Fentanyl Transdermal System (Fentanyl Transdermal System)

Trade Name : FENTANYL TRANSDERMAL SYSTEM

Bryant Ranch Prepack

PATCH, EXTENDED RELEASE

Strength 25 ug/h

FENTANYL Full Opioid Agonists [MoA],Opioid Agonist [EPC]

Delivery Process

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fentanyl Transdermal System (Fentanyl Transdermal System) which is also known as FENTANYL TRANSDERMAL SYSTEM and Manufactured by Bryant Ranch Prepack. It is available in strength of 25 ug/h per ml. Read more

Fentanyl Transdermal System (Fentanyl Transdermal System) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Addiction, Abuse, and Misuseu00a0Fentanyl transdermal system exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientu2019s risk prior to prescribing fentanyl transdermal system, and monitor all patients regularly for the development of these behaviors and conditions n n Life-Threatening Respiratory Depressionu00a0Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system. Monitor for respiratory depression, especially during initiation of fentanyl transdermal system or following a dose increase. Because of the risk of respiratory depression, fentanyl transdermal system is contraindicated for use as an as-needed analgesic, in non-opioid tolerant patients, in acute pain, and in postoperative pain n n Accidental Exposureu00a0Accidental exposure to even one dose of fentanyl transdermal system, especially in children, can result in a fatal overdose of fentanyl. Deaths due to an overdose of fentanyl have occurred when children and adults were accidentally exposed to fentanyl transdermal system. Strict adherence to the recommended handling and disposal instructions is of the utmost importance to prevent accidental exposure n n Neonatal Opioid Withdrawal Syndrome Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available n n Cytochrome P450 3A4 Interactionu00a0The concomitant use of fentanyl transdermal system with all cytochrome P450 3A4 inhibitors may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in fentanyl plasma concentration. Monitor patients receiving fentanyl transdermal system and any CYP3A4 inhibitor or inducer n n Risk of Increased Fentanyl Absorption with Application of External HeatExposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, sunbathing, hot baths, saunas, hot tubs, and heated water beds may increase fentanyl absorption and has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the application site and surrounding area to direct external heat sources n n Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death n
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISK OF INCREASED FENTANYL ABSORPTION WITH APPLICATION OF EXTERNAL HEAT; and RISKS FROM CONCOMITANT USE OF BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.

Fentanyl transdermal system exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patientu2019s risk before prescribing, and monitor regularly for these behaviors or conditions. (5.1)n
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2)n
Accidental exposure to fentanyl transdermal system, especially in children, can result in fatal overdose of fentanyl. (5.3)n
Prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. (5.4)n
Concomitant use with CYP 3A4 inhibitors (or discontinuation of CYP 3A4 inducers) can result in a fatal overdose of fentanyl. (5.5)
Exposure of the fentanyl transdermal system application site and surrounding area to direct external heat sources has resulted in fatal overdose of fentanyl. Warn patients to avoid exposing the fentanyl transdermal system application site and surrounding area to direct external heat sources. (5.6)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.7, 7)

Boxed Warningu00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a0 u00a004/2017
Indications and Usage (1) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2017
Dosage and Administration (2)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2017
Contraindications (4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2017
Warnings and Precautions (5)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 04/2017

Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
Arrayn- Limitations of Use
u00a0Limitations of use:u00a0

No data

To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain. (2.1)
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. (2.1)
Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. (2.1)
Initial dose selection: consult conversion instructions. (2.2)
Each transdermal system is intended to be worn for 72 hours. (2.2)
Adhere to instructions concerning administration and disposal of fentanyl transdermal system. (2.6, 2.7)
Mild to Moderate Hepatic and Renal Impairment: Initiate treatment with one half the usual starting dose, titrate slowly, and monitor for signs of respiratory and central nervous system depression. (2.4, 2.5)
Do not abruptly discontinue fentanyl transdermal system in a physically-dependent patient. (2.8)

Fentanyl transdermal system is available as:
*This lowest dosage is designated as 12 mcg/hour (however, the actual dosage is 12.5 mcg/hour) to distinguish it from a 125 mcg/hr dosage that could be prescribed by multiple patches.
Transdermal system: 12 mcg/hr, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr, 100 mcg/hr. (3)

Fentanyl transdermal system is contraindicated in:u00a0
u2022 patients who are not opioid-tolerant.u00a0
u2022 the management of acute or intermittent pain, or in patients who require opioid analgesia for a short period of time.u00a0
u2022 the management of post-operative pain, including use after out-patient or day surgeries, (e.g., tonsillectomies).u00a0
u2022 the management of mild pain.u00a0
u2022 patients with significant respiratory depression [see Warnings and Precautions (5.9)].
u2022 in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.9)].
u2022 in patients with known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.17)].u00a0
u2022 in patients with hypersensitivity to fentanyl (e.g., anaphylaxis) or any components of the transdermal system [see Adverse Reactions (6.2)].

Opioid non-tolerant patients. (4)u00a0
Acute or intermittent pain, postoperative pain, mild pain. (4)u00a0
Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)u00a0
Known hypersensitivity to fentanyl or any of the components of the transdermal system. (4)u00a0

No data

Risk of Increased Fentanyl Absorption with Elevated Body Temperature: Monitor patients with fever closely for sedation and respiratory depression and reduce the dose if necessary. Warn patients to avoid strenuous exertion that may lead to increased body temperature. (5.8)
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.9)
Serotonin Syndrome with Concomitant Use of Serotonergic Drugs: Potentially life-threatening condition could result from concomitant serotonergic drug administration. Discontinue fentanyl transdermal system immediately if serotonin syndrome is suspected. (5.10)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.11)
Severe Hypotension: Monitor during dose initiation and titration. Avoid the use of fentanyl transdermal system in patients with circulatory shock. (5.12)
Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of fentanyl transdermal system in patients with impaired consciousness or coma. (5.13)

The following serious adverse reactions are discussed elsewhere in the labeling:
Most common adverse reactions (u22655%) are nausea, vomiting, somnolence, dizziness, insomnia, constipation, hyperhidrosis, fatigue, feeling cold, anorexia, headache, and diarrhea. ()
To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt at 1-800-778-7898 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Table 6 includes clinically significant drug interactions with fentanyl transdermal system.
u00a0
Table 6: Clinically Significant Drug Interactions with Fentanyl Transdermal System

Mixed agonist/antagonist and partial agonist opioid analgesics: Avoid use with fentanyl transdermal system because they may reduce analgesic effect of fentanyl transdermal system or precipitate withdrawal symptoms. (5.19, 7)u00a0n n

No data

Pregnancy: May cause fetal harm. (8.1)
Lactation: Not recommended. (8.2)
Severe Hepatic and Renal Impairment: Use not recommended. (8.6, 8.7)u00a0

No data

Arrayn- Clinical Presentation
Acute overdose withu00a0fentanyl transdermal system can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations .
Arrayn- Treatment of Overdose
Give primary attention to the reestablishment of a patent airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques. Once stable, ensure examine the patient and ensure that all fentanyl transdermal systems have been removed.
The opioid antagonists, such as naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to fentanyl overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to fentanyl overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of fentanyl in fentanyl transdermal systems, carefully monitor the patient until spontaneous respiration is reliably reestablished. After fentanyl transdermal system removal, serum fentanyl concentrations decline gradually, falling about 50% in approximately 20 to 27 hours. Therefore, management of an overdose must be monitored accordingly, at least 72 to 96 hours beyond the overdose.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
%

Fentanyl transdermal system contains fentanyl, an opioid agonist, available as a patch for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hr per 7.8 cm). The composition per unit area of all system sizes is identical.
The nu2011octanol: water partition coefficient is 860:1. The pKa is 8.4.
The chemical name is N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is:
Arrayn- Array
Fentanyl transdermal system is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are:
1)u00a0u00a0 a backing layer of PET foil;
2)u00a0u00a0 a drug containing layer of fentanyl and dipropylene glycol with hydroxypropyl cellulose;
3)u00a0u00a0 an ethylene vinyl-acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and
4)u00a0u00a0 a silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded.

No data

Carcinogenesis
In a two-year carcinogenicity study conducted in rats, fentanyl was not associated with an increased incidence of tumors at subcutaneous doses up to 33 mcg/kg/day in males or 100 mcg/kg/day in females (0.16 and 0.39 times the human daily exposure obtained via the 100 mcg/hr patch based on AUCcomparison).
Mutagenesis
There was no evidence of mutagenicity in the Ames Salmonella mutagenicity assay, the primary rat hepatocyte unscheduled DNA synthesis assay, the BALB/c 3T3 transformation test, and the human lymphocyte and CHO chromosomal aberration assays.
Impairment of Fertility
The potential effects of fentanyl on male and female fertility were examined in the rat model via two separate experiments. In the male fertility study, male rats were treated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuous intravenous infusion for 28 days prior to mating; female rats were not treated. In the female fertility study, female rats were treated with fentanyl (0, 0.025, 0.1 or 0.4 mg/kg/day) via continuous intravenous infusion for 14 days prior to mating until day 16 of pregnancy; male rats were not treated. Analysis of fertility parameters in both studies indicated that an intravenous dose of fentanyl up to 0.4 mg/kg/day to either the male or the female alone produced no effects on fertility (this dose is approximately 1.6 times the daily human dose administered by a 100 mcg/hr patch on a mg/mbasis). In a separate study, a single daily bolus dose of fentanyl was shown to impair fertility in rats when given in intravenous doses of 0.3 times the human dose for a period of 12 days.

Fentanyl transdermal system as therapy for pain due to cancer has been studied in 153 patients. In this patient population, fentanyl transdermal system has been administered in doses of 25 mcg/hr to 600 mcg/hr. Individual patients have used fentanyl transdermal system continuously for up to 866 days. At one month after initiation of fentanyl transdermal system therapy, patients generally reported lower pain intensity scores as compared to a pre-study analgesic regimen of oral morphine.
The duration of fentanyl transdermal system use varied in cancer patients; 56% of patients used fentanyl transdermal system for over 30 days, 28% continued treatment for more than 4 months, and 10% used fentanyl transdermal system for more than 1 year.
In the pediatric population, the safety of fentanyl transdermal system has been evaluated in 289 patients with chronic pain 2 to 18 years of age. The duration of fentanyl transdermal system use varied; 20% of pediatric patients were treated for u2264 15 days; 46% for 16 to 30 days; 16% for 31 to 60 days; and 17% for at least 61 days. Twenty-five patients were treated with fentanyl transdermal system for at least 4 months and 9 patients for more than 9 months.

Product: 71335-0683
NDC: 71335-0683-1 1 h in a BOTTLE
NDC: 71335-0683-2 2 h in a BOTTLE
NDC: 71335-0683-3 5 h in a BOTTLE

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Arrayn- Addiction, Abuse, and Misuse
Inform patients that the use of fentanyl transdermal system, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death . Instruct patients not to share fentanyl transdermal system with others and to take steps to protect fentanyl transdermal system from theft or misuse.
Arrayn- Life-Threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting fentanyl transdermal system or when the dosage is increased, and that it can occur even at recommended dosages . Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Arrayn- Accidental Exposure
Inform patients that accidental exposure, especially in children, may result in respiratory depression or death . Instruct patients to take steps store fentanyl transdermal system securely and to dispose of unused fentanyl transdermal system by flushing down the toilet .
Fentanyl transdermal system can be accidentally transferred to children. Instruct patients to take special precautions to avoid accidental contact when holding or caring for children.
Instruct patients that, if the patch dislodges and accidentally sticks to the skin of another person, to immediately take the patch off, wash the exposed area with water and seek medical attention for the accidentally exposed individual as accidental exposure may lead to death or other serious medical problems.
Arrayn- Disposal
Instruct patients to refer to the Instructions for Use for proper disposal of fentanyl transdermal system. To properly dispose of a used patch, instruct patients to remove it, fold so that the adhesive side of the patch adheres to itself, and immediately flush down the toilet. Unused patches should be removed from their pouches, the release liners removed, the patches folded so that the adhesive side of the patch adheres to itself, and immediately flushed down the toilet.
Inform patients that deaths have occurred from accidental exposure to fentanyl transdermal systems discarded in the trash.
Instruct patients to dispose of any patches remaining from a prescription as soon as they are no longer needed.
Arrayn- Interactions with Benzodiazepines and Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if fentanyl transdermal system is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider n
Arrayn- Serotonin Syndrome
Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms and signs of serotonin syndrome, and to seek medical attention right away if symptoms develop. Instruct patients to inform their healthcare providers if they are taking, or plan to take serotonergic medications and .
Arrayn- MAOI Interaction
Inform patients to avoid taking fentanyl transdermal system while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking fentanyl transdermal system .
Arrayn- Adrenal Insufficiency
Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms .
Arrayn- Important Administration Instructions
Advise patients never to change the dose of fentanyl transdermal system or the number of patches applied to the skin unless instructed to do so by the prescribing healthcare professional.
When no longer needed, advise patients how to safely taper fentanyl transdermal system and not to stop it abruptly to avoid the risk of precipitating withdrawal symptoms.
Arrayn- Warnings About Heat
Warn patients of the potential for temperature-dependent increases in fentanyl release from the patch that could result in an overdose of fentanyl. Instruct patients to contact their healthcare provider if they develop a high fever. Instruct patients to:
Arrayn- Hypotension
Inform patients that fentanyl transdermal system may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position) .
Arrayn- Anaphylaxis
Inform patients that anaphylaxis, including anaphylactic shock, has been reported with ingredients contained in fentanyl transdermal system. Advise patients how to recognize such a reaction and when to seek medical attention .
Arrayn- Pregnancy
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of fentanyl transdermal system during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated .
Embryo-Fetal Toxicity
Inform female patients of reproductive potential that fentanyl transdermal system can cause fetal harm and to inform their healthcare provider of known or suspected pregnancy .u00a0
Arrayn- Lactation
Advise patients that breastfeeding is not recommended during treatment with fentanyl transdermal system .
Arrayn- Infertility
Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible .
Arrayn- Driving or Operating Heavy Machinery
Inform patients that fentanyl transdermal system may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication .
Arrayn- Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention .
An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/X30000067.pdf or by calling 1-800-778-7898 for alternate delivery options.

Medication Guiden- Fentanyl Transdermal System, CIIn n- (fu0115nu00b4 tu04d9-nu012dl)
Fentanyl transdermal system is:
Important information about fentanyl transdermal system:
Do not use fentanyl transdermal system if you have:
Before applying fentanyl transdermal system, tell your healthcare provider if you have a history of:
Tell your healthcare provider if you:
When using fentanyl transdermal system:
While using fentanyl transdermal system DO NOT:
The possible side effects of fentanyl transdermal system are:
Get emergency medical help if you have:
These are not all the possible side effects of fentanyl transdermal system. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. n
Manufactured by: LTS Lohmann Therapy Systems, Corp., W. Caldwell, NJ 07006n Manufactured for: Mallinckrodt Inc., Hazelwood, MO 63042 USA, www.Mallinckrodt.com or call 1-800-778-7898u00a0u00a0
Mallinckrodtn
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 04/2017

Instructions for UseFentanyl Transdermal System CII
Instructions for Applying a Fentanyl Transdermal System
Be sure that you read, understand, and follow these Instructions for Use before you use fentanyl transdermal system. Talk to your healthcare provider or pharmacist if you have any questions.
Parts of the fentanyl transdermal system:
Before applying fentanyl transdermal system
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Mallinckrodt, the u201cMu201d brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company.
u00a9 2017 Mallinckrodt.
Bioclusive is a trademark of Systagenix Wound Management (US), Inc.Tegaderm is a trademark of 3M Company.
Rx only
Manufactured by:n
Manufactured for:n
Printed in USA
0004055
Issued: 04/2017
Mallinckrodtu2122

No data

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Fentanyl Transdermal System (Fentanyl Transdermal System)

Trade Name : FENTANYL TRANSDERMAL SYSTEM

PATCH, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Fentanyl Transdermal System (Fentanyl Transdermal System)

Trade Name : FENTANYL TRANSDERMAL SYSTEM

PATCH, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?