Fentanyl 100 mcg/2 ml injection

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Fentanyl 100 mcg/2 ml Injection

Fentanyl 100 mcg/2 ml Injection is indicated for the management of breakthrough pain in cancer patients who are already receiving, and are tolerant to opioid therapy for persistent cancer pain.

Patients are considere opioid tolerant if they are taking for one week or longer at least:

60 mg oral morphine daily
25 mcg/hour transdermal fentanyl
30 mg oral oxycodone daily
8 mg oral hydromorphone daily
Or an equianalgesic dose of another opioid.

Pharmacology of Fentanyl 100 mcg/2 ml injection

Fentanyl is a potent opioid analgesic that mainly binds to mu-opioid receptors, with additional activity at kappa and delta receptors. These receptors are located in the brain, spinal cord, and other tissues. Its primary effects involve the central nervous system, producing analgesia (pain relief) and sedation. It increases pain tolerance and reduces the perception of suffering, though the sensation of pain may still be notice. Fentanyl also commonly causes euphoria or mood changes, drowsiness, respiratory depression, cough suppression, and pupil constriction.

Dosage of (Fentanyl) 100 mcg/2 ml

Oral / Buccal Use

Starting dose: 100 mcg.
If pain persists, one repeat dose after 30 minutes may be use with the same strength.
Dose may be increase stepwise using multiples of 100 mcg.
Maximum studie dose at one time: 4 tablets (400 mcg total).
To reduce overdose risk, patients should keep only one tablet strength at a time.
Dose increases are considered when repeate doses are neede consistently.

Injection (IV/IM)

Dose must be individualize by a clinician according to age, weight, disease, other drugs, and surgery type.
Use IV/IM for premedication, anesthesia, or pain control.
Doses above 200 mcg are use only for anesthesia.
Fentanyl may be given as IV bolus or infusion; infusion rates adjuste to response.
Elderly or frail patients require reduced doses.

Transdermal Patch

For chronic pain only, not for opioid-naive patients.
Patch strengths: 12–100 mcg/hr.
Initial dose depends on previous opioid use.
Replace patch every 72 hours, change skin site each time.
Higher needs (>100–300 mcg/hr) may require multiple patches or alternative therapy.
Elderly: dose reduction recommende.

Administration of Fentyl 100 mcg/2 ml

Tablet Administration: Patients should remove the tablet from the blister strip and immediately place the entire tablet in the buccal cavity (above a rear molar, between the upper cheek and gum). Patients should not attempt to split the tablet. The tablet should not be chewed or swallowed, as this will result in lower plasma concentrations than when taken as directed. The tablet should be left between the cheek and gum until it has disintegrated, which usually takes approximately 14-25 minutes. After 30 minutes, if remnants from the tablet remain, they may be swallowe with a glass of water.

Interaction of Fentyl 100 mcg/2 ml

Co-administration of different antifungals, macrolide antibiotics, CNS depressant drugs like ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazadone may enhance or prolong the effects of Fentanyl. The concomitant use of amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil with Fentanyl may also result in an increase in Fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.

Contraindications

Fentanyl is contraindicated in the management of acute or postoperative pain. This product must not be used in opioid non-tolerant patients. Fentanyl is contraindicated in patients with known intolerance or hypersensitivity to any of its components or the drug Fentanyl.

Side Effects of Fentyl 100 mcg/2 ml

As with other narcotic analgesics, the most common serious adverse reactions reported to occur with Fentanyl are respiratory depression, apnoea, muscular rigidity, myoclonic movements, and bradycardia. Respiratory depression is more likely to occur with intravenous administration if a dose is given too rapidly and it rarely occurs with intramuscular administration.

Pregnancy & Lactation

Pregnancy category C. There are no adequate and well-controlle studies in pregnant women. Fentanyl should be use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excrete in human milk; therefore Fentanyl should not be use in nursing women because of the possibility of sedation and/or respiratory depression in their infants.

Precautions & Warnings

Opioid analgesics can impair the mental and physical ability needed for activities requiring alertness (e.g., driving or operating machinery). Patients taking Fentanyl must be warne and counseled accordingly.
Use with other CNS depressants requires close monitoring and special care.

Chronic pulmonary disease: Administer carefully in patients with COPD or conditions that increase the risk of respiratory depression.
Head injuries / increased intracranial pressure: Opioids may mask neurological symptoms; use only if clearly required.
Cardiac disease: IV Fentanyl may cause bradycardia; use with caution in patients with bradyarrhythmias.
Hepatic or renal impairment: Fentanyl metabolism and excretion may be affected; use carefully.

Overdose Effects of Fentanyl 100 mcg/2 ml

Overdose may cause narcosis, severe muscle rigidity, cyanosis, and cardio-respiratory depression. In case of hypoventilation or apnea, immediate oxygen support and assiste ventilation should be provide.
A specific opioid antagonist (Naloxone) must be available and use to reverse respiratory depression when needed.

Therapeutic Class

Opioid Analgesic

Storage Conditions

Store at 20–25°C, away from light.

Drug Class

Opioid Analgesics

Mode of Action (Short Summary)

Fentanyl is a potent opioid that primarily binds to mu-opioid receptors, with additional activity at kappa and delta receptors. It acts on the central nervous system, producing analgesia and sedation, increases pain tolerance, and may cause mood changes, drowsiness, respiratory depression, cough suppression, and pupil constriction.

Pregnancy & Lactation

Pregnancy (Category C):
There are no adequate, well-controlled studies of Fentanyl use in pregnant women. It should be use during pregnancy only if the potential benefits outweigh the potential risks to the fetus.

Breastfeeding:
Fentanyl is excrete in human breast milk and may cause sedation or respiratory depression in a nursing infant. Therefore, Fentanyl should not be use during breastfeeding.

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