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Fentanyl Buccal Soluble Film

Latest prescription information about Fentanyl Buccal Soluble Film. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Fentanyl Buccal Soluble Film
Pronunciation : FEN-ta-nil
Trade Name(s): 
International- Onsolis.
Why it is prescribed (Indications) : 
This medication is a narcotic (opioid) analgesic, prescribed for breakthrough cancer pain in adults.  
When it is not to be taken (Contraindications): It should not be administered in opioid non- tolerant patients.Contraindicated in the management of postoperative pain, known hypersensitivity.

Pregnancy Category :

A B C D X
Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Dosage & When it is to be taken : 
The recommended initial dose is one 200-mcg film.
How it should be taken : 
It comes as a buccal soluble film, to be placed on both sides of the mouth.
Warnings and Precautions : 
* Caution should be exercised in patients with history of lung, urinary obstruction, heart, liver or kidney disease, low blood pressure, mouth inflammation, enlarged prostate, stomach problems, under active thyroid, seizures, alcoholism, mental illness, suicidal thoughts, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
* It may cause drowsiness or dizziness, do not drive a car or operate machinery while taking this medication.
* Avoid alcohol consumption.
Side Effects : 
Most Common - Respiratory depression, circulatory depression, low blood pressure, and shock.
Gastrointestinal - Nausea, vomiting, constipation, diarrhea, dry mouth, abdominal pain.
General - Weakness, fatigue.
Metabolic - Dehydration, decreased weight and loss of appetite.
Central Nervous System - Dizziness, headache, drowsiness, confusion, depression, sleeplessness, and anxiety.
Respiratory - Difficulty in breathing, cough.
Other Precautions : 
* Avoid excess dosage.
Storage Conditions : 
Store at 20°-25°C.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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