Universal reference book for medicines
Name of the product: FENNIVIA (FENDIVIA)

Active substance: fentanyl

Type: Actually an opioid receptor agonist.
Analgesic
Manufacturer: NYCOMED DANMARK (Denmark) manufactured by LTS LOHMANN THERAPIE-SYSTEME (Germany)
Composition, form of production and packaging
Transdermal therapeutic system (TTS)
with a contact area of ​​4.2 cm 2 and a release rate of fentanyl of 12.5 μg / h;
is a semitransparent patch (18 ± 0.5 mm wide, 24 ± 0.5 mm long) of rectangular shape with rounded corners on the transparent transparent protective film; The protective film is larger in size than the patch, and divided by a sinusoidal cut into two parts; on the band-aid by the method of color printing there is a brown inscription "Fentanyl 12.5? g / hour".
1 TTC

fentanyl 1.38 mg

The composition of the outer protective film: polyethylene terephthalate film.

Composition of the reservoir layer: silicone adhesive layer, dimethicone (E900).

Composition of microreservoirs containing fentanyl: dipropylene glycol, giprolose (E463).

Composition of the release membrane: ethylene and vinyl acetate copolymer.

Composition of the skin-adhesive layer: silicone adhesive layer, dimethicone (E900).

Composition of removable protective film: polyester film with fluorine-containing polymer coating.

1 PC.
- heat-sealing bags (5) - packs cardboard.
Transdermal therapeutic system (TTC) with a contact area of ​​8.4 cm 2 and a release rate of fentanyl of 25 μg / h;
is a translucent patch (24.6 ± 0.5 mm wide, 37 ± 0.5 mm long) of rectangular shape with rounded corners on the transparent transparent protective film; The protective film is larger in size than the patch, and divided by a sinusoidal cut into two parts; on the band-aid by the method of color printing there is a red inscription "Fentanyl 25? g / hour".
1 TTC

fentanyl 2.75 mg

The composition of the outer protective film: polyethylene terephthalate film.

Composition of the reservoir layer: silicone adhesive layer, dimethicone (E900).

Composition of microreservoirs containing fentanyl: dipropylene glycol, giprolose (E463).

Composition of the release membrane: ethylene and vinyl acetate copolymer.

Composition of the skin-adhesive layer: silicone adhesive layer, dimethicone (E900).

Composition of removable protective film: polyester film with fluorine-containing polymer coating.

1 PC.
- heat-sealing bags (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​16.8 cm 2 and a release rate of fentanyl of 50 μg / h;
is a translucent patch (width 34 ± 0.5 mm, length 51.3 ± 0.5 mm) of rectangular shape with rounded corners on the transparent transparent protective film; The protective film is larger in size than the patch, and divided by a sinusoidal cut into two parts; on the band-aid by the method of color printing there is a green inscription "Fentanyl 50? g / hour".
1 TTC

fentanyl 5.5 mg

The composition of the outer protective film: polyethylene terephthalate film.

Composition of the reservoir layer: silicone adhesive layer, dimethicone (E900).

Composition of microreservoirs containing fentanyl: dipropylene glycol, giprolose (E463).

Composition of the release membrane: ethylene and vinyl acetate copolymer.

Composition of the skin-adhesive layer: silicone adhesive layer, dimethicone (E900).

Composition of removable protective film: polyester film with fluorine-containing polymer coating.

1 PC.
- heat-sealing bags (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​25.2 cm 2 and a release rate of fentanyl of 75 μg / h;
is a translucent patch (42 ± 0.5 mm wide, 61.7 ± 0.5 mm long) of rectangular shape with rounded corners on the transparent transparent protective film; The protective film is larger in size than the patch, and divided by a sinusoidal cut into two parts; on the band-aid by the method of color printing the light blue inscription "Fentanyl 75? g / hour" is put.
1 TTC

fentanyl 8.25 mg

The composition of the outer protective film: polyethylene terephthalate film.

Composition of the reservoir layer: silicone adhesive layer, dimethicone (E900).

Composition of microreservoirs containing fentanyl: dipropylene glycol, giprolose (E463).

Composition of the release membrane: ethylene and vinyl acetate copolymer.

Composition of the skin-adhesive layer: silicone adhesive layer, dimethicone (E900).

Composition of removable protective film: polyester film with fluorine-containing polymer coating.

1 PC.
- heat-sealing bags (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​33.6 cm 2 and a release rate of fentanyl of 100 μg / h;
is a semitransparent patch (width 49 ± 0.5 mm, length 70 ± 0.5 mm) of rectangular shape with rounded corners on the transparent transparent protective film; The protective film is larger in size than the patch, and divided by a sinusoidal cut into two parts; on the band-aid by the method of color printing there is a gray inscription "Fentanyl 100? g / hour".
1 TTC

fentanyl 11 mg

The composition of the outer protective film: polyethylene terephthalate film.

Composition of the reservoir layer: silicone adhesive layer, dimethicone (E900).

Composition of microreservoirs containing fentanyl: dipropylene glycol, giprolose (E463).

Composition of the release membrane: ethylene and vinyl acetate copolymer.

Composition of the skin-adhesive layer: silicone adhesive layer, dimethicone (E900).

Composition of removable protective film: polyester film with fluorine-containing polymer coating.

1 PC.
- heat-sealing bags (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

The drug Fendivia is a transdermal patch that provides a constant systemic intake of fentanyl for 72 hours.

Fentanyl is an opioid analgesic with affinity, mainly to opioid receptors of the CNS, spinal cord and peripheral tissues.
Increases the activity of the antinociceptive system, increases the threshold of pain sensitivity. The drug mainly has analgesic and sedative effects.
Fentanyl exerts a depressant effect on the respiratory center, slows the heart rate, excites the n.vagus centers and the vomiting center, increases the tone of the smooth muscles of the bile ducts, sphincters (including the urethra, bladder and sphincter of Oddi), improves the absorption of water from the digestive tract .
Reduces blood pressure, intestinal peristalsis and renal blood flow. Increases the concentration of amylase and lipase in the blood; reduces the concentration of somatotropic hormone, catecholamines, ACTH, cortisol, prolactin.
Promotes the onset of sleep (mainly in connection with the removal of the pain syndrome).
Causes euphoria. The rate of development of drug dependence and tolerance to analgesic effect has significant individual differences. Unlike other opioid analgesics, histamine reactions are much less likely to occur.
PHARMACOKINETICS

The minimum effective analgesic concentration in the blood in patients who did not previously use opioid analgesics is 0.3-1.5 ng / ml.

Suction

After the first patch application, the fentanyl concentration in the serum increases gradually, leveling usually between 12 and 24 hours, and then remains relatively constant for the remaining 72-hour period of time.
By the second 72-hour patch application, a constant concentration of the drug in the serum is achieved, which persists with subsequent patches of the same size patch. The concentration of fentanyl in the blood is proportional to the size of the TTS. Absorption of fentanyl may differ slightly depending on the site of application. A slightly reduced absorption of fentanyl (approximately 25%) was observed in studies conducted with healthy volunteers during the application of the patch on the chest in comparison with the upper arm and back.
Distribution

Fentanyl binds to plasma proteins by 84%, penetrates through the BBB, placenta and into breast milk.

Metabolism

Fentanyl possesses linear biotransformation kinetics and is metabolized, primarily, in the liver by means of CYP3A4 enzymes.
The main metabolite of fentanyl is norfentanil, which is not active.
Excretion

After removing the patch containing fentanyl, its serum concentrations decrease gradually.
T 1/2 of fentanyl after TTC application is 17 h (13-22 h) with a single application and 17-30.8 h after 5 applications for a duration of 72 h. Continued absorption of fentanyl with transdermal administration causes a slower withdrawal of the drug from serum as compared to / in the introduction.
Fentanyl is excreted in urine (75% in the form of metabolites and 10% in unchanged form) and with bile (9% in the form of metabolites).

Pharmacokinetics in special clinical cases

Violation of the liver or kidney function can cause an increase in serum fentanyl concentration.

In elderly patients, debilitated or debilitated patients, a decrease in the clearance of fentanyl is possible, which can lead to a longer T 1/2 .

INDICATIONS

Chronic pain syndrome of strong and moderate severity, requiring analgesia with opioid analgesics:

- pain caused by an oncological disease;

- pain syndrome of non-oncological genesis, requiring repeated analgesia with opioid analgesics (eg, neuropathic pains, arthritis and arthrosis, phantom pain after limb amputation).

DOSING MODE

Transdermal patches containing fentanyl release the active substance for 72 hours. The release rate of fentanyl is 12.5;
25; 50; 75 and 100 μg / h, and the area of ​​the corresponding active surface is 4.2; 8.4; 16.8; 25.2 and 33.6 cm 2 .
The required dose of fentanyl is selected individually and should be evaluated regularly after each use.

Choice of initial dose

The dose of fentanyl is determined depending on the level of opioid intake in the previous period, as well as taking into account the possible development of tolerance, concomitant medication, the general health of the patient and the severity of the disease.

If the nature of the response to opioids for a given pain syndrome is not fully understood, the initial dose should not exceed 25 μg / h.

Transition from taking other opioid analgesics

When transferring a patient from oral or parenteral administration of opioid analgesics to fentanyl treatment, the initial dose is calculated as follows:

- The number of analgesics required in the last 24 hours should be determined;

- the amount received should be transferred to the appropriate oral dose of morphine using Table 1;

- the appropriate dose of fentanyl should be determined using Table 2.

Table 1. Doses of drugs equivalent to the effectiveness of analgesia

All IM and oral doses presented in the table are equivalent to the analgesic effect of 10 mg of morphine administered in m.

Name of the drug Equal - effective dose (mg)

in / m * orally

Morphine 10 30 (with regular administration) ** 60 (with a single or intermittent administration)

Hydromorphone 1.5 7.5

Methadone 10 20

Oxycodone 10-15 20-30

Levorphanol 2 4

Oxymorphine 1 10 (rectally)

Diamorphine 5 60

Pethidine 75 -

Codeine - 200

Buprenorphine 0.4 0.8 (sublingually)

Ketobemidone 10 30

* Based on the results of studies obtained after a single administration of drugs, with / m the administration of each drug was compared with morphine in order to achieve equivalent efficacy.
Oral doses are the doses recommended for switching from a parenteral route of administration to an oral route of administration.
** The morphine efficacy ratio for intramuscular / oral administration is 3: 1, which is based on the results of studies obtained in the treatment of patients with chronic pain.

Table 2. Recommended initial dose of the drug Fendivia
depending on the daily oral dose of morphine
Oral daily dose of morphine (mg / day) Dose of Fendivia (μg / h)

<135 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

Initial assessment of the maximal analgesic effect of the drug Fendivia
can be carried out no earlier than 24 hours after the application. This restriction is due to the fact that the increase in serum fentanyl concentration in the first 24 hours after the application is gradual. Therefore, when switching from one drug to another, the previous analgesic therapy should be canceled gradually after the initial dose of Fendivia is applied until its analgesic effect stabilizes.
Dose selection and maintenance therapy

The transdermal patch should be replaced with a new one every 72 hours. The dose is selected individually before reaching the required level of anesthesia.
If 48-72 hours after the application of the initial dose, a significant reduction in the analgesic effect occurs, then the patch replacement may be needed after 48 hours. A dose of 12.5 μg / h is usually sufficient to select a dose in the lower dosage range. If anesthesia was not sufficient by the end of the first application period, the dose can be increased after 3 days until the desired effect is obtained.
Usually, the dose is increased by 12.5 μg / h or 25 μg / h for 1 time, however, the patient's condition and the need for additional anesthesia should be taken into account.
To achieve a dose of more than 100 mcg / h, several patches can be used at the same time. In the event of "breakthrough" pain, patients may occasionally need additional doses of short-acting analgesics. If the dose of the drug Fendivia more than 300 μg / h, the possibility of using additional or alternative methods of anesthesia or alternative methods of administering opioid analgesics should be considered.
When switching from long-term morphine treatment to transdermal administration of fentanyl, withdrawal may occur, despite adequate analgesic effects.
When there is a withdrawal syndrome, it is recommended that short-acting morphine is administered to patients in low doses.
Discontinuation of treatment with Fendivia

If it is necessary to interrupt the use of the transdermal patch, the substitution for any other opioids should be carried out gradually, starting with a low dose and slowly increasing it.
This is due to the fact that the fentanyl content in the blood serum decreases gradually after removal of the patch; it takes at least 17 hours to reduce the serum fentanyl concentration by 50%. There is a general rule: the abolition of opioid analgesia should be gradual in order to prevent the occurrence of withdrawal syndrome (nausea, vomiting, diarrhea, anxiety and muscle tremor).
Mode of application

The drug is used transdermally.
The patch should be applied to the flat surface of intact and unirradiated skin of the trunk or shoulder. For application it is recommended to choose a place with a minimal hair cover (preferably without hair). Before application, the hair should be cut at the application site (do not shave!). If the application site needs to be cleaned before applying the patch, then this should be done with clean water. Do not use soap, lotions, oils, alcohol or other products.they can cause skin irritation or change its properties. Before application, the skin should be absolutely dry.
Because
The transdermal patch is protected by a waterproof outer protective film, it can be removed without a brief stay in the shower.
The transdermal patch containing fentanyl should be applied immediately after removal from the heat-seal bag.
After removing the protective film, the transdermal patch should be pressed firmly with the palm of the hand in place of the application for about 30 seconds. It should be ensured that the patch is tight against the skin, especially around the edges. Additional patch fixation may be required. The drug should be worn continuously for 72 hours, after which it must be changed to a new patch. A new transdermal patch should always be applied to another area of ​​the skin, without seizing the place of the previous application. At the same place applications patch can be applied repeatedly not earlier than 7 days.
The transdermal patch should not be divided or cut.

SIDE EFFECT

To describe the frequency of unwanted effects, the following terms are used: very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000), very rarely (<1/10 000), including individual messages.

The most dangerous side effect is respiratory depression.

From the side of the central nervous system and peripheral nervous system: very often - drowsiness, hypersomnia, headache, dizziness;
often sedation, confusion, depression, anxiety, nervousness, hallucinations, anorexia nervosa, involuntary muscle contractions, hypoesthesia; infrequently - euphoria, amnesia, insomnia, agitation, tremor, paresthesia, speech disorders; rarely - amblyopia; very rarely - delirium, asthenia, sexual dysfunction, ataxia, myoclonic cramps.
From the cardiovascular system: often - a feeling of heartbeat;
infrequently bradycardia, tachycardia, arterial hypotension, arterial hypertension; rarely - arrhythmia, vasodilation.
From the respiratory system: often - yawning, rhinitis;
infrequently - dyspnea, hypoventilation; very rarely - respiratory depression (including respiratory failure, apnea and bradypnoea), hemoptysis, obstructive pulmonary disease, pharyngitis, laryngospasm.
From the side of the digestive system: very often - nausea, vomiting, constipation;
often - abdominal pain, xerostomia, dyspepsia; infrequently, diarrhea; rarely - hiccups; very rarely - ileus, painful flatulence.
Allergic reactions: seldom - itching; very rarely - anaphylactic shock, anaphylactic reactions, anaphylactoid reactions, rash.
Dermatological reactions: very often - sweating, itching; often - a skin reaction at the site of application (changing the appearance of the skin, peeling, exudation, petechial erosion, micro-cracks, scab); seldom - rash, erythema. Rash, erythema, and itching at the site of application, in most cases disappear within one day after removing the patch.
From the urinary system: Infrequent - urinary retention, urinary tract infection; very rarely - oliguria, pain in the bladder, ureter spasms.
Other:infrequently - conjunctivitis, fatigue, malaise, flu-like symptoms; rarely - swelling, feeling cold.
Chronic administration of fentanyl can develop tolerance, psychic and physical dependence, transient muscle rigidity (including thoracic). When replacing the previously prescribed opioid analgesics in a transdermal patch containing fentanyl, or in case of a sudden cessation of therapy can develop withdrawal symptoms, including, for example, nausea, vomiting, diarrhea, anxiety and tremors.
CONTRAINDICATIONS

- inhibition of the respiratory center, including acute respiratory depression;
- irritated, irradiated or damaged skin at the site of application;
- diarrhea with pseudomembranous colitis caused by intake of cephalosporins, lincosamides, penicillins;
- toxic dyspepsia;

- age up to 18 years;

- the drug should not be used for the treatment of acute or postoperative pain due to lack of possibilities of selection of doses in a short period of time and the likelihood of developing a life-threatening respiratory depression;
- severe CNS;
- simultaneous use of MAO inhibitors or reception within 14 days after their withdrawal;
- increased sensitivity to the active substance or auxiliary substance preparation.
With cautionuse in patients with chronic pulmonary diseases, intracranial hypertension, brain tumors, traumatic brain injuries, bradyarrhythmia, hypotension, hepatic and renal failure, renal or hepatic colic (including history), cholelithiasis, hypothyroidism, the elderly, malnourished and debilitated patients with acute surgical diseases of the abdominal cavity to establish the diagnosis in acute serious condition, benign prostatic hypertrophy, strictures urethra, drug addiction, alcoholism, suicidal tendencies, hyperthermia, while taking insulin, corticosteroids, anti-hypertensive drugs.
PREGNANCY AND LACTATION

Safety of application of transdermal patches containing fentanyl, has not been established during pregnancy.
Fentanyl during pregnancy should only be used when absolutely necessary. Long-term treatment during pregnancy may cause withdrawal symptoms in newborns.
Fentanyl is not to be taken during labor and delivery (including caesarean section), because fentanyl passes through the placental barrier and may cause respiratory depression fetus or newborn.
Fentanyl is excreted in breast milk and may cause sedation and respiratory depression in the breastfed child. Hence, breast-feeding (for the duration of application and 72 hours after the last administration) should be discontinued as appropriate destination during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER

Caution should be used in cases of kidney failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Fentanyl is metabolised in the liver, thus, in patients with liver diseases can be slowed elimination. Patients with impaired liver function should be monitored and if necessary dose for these patients should be reduced.
APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution the drug in elderly patients should be applied.
SPECIAL INSTRUCTIONS

Application Fendiviya the drug should be used as part of an integrated treatment of pain in patients provided with adequate medical, social and psychological assessment of their condition.
After development of severe side effects the patient should be monitored for 24 hours after removal of the transdermal patch containing fentanyl, due to the long T 1/2fentanyl.
As unused and used transdermal patches containing fentanyl, should be kept out of reach of children.
Transdermal patches should not be separated or cut into pieces, because has not been established quality, efficacy and safety of the patch, split into parts.
As in the case of other strong opioids, using a transdermal patch containing fentanyl, some patients may develop respiratory depression, and in this regard, patients should be monitored. Respiratory depression may persist after removal of the patch. The incidence of respiratory depression increases with increasing fentanyl doses. Neurotropic drugs may enhance the effects of respiratory depression. In patients with existing respiratory depression symptoms of fentanyl should be administered with extreme caution and only in small doses.
If the patient has to undergo the procedure, which completely removes the feeling of pain (eg regional analgesia), it is expedient to provide for the possibility of respiratory depression. Prior to these procedures should be to reduce the dosage of fentanyl or replace it with an opioid drug or a short series of quick action.
In patients with chronic obstructive or other pulmonary diseases fentanyl may cause more dangerous side effects. In such patients, opioids may decrease respiratory function and increase resistance in the airways.
With regular administration of opioids may develop tolerance, physical and psychological dependence, but they are rare in the treatment of pain associated with tumors.
Fendiviya drug should be used with caution in patients who may be especially sensitive to an increase in the content of CO 2 . These patients are those in which there was an increase in intracranial pressure, impaired consciousness or coma. Fentanyl should be used with caution in patients diagnosed with a brain tumor.
Fentanyl may cause bradycardia. Consequently, patients with bradyarrhythmias Fendiviya drug must be administered with caution.
Opioids may cause hypotension, especially in patients with hypovolemia. Therefore, care should be taken when treating patients with hypotension and / or hypovolaemia.
Fentanyl is metabolised in the liver, thus, in patients with liver diseases can be slowed elimination. Patients with impaired liver function should be monitored and if necessary dose for these patients should be reduced.
Less than 10% of the fentanyl is released by the kidneys in unchanged form, and, unlike morphine, there is no active metabolites excreted by the kidneys. The data obtained from I / fentanyl in patients with renal failure, suggests that dialysis V dFentanyl may vary. This may affect serum concentrations of the drug. If patients with renal impairment receive transdermal fentanyl they should be observed carefully for signs of fentanyl toxicity and, where appropriate dose for such patients should be reduced.
Patients with elevated body temperature particularly careful observation is required on the presence of opioid side effects, and if necessary - a correction dose of fentanyl. Patients also should be advised to avoid exposure to the field of application of a transdermal patch Fendiviya direct external heat sources, such as heating pads, hot water bottles, blankets, heating, heat lamps, hot tubs, whirlpool, since there is a possibility temperature-dependent increase of the release of fentanyl from the patch.
Before visiting the sauna transdermal patch must always be removed from the skin. Saunas reception is possible only when replacing a transdermal patch (at intervals of 72 hours). A new patch should be superimposed on the cold and completely dry skin.
The results of studies on / in the use of fentanyl suggest that elderly patients reduced clearance, increased T 1/2 , and that they are more sensitive to the drug than younger patients. Elderly patients should be carefully monitored for signs of fentanyl toxicity and should reduce the dose if necessary.
Due to the fact that reduced clearance in malnourished and debilitated patients and increased T 1/2fentanyl, such patients need careful monitoring to detect possible symptoms of fentanyl overdose, and should reduce the dose if necessary.
In applying the drug may occur Fendiviya myoclonic seizures. Precautions should be taken when treating patients with myasthenia.
In applying the drug Fendiviya alcohol is not recommended.
Even after the use of transdermal patches are large amounts of fentanyl. For safety and environmental friendliness used transdermal patches, as well as unused patches should be removed. Used transdermal patches should be folded into a sticky surface to release the membrane was completely closed, and return the medical or pharmaceutical personnel. Unused transdermal patches should be returned to medical or pharmaceutical personnel.
Use in Pediatrics

The use of a transdermal patch Fendiviya not recommended for use in children.
Impact on the ability to drive vehicles and manage mechanisms

Transdermal patches containing fentanyl, can affect the mental and / or physical functions needed to perform potentially hazardous activities such as driving a vehicle or working with machinery. Mainly, it is to be expected at the beginning of the treatment, as well as any dosage change.
In the period of treatment should refrain from activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
No need to impose restrictions on the patients continuously receiving individually tailored dose. In this case, the doctor must decide whether the patient is allowed to drive a vehicle or equipment.
OVERDOSE

Symptoms: lethargy, coma, respiratory center depression with Cheyne-Stokes respiration and / or cyanosis. Other symptoms may be hypothermia, decreased muscle tone, bradycardia, hypotension. Signs of toxicity are profound CNS depression, ataxia, miosis, convulsions and respiratory depression (a major symptom).
Treatment: the removal of the patch, the introduction of a specific antagonist - naloxone, verbal or physical impact on the patient; symptomatic and supportive therapy of vital functions (including the introduction of muscle relaxants, mechanical ventilation, with bradycardia - atropine, with marked decrease in blood pressure - volume replacement).
The recommended starting dose for adults is 0.4-2 mg of naloxone / in. If necessary, it can be administered the same dose every 2-3 min or assign prolonged administration of 2 mg of the drug, dissolved in 500 ml of 0.9% sodium chloride solution or 5% dextrose solution (0.004 mg / ml). The administration rate should be adjusted to the previous bolus injections and the individual response of the patient. If / introduction impossible, the naloxone can be designated / m or m / k. After / m or p / naloxone onset of action is slower compared to the on / in the introduction. V / m administration provides a more prolonged effect than on / in the introduction. respiratory depression due to overdose can persist longer than the effect of the opioid antagonist.Removing the narcotic effect may result in an increase in acute pain and release of catecholamines. If necessary to carry out treatment of a patient in the ICU.
DRUG INTERACTION

Simultaneous reception of the derivatives of barbituric acid should be avoided, since they can enhance the effect of fentanyl respiratory depression.
Concomitant administration of other agents that suppress the CNS, including opioids, anxiolytics, tranquilizers, agents for anesthesia, general anesthetics, phenothiazine derivatives, muscle relaxants, antihistamines with sedative action, ethanol, can cause the additive effects of sedative; may be hypoventilation, hypotension, profound sedation, or coma. Consequently, the receipt of any of the above means requires patient monitoring.
Dinitrogen oxide enhances muscle rigidity; It reduces the effect of buprenorphine.
MAO inhibitors enhance the effects of opioid analgesics, especially in patients with heart failure. Therefore, fentanyl should not take over the entire period of application of MAO inhibitors as well as 14 days after their withdrawal.
Fentanyl has a high clearance, it is rapidly and largely metabolized mainly through the cytochrome CYP3A4. Simultaneous treatment with strong inhibitors CYP3A4 (for example ritonavir, ketoconazole, itraconazole, macrolide antibiotics) with fentanyl administered transdermally, may lead to an increase in plasma fentanyl concentrations. This may enhance or prolong the therapeutic effect of both, and side reactions which can cause severe respiratory depression. In such situations should be given intensive care and to conduct a more careful monitoring of patients. Combined reception ritonavir, or other strong CYP3A4 inhibitor with transdermal administration of fentanyl is not recommended, if not a careful observation of the patient is performed.
Fentanyl, while the application enhances the effect of antihypertensive agents.
Buprenorphine, nalbuphine, pentazocine, naloxone, naltrexone reduce the analgesic effect of fentanyl eliminate its inhibitory effect on the respiratory center and may induce withdrawal symptoms in patients with opioid dependence.
It is necessary to reduce the dose of fentanyl while the use of insulin, SCS and antihypertensive agents.
Muscle relaxants, while the use of fentanyl, prevent or eliminate muscle rigidity; muscle relaxants with vagolytic activity (including pancuronium bromide) reduce the risk of hypotension and bradycardia (especially against the use of beta-blockers, and other vasodilators) and may increase the risk of tachycardia and arterial hypertension; muscle relaxants which do not have vagolytic activity (including succinylcholine) do not reduce the risk of hypotension and bradycardia (especially with aggravated Cardiology anamnesis) and increase the risk of severe side effects from Storo
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