Universal reference book for medicines
Name of the preparation: DUROGESIC В® MATRIX (DUROGESIK В®MATRIX)

Active substance: fentanyl

Type: Actually an opioid receptor agonist.
Analgesic
Manufacturer: JOHNSON & JOHNSON (Russia) manufactured by JANSSEN PHARMACEUTICA (Belgium)
Composition, form of production and packaging
A transdermal therapeutic system (TTC)
with a contact surface area of ​​5.25 cm 2 and a release rate of fentanyl of 12.5 μg / h (approximately 300 μg per day);
is a translucent patch of rectangular shape with rounded corners, a matte substrate, a colorless adhesive layer and a transparent removable protective coating; the trade name "Durogesic" with a warning marking В® and the dosage of the preparation "12.5? g fentanyl / h" in Latin in orange color is indicated on the substrate of the patch.
1 TTC

fentanyl 2.1 mg

Substrate composition: polyethylene terephthalate (PET) and ethylene vinyl acetate (EVA) copolymer.

Composition of the adhesive layer: polyacrylate (Duro-Tak 87-4287).

Composition of the containment: siliconeized polyethylene terephthalate (PET).

1 PC.
- packages from the combined material (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​10.5 cm 2 and a release rate of fentanyl of 25 μg / h (approximately 600 μg per day);
is a translucent patch of rectangular shape with rounded corners, a matte substrate, a colorless adhesive layer and a transparent removable protective coating; the trade name "Durogesic" with the preventive labeling В® and the dosage of the preparation "25? g fentanyl / h" in Latin in pink is indicated on the substrate of the patch.
1 TTC

fentanyl 4.2 mg

Substrate composition: polyethylene terephthalate (PET) and ethylene vinyl acetate (EVA) copolymer.

Composition of the adhesive layer: polyacrylate (Duro-Tak 87-4287).

Composition of the containment: siliconeized polyethylene terephthalate (PET).

1 PC.
- packages from the combined material (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​21 cm 2 and a release rate of fentanyl of 50 μg / h (approximately 1.2 mg per day);
is a translucent patch of rectangular shape with rounded corners, a matte substrate, a colorless adhesive layer and a transparent removable protective coating; the trade name "Durogesic" with a warning marking В® and a dosage of the preparation "50? g fentanyl / h" in Latin in light green color is indicated on the substrate of the patch.
1 TTC

fentanyl 8.4 mg

Substrate composition: polyethylene terephthalate (PET) and ethylene vinyl acetate (EVA) copolymer.

Composition of the adhesive layer: polyacrylate (Duro-Tak 87-4287).

Composition of the containment: siliconeized polyethylene terephthalate (PET).

1 PC.
- packages from the combined material (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​31.5 cm 2 and a release rate of fentanyl of 75 μg / h (about 1.8 mg per day);
is a translucent patch of rectangular shape with rounded corners, a matte substrate, a colorless adhesive layer and a transparent removable protective coating; the trade name "Durogesic" with the warning marking В® and the dosage of the preparation "75? g fentanyl / h" in Latin in blue is indicated on the substrate of the patch.
1 TTC

fentanyl 12.6 mg

Substrate composition: polyethylene terephthalate (PET) and ethylene vinyl acetate (EVA) copolymer.

Composition of the adhesive layer: polyacrylate (Duro-Tak 87-4287).

Composition of the containment: siliconeized polyethylene terephthalate (PET).

1 PC.
- packages from the combined material (5) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​42 cm 2 and a release rate of fentanyl of 100 μg / h (about 2.4 μg per day);
is a translucent patch of rectangular shape with rounded corners, a matte substrate, a colorless adhesive layer and a transparent removable protective coating; the trade name "Durogesic" with a warning marking В® and a dosage of the preparation "100? g fentanyl / h" in Latin gray are indicated on the substrate of the patch.
1 TTC

fentanyl 16.8 mg

Substrate composition: polyethylene terephthalate (PET) and ethylene vinyl acetate (EVA) copolymer.

Composition of the adhesive layer: polyacrylate (Duro-Tak 87-4287).

Composition of the containment: siliconeized polyethylene terephthalate (PET).

1 PC.
- packages from the combined material (5) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2012.

PHARMACHOLOGIC EFFECT

Opioid analgesic for transdermal application.
Fentanyl is a synthetic analgesic that interacts predominantly with opioid? -receptors. Refers to the list of II narcotic drugs, psychotropic substances and their precursors, approved by Resolution of the Government of the Russian Federation No. 681 of 30.06.98. Increases the activity of the antinociceptive system, raises the threshold of pain sensitivity. Violates the transmission of excitation by specific and nonspecific painful pathways to the nuclei of the thalamus, the hypothalamus, the amygdala complex.
The main therapeutic effects of the drug are analgesic and sedative.
The minimum effective analgesic concentration of fentanyl in plasma in patients who did not previously use opioid analgesics is 0.3-1.5 ng / ml. The total time of action of the drug is 72 hours.
Has a depressing effect on the respiratory center, slows the heart rhythm, excites the centers of the vagus nerve and vomiting center.
Increases the tone of smooth muscles of the bile ducts, sphincters (including the urethra, bladder, sphincter of Oddi), reduces peristalsis of the intestine, improves the absorption of water from the digestive tract. Virtually no effect on blood pressure, reduces renal blood flow. In the blood increases the content of amylase and lipase.
Promotes the onset of sleep.
Causes euphoria.
The rate of development of drug dependence and tolerance to analgesic effect is characterized by significant individual differences.

PHARMACOKINETICS

Suction and distribution

The minimum effective anesthetic concentration of fentanyl in blood plasma in patients who did not previously use opioid analgesics is 0.3-1.5 ng / ml.
Durogezik В®Matrix provides a constant systemic release of fentanyl for 72 hours after application. Fentanyl is released at a relatively constant rate, which is determined by the copolymer membrane and the diffusion of fentanyl through the skin. After the application of Durogesic Matrix, fentanyl concentration in the blood plasma gradually increases during the first 12-24 hours and remains relatively constant over the remainder of the time. The level of fentanyl concentration in the blood plasma is proportional to the size of the TTS.
After repeated applications, C ss is reached in the blood plasma, which is maintained by subsequent TTS applications of the same size.

The mean values ​​of the content of fentanyl fractions unrelated to plasma proteins in plasma are 13-21%.

Excreted in breast milk.

Metabolism and excretion

After removal of the TTC Durogezik В® Matrix, fentanyl concentration in the blood plasma is gradually reduced, with T 1/2 being approximately 17 hours (13-22 h).Continued absorption of fentanyl from the skin (more typically after 4 applications) explains the slow disappearance of the drug from the blood plasma.

Fentanyl is metabolized predominantly in the liver, mainly with the participation of CYP3A4 (N-dealkylation and hydroxylation), as well as in the kidneys, intestines and adrenal glands.

About 75% of fentanyl is excreted in the urine, mainly in the form of metabolites (not having pharmacological activity), while less than 10% of the drug is excreted unchanged.
About 9% of the drug is excreted with feces, mainly in the form of metabolites.
Pharmacokinetics in special clinical cases

In elderly, debilitated or weakened patients, the clearance of fentanyl may be reduced, which leads to an elongation of T 1/2 of fentanyl.

Since fentanyl is metabolized to inactive metabolites in the liver, liver disease can lead to a delay in the excretion of the drug.
In patients with cirrhosis of the liver with a single application of Durogesic Matrix, there was no change in pharmacokinetics, although there was a tendency to increase the concentration of the drug in the blood plasma.
Data obtained with intravenous administration of fentanyl to patients with renal insufficiency suggest that hemodialysis may alter V d of fentanyl, which may affect the concentration of the drug in the serum.

In studies of the drug DurogesicВ® Matrix, the pharmacokinetics of fentanyl in elderly patients did not differ significantly from pharmacokinetics in young patients, although serum concentrations were slightly higher.

The pharmacokinetic model suggests that serum fentanyl concentrations may increase by about 1/3 if the body temperature rises to 40 В° C.

INDICATIONS

Chronic pain syndrome of strong and moderate severity:

- pain caused by an oncological disease;

- pain syndrome of non-oncological genesis, requiring analgesia with narcotic analgesics: neuropathic pains (including pain syndrome in diabetic polyneuropathy, nerve trauma, syringomyelia, multiple sclerosis, shingles / Herpes zoster), pain in arthritis and arthrosis, phantom pain after amputation of limbs.

DOSING MODE

The dose of Durogezik В® Matrix should be selected individually depending on the patient's condition and regularly evaluated for its adequacy after TTS application.

The initial dose of Durogezik ® Matrix is ​​selected based on the previous use of opioid analgesics.
It is recommended to prescribe Durogezik В® Matrix to patients with opioid tolerance. Other factors are also taken into account: the general condition of the patient, incl. body weight and height, age, degree of depletion and the degree of opioid tolerance.
Patients previously taking opioids

Transition from oral or parenteral forms of opioid analgesics to DurogesicВ® Matrix in patients with tolerance to opioid analgesics should be carried out in accordance with the recommendations in Tables 1 and 2. The dose may be subsequently reduced or increased as necessary by 12.5 or 25 Ојg / h to achieve the lowest dose of Durogezik В® Matrix, depending on the reaction and additional requirements for anesthesia.

Patients who had not previously taken opioids

The experience of using DurogesicВ® Matrix in patients who had not previously taken opioid analgesics is limited.
In cases where the administration of DurogesicВ® Matrix to patients who have not previously taken opioid analgesics is recommended, it is recommended to start with small doses of opioid analgesics equivalent to a dose of DurogesicВ® Matrix 25 Ојg / h. After this, patients can be transferred to a dose of 25 Ојg / h of DurogesicВ® Matrix. The dose can be subsequently reduced or increased as necessary by 12.5 or 25 Ојg / h to achieve the lowest dose of DurogesicВ® Matrix, depending on the response and additional pain management requirements (as recommended in Tables 1 and 2).
Transfer to an equivalent analgesic dose

1. Calculate the previous 24-hour need for analgesia.

2. Transfer this amount to an equivalent oral dose of morphine according to Table 1. All IM and oral doses of opioid analgesics given in this table are equivalent to the analgesic effect of 10 mg of morphine IM.

3. In Table 2, find the 24-hour dose of morphine required for the patient and the dose of DurogesicВ® Matrix corresponding to her.

Table 1. Transfer to an equivalent analgesic dose

Name of the drug Equivalent analgesic dose (mg)

in / m * inside

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

Omnepon 45 -

Hydromorphone 1.5 7.5

Methadone 10 20

Oxycodone 15 30

Levorphanol 2 4

Oxymorphone 1 10 (rectally)

Diamorphine 5 60

Pethidine 75 -

Codeine 130 200

Buprenorphine 0.3 0.8 (sublingually)

* These oral doses are recommended when switching from parenteral to oral administration.

** The ratio of the strength of action of morphine with the / m or oral route of administration is based on the clinical experience obtained in the treatment of patients with chronic pain.

Table 2. Recommended dose of DurogesicВ® Matrix (depending on the daily oral dose of morphine) *

Oral daily dose of morphine (mg / day) Dose dose of DurogesicВ® Matrix (Ојg / 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

* In clinical trials, these values ​​of daily doses of morphine were used as the basis for the transition to Durogesic® Matrix.

An initial evaluation of the maximal analgesic effect of DurogesicВ® Matrix can not be performed less than 24 hours after application.
This time interval is due to a gradual increase in serum fentanyl concentration after application.
To successfully transition from one drug to another, previous analgesic therapy should be discontinued gradually after the application of DurogesicВ® Matrix at the initial dose.

Dose selection and maintenance therapy

To select the dose, TTC Durogezik В® Matrix 12.5 Ојg / h is used.
TTC Durogezik В® Matrix should be replaced with a new one every 72 hours. The dose is selected individually depending on the achievement of the necessary anesthesia. If the initial dose is not adequately anesthetized, then after 3 days the dose may be increased.Then the dose can be increased every 3 days. Usually, the dose is increased by 12.5 Ојg / h or 25 Ојg / h at one time, however, the patient's condition and the need for additional analgesia should be taken into account (oral doses of morphine 45 mg / day and 90 mg / day approximately correspond to durogesicВ® Matrix 12.5 Ојg / h and 25 Ојg / h, respectively).
To achieve a dose of more than 100 Ојg / h, several TTS can be used simultaneously.

Patients may occasionally require additional doses of short-acting analgesics in the event of "breakthrough" pain.
Some patients may require additional or alternative routes of administration of opioid analgesics with Durogezik В® Matrix in a dose exceeding 300 Ојg / h.
Mode of application

TTC Durogezik В® Matrix should be applied on a flat surface of the skin of the trunk or upper parts of the hands.
For the application it is recommended to choose a place with a minimal hair cover. 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 it should be done with clean water. Do not use soap, lotions, oils or other products, because they can cause skin irritation or change its properties. Before application, the skin should be absolutely dry.
Before applying the TTC it is necessary to check carefully for damage.
TTS, divided into parts, cut or otherwise damaged, should not be used under any circumstances.
TTS should be glued immediately after removal from the sealed bag.
To remove the TTS from the package, it is necessary to fold the top part of the sachet along the notch (indicated by an arrow) and tear it off. Then open the package as you open the book. The protective film has a cut in the middle. Fold the TTS in half in the middle and remove each half of the protective film, without touching your fingers with the sticky layer. TTS should be pressed tightly with the palm of the hand in place of the application for 30 seconds. It should be ensured that the patch is tight against the skin, especially around the edges. After applying the TTS, wash hands with clean water.
TTC Durogezik ® Matrix is ​​designed for continuous use within 72 hours. The new TTS can be glued to another area of ​​the skin after removing the previously pasted patch.
TTS can be pasted on the same skin area only with an interval of several days.
SIDE EFFECT

Determination of the frequency of side effects: 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 cases).

From the nervous system: very often - drowsiness, insomnia, dizziness;
often - anxiety, depression, hypoesthesia; very rarely - confusion, hallucinations, euphoria, agitation, convulsions (including clonic convulsions and a large epiletic fit), amnesia, headache, tremor, paresthesia.
From the respiratory system: often - yawning, rhinitis;
very rarely - respiratory depression (including respiratory failure, apnea and bradypnoea), hypoventilation, dyspnea.
From the side of the digestive system: very often - nausea, vomiting, constipation;
often - anorexia, abdominal pain, dyspepsia, dry mouth; very rarely diarrhea.
From the cardiovascular system: often - palpitations;
very rarely - tachycardia, bradycardia, increase or decrease in blood pressure.
From the side of the urinary system: infrequently - urinary tract infections, spasm of ureters;
very rarely - retention of urine.
Allergic reactions: infrequently - itching;
very rarely - rash, anaphylactic shock, anaphylactic reactions, anaphylactoid reactions.
Other: often - involuntary muscle contraction;
infrequently - conjunctivitis, sensation of changes in body temperature, increased sweating, fatigue, malaise, flu-like symptoms, peripheral edema, asthenia, withdrawal syndrome; very rarely - erythema, sexual dysfunction, reactions in the place of application.
Like other opioid analgesics, with repeated use of the drug Dyurogezik В® Matrix can develop psychic and physical dependence and tolerance.
In the transition from the previously received narcotic analgesic drug to the use Dyurogezik В® Matrix or in case of a sudden cessation of therapy possible symptoms associated with opioid withdrawal (nausea, vomiting, diarrhea, anxiety, vomiting).
CONTRAINDICATIONS

- inhibition of the respiratory center, including acute respiratory depression;
- severe pain or postoperative pain, requiring a short period of treatment;
- diarrhea with pseudomembranous colitis associated with the use of cephalosporins, lincosamides, penicillins;
- toxic diarrhea;
- irritated, irradiated or damaged skin at the site of application;
- Pregnancy;

- lactation period;

- children and adolescence under 18;

- increased sensitivity to fentanyl or adhesive substances forming part of TTC.
With cautionuse in patients with chronic pulmonary diseases, intracranial hypertension, brain tumors, traumatic brain injuries, bradyarrhythmia, hypotension, renal and liver failure, patients with hepatic or renal colic (including history), cholelithiasis , hypothyroidism, elderly patients, malnourished and debilitated patients with acute surgical diseases of the abdominal cavity to establish the diagnosis, the general condition, benign hy rplazii prostate, urethral strictures, when drug dependence, alcoholism, suicidal tendencies, hyperthermia while at the same time taking insulin, corticosteroids, anti-hypertensive drugs and MAO inhibitors.
PREGNANCY AND LACTATION

Data on the use of the drug Dyurogezik В® Matrix pregnancy insufficient. There have been very rare cases of withdrawal symptoms in newborns whose mothers chronically used Dyurogezik В® Matrix during pregnancy. Dyurogezik В® Matrix should not be used during pregnancy except in cases of urgent need.
Not recommended Dyurogezik В® Matrix at delivery, since fentanyl crosses the placenta and may cause respiratory depression in the neonate.
Fentanyl is excreted in breast milk and may cause sedation and cause respiratory depression in children. Consequently, Dyurogezik В® Matrix should not be used in nursing mothers 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

With caution , use the drug for liver failure.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

With caution should be used in elderly patients.

SPECIAL INSTRUCTIONS

Dyurogezik В® Matrix should not be prescribed for the relief of acute or postoperative pain, because there is no opportunity for dose titration in the short-term use, and there is a risk of serious and life-threatening hypoventilation as a result of the application.
Patients who have severe side effects were observed, requires careful control of the state for 24 hours after removal of the TTS Dyurogezik В® Matrix because fentanyl plasma concentration decreases gradually and its 50% reduction is achieved within about 17 (13-22) hours.
TTS Dyurogezik В® Matrix can not be cut or divided into parts, as well as damaging in any way, as this may lead to the uncontrolled release of fentanyl.
In applying Dyurogezik TTS В® Matrix patients not previously treated with opioid analgesics rarely observed cases of significant respiratory depression and / or death when used as initial therapy opioid analgesics. The possibility of serious or life-threatening hypoventilation exists even in the case of a minimum dose Dyurogezik TTS В® Matrix as in the initial treatment of opioid analgesics in patients previously treated with such drugs.
Respiratory depression. As with other potent opioid analgesics, when applying Dyurogezik preparation В®Matrix, some patients may experience significant respiratory depression. Patients should be carefully evaluated for these effects. Ventilatory depression may continue after the removal of the TTS Dyurogezik В® Matrix. The degree of respiratory depression increases with increasing dose of drug Dyurogezik В® Matrix. Drugs affecting the central nervous system, may potentiate the respiratory depression.
Dyurogezik В® Matrix can cause a number of severe side effects in patients with COPD and other chronic lung diseases. In such cases, opioid analgesics may reduce the excitability of the respiratory center and to increase the breathing resistance.
Caution should be used in patients who may be particularly sensitive to an increase in the CO 2 - if there was an increase in intracranial pressure, impaired consciousness or coma. Dyurogezik В® Matrix should be used with caution in patients with a brain tumor.
Fentanyl may cause bradycardia, and thus it should be used with caution in patients with bradyarrhythmias. It should be used with caution Dyurogezik В® Matrix in patients with arterial hypertension.
Because
Fentanyl is metabolised to inactive metabolites in the liver, the liver disease may lead to delay clearance of the drug. In patients with cirrhosis of the liver after a single application of the drug Dyurogezik В® Matrix were observed changes in the pharmacokinetics, although the concentration of the drug in serum tended to increase. Patients with hepatic impairment need to be carefully monitored for signs of fentanyl overdose. In this case, reduction in the dose of the drug Dyurogezik В®Matrix.
Opioid analgesics can raise the tone of smooth muscles of the gastrointestinal tract and biliary tract. Dyurogezik В® Matrix should be used with caution in patients with hepatic colic history.
Less than 10% of fentanyl excreted by the kidneys in unchanged form, fentanyl in no known active metabolites that would be displayed by the kidneys. The data obtained from I / fentanyl in patients with renal failure suggest that V d fentanyl may be changed during hemodialysis, and it can affect the concentration of drug in the serum. Patients with kidney failure need careful monitoring. When symptoms of an overdose should be reduced dose Dyurogezik В® Matrix.
The combined use of transdermal fentanyl CYP3A4 inhibitors is not recommended, but it is possible with close patient monitoring. When assigning Dyurogezik preparation В®Matrix simultaneously with the CYP3A4 inhibitors require strict control for the detection of respiratory depression symptoms, in which case the dose adjustment is required.
Data obtained in studies on / in the fentanyl suggest that elderly patients may decrease the clearance and extends T 1/2 fentanyl. Elderly patients may be more sensitive to fentanyl than younger patients. Studies Dyurogezik preparation В®Matrix pharmacokinetics of fentanyl in elderly patients is not significantly different from the pharmacokinetics in younger patients, although the serum concentration was slightly higher. Elderly patients need careful monitoring to detect possible fentanyl overdose symptoms that require dose reduction Dyurogezik preparation В® Matrix.
Since depleted and weakened patients may decrease clearance and lengthen the half-life of the drug depleted and weakened patients need careful monitoring to detect possible fentanyl overdose symptoms that require dose reduction Dyurogezik preparation В® Matrix.
Repeated administration of opioid analgesics possible development of tolerance and physical and psychological dependence. Iatrogenic dependence with use of opioids is rare.
As with other agonists of opioid receptors possible abuse of fentanyl. Misuse or intentional use of the drug Dyurogezik В® Matrix for other purposes may result in overdose and / or death. Patients who are at increased risk of opioid abuse may still receive adequate therapy of opioid analgesics modified release, but should be monitored for signs of misuse, abuse, or addiction.
Pharmacokinetic model suggests that fentanyl concentration in serum may increase by about one-third if the body temperature is raised to 40 В° C. Consequently, with fever, patients should be monitored closely to detect characteristic side effects of opioid analgesics, and if necessary, followed by dose correction. All patients must avoid direct exposure to external heat sources such as heat lamps, intensive sunbathing, hot water bottles, saunas, hot tubs with the water in the place of application Dyurogezik TTS В® Matrix.
If required discontinuation of drug Dyurogezik В®Matrix replacement of the preparation other opioid analgesics should be gradual, beginning with low doses. This mode requires the replacement of drugs due to the gradual reduction of the concentration of fentanyl after removal Dyurogezik TTS В® Matrix, with 50% reduction in fentanyl concentration in serum takes 17 hours. Cancel opioid analgesia must always be gradual in order to prevent the development of withdrawal syndrome.
Impact on the ability to drive vehicles and manage mechanisms

Dyurogezik В® Matrix can affect the mental and / or physical functions needed to perform potentially hazardous activities such as driving a vehicle or working with machinery. During treatment, patients should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
OVERDOSE

Symptoms: bradypnea, apnea, muscle rigidity, respiratory center depression, decreased blood pressure, bradycardia.
Treatment: removal of the TTS, physical and verbal stimulation (patient should pat cheeks, call name), if necessary - and an auxiliary mechanical ventilation. The introduction of a specific antagonist - naloxone. Respiratory depression overdose can be longer than the period of the opioid receptor antagonist may therefore require repeated administration of naloxone. Symptomatic and supportive therapy (including administering muscle relaxant, ventilator, bradycardia - atropine, while lowering blood pressure - replenishing of bcc). The disappearance of the analgesic effect may lead to a sharp pain attack and release of catecholamines.
DRUG INTERACTION

With the simultaneous use of other drugs that have a depressant effect on the central nervous system, including opioid analgesics, sedatives and hypnotics, means for general anesthesia, phenothiazines, tranquilizers, central muscle relaxants, antihistamines, which have a sedative effect, and alcohol, may increase the risk of development and amplification hypoventilation , decrease blood pressure, excessive sedation (reception of any of the drugs at the same time using Dyurogezik TTS В®Matrix requires special observation na cient).
Simultaneous reception inhibitors isoenzyme CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefadozon, verapamil, diltiazem, amiodarone) may increase the fentanyl concentration in the blood plasma. The consequence of this is to increase the intensity and duration as a therapeutic effect and possible side effects, marked respiratory depression. In such cases it is necessary to carefully monitor the patient's condition. The combined use of transdermal fentanyl CYP3A4 inhibitors is not recommended, but it is possible with close patient monitoring.
Dyurogezik В®Matrix antigipertezivnyh enhances the effect of drugs. Beta-blockers can reduce the incidence and severity of hypertensive reaction in cardiac surgery (including the sternotomy), but increases the risk of bradycardia.
Buprenorphine, nalbuphine, pentazocine, naloxone, naltrexone reduce the analgesic effect of fentanyl and eliminate its inhibitory effect on the respiratory center.
Muscle relaxants 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, non-vagolytic activity (in t. h. succinylcholine) does not reduce the risk of bradycardia and hypertension (especially with aggravated cardiac history) increase the risk of severe side effects of the cardiovascular system.
Nitrous oxide enhances muscle rigidity.
Buprenorphine reduces the effects of fentanyl.
It is necessary to reduce the dose of fentanyl while the use of insulin, SCS and antihypertensive agents.
There were serious and unpredictable effects of interaction with MAO inhibitors, with amplification of opioid analgesic effects or enhanced serotonergic effects. Not recommended for co-administration of fentanyl with MAO inhibitors.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.
II refers to the list of narcotic drugs.
TERMS AND CONDITIONS OF STORAGE

The drug should be stored at a temperature of from 15 В° to 25 В° C.
Shelf life - 2 years.
Dyurogezik should be stored out of the reach of children both before and after use.
The patient should be informed that the used TTS should be folded in half with the adhesive side inwards and get medical attention for the destruction of the established order. Unused patches should be returned as a doctor to kill. Before you use the product should be stored in a sealed bag.
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