Fentanyl Cit 200mcg 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 action is analgesia. Other effects include respiratory depression, euphoria, miosis, 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 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
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
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. Seek medical help immediately if you experience:

Extreme fatigue or weakness
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

Dizziness
Drowsiness
Fatigue or weakness
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Headache
Feeling cold
Sleep disturbances
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 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use of this medication. 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
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down position, and 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 needed 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 can 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
Do not exceed the prescribed dose, frequency, or duration of treatment, as this can 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 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 can lead to lower 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 visit your dentist regularly.

Diabetes Considerations
If you have 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 can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Benzodiazepines and other CNS depressants (unless benefits outweigh risks, with dose reduction and close monitoring)
• CYP3A4 inhibitors (strong, e.g., ketoconazole, itraconazole, ritonavir, clarithromycin, grapefruit juice) - risk of increased fentanyl plasma concentrations and respiratory depression
• Monoamine Oxidase Inhibitors (MAOIs) - risk of serotonin syndrome or opioid toxicity (concurrent use or within 14 days of MAOI discontinuation)

• Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, other opioids, alcohol) - increased risk of respiratory depression, profound sedation, coma, death
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased fentanyl plasma concentrations, leading to reduced efficacy
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol) - risk of serotonin syndrome
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce fentanyl's analgesic effect and/or precipitate withdrawal symptoms
• Opioid antagonists (e.g., naltrexone, naloxone) - may precipitate withdrawal symptoms

• Anticholinergics - increased risk of urinary retention and/or severe constipation
• Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
• Antihypertensives - additive hypotensive effects

• Not available

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness or lightheadedness
• Nausea and vomiting
• Constipation
• Confusion or disorientation
• Miosis (pinpoint pupils)
• Itching
• 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. Use is generally not recommended due to potential for serious adverse reactions in breastfed infants, including sedation, respiratory depression, and withdrawal symptoms. If use is unavoidable, monitor the infant closely for signs of sedation and respiratory depression.

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

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

• Fentanyl transmucosal products are ONLY for the management of breakthrough cancer pain (BTCP) in opioid-tolerant patients. They are NOT for opioid-naive patients or for acute pain, postoperative pain, or headache.
• Opioid tolerance is defined as taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid for at least one week.
• Dosing is highly individualized and requires careful titration to find the effective dose for each BTCP episode. Patients should be instructed to use only one unit per episode and wait at least 4 hours before treating another episode with the same dose.
• Due to the risk of life-threatening respiratory depression, accidental ingestion, abuse, and misuse, fentanyl transmucosal products are subject to a strict REMS (Risk Evaluation and Mitigation Strategy) program.
• Patients and caregivers must be educated on proper administration, safe storage (out of reach of children), and proper disposal (e.g., flushing down the toilet) to prevent accidental exposure.
• Concomitant use with CNS depressants (e.g., benzodiazepines, alcohol) or CYP3A4 inhibitors can significantly increase the risk of serious adverse events, including fatal respiratory depression.

• Other rapid-onset opioids for breakthrough cancer pain (e.g., oral transmucosal fentanyl citrate (different formulations like buccal tablets, sublingual tablets, nasal spray), sufentanil sublingual tablet)
• Short-acting oral opioids (e.g., immediate-release morphine, oxycodone, hydromorphone) - generally slower onset than transmucosal fentanyl
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) - for mild to moderate pain, not typically sufficient for BTCP
• Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) - for neuropathic pain components
• Regional anesthesia or nerve blocks
• Radiation therapy (for localized pain from tumors)

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. Read this guide carefully 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 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 seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.