Wednesday, June 17, 2015

Fentanyl Citrate : Product Information

For the use of a Registered Medical Practitioner or a Hospital or Laboratory only.

Fentanyl is a synthetic phenethylpiperidine derivative drug is commercially available for parenteral use as the citrate salt.

Clinical Pharmacology:

Fendrop is a narcotic analgesic. It is short-acting after single doses, but has a relatively long elimination half-life because of rapid redistribution in the body. Fendrop is usually given intravenously and is used particularly in anaesthesia. A dose of 100 mcg (in 2 ml) is approximately equivaient in analgesic activity to 10 mg of morphine or 75 mg of meperidine. The principal actions of therapeutic value are analgesia and sedation. Large doses may produce apnea.


Pharmacokinetics:

After parenteral administration Fendrop has a rapid onset and short duration of action. It is metabolised in the liver by N-dealkylation and hydroxylation. Metabolites and some unchanged drug are excreted mainly in the urine. The short duration of action is probably due to rapid redistribution into the tissues rather than metabolism and excretion. An elimination half life of about 4 hours reflects slower release from tissue depots. About 80% has been reported to be bound to plasma proteins. Fendrop appears in the cerebrospinal fluid. It crosses the placenta and small amounts have been detected in breast milk.

Indications and Usage:

Fendrop is indicated:
• For analgesic action of short duration during the anaesthetic periods. Premedication induction and maintenance and in the immediate post-operative period as the need arises.
• Fendrop as a narcotic supplement in regional anaesthesia.
• For use as an anaesthetic agent with oxygen in selected high risk patients, such as those undergoing open heart surgery.
• For administration with a neuroleptic such as Droperidol injection as an anaesthetic premedication and as an adjunct in the maintenance of regional anaesthesia.

Contra-indications:

Fendrop Is contraindicated in patients with known intolerance to the drug.

Warnings: 

Fendrop should be administered only by persons specifically trained in the use of intravenous anaesthetics and management of the respiratory effects of potent opioids. An opioid antagonist, resuscitative and intubation equipment and oxygen should be readily available. it is administered with a tranquilizer such as Droperidol, the user should become familiar with the special properties of each drug. In addition, when such a combination is used; fluids and other counter-measures to manage hypotension should be available. Adequate facilities should be available for post-operative monitoring and ventilation of patients administered anaesthetic doses of Fendrop. It is essential that these facilities be fully equipped to handle all degrees of respiratory depression.

Precautions: 

General: The initial dose of Fendrop should be appropriately reduced in elderly and debilitated patients. The effect of initial dose should be considered in determining incremental doses. Fendrop should be used with caution in patients with chronic pulmonary disease and to the patients with liver and kidney dysfunction. Intravenous Fendrop may produce bradycardia, which may be treated with atropine. Fendrop should be administered with caution in patients with bradyarrhythmias. As with other opoids, orthostatic hypotension is possible.

Drug Interactions: 

Other CNS depressant drugs (e.g. barbiturates, tranquilizers, narcotics and general anaesthetics) will have additive or potentiating effects with Fendrop. When Patients have received such drugs, the dose of Fendrop required will be less than usual. Following the administration of Fendrop the dose of other CNS depressant drugs should be reduced.

Pregnancy :There is no adequate and well-controlled studies in pregnant women, so Fendrop should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Fentanyl is excreted in human milk, therefore Fendrop is not recommended for use in nursing women because of the possibillty of effects in their infants.

Paediatric Use: The safety and efficacy of Feedrep in children under 2 years of age has not been established.

Adverse Reactions:

As with other narcotic analgesics, the most reactions reported to occur with Fendrop are apnea, respiratory depression, rigidity and trachecardia. if these remain untreated respiratory arrest or cardiac arrest could occur. Other adverse reactions lhat been reported are hypertension, hypotension, dizziness, blurred vision, nausea, emesis and diaphoresis. When a tranquilizer such as Droperidol used with Fendrop the following adverse reaction may occur: chills and/or shivering, restlessness and post-operative hallucinatory episodes, extrapyramidal symptoms have been observed upto 24 hrs. Post-operatively when they occur extrapyramidal symptoms can usually controlled with antiparkinson agents.

Drug Abuse and Dependence:

Fendrop can produce dependence of the morphine type and therefore has the potential for being abused.

Dosage and Administration

Dosage of Fendrop is expressed in terms of microgram. Fendrop is administered by intramuscular or intravenous injection.

For use as a preoperative medication 50-100 mcg of Fendrop is administered by IM, 30 to 60 minutes prior to surgery.

As an adjunct to general anaesthesia, Fendrop may be given in low-dose, moderate dose and high dose regimens. In low dose regimen, an IV dose of 2 mcg/kg is administered; additional doses are not necessary. In the moderate dose regimen an initial IV dose of 2-20 mcg/kg is administered; additional dose of 25-100 mcg may be given by IV or IM as necessary.

In the high dose regimen an initial IV dose of 20-50 mcg/kg may be given: additional doses ranging from 25 mcg to one half of the initial dose may be administered as necessary.

To provide general anaesthesia without additional anaesthetic agents, Fendrop doses of 50-100 mcg/kg may be administered in conjugation with oxygen and a skeletal muscle relaxant; in some other doses. upto 150 mcg/kg of Fendrop may be required.

As an adjunct to regional anaesthesia 50-100 mcg/kg of Fendrop may be administered by IM injection or by slow IV injection over 1-2 minutes when additional analgesia is required.

For the control of post operative pain; restlessness, tachypnea and emergence delirium, 50-100 mcg/kg of the drug may be administered by 1M every 1-2 hours as needed.

During the induction and maintenance of general anaesthesia in children 2- 12 years of age, a Fendrop dose of 1.7-3.3 mcg/kg is recommended.

Presentation:
Fendrop is available in ampoules of 2 ml and 10 mi.
Each ml contains Fendrop 50 mcg (as Fentanyl Citrate IP).

Fendrop is a product of Sun Phama company.


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