Fentanyl Cit 50mcg/ml Pf Inj, 1ml

Fentanyl is a potent, synthetic opioid agonist that primarily interacts with the mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic actions are analgesia and sedation. It produces its effects by mimicking the actions of endogenous opioid peptides, leading to inhibition of pain signal transmission and modulation of emotional responses to pain.

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 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 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 immediately if you experience:

Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
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 severe adrenal gland problem. Contact your doctor right away if you experience:

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

Other Possible Side Effects

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

Dizziness, drowsiness, tiredness, or weakness
Dry mouth
Constipation, diarrhea, stomach pain, nausea, vomiting, or 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 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 disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing health conditions and other medications. Never start, stop, or adjust 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 activities that require you to be alert. 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 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, long-term or 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 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, 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.

Hormonal Effects
Long-term use of opioid medications like this one 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.

Special 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 excessively sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) (within 14 days)

• Other CNS depressants (e.g., benzodiazepines, barbiturates, alcohol, other opioids, general anesthetics, tricyclic antidepressants, phenothiazines, skeletal muscle relaxants, sedating antihistamines) - increased risk of respiratory depression, profound sedation, coma, and death.
• CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, grapefruit juice) - increased fentanyl plasma concentrations, leading to increased or prolonged opioid effects.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol) - risk of serotonin syndrome.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - decreased fentanyl plasma concentrations, leading to reduced efficacy.
• Anticholinergic drugs - increased risk of urinary retention and/or severe constipation.

• Not available

• Respiratory depression (slow, shallow breathing)
• Profound sedation or somnolence
• Dizziness or lightheadedness
• Nausea and vomiting
• Constipation
• Urinary retention
• Pruritus (itching)
• Muscle rigidity (especially with rapid IV administration or high doses)

Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Prolonged use can lead to neonatal opioid withdrawal syndrome.

Fentanyl is excreted into breast milk. A single dose is generally considered compatible with breastfeeding with close infant monitoring. Avoid repeated doses or prolonged use.

Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depressant effects. Dosing must be carefully titrated based on age, weight, and clinical response. Close monitoring of respiratory status and sedation is crucial.

Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. A reduced initial dose and slower titration are recommended. Monitor closely for adverse effects, especially respiratory and CNS depression.

• 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 repeated administration, even over short periods.
• Naloxone should always be readily available when administering fentanyl.
• Monitor patients closely for at least 1-2 hours after administration due to potential for delayed or recurrent respiratory depression, especially with larger doses or in susceptible patients.
• The 50 mcg/ml concentration is common; always double-check the concentration to avoid dosing errors.

• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone, sufentanil, remifentanil)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen, regional anesthesia, local anesthetics)
• Adjunctive pain medications (e.g., gabapentin, pregabalin, ketamine)

If your symptoms or health problems do not improve 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. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

When disposing of unused doses, follow the instructions provided with the medication. If you have questions or concerns about disposal, consult your pharmacist for guidance. Additionally, some medications may have a separate patient information leaflet; check with your pharmacist to determine if this applies to your medication.

If you have any questions or concerns about this medication, it is crucial to 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.

In the event of a suspected overdose, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the medication 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.