Fentanyl Cit 200mcg Tablets

Fentanyl is a potent 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, 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 signs or symptoms, contact your doctor or seek immediate medical attention:

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
Mouth sores
Swelling in the feet or hands

Serotonin Syndrome: A Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk of developing 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
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. Seek medical help 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 any side effects or only minor 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
* Mouth tingling

If you experience any of these side effects or any other unusual symptoms, contact your doctor for advice. 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 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 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
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise 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 you may need higher doses 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 lower your 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 Guidelines
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 after taking this medication, 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 can lead to unsafe and potentially deadly 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 like this one can lead to lower sex hormone levels. If you experience a decreased interest in sex, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.

Special Considerations
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 overly sleepy, limp, or has breathing difficulties.

• Concomitant use with CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, verapamil, diltiazem, grapefruit juice) due to increased fentanyl plasma concentrations and risk of respiratory depression.
• Patients who are not opioid tolerant.
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
• Significant respiratory depression.
• Known or suspected paralytic ileus.

• CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
• Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May reduce the analgesic effect of fentanyl and/or precipitate withdrawal symptoms.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease fentanyl plasma concentrations, leading to reduced efficacy or 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)
• Excessive sedation/somnolence
• Dizziness
• Nausea/vomiting
• Constipation
• Confusion
• Miosis (pinpoint pupils)
• Itching
• Signs of opioid withdrawal (if abruptly discontinued)

Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Prolonged use can lead to neonatal opioid withdrawal syndrome.

Fentanyl is excreted into breast milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression), breastfeeding is not recommended during treatment with fentanyl buccal tablets. 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 18 years of age. Accidental ingestion in children can be fatal. Strict storage and disposal precautions are essential.

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

• Fentanyl buccal tablets are ONLY for opioid-tolerant patients with breakthrough cancer pain. It is NOT for opioid-naive patients or for acute pain.
• Strict adherence to the TIRF REMS Access program is mandatory for prescribing, dispensing, and patient enrollment.
• Dosing is individualized and requires careful titration. Do not convert from other fentanyl products on a mcg-per-mcg basis due to different absorption profiles.
• Patients should be instructed to place the tablet in the buccal cavity (between gum and cheek) or sublingually and allow it to dissolve completely without chewing, crushing, or swallowing.
• Educate patients and caregivers on the signs of respiratory depression and the importance of immediate medical attention and naloxone administration if an overdose is suspected.
• Emphasize secure storage and proper disposal (flushing down the toilet) to prevent accidental exposure, especially to children.
• Monitor for drug interactions, particularly with CYP3A4 inhibitors, which can significantly increase fentanyl levels and risk of toxicity.

• Other short-acting opioids for breakthrough pain (e.g., immediate-release oxycodone, hydromorphone, morphine)
• Non-opioid analgesics (for non-cancer pain or as adjuncts)
• Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic 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 safe and effective 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 essential 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 for clarification.

In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide detailed information about the medication, including the amount taken and the time of ingestion.