Dyurogezik

Dyurogezik – drug with analgeziruyushchy action.

Form of release and structure

Dyurogezik release in the form of the transdermal therapeutic system (TTS): the squared plaster with the rounded-off corners, translucent, hermetically soldered, contains transparent gel; in gel existence of crystalline particles and vials of air is allowed; texts on an outside cover: 0,025 mg/h – pink color, 0,05 mg/h – light green color, 0,075 mg/h – blue color, 0,1 mg/h – gray color (on 1 piece in packages from the combined material, on 5 packages in a cardboard pack).

Is a part of 1 system:

• Active agent: fentanyl – 2,5 mg, 5 mg, 7,5 mg or 10 mg;
• Auxiliary components: hydroxyethylcellulose, alcohol, the purified water.

Structure of functional layers of a plaster:

• Outside protective cover: copolymer of an etilenvinilatsetat and polyether;
• Tank: ethanol (0,1 ml / 10 ^cm2) and fentanyl (2,5 mg / 10 ^cm2) in the form of water gel on the basis of hydroxyethylcellulose;
• The releasing membrane: этиленвинилацетат (controls the speed of release of active agent);
• The silicone adherent layer covered with the protective deleted film: polyester and fluorocarbon diacrylate.

Indications to use

Dyurogezik appoint at a chronic pain syndrome of average and strong expressiveness, including:

• The pains connected with oncological diseases;
• The pain syndromes of not oncological etiology demanding anesthesia by narcotic analgetics: neyropatichesky pains (at shingles (Herpes zoster), a myelosyringosis, diabetic polyneuropathy, multiple sclerosis, nerve injuries), the stump neuralgias connected with amputation of extremities.

Contraindications

Absolute:

• Oppression of a respiratory center;
• The angry, irradiated or injured skin;
• The acute and/or postoperative pains demanding the short period of therapy;
• Age up to 18 years;
• Pregnancy and period of a lactation;
• Hypersensitivity to drug components.

Relative (Dyurogezik it is necessary to apply with care):

• Chronic pulmonary diseases;
• The increased intracranial pressure, including at brain tumors;
• Bradyarrhythmias;
• Arterial hypotension;
• Liver and renal failure;
• Acute surgical diseases of abdominal organs (before establishment of the diagnosis);
• Hepatic colic in the anamnesis;
• Cesarean section and other obstetric operations (before extraction of a fruit);
• Simultaneous use with insulin, glucocorticosteroids and hypotensive medicines;
• Advanced age.

Route of administration and dosage

Dyurogezik apply locally. TTS needs to apply on absolutely dry, flat surface of skin of upper parts of hands or a trunk. For application it is recommended to choose the place with the smallest indumentum. Hair on site applications need to be sheared (not to shave off). If before Dyurogezik's use the place of application needs to be washed up, it should be made by means of clear water without use of soap, lotions, oils or other means as they can lead to irritation of skin or change of its property.

It is necessary to paste Dyurogezik right after extraction of a plaster from the soldered package. TTS on site of application should be pressed densely a palm for 30 seconds. It is necessary to be convinced that the plaster densely adjoins to skin, in particular at the edges.

Dyurogezik is expected 72 hours of continuous use. The new system can be pasted on other site of skin after removal of the plaster pasted earlier. On the same site of skin the plaster can be pasted only with a break in several days.

The dose of drug is selected individually depending on a condition of the patient (it needs to be estimated again after each application of TTS).

At the first use of Dyurogezik the size of system (dose) is selected proceeding from the previous use of opioid analgetics, by conditions of the patient and degree of tolerance. At the patients who were not accepting earlier opioids as an initial dose appoint the smallest dose – 0,025 mg/h. The same dose is applied to the patients receiving earlier Promedolum.

Upon transition from parenteral or peroral forms of opioids to Dyurogezik at patients with tolerance to opioids the dose is calculated individually.

Initial assessment of the maximum analgesic effect of drug cannot be carried out earlier, than in 24 hours after application that is caused by gradual increase in serum of concentration of fentanyl.

For successful transition from one medicine to another the previous anesthetizing treatment needs to be cancelled gradually after application of an initial dose of Dyurogezik.

If adequate anesthesia after application of an initial dose is not reached, in 3 days the dose can be increased. Further increase in a dose is possible each 3 days. For once the dose is usually increased by 0,025 mg/h, however at the same time it is necessary to consider a condition of the patient and the need for performing additional anesthesia (the daily peroral dose of morphine of 90 mg approximately corresponds to Dyurogezik's dose of 0,025 mg/h). For achievement of a dose more than 0,1 mg/h perhaps simultaneous use of several TTS. Periodically, when developing of the "breaking" pains, additional doses of analgetics of short action can be required for patients. Some patients when using a dose of Dyurogezik higher than 0,3 mg/h can need additional or alternative ways of introduction of opioid analgetics.

Side effects

• Nervous system: headache, depression, drowsiness, alarming states, confusion of consciousness, hallucination, anorexia; seldom – agitation, euphoria, a tremor, sleeplessness, amnesia, paresthesia;
• Alimentary system: vomiting, nausea, a lock, bilious colic (at patients with instructions in the anamnesis), dyspepsia, dryness in a mouth; seldom – diarrhea;
• Respiratory system: hypoventilation, respiratory depression and a bronchospasm (at overdose); in rare instances – an asthma;
• Local reactions: sometimes – skin rash, an itch and an erythema in the place of application (as a rule, pass independently for 24 hours after removal of TTS);
• Others: tachycardia, short-term muscle tension (including chest), bradycardia, hypertensia, a lowering of arterial pressure, an ischuria, the strengthened sweating, an itch, tolerance, and also physical and mental dependence; very seldom – sexual dysfunction, an adynamy, "withdrawal".

Upon transition to Dyurogezik from the accepted earlier narcotic analgetics or in cases of the sudden termination of treatment symptoms which are characteristic of cancellation of opioids are possible (vomitings, diarrheas, alarming states, a fever are shown in the form of nausea). Reduction of expressiveness of these symptoms is promoted by a gradual dose decline.

Special instructions

Dyurogezik appoint with care in the presence of the following diseases / states:

• Chronic diseases of lungs: against the background of chronic obstructive and other diseases of lungs Dyurogezik can lead to development of a number of heavy side effects (in the form of decrease in excitability of a respiratory center and increase in respiratory resistance);
• Increase in intracranial pressure: the patient showing special sensitivity to increase in maintenance of CO2, Dyurogezik it is necessary to appoint with care. Patients with the increased intracranial pressure, disturbances of consciousness and the patients who are in a coma treat risk group. Drug is appointed with care at brain tumors;
• Cardiovascular diseases: because of probability of development of bradycardia of care demands use of TTS for patients with bradyarrhythmias and arterial hypotension;
• Liver diseases: it is necessary to make careful observation of a condition of patients with liver pathologies as such diseases can lead to a delay of removal of active agent; at emergence of symptoms of overdose of fentanyl the drug dose decline is required;
• Hepatic colic in the anamnesis: Dyurogezik can raise a tone of smooth muscles of biliary tract and digestive tract therefore such patients need careful observation;
• Diseases of kidneys: at a renal failure behind a condition of patients careful control is necessary; at emergence of symptoms of overdose by active agent, it is necessary to lower a drug dose;
• Advanced age: because of risk of decrease in clearance of fentanyl and lengthening of the period of its semi-removal, and also probability of existence of hypersensitivity to effect of drug, behind a condition of elderly patients careful control is necessary; at emergence of symptoms of overdose by active agent it is necessary to lower Dyurogezik's dose;
• Respiratory depression: some patients because of probability of development of considerable respiratory depression need careful inspection for the purpose of identification of similar effects. After removal of TTS respiratory depression can proceed;
• Medicinal dependence: in cases of repeated use of opioids tolerance, and also mental and physical dependence can develop. Iatrogenic dependence during therapy by Dyurogezik is noted seldom;
• Fever / external sources of heat: at increase body temperature increases to 40 °C concentration of fentanyl therefore patients with fever need careful observation for identification of side effects, characteristic of opioids. If necessary Dyurogezik's dose is adjusted. Patients are recommended to avoid direct influence of external sources of heat to the place of application of TTS (heating lamps, intensive solar bathtubs, hot-water bottles, saunas, bathtubs with hot water, etc.).

It is necessary to watch a condition of patients at whom development of heavy side effects was noted carefully as concentration of fentanyl in plasma goes down gradually.

Plasters cannot be divided into parts, to cut or damage in any way as it can lead to uncontrollable release of fentanyl.

In need of the therapy termination Dyurogezik's replacement with other opioids needs to be made gradually, since low doses. For prevention of development of "withdrawal" it is necessary to cancel an opioid analgesia gradually.

As Dyurogezik can influence the physical and/or mental functions necessary at performance of potentially dangerous works (including driving or work with the equipment), during therapy it is recommended to refrain from participation in them.

Medicinal interaction

At simultaneous use of Dyurogezik with some medicines there can be following effects:

• Other medicines having the oppressing effect on the central nervous system including opioids, hypnotic drugs and sedative drugs, fenotiazina, means for the general anesthesia, the central muscle relaxants, tranquilizers, antihistaminic drugs with sedative action, alcoholic beverages: increase in risk of development and strengthening of hypoventilation, lowering of arterial pressure, excessive sedation (joint therapy demands special observation of a condition of the patient);
• Potential inhibitors _{of P450 CYP3A4 cytochrome} (ритонавир): increase in concentration of fentanyl in plasma that increases probability of strengthening or lengthening of therapeutic action and emergence of side effects (the combination is not recommended);
• Nitrous oxide: strengthening of muscular rigidity;
• Buprenorphine: decrease in effect of Dyurogezik;
• Monoamine oxidase inhibitors: increase in risk of development of heavy complications.

At combined use with insulin, glucocorticosteroids and hypotensive medicines it is necessary to lower a fentanyl dose.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature of 15-25 °C.

Period of validity – 2 years.