Fentanyl Cit 100mcg/2ml Pf Inj, 2ml

Fentanyl is a potent, synthetic opioid analgesic that primarily acts as a full agonist at the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic effects (analgesia and sedation) are mediated through these receptors. It also produces 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 passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
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
Changes in balance
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 Problem: 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
Passing out
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:

Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Excessive sweating
* Irritation at the site of administration

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for guidance. 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 obstruction 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

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Precautions

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, consult your doctor. Do not take more than the prescribed dose.

Additionally, long-term or regular use of opioid medications like this one may 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, 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 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 may cause unsafe and potentially fatal effects.

Seizure Risk
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.

Hormonal Effects
Long-term 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.

Special Populations
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 passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) concurrently or within 14 days of MAOI therapy (risk of serotonin syndrome or severe, unpredictable reactions)

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of profound sedation, respiratory depression, coma, and death.
• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, grapefruit juice): Increased fentanyl plasma concentrations, leading to increased and prolonged opioid effects, including respiratory depression.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased fentanyl plasma concentrations, potentially leading to reduced efficacy or withdrawal symptoms.
• Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation.

• Not specifically categorized as minor for fentanyl due to its potency and narrow therapeutic index; all interactions should be considered significant.

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/drowsiness
• Nausea and vomiting
• Constipation
• Pruritus
• Urinary retention
• Dizziness
• Confusion
• Muscle rigidity (especially with rapid IV administration or high doses)

Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated.

Fentanyl is excreted into breast milk. A single dose is generally considered compatible with breastfeeding if the infant is monitored for sedation and respiratory depression. For repeated doses or continuous infusions, caution is advised, and an alternative analgesic may be preferred. Monitor the infant for increased sleepiness, difficulty breathing, or poor feeding.

Pediatric patients, especially infants and neonates, are more sensitive to the respiratory depressant effects of opioids. Dosing must be highly individualized and carefully titrated based on age, weight, clinical condition, and concomitant medications. Close monitoring for respiratory depression and sedation is crucial.

Elderly patients may be more sensitive to the effects of fentanyl, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor closely for adverse effects. Reduced hepatic and renal function in the elderly may prolong fentanyl's effects.

• Fentanyl is highly potent; even small errors in dosing can lead to severe respiratory depression or death.
• Rapid IV administration can cause chest wall rigidity, making ventilation difficult. Administer slowly over 1-2 minutes.
• Tolerance and physical dependence can develop with prolonged use, even at therapeutic doses.
• Always have naloxone readily available when administering fentanyl.
• Monitor patients closely for at least 2 hours after the last dose due to potential for delayed or recurrent respiratory depression.
• Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of serious adverse events, including death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate.

• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone, sufentanil, remifentanil)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain
• Regional anesthesia/analgesia (e.g., nerve blocks, epidural analgesia)
• Non-pharmacologic pain management strategies (e.g., physical therapy, heat/cold therapy, massage, acupuncture)

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. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

To dispose of unused doses, follow the instructions provided with your medication. If you have questions or concerns about disposal, consult your pharmacist. Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be used as part of the treatment. Consult your doctor or pharmacist about obtaining or using naloxone. If you suspect an overdose, 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. You can also contact your local poison control center or seek emergency medical care, providing the same detailed information about the overdose.