adenylate cyclase, leading to a decrease in intracellular cAMP. This results in hyperpolarization of neurons and inhibition of neurotransmitter release, thereby modulating pain perception.

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 signs or symptoms, contact your doctor or seek medical attention immediately:

Allergic reaction symptoms, 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
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ 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 Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:

Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or slow)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Adrenal Gland Problems: A Rare but Serious Condition

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

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

Other Possible Side Effects

While many people may not experience side effects or may only have mild ones, it's essential to be aware of the following possible side effects:

Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
Excessive sweating
Irritation at the site of administration

If you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 blockage 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks 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.

Prolonged or regular use of opioid medications like this one can cause dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or severe problems. Consult your doctor before changing your dose or stopping the medication. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

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 you experience new pain, contact your doctor immediately. Do not take more than the prescribed dose.

Interactions and Precautions
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.

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

Long-term Effects
Prolonged 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 problems, contact your doctor.

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

Special Considerations
If you have diabetes (high blood sugar), consult your doctor, as some products may contain sugar. 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 excessively sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) (within 14 days of use due to risk of serotonin syndrome or severe respiratory depression)
• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, saquinavir, troleandomycin, nefazodone) due to increased fentanyl exposure and risk of respiratory depression.

• Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol) due to additive CNS depression, respiratory depression, hypotension, and profound sedation, coma, or death.
• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice) due to increased fentanyl exposure.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) due to risk of serotonin syndrome.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) due to decreased fentanyl exposure and potential for reduced efficacy or withdrawal symptoms.
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) due to potential for reduced analgesic effect or precipitation of withdrawal symptoms.

• Anticholinergic drugs (e.g., atropine, scopolamine) due to increased risk of urinary retention and severe constipation.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness or lightheadedness
• Nausea and vomiting
• Constipation
• Dry mouth
• Pruritus (itching)
• Confusion or disorientation
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)

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. Breastfeeding is not recommended during treatment with Fentanyl Citrate Oral Transmucosal Lozenge due to the potential for serious adverse reactions in breastfed infants, including sedation and respiratory depression.

Safety and efficacy have not been established in pediatric patients under 16 years of age. Accidental ingestion in children is a major risk and can be fatal. Strict storage and disposal instructions must be followed.

Use with caution in elderly patients. Start with the lowest effective dose (200 mcg) and titrate slowly. Elderly patients may be more sensitive to the effects of fentanyl, including respiratory depression, and may have decreased hepatic or renal function, which can affect drug clearance.

• Fentanyl Citrate Oral Transmucosal Lozenge is for opioid-tolerant patients only. Never prescribe to opioid-naive patients due to the risk of fatal respiratory depression.
• Strict adherence to the REMS program is mandatory for prescribing and dispensing this medication.
• Patients must be carefully titrated to an effective dose for breakthrough pain. The initial dose is always 200 mcg, regardless of the patient's prior opioid use.
• Emphasize proper administration: the lozenge should be sucked, not chewed, and consumed over 15 minutes. No food or drink during administration.
• Educate patients and caregivers on the critical importance of safe storage (locked, out of reach of children) and proper disposal (flush down toilet immediately after use or when no longer needed).
• Monitor closely for signs of respiratory depression and sedation, especially during dose titration or with concomitant use of other CNS depressants or CYP3A4 inhibitors.
• Naloxone should be readily available for patients prescribed this medication, and patients/caregivers should be educated on its use.
• This formulation is specifically for breakthrough cancer pain and should not be used for acute pain, post-operative pain, or non-cancer pain.

• Other short-acting opioids for breakthrough pain (e.g., immediate-release oxycodone, hydromorphone, morphine)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild-moderate pain or as adjuncts
• Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
• Regional anesthesia or nerve blocks
• Radiation therapy or chemotherapy for cancer-related 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 counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, 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 without delay. When seeking help, be prepared to disclose what was taken, the quantity, and the timing of the incident to ensure appropriate treatment.