Fentanyl Cit 0.05mg/ml Inj, 20ml

Fentanyl is a potent, synthetic opioid agonist that primarily interacts with the mu-opioid receptors in the central nervous system (CNS). These receptors are coupled to G-proteins and their activation leads to inhibition of adenylyl cyclase, hyperpolarization of neurons (due to increased potassium efflux), and inhibition of neurotransmitter release (e.g., substance P, acetylcholine, norepinephrine, dopamine). This results in analgesia, sedation, euphoria, and respiratory depression.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects when 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 be signs of a severe bowel problem
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Chest pain
Fast or slow heartbeat
Seizures
Depression
Trouble controlling body movements
Swelling in the arms or legs
Change in eyesight

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. Seek medical help immediately if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea
Upset stomach
Throwing up
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 right away if you experience:

Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite

Other Possible Side Effects

Like all medications, this drug may cause side effects. While many people do not experience any side effects or only have minor ones, it is essential to contact your doctor or seek medical help if you notice any of the following:

Feeling dizzy, sleepy, tired, or weak
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Throwing up
Decreased appetite
Headache
Feeling cold
Trouble sleeping
Sweating a lot
* Irritation where the medication was administered

Reporting Side Effects

If you have questions about side effects or experience any that bother you or do not go away, 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including 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

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any concerns you may have
Verify that it is safe to take this medication with your existing medications and health conditions
* Avoid starting, stopping, or changing the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

It is crucial to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other medications or treatments.

Caution with Daily Activities

Until you know how this medication affects you, avoid driving and engaging in activities that require your full attention. 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 can lead to tolerance, where the medication may not work as well, 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 suddenly stopping or reducing the dose can lead to withdrawal symptoms 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 life-threatening 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.

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

• CNS Depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tricyclic antidepressants, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
• CYP3A4 Inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, erythromycin, verapamil, diltiazem, grapefruit juice): Increased fentanyl plasma concentrations, leading to increased or 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, leading to reduced efficacy or withdrawal symptoms.
• Anticholinergic Drugs: Increased risk of urinary retention and/or severe constipation.

• Not available

• Respiratory depression (slow, shallow breathing, cyanosis)
• Sedation/somnolence
• Nausea and vomiting
• Constipation
• Pruritus
• Urinary retention
• Muscle rigidity (especially chest wall rigidity with rapid IV administration)
• Hypotension
• Bradycardia

Category C. Fentanyl should be used during pregnancy 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 in breast milk. A single dose is generally considered compatible with breastfeeding with close infant monitoring. However, repeated doses or prolonged use are not recommended due to potential for infant sedation, respiratory depression, and withdrawal.

Fentanyl injection is used in pediatric patients for analgesia and as an anesthetic adjuvant. Dosing must be carefully calculated based on weight and age, and titrated to effect. Neonates and very young infants are particularly sensitive to respiratory depressant effects and require extreme caution and close monitoring. Chest wall rigidity can occur, especially with rapid IV administration.

Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression, and may have reduced clearance due to age-related decline in hepatic and renal function. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects.

• Fentanyl is extremely potent; ensure accurate dose calculation and dilution.
• Rapid IV administration can cause chest wall rigidity, making ventilation difficult. Administer slowly over 1-2 minutes.
• Always have naloxone readily available when administering fentanyl.
• Monitor patients closely for respiratory depression and sedation for at least 30-60 minutes after administration, or longer if other CNS depressants are co-administered.
• Tolerance and physical dependence can develop with prolonged use, even in therapeutic settings.
• Consider the patient's opioid tolerance status; opioid-naive patients are at higher risk for adverse effects.

• Other opioid analgesics (e.g., morphine, hydromorphone, sufentanil, remifentanil)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen, ketamine, regional anesthesia, local anesthetics)
• Alpha-2 adrenergic agonists (e.g., dexmedetomidine for sedation/analgesia)

If your symptoms or health problems persist 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 proper disposal, consult your pharmacist for guidance. Additionally, some medications may come with a separate patient information leaflet; check with your pharmacist to see 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. It is also important to note that naloxone, a specific medication, can be used to treat an overdose of this drug. Consult your doctor or pharmacist about obtaining and 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 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 right away, providing the same detailed information about the overdose.