Fentanyl Cit 600mcg Oraltransmcsl

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. Other effects include 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 medical attention immediately:

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
+ 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 for serotonin syndrome, a severe and potentially deadly condition. Seek medical help right away if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Abnormal heartbeat
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 immediately 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 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 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 have. This will help ensure your safety while taking this medication. Never start, stop, or change 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, 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 increased pain, mood changes, suicidal thoughts, or other adverse effects.

Safe Use Guidelines
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 higher risk.

Long-term Use Considerations
Prolonged use of opioid medications like this one 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.

Maintain good oral hygiene and schedule regular dental check-ups. If you have diabetes, inform your doctor, as some products may contain sugar.

Special Populations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and 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 therapy (risk of serotonin syndrome or severe respiratory depression)
• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, saquinavir, troleandomycin, nefazodone) in patients not already receiving fentanyl (risk of increased fentanyl plasma concentrations and potentially fatal respiratory depression)

• Other CNS depressants (e.g., benzodiazepines, other opioids, sedatives/hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
• Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nelfinavir, saquinavir, troleandomycin, nefazodone): Increased fentanyl exposure, leading to potentially fatal respiratory depression. If co-administration is necessary, reduce fentanyl dose and monitor closely.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid): Risk of serotonin syndrome.
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine): May reduce the analgesic effect of fentanyl or precipitate withdrawal symptoms.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole, grapefruit juice): Increased fentanyl exposure, monitor for respiratory depression.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl exposure, 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)

• Severe drowsiness
• Dizziness
• Confusion
• Slow or shallow breathing
• Difficulty breathing
• Pinpoint pupils
• Extreme fatigue
• Unresponsiveness
• Nausea
• Vomiting
• Constipation
• Itching

Use during pregnancy is generally not recommended due to potential for fetal harm, including neonatal opioid withdrawal syndrome (NOWS). Benefits must clearly outweigh risks.

Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression, poor feeding), breastfeeding is not recommended during treatment with fentanyl lozenge. If breastfeeding cannot be avoided, monitor the infant closely for signs of sedation and respiratory depression.

Safety and efficacy have not been established in pediatric patients under 16 years of age. Use in opioid-tolerant adolescents 16 years and older should follow adult titration guidelines with extreme caution and close monitoring due to potential for increased sensitivity to respiratory depression.

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

• Fentanyl lozenge is for opioid-tolerant cancer patients only. Use in opioid-naïve patients can be fatal due to severe respiratory depression.
• Strict adherence to the REMS (Risk Evaluation and Mitigation Strategy) program is mandatory for prescribing, dispensing, and patient counseling.
• Patients and caregivers must be educated on the signs of respiratory depression and the availability and use of naloxone.
• Accidental ingestion by children or pets is a significant risk and can be fatal. Emphasize secure storage and proper disposal.
• Dose titration is crucial; start low and go slow, assessing efficacy and tolerability for each breakthrough pain episode.
• Only one lozenge should be used per breakthrough pain episode. Do not use more than 4 doses per day.
• Patients should not chew, suck, or swallow the lozenge whole, as this will reduce the transmucosal absorption and may lead to lower efficacy or delayed onset.

• 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 nerve blocks or other interventional pain procedures
• Radiation therapy for localized cancer pain

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or 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 whenever 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 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 seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.