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Opifen (Fentanyl Buccal )
Therapeutic Group: Analgesic, Anti Inflammatory » Opoid Analgesic

Opifen 100 tablet: Each buccal tablet contains Fentanyl Citrate BP equivalent to Fentanyl 100 mcg.

Opifen 200 tablet: Each buccal tablet contains Fentanyl Citrate BP equivalent to Fentanyl 200 mcg.

Fentanyl is a potent opioid analgesic, intended for buccal mucosal administration. It is designed to be placed and retained within the buccal cavity for a period sufficient to allow disintegration of the tablet and absorption of Fentanyl across the oral mucosa. Following buccal administration Fentanyl is readily absorbed with a bioavailability of 65%. The plasma protein binding of Fentanyl is 80-85%. Fentanyl is metabolized in the liver and in the intestinal mucosa to nor-fentanyl by cytochrome P450. Fentanyl is primarily (>90%) eliminated by biotransformation. The metabolites are mainly excreted in the urine, while fecal excretion is less important.
Fentanyl is indicated for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg of oral morphine/day, at least 25 mcg of transdermal Fentanyl/hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Dosage & Administration
Starting Dose:
The initial dose of Fentanyl should be 100 mcg.

Re-dosing patients within a single episode:
Dosing may be repeated once during a single episode of breakthrough pain if pain is not adequately relieved by one Fentanyl dose. Re-dosing may occur 30 minutes after the start of administration of Fentanyl and the same dosage strength should be used.

Increasing the dose:
Titration should be initiated using multiples of the 100 mcg Fentanyl tablet. Patients require to titrate above 100 mcg can be instructed to use two 100 mcg tablets (one on each side of the mouth in the buccal cavity). If this dose is not successful in controlling the breakthrough pain episode, the patient may be instructed to place two 100 mcg tablets on each side of the mouth in the buccal cavity (total of four 100 mcg tablets). Titrate above 400 mcg by 200 mcg increments bearing in mind using more than 4 tablets simultaneously has not been studied and it is important to minimize the number of strengths available to patients at any time to prevent confusion and possible overdose.
To reduce the risk of overdose during titration, patients should have only one strength of Fentanyl tablet available at any one time.

Dosage Adjustment:
Generally, the dose of Fentanyl should be increased when patients require more than one dose per breakthrough pain episode for several consecutive episodes.

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 swallowed with a glass of water.
Side Effects
As with other narcotic analgesics, the most common serious side-effects reported to occur with Fentanyl are dizziness, somnolence, respiratory depression, apnoea, muscular rigidity, bradycardia, hypotension and constipation.
Opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g. driving a car or operating machinery). Patients taking Fentanyl should be warned of these dangers and should be counseled accordingly. The use of concomitant CNS active drugs requires special patient care and observation.

Chronic pulmonary disease:
Fentanyl should be titrated with caution in patients with chronic obstructive pulmonary disease or pre-existing medical conditions predisposing them to respiratory depression.

Head injuries and increased intracranial pressure:
Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.

Cardiac disease:
Intravenous Fentanyl may produce bradycardia. Therefore, Fentanyl should be used with caution in patients with bradyarrhythmias.

Hepatic or renal disease:
Fentanyl should be used with caution because of the hepatic metabolism and renal excretion of Fentanyl.
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.
Use in Pregnancy & Lactation
Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Fentanyl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Fentanyl is excreted in human milk; therefore Fentanyl should not be used in nursing women because of the possibility of sedation and/or respiratory depression in their infants.
Drug Interaction
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.
In insufficient overdosage, Fentanyl would produce narcosis, marked skeletal muscle rigidity. Cardio-respiratory depression and cyanosis may also occur. In the presence of hypoventilation or apnoea, oxygen should be administered and respiration should be assisted. A specific narcotic antagonist, such as naloxane, should be available for use as indicated to manage respiratory depression.
Store at 20-25 °C.
Commercial Packaging
Opifen 100 tablet: Each box contains 3 blister strips of 10 buccal tablets.

Opifen 200 tablet: Each box contains 3 blister strips of 10 buccal tablets.
Pediatric Use: The safety and efficacy of Fentanyl have not been established in pediatric patients below the age of 18 years.

Physicians and other healthcare providers must become familiar with the important warnings in this label. Opifen tablet contains Fentanyl, an opioid agonist, with an abuse liability similar to other opioid analgesics. It can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression. As life-threatening respiratory depression could occur at any dose in opioid non-tolerant patients, Opifen tablet is contraindicated in the management of acute or postoperative pain. This product is not indicated for use in opioid non-tolerant patients. Patients and their caregivers must be instructed that Opifen contains a medicine in an amount which can be fatal to a child. Patients and their caregivers must be instructed to keep all tablets out of the reach of children. Due to the higher bioavailability of Fentanyl in Opifen tablet, when converting patients from other oral Fentanyl products to Opifen tablet, do not substitute Opifen tablet on a mcg per mcg basis. Adjust doses as appropriate. Opifen tablet is intended to be used only in the care of opioid tolerant cancer patients and only by healthcare professionals who are knowledgeable and skilled in the use of opioids to treat cancer pain.
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