Fendivia

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Fendivia: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Fendivia

ATX code: N02AB03

Active ingredient: fentanyl (Fentanyl)

Producer: LTS Lohmann Therapie-Systeme, AG (Germany)

Description and photo update: 2018-27-11

Fendivia is an analgesic narcotic (opioid narcotic analgesic).

Release form and composition

The drug is produced in the form of a transdermal therapeutic system (TTS): a translucent rectangular patch with rounded edges on a removable transparent protective film, which is larger in size than the patch; the protective film is divided into two parts by a sinusoidal cut; patches 12.5 / 25/50/75/100 μg / h are 24/37 / 51.3 / 61.7 / 70 mm long (± 0.5 mm each) and 18 / 24.6 / 34/42 wide / 49 mm (± 0.5 mm each) respectively; on the plasters by means of color printing (depending on the rate of release of the active substance) the following inscriptions are applied: 12.5 μg / h - brown Fentanyl 12.5 μg / hour; 25 μg / h - red Fentanyl 25 μg / hour; 50 μg / h - green Fentanyl 50 μg / hour; 75 μg / h - light blue Fentanyl 75 μg / hour;100 μg / h - gray Fentanyl 100 μg / hour [each TTS is packed in a heat-sealable bag made of aluminum, paper and polyacrylonitrile (PAN), in a cardboard box 5 bags and Fendivia instructions for use].

Composition for 1 patch (TTS):

active ingredient: fentanyl, the content of which in 1 TTS is: 1.38; 2.75; 5.5; 8.25 or 11 mg in a patch with a release rate of 12.5; 25; 50; 75 and 100 μg / h and with a contact area of 4.2; 8.4; 16.8; 25.2 and 33.6 cm², respectively;
Removable protective film: polyester film with a fluorine-containing polymer coating;
outer protective film: polyethylene terephthalate film (PET film);
microreservoirs containing an active ingredient: hyprolose (E463), dipropylene glycol;
reservoir / skin-adhesive layer: dimethicone (E900), silicone adhesive layer;
release membrane: vinyl acetate / ethylene copolymer.

Pharmacological properties

Pharmacodynamics

Fendivia is a transdermal patch that provides a constant systemic supply of the active ingredient, fentanyl, for 72 hours.

Fentanyl is an opioid analgesic with an affinity mainly for the opiate μ receptors of the spinal cord, central nervous system (CNS), and peripheral tissues. The agent enhances the activity of the antinociceptive (analgesic) system, increases the pain threshold, demonstrating mainly sedative and analgesic effects. The active substance has a depressing effect on the respiratory center, leads to a slowdown in the heart rate, excites the vomiting center and the nervus vagus (vagus nerve), helps to increase the tone of the smooth muscles of the biliary tract, sphincters (including the bladder, urethra and the sphincter of Oddi), and improving the absorption of water from the gastrointestinal tract (GIT).

Fentanyl causes a decrease in blood pressure (BP), intestinal peristalsis, and renal blood flow. Due to its action in the blood, the concentration of lipase and amylase increases, the level of catecholamines, growth hormone (STH), cortisol, adrenocorticotropic hormone (ACTH), and prolactin decreases.

Fendivia promotes the onset of sleep (mainly as a result of pain relief), can cause euphoria. The rate of drug dependence and addiction to the analgesic effect has significant individual differences. Therapy rarely leads to the development of histamine reactions.

Pharmacokinetics

The lowest effective analgesic concentration of the active substance in the blood in patients who have not previously used opioid analgesics is 0.3–1.5 ng / ml. With an increase in the concentration of fentanyl in the blood plasma and exceeding 2 ng / ml in such patients, the development of undesirable reactions increases. When tolerance occurs, the minimum effective analgesic concentration of fentanyl increases, as well as the concentration against which side effects appear.

After the first application of the transdermal patch, the serum level of the active substance rises gradually, leveling off, usually between 12 and 24 hours, and then remains relatively constant over the remaining 72 hour period. By the time of the second 72-hour application, a constant level of the agent is achieved in the blood serum, which is maintained with subsequent uses of the patch of the same size. The serum concentration of fentanyl in the blood is proportional to the size of the TTC. The absorption of the substance may vary slightly depending on the area of application.

Slightly reduced absorption of fentanyl (approximately 25%) was found in studies of healthy volunteers applying the patch to the chest when compared to the back and upper arm.

The connection of the substance with blood plasma proteins is 84%. Fentanyl crosses the blood-brain barrier (BBB) and the placenta, and is detected in human milk. The substance is characterized by linear kinetics of biotransformation, the metabolic process occurs with the participation of CYP3A4 enzymes, mainly in the liver. The main metabolite of fentanyl, norfentanyl, is inactive.

After using the transdermal patch, the serum fentanyl level gradually decreases. The half-life (T _1/2) of the substance after removing the patch is 17 hours (13-22 hours) in adults, and 22-25 hours in children. Prolonged absorption of fentanyl from the skin surface leads to its slower elimination from the blood serum when compared with intravenous (IV) administration. Approximately 75% of the substance is excreted in the urine, mainly in the form of metabolites, of which less than 10% is unchanged; about 9% is excreted in feces, mainly in the form of metabolites.

Indications for use

chronic severe pain syndrome in adults, requiring long-term continuous pain relief with opioid analgesics;
chronic pain syndrome in children aged 2 years and older, receiving treatment with opioid analgesics, requiring long-term therapy.

Contraindications

Absolute:

oppression of the respiratory center, including acute respiratory depression;
toxic dyspepsia;
diarrhea due to pseudomembranous colitis associated with the intake of lincosamides, cephalosporins, penicillins;
severe disorders of the central nervous system;
treatment of acute or postoperative pain, due to the inability to select a dose for short-term use and the risk of life-threatening respiratory depression;
irradiated, damaged or irritated skin at the site of application;
use in combination with monoamine oxidase inhibitors (MAO) or within 14 days after the latter is canceled;
age up to 2 years;
hypersensitivity to any of the constituents of the drug.

Relative (apply Fendivia patches with extreme caution):

intracranial hypertension, traumatic brain injury, brain tumor;
chronic lung disease (because respiratory function decreases and airway resistance increases);
arterial hypotension, bradyarrhythmia;
renal and / or hepatic impairment;
hepatic / renal colic, including history;
cholelithiasis;
undiagnosed acute surgical diseases of the abdominal organs;
general serious condition;
stricture of the urethra;
benign prostatic hypertrophy;
hypothyroidism;
alcoholism;
hyperthermia;
drug dependence, suicidal tendencies;
combined use with insulin, glucocorticosteroids (GCS), antihypertensive drugs (a reduction in the dose of fentanyl is required).

With caution, Fendivia should also be used in weakened, emaciated and elderly patients due to a decrease in clearance and an increase in their T _{1/2 of} fentanyl, which can lead to an overdose.

Fendivia, instructions for use: method and dosage

The Fendivia patch is used transdermally.

Fentanyl is released at a rate of 12.5; 25; 50; 75 or 100 μg / h, which is approximately 0.3; 0.6; 1.2; 1.8 or 2.4 mg per day, respectively.

The dosage is determined individually, depending on the condition of the patient, and should be evaluated regularly after each use. The minimum effective dose must be used.

It is recommended to apply the patch containing fentanyl to the flat, intact skin of the shoulder or torso. For young children, it should be glued to the upper back to reduce the risk of self-removal.

The area for application should be chosen with a minimum of hair. Before applying TTS, the hair at the application site must be cut (without shaving). If it is necessary to wash the application site before gluing the patch, this should be done with clean water. Lotions, soaps, alcohol, oils or other products are not recommended as they can irritate the skin or change its properties. The skin must be completely dry before the procedure. Since the patch is covered with a waterproof protective film, it does not need to be removed if you shower for a short time.

Immediately after removing the patch from the heat seal bag and removing the protective film, apply it to the skin, without touching the adhesive side, and press firmly against the application site with the palm of your hand for about 30 seconds. The TTS should fit snugly to the skin, especially at the edges, if necessary, it should be fixed additionally, and then wash your hands with clean water.

Fendivia is designed to be used continuously for 72 hours. A new patch must always be applied on a different area of the skin, without using the site of the previous application. You can apply the patch to the same area again no earlier than 7 days later.

The initial dose is set taking into account the level of opioid intake in the period preceding Fendivia therapy, the risk of tolerance development, concomitant treatment with other drugs, the patient's general health and medical status, i.e. age, body weight, degree of exhaustion and severity of the lesion.

Patients who have not previously undergone opioid therapy are not recommended transdermal use; in this case, one should resort to oral and parenteral drug administration. To prevent overdose, they should use low initial doses of immediate-release opioids (including tramadol, oxycodone, hydromorphone, morphine, and codeine). The dose of these funds for adults must be titrated in such a way that in terms of the effectiveness of the analgesic effect it corresponds to 12.5 / 25 μg / h of Fendivia. In the future, patients can make the transition to the use of a transdermal patch.

In the case when oral administration of opioids is contraindicated or unacceptable, and the use of TTS is recognized as the only possible method of therapy, it is necessary to start treatment with the drug with the lowest dose - 12.5 μg / h.

When switching to the use of a transdermal patch, for a patient who has used orally / parenterally opioids in the previous period, it is necessary to establish the amount of previously received opioid analgesics that he needed in the last 24 hours (mg / day). The resulting dose must be converted into an equivalent oral daily dose of morphine (mg / day) using the appropriate factor.

The equivalent dose of morphine is set by multiplying the dose of opioid analgesics by the following factors (previously used opioid in mg / day × factor) used to recalculate the daily dose for oral / parenteral administration:

morphine - 1 ^a / 3;
fentanyl - ^- / 300;
codeine - 0.15 / 0.23 ^b;
diamorphine - 0.5 / 6 ^b;
ketobemidone - 1/3;
hydromorphone - 4/20 ^b;
levorphanol - 7.5 / 15 ^b;
oxycodone - 1.5 / 3;
pethidine - ^- / 0.4 ^b;
tramadol - 0.25 / 0.3;
tapentadol - 0.4 / -;
methadone - 1.5 / 3 ^b.

^a - the activity of morphine obtained orally or intramuscularly (i / m) based on clinical experience of use in patients with chronic pain syndrome.

^b - according to the results of studies obtained with a single intramuscular injection of each of these drugs, to determine their relative activity in comparison with morphine; oral doses - doses that are recommended when switching from parenteral to oral administration.

The appropriate starting dose of fentanyl is adjusted according to the oral daily dose of morphine.

For adults, clinically less stable patients who need opioid replacement, the following transition from a daily dose of oral morphine to a dose of transdermal fentanyl is recommended at a transition ratio of 150 ÷ 1 [morphine (mg / day) - fentanyl (mcg / h)]:

less than 90 - 12.5;
90-134 - 25;
135-224 - 50;
225-314 - 75;
315-404 - 100;
405-494 - 125;
495-584 - 150;
585-674 - 175;
675-764 - 200;
765-854 - 225;
855-944 - 250;
945-1034 - 275;
1035-1124 - 300.

For adults taking well-tolerated stable opioid treatment, the following transition is recommended from a daily dose of oral morphine to a dose of transdermal fentanyl at a transition ratio of 100 ÷ 1 [morphine (mg / day) - fentanyl (mcg / h)]:

less than 44 - 12.5;
45–89 - 25;
90-149 - 50;
150-209 - 75;
210-269 - 100;
270-329 - 125;
330–389 - 150;
390-449 - 175;
450-509 - 200;
510-569 - 225;
570-629 - 250;
630-689 - 275;
690-749 - 300.

The initial assessment of the maximum analgesic effect of Fendivia should be carried out no earlier than 24 hours after application. The reason for this limitation is a gradual increase in the serum concentration of fentanyl in the first 24 hours after applying the patch. As a result, when switching from one analgesic drug to another, the previous therapy should be stopped gradually, after the application of the initial dose of fentanyl and until its analgesic effect stabilizes.

The TTC should be replaced with a new one every 72 hours. Maintenance dose titration is performed individually until an adequate level of pain relief is achieved, taking into account the tolerability of the drug. As a rule, the dose can be increased at a time by 12.5 or 25 μg / h, depending on the patient's condition and the need for additional pain relief (morphine when used orally at doses of 45 and 90 mg / day is approximately equivalent to Fendivia at doses of 12.5 and 25 μg / h, respectively). Stable pain relief may occur 6 days after the dose is increased. Therefore, after adjusting the dose, it is required to apply an increased dosage patch at least 2 times for 72 hours, and only then, if necessary, make its next increase.

In order to achieve a dose exceeding 100 mcg / h, several patches can be used simultaneously. When breakthrough pain occurs, it may be necessary to prescribe additional doses of short-acting analgesics. When using Fendivia at a dose exceeding 300 mcg / h, it is necessary to consider the use of additional / alternative analgesic methods or routes of administration of opioid analgesics.

At the beginning of the course of therapy, in case of a significant decrease in the analgesic effect after the application of the initial dose, after 48 hours, the patch can be replaced with a similar one, and after 72 hours the dose can be increased.

If the patch comes off or needs to be replaced for some other reason before 72 hours have elapsed, you can apply a patch with a similar dose to another skin area. In this case, the patient's condition should be carefully monitored, due to the risk of an increase in the plasma concentration of the drug.

With the transition from long-term morphine therapy to transdermal patch treatment, withdrawal syndrome may develop, even with an adequate analgesic effect. If this disorder occurs, it is recommended that short-acting low-dose morphine be continued.

If it is necessary to interrupt therapy with a transdermal patch, it should be replaced with other opioids gradually, starting with a low dose, due to the slow decline in serum fentanyl levels after removal of the patch and the threat of withdrawal syndrome. It takes at least 17 hours to reduce the concentration of fentanyl in the blood by 50%.

In children and adolescents 2–16 years old, Fendivia can only be used in cases where patients have already taken oral morphine in equivalent amounts (at a dose of at least 30 mg / day). When switching from oral / parenteral use of opioid analgesics to the fentanyl patch, the initial dose in children is calculated depending on the daily oral dose of morphine. Fendivia at a dose of 12.5 and 25 mcg / h is equivalent to morphine at an oral dose of 30–44 and 45–134 mg / day, respectively. The transition in children to the use of fentanyl in doses exceeding 25 μg / h does not differ from that in adult patients.

One transdermal patch 12.5 mcg / h can replace only morphine when taken orally at a dose of 30–44 mg / day or other opioid analgesics in an equivalent amount. This regimen cannot be used to transfer children from the use of fentanyl to other opioid analgesics due to the possible occurrence of an overdose.

Since the analgesic effect of the initial dose of the patch during the first 24 hours does not reach an adequate level, after switching to Fendivia treatment, children should receive the previous analgesics in the usual amount. For the next 12 hours, previously used analgesics can be used if clinically necessary. The dose is set individually, after the start of treatment, the patch needs to be replaced with a new one every 72 hours. If there is a need to increase the dose, its correction in children is carried out gradually, in increments of 12.5 mcg / h, without increasing more often than once every 72 hours. If the analgesic effect is insufficient, additional use of morphine or another short-acting opioid analgesic is possible.

Side effects

CNS: very often - dizziness, drowsiness, headache; often - paresthesia, tremor; infrequently - amnesia, hypesthesia, decreased level of consciousness, convulsions (including clonic and grand mal), loss of consciousness;
mental disorders: often - insomnia, anxiety, depression, confusion, hallucinations; infrequently - agitation, euphoria, disorientation;
cardiovascular system (CVS): often - palpitations, arterial hypertension, tachycardia; infrequently - arterial hypotension, cyanosis, bradycardia;
metabolism and nutritional disorders: often - anorexia;
Gastrointestinal tract: very often - nausea, constipation, vomiting; often - dry mouth, abdominal pain / epigastric pain, dyspepsia, diarrhea; infrequently - intestinal obstruction; rarely - partial intestinal obstruction;
kidneys and urinary tract: often - urinary retention;
genitals and mammary gland: infrequently - sexual dysfunction, erectile dysfunction;
skin and subcutaneous tissues: often - itching, sweating, rash, erythema; infrequently - skin inflammation, dermatitis, allergic / contact dermatitis, eczema;
musculoskeletal system and connective tissue: often - muscle spasms; infrequently - muscle twitching;
immune system: often - hypersensitivity; with an unknown frequency - anaphylactoid reactions, anaphylactic reactions, anaphylactic shock;
respiratory system, organs of the chest and mediastinum: often - dyspnea; infrequently - respiratory failure, respiratory depression; rarely - hypoventilation, apnea; with an unknown frequency - bradypnea;
organ of hearing and labyrinthine disorders: often - vertigo;
organ of vision: infrequently - decreased visual acuity; rarely - miosis;
general disorders and disorders at the site of application: often - malaise, asthenia, fatigue, feeling of coldness, peripheral edema; infrequently - a feeling of a change in body temperature, skin reaction / hypersensitivity at the site of application, flu-like symptoms, fever, withdrawal syndrome; rarely - eczema / dermatitis at the site of application.

With prolonged use of Fendivia, the appearance of tolerance, physical and mental dependence, short-term muscle stiffness (including chest muscles) is possible.

In the case of abrupt cessation of treatment or replacement of previously received opioid analgesics with a transdermal patch, a withdrawal syndrome may occur, the symptoms of which are: vomiting, diarrhea, nausea, anxiety, fever, tremors.

The side effect profile in children and adolescents was similar to that in adults. When using Fendivium in children, the most common disorders were headache, vomiting, nausea, diarrhea, constipation, itching.

Overdose

Symptoms of a Fendivia overdose may be: lethargy, depression of the respiratory center with Cheyne-Stokes breathing and / or cyanosis, coma. Also, against the background of an overdose, there may be: hypothermia, arterial hypotension, bradycardia, decreased muscle tone. Signs of toxicity include miosis, ataxia, deep sedation, convulsions, and respiratory depression.

In this condition, it is necessary to remove the patch and inject a specific fentanyl antagonist, naloxone. It is recommended to carry out physical / verbal exposure to the patient, symptomatic and vital functions support treatment (including artificial ventilation, the administration of muscle relaxants, with a significant decrease in blood pressure - replenishment of the circulating blood volume, with bradycardia - the administration of atropine).

For adults, the initial dose of naloxone is 0.4-2 mg IV, if necessary, it is possible to administer this dose every 2-3 minutes or a long-term infusion of 2 mg of the substance diluted in 0.9% sodium chloride solution at a dose of 500 ml, or 5% dextrose solution (0.004 mg / ml). The infusion rate is determined based on the patient's individual response and previous bolus infusions. If intravenous administration is impossible, naloxone can be administered subcutaneously (s.c.) or intramuscularly. Moreover, its injection into the muscle leads to a more prolonged effect than the injection into a vein.

Respiratory depression due to overdose may last longer than the effect of the opioid antagonist. When the narcotic effect is removed, it is possible to increase acute pain and release catecholamines. In some cases, treatment in an intensive care unit is required.

special instructions

Fendivia should be used as part of comprehensive pain therapy, provided there is adequate psychological, social and medical assessment of the patient's condition.

After removal of the TTS, the patient needs to be monitored for 24 hours due to the prolonged T _{1/2 of} fentanyl.

Transdermal patches should not be cut / divided into parts, as their effectiveness and safety in this case have not been established.

In patients who had not previously received opioids and who use Fendivia as an initial therapy, especially for pain syndrome of non-oncological genesis, severe respiratory depression and / or death were extremely rare. The risk of developing these conditions exists even with a dose of 12.5 mcg / h. In this case, the resulting respiratory depression can persist after removal of the TTS. The incidence of this complication increases with an increase in the dose of fentanyl.

In the case when the patient is prescribed procedures that completely eliminate the feeling of pain (for example, regional analgesia), the threat of respiratory depression is aggravated. It is recommended that the dose of fentanyl be reduced or replaced with a fast- or short-acting opioid before such procedures.

Opioids can cause hypotension, especially in patients with hypovolemia. As a consequence, it is necessary to take precautions when treating patients with hypovolemia and / or arterial hypotension.

With constant use of Fendivia, tolerance, physical and mental dependence may appear, but they are rarely observed in the treatment of pain associated with tumors.

Patients with fever require careful monitoring for adverse reactions to opioids and, if necessary, dose adjustment of fentanyl. Also, such patients need to beware of exposure to the application site of the transdermal patch of direct external heat sources, which include: heated blankets, heating pads, tanning lamps, heating lamps, hot baths, intense sunbathing. In these situations, the risk of a temperature-dependent increase in the release of fentanyl from the patch is exacerbated, which can lead to overdose and death.

With the combined use of TTS with fentanyl and drugs that affect the serotonergic systems of neurotransmitters, the threat of serotonin syndrome is aggravated. With the development of this potentially life-threatening complication, the following effects may appear: disorders of the autonomic nervous system (hyperthermia, labile blood pressure, tachycardia), changes in the mental state (hallucinations, agitation, coma), neuromuscular disorders (rigidity, increased reflexes, impaired coordination), gastrointestinal disorders (vomiting, diarrhea, nausea). If you suspect serotonin syndrome, you must stop using Fendivia.

Fentanyl, as a result of an increase in the transit time of food through the gastrointestinal tract, can provoke a fixing effect on the stool. Patients with chronic constipation should use Fendivia with extreme caution. If ileus (paralytic bowel obstruction) is suspected, therapy should be discontinued.

During treatment, you should stop drinking ethanol-containing drinks.

Influence on the ability to drive vehicles and complex mechanisms

Since the use of TTS with fentanyl can have a negative effect on mental and physical abilities, it is not recommended to drive vehicles and other complex equipment during treatment.

Application during pregnancy and lactation

There is no data confirming the safety of using Fendivia during pregnancy. In the process of research on animals, a certain reproductive toxicity was revealed. Prolonged use of transdermal fentanyl patches during pregnancy can trigger withdrawal symptoms in newborns. There have been separate reports of the existing symptoms of this syndrome in newborns whose mothers constantly used TTS during pregnancy.

The use of fentanyl during pregnancy is allowed only if absolutely necessary. Fendivia is not recommended for use during labor and childbirth (including through a cesarean section), since the agent crosses the placenta and can cause respiratory depression in the fetus / newborn.

The drug is found in human milk and may cause respiratory depression and sedation in a breastfed baby. In this connection, if it is necessary to use Fendivia during lactation, it is necessary to interrupt breastfeeding (for the entire period of use, as well as for a time of at least 72 hours after the last application).

Pediatric use

The use of TTS in children under 2 years of age is contraindicated, since there are no data confirming the safety and effectiveness of therapy. For adolescents over 16 years of age, a dosage regimen similar to that in adult patients is recommended.

Fendivia should not be given to children over 2 years of age who have not previously received opioid analgesic treatment. The use of the drug is possible only if children have opioid tolerance. It should be borne in mind that the potential for serious / life-threatening respiratory depression exists regardless of the dose received. It is recommended to monitor patients for the development of adverse events for at least 48 hours after starting treatment or after increasing doses.

Care should be taken when choosing an application site and carefully monitor how the patch is adhered to prevent accidental ingestion by a child.

With impaired renal function

Patients with impaired renal function require careful monitoring of the condition due to the risk of signs of fentanyl toxicity. In the event of the latter, the dose must be reduced.

The initial dose of Fendivia should be 12.5 mcg / h.

For violations of liver function

Since the metabolic transformation of fentanyl occurs in the liver, in the presence of impaired hepatic function, the rate of its excretion may decrease.

In view of the risk of potential overdose with existing functional disorders of the liver, patients should be monitored during therapy. If necessary, you may need to reduce the dose of fentanyl.

The initial dose of Fendivia should not exceed 12.5 mcg / h.

Use in the elderly

In elderly patients, a decrease in fentanyl clearance is possible due to an increase in its T _1/2. Therefore, they need to be closely monitored for symptoms of drug toxicity.

In elderly patients who have not previously used opioids, Fendivia should be used only after careful assessment of the benefits and risks of therapy, at an initial dose of 12.5 mcg / h.

Drug interactions

derivatives of barbituric acid: the danger of respiratory depression is aggravated; this combination is contraindicated;
inhibitors of cytochrome P450 3A4 (CYP3A4) - nefazodone, nelfinavir, erythromycin, voriconazole, fluconazole, clarithromycin, ketoconazole, ritonavir, itraconazole, cimetidine, verapamil, amiodarone, as a result of which its concentration is increased by diltiazine or its concentration may increase: effect, and the likelihood of adverse reactions, including severe respiratory depression, increases. It is required to monitor the patient and, if necessary, reduce the dose of fentanyl or discontinue its use, and in the absence of careful monitoring, avoid this combination of drugs. The interval between discontinuation of therapy with CYP3A4 inhibitors and the first application of the patch should be at least 48 hours;
CYP3A4 inducers - phenobarbital, carbamazepine, rifampicin, phenytoin: the concentration of fentanyl in plasma decreases and its therapeutic effect is weakened, as a result of which dose adjustment can be made. This combination requires special care. If concomitant treatment with a CYP3A4 inducer is discontinued, it may be necessary to reduce the dose of fentanyl and monitor the patient;
agents that suppress the central nervous system - general anesthetics, other opioids, hypnotics and sedatives, phenothiazine derivatives, muscle relaxants, tranquilizers, alcohol, antihistamines with a sedative effect: additive sedative effects may develop, hypotension, hypoventilation, deep sedation / coma may appear; careful observation of the condition is necessary;
serotonergic drugs - selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SSRIs), MAO inhibitors: this combination is not recommended due to the threat of serotonin syndrome. When combined with MAO, it is also possible to enhance the action of narcotic analgesics;
nalbuphine, buprenorphine, pentazocine: the analgesic effect is weakened, the appearance of a withdrawal syndrome in patients with dependence on opioids is possible; the combination is not recommended;
muscle relaxants with vagolytic activity (including pancuronium bromide): the risk of arterial hypotension and bradycardia decreases (especially when using beta-blockers and other vasodilators) and the threat of arterial hypertension and tachycardia is aggravated;
muscle relaxants that do not show vagolytic activity (succinylcholine): the risk of severe CVD disorders is aggravated; the risk of bradycardia and arterial hypotension (especially with a burdened cardiac history) does not decrease.

Analogs

The analogues of Fendivia are: Lunaldin, Durogesic Matrix, Fentanyl, Dolforin, Fentadol Reservoir, Fentadol Matrix, Fentanyl M Sandoz.

Terms and conditions of storage

Store at a temperature of 15-25 ° C, out of the reach of children (even after use).

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Fendivia

According to most reviews, Fendivia is an effective remedy that demonstrates a stable analgesic effect in chronic severe pain syndrome. All patients note that the drug can be used only as directed by a physician, after individual selection of the optimal dose.

The disadvantage of the drug is its high cost, the presence of a large number of adverse reactions and contraindications, as well as the possible emergence of addiction to its action during prolonged therapy. There are some reviews with complaints about the lack of the desired result when using the patch.

Price for Fendivia in pharmacies

The price of Fendivia for a package containing 5 plasters (TTS) can be:

dose of 12.5 mcg / h - 1700 rubles;
dose of 25 mcg / h - 2100 rubles;
dose 50 mcg / h - 3100 rubles;
dose 75 mcg / h - 3800 rubles;
dose of 100 mcg / h - 4500 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!