Fentanyl Cit 0.05mg/ml Inj, 2ml

Fentanyl is a potent, synthetic opioid agonist primarily acting at the mu-opioid receptors in the central nervous system (CNS). Its principal therapeutic actions are analgesia and sedation. It produces its effects by binding to stereospecific opioid receptors at many sites within the CNS, altering the perception of and response to pain. It also produces respiratory depression by direct action on brainstem respiratory centers.

WHAT ARE SOME SIDE EFFECTS THAT I NEED TO CALL MY DOCTOR ABOUT RIGHT AWAY? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.Severe dizziness or passing out.Feeling confused.Severe constipation or stomach pain. These 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.A severe and sometimes deadly problem called serotonin syndrome may happen if you take this drug with certain other drugs. Call your doctor right away if you have 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, or throwing up; or severe headache.Taking an opioid drug like this drug may lead to a rare but severe adrenal gland problem. Call your doctor right away if you feel very tired or weak, you pass out, or you have severe dizziness, very upset stomach, throwing up, or decreased appetite. WHAT ARE SOME OTHER SIDE EFFECTS OF THIS DRUG? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:Feeling dizzy, sleepy, tired, or weak.Dry mouth.Constipation, diarrhea, stomach pain, upset stomach, throwing up, or decreased appetite. Headache.Feeling cold.Trouble sleeping.Sweating a lot.Irritation where this drug was used.These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.You may report side effects to the FDA at 1- 800-332-1088. You may also report side effects 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. Be sure to describe the allergic reaction you experienced, including any 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 obstruction 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 increase the risk of severely high blood pressure
* Current use of certain medications, such as 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 whether it is safe to take this medication in conjunction with your other treatments and health status. 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 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 lower your dose or stop taking this medication, consult your doctor first, as sudden changes may lead to 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 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 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 may 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 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 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 passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Concomitant use with strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin, nefazodone) in patients not receiving chronic opioid therapy, due to risk of fatal respiratory depression.
• Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation, due to risk of severe, unpredictable reactions including serotonin syndrome.

• Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
• Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce fentanyl's analgesic effect and/or precipitate withdrawal symptoms.
• Partial agonist opioids (e.g., buprenorphine): May reduce fentanyl's analgesic effect and/or precipitate withdrawal symptoms.

• Moderate CYP3A4 inhibitors (e.g., erythromycin, diltiazem, verapamil, fluconazole): Increased fentanyl plasma concentrations, leading to increased opioid effects.
• 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, which may lead to paralytic ileus.

• Not available

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/somnolence
• Hypotension
• Bradycardia
• Nausea/vomiting
• Constipation
• Pruritus
• Muscle rigidity (especially chest wall)
• Serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)

Use 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 (NOWS), which may be life-threatening if not recognized and treated.

Fentanyl is excreted in breast milk. Monitor breastfed infants for signs of sedation and/or respiratory depression (e.g., increased sleepiness, difficulty breastfeeding, limpness, shallow breathing). A single dose is generally considered compatible with breastfeeding, but caution is advised.

Use with extreme caution, especially in neonates and infants, due to increased sensitivity to respiratory depression. Dosing must be individualized and carefully titrated. Close monitoring of respiratory status is essential.

Elderly patients may be more sensitive to the effects of fentanyl, particularly respiratory depression. Consider lower initial doses and slower titration. Monitor closely for adverse effects, including respiratory depression, sedation, and hypotension.

• Fentanyl is extremely potent; even small errors in dosing can be fatal. Always double-check calculations and concentrations.
• Rapid IV administration can cause chest wall rigidity, which may impair ventilation. Administer slowly over 1-2 minutes.
• Be prepared to manage respiratory depression with naloxone and ventilatory support.
• Tolerance and physical dependence can develop with prolonged use, even at therapeutic doses.
• The short duration of action of IV fentanyl means repeated doses may be needed for sustained analgesia, increasing the risk of cumulative effects and respiratory depression.
• Patients with head injury or increased intracranial pressure should receive fentanyl with extreme caution due to the risk of increased ICP and masking of neurological signs.

• Morphine
• Hydromorphone
• Sufentanil
• Remifentanil
• Meperidine (less common due to side effects)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts.

If your symptoms or health issues 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 about disposal, consult your pharmacist. Some medications may come with an additional patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Consult your doctor or pharmacist about obtaining and using naloxone. 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, and be ready to provide details about the incident.