Universal reference book for medicines
Product name: FENTADOL RESERVUAR (FENTADOL RESERVUAR)

Active substance: fentanyl

Type: Actually an opioid receptor agonist.
Analgesic
Manufacturer: SANDOZ (Slovenia) produced by HEXAL (Germany)
Composition, form of production and packaging
A transdermal therapeutic system (TTC)
with a contact surface area of ​​30 cm 2 and a release rate of fentanyl of 75 μg / h.

1 TTC

fentanyl 7.5 mg

1 PC.
- packages from the combined material (5) - packs cardboard.
1 PC.
- packages from the combined material (10) - packs cardboard.
1 PC.
- packages from the combined material (20) - packs cardboard.
Transdermal therapeutic system (TTC) with a contact surface area of ​​10 cm 2 and a release rate of fentanyl of 25 μg / h.

1 TTC

fentanyl 2.5 mg

1 PC.
- packages from the combined material (5) - packs cardboard.
1 PC.
- packages from the combined material (10) - packs cardboard.
1 PC.
- packages from the combined material (20) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​20 cm 2 and a release rate of fentanyl of 50 μg / h.

1 TTC

fentanyl 5 mg

1 PC.
- packages from the combined material (5) - packs cardboard.
1 PC.
- packages from the combined material (10) - packs cardboard.
1 PC.
- packages from the combined material (20) - packs cardboard.
A transdermal therapeutic system (TTC) with a contact surface area of ​​30 cm 2 and a release rate of fentanyl of 75 μg / h.

1 TTC

fentanyl 7.5 mg

1 PC.
- packages from the combined material (5) - packs cardboard.
1 PC.
- packages from the combined material (10) - packs cardboard.
1 PC.
- packages from the combined material (20) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Fentanyl is an opioid analgesic, an opioid receptor agonist (predominantly? -receptors) of the central nervous system, spinal cord and peripheral tissues.
Increases the activity of the antinociceptive system, raises the threshold of pain sensitivity.
The main therapeutic effects of the drug are analgesic and sedative.

Duration of the drug - 72 h.

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.

Increases the concentration of amylase and lipase in the blood;
reduces the concentration of somatotropic hormone (STH), catecholamines, 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.
The minimum effective analgesic concentration of fentanyl in plasma in patients not previously used narcotic analgesics is 0.3-1.5 ng / ml, with serum fentanyl concentrations higher than 2 ng / ml, the likelihood of side effects increases.

Unlike other narcotic analgesics, it is much less likely to cause histamine reactions.

The transdermal therapeutic system (TTS) is a dosage form for maintaining a constant release of fentanyl for 72 hours.

PHARMACOKINETICS

Communication with plasma proteins - 80-89% (mainly with albumins and lipoproteins, depends on the pH of the plasma).
The volume of distribution is 60-80 l (3.1-7.8 l / kg). The fentanyl fraction in the plasma unbound with plasma proteins is 13-21%.
After the application of TTS, fentanyl accumulates in adipose tissue and muscles and then is slowly released into the blood.
The release of fentanyl occurs at a constant rate for 72 hours, with the therapeutic serum concentration gradually increasing in the first 12-24 hours and remains relatively constant over the remainder of the period.
The concentration of fentanyl in blood plasma is proportional to the area of ​​the TTS.

After repeated applications, an equilibrium concentration in the blood plasma is achieved, which is maintained by subsequent TTS applications of the same size.
After removal of the TTS, the fentanyl concentration in the blood plasma gradually decreases, with T 1/2 being approximately 17 hours (13-22 hours). Continued absorption of fentanyl from the skin (more typically after 4 applications) explains the slow disappearance of the drug from the blood plasma. In elderly, debilitated or impaired patients, the clearance of fentanyl can be reduced, which leads to an elongation of T 1/2 of fentanyl.
Fentanyl is metabolized predominantly in the liver (by N-dealkylation and hydroxylation) involving cytochrome P450 (isoenzyme CYP3A4), as well as in.
kidney, intestines and adrenal glands. The main metabolite of norfentanil is inactive.
It is excreted by the kidneys (75% - in the form of metabolites and 10% - in unchanged form) and with bile (9% - in the form of metabolites).

It penetrates the blood-brain barrier (GEB), the placenta and into breast milk.

INDICATIONS

Chronic pain syndrome of strong and moderate severity:

- pain caused by an oncological disease;

- pain syndrome of non-oncological genesis, requiring multiple analgesia with narcotic analgesics (for example, neuropathy, arthritis and arthrosis, "phantom" pain after limb amputation).

DOSING MODE

Dose of the drug Fentadol Tank is selected individually depending on the patient's condition, the effectiveness of the dose should be regularly evaluated after each TTS application.

TTS is applied to intact and unirradiated skin surface with minimal hair covering: chest, back, shoulders.
If you need to remove the hairline - it should be cut (do not shave!). If the place of application is to be washed before applying the TTS, it 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 TTS is protected by a waterproof outer protective film, it can be removed without a brief stay in the shower.
Before applying the TTC, it is necessary to check carefully for damage: the TTS cut or damaged in any other way should not be used!

The drug Fentadol Tank should be used immediately after extraction from a sealed original package:

1. Separate part of the protective film from the back of the TTC.

2. Apply a part of the TTS that is free of the film to the selected area of ​​the skin and squeeze it well.

3. Remove the remaining part of the protective film without touching the adhesive layer with your fingers.

4. After removing the entire protective film, it is necessary to tightly press the TTS palm in place of the application for about 30 seconds.
It should be ensured that the TTS tightly adheres to the skin, especially along the edges. If necessary, additional fixation of the TTC may be used.
5. After the TTC application, the Fentadol Tank should be washed with clean water (no soap).

TTS should be pasted for 72 hours, after which it must be changed to a new one (in exceptional cases, the replacement of the TTS is made 48 hours, but not earlier!).New TTS should always be applied to another area of ​​the skin, without capturing the place of the previous application.
At the same place applications TTS can be applied again not earlier than 7 days later.
The analgesic effect may persist for some time after removal of the TTS.

TTS Fentadol The tank should not be divided or cut!

If after removal of the TTS on the skin there are its residues, it is necessary to remove them with a large amount of water with soap.

Do not use alcohol and other solvents for this purpose.
organic solvents (due to the effect of TTS) can penetrate through the skin.
Selection of initial dose

The initial dose of the drug Fentadol Tank is selected individually, based on the previous use of narcotic analgesics, and also taking into account the possible development of tolerance and its degree, concomitant drug treatment, the general condition of the patient (including body surface area, age, degree of exhaustion).

Patients who had not previously taken narcotic analgesics

In the absence of previous treatment with narcotic analgesics, it is recommended to begin treatment with small doses of 25 μg / h of the drug Fentadol Tank.

The dose may be subsequently reduced or increased if necessary by 12.5-25 μg / hr to achieve the lowest effective dose of the drug Fentadol Tank, depending on the effect and the need for additional analgesia (see Table 1 "Transfer to an equivalent analgesic dose" and Table No. 2 "The recommended dose of the drug is Fentadol Tank.)

Patients who had previously taken narcotic analgesics

At the transition from oral or parenteral use of narcotic analgesics to the drug Fentadol Tank in patients with tolerance to narcotic analgesics the initial dose is calculated as follows:

- determine the total daily dose of previously used narcotic analgesics;

- the resulting total dose is transferred to the corresponding oral dose of morphine using Table 1 "Transfer to an equivalent analgesic dose";

- the appropriate dose of fentanyl is determined using Table No. 2, "Recommended dose of the drug Fentadol Tank" (depending on the daily oral dose of morphine).

The dose can be subsequently reduced or increased if necessary by 12.5-25 μg / h to achieve the minimum effective dose of the drug Fentadol Tank depending on the reaction and the need for additional analgesia.
All intramuscular (IM) and oral doses of narcotic analgesics listed in Table 1 are equivalent in terms of the analgesic effect of 10 mg of morphine IM.
Table 1. Transfer to an equivalent analgesic dose

Name of Drug Equivalent Analgesic Dose (mg)

intramuscularly inside

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

Omnompon 45

Hydromorphone 1.5 7.5

Methadone 10 20

Oxycodone 15 30

Levorphanol 2 4

Oxymorphone 1 10 (rectally)

Pethidine 75 -

Codeine 130 200

Buprenorphine 0.4 0.8 (sublingually)

Ketobemidone 10 30

Table 2. Recommended dose of the drug Fentadol Tank (depending on the daily oral dose of morphine)

Oral daily dose of morphine (mg / day) Dose of Fentadol® Tank (μg / h)

<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

Initial assessment of the maximum analgesic effect of the drug Fentadol The reservoir can be conducted 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, for a successful transition from one drug to another, previous analgesic therapy should be canceled gradually after the application of the initial dose of the drug Fentadol Tank until its analgesic effect stabilizes.
In the first 12 hours after the appointment of TTS with fentanyl, patients should continue to receive narcotic analgesics in the previous dose;
if the application is more than 12 hours, this analgesic is prescribed as required. Dose selection and maintenance therapy
TTS should be replaced every 72 hours. The dose is selected individually until the required analgesic effect is achieved.

If, after 48-72 hours after the initial dose, a significant reduction in the analgesic effect occurs, the replacement of the TTS may be required after 48 hours.

A dose of 25 μg / h is usually sufficient to select a dose in the lower dose range.
If the analgesia was insufficient by the end of the first application period, the dose can be increased every 3 days until the desired effect is achieved.
Usually, the dose is increased by 12.5-25 μg / h for 1 time, however, the patient's condition and the need for additional analgesia must be taken into account.

To achieve a dose of more than 100 μg / h, several TTS can be used simultaneously.

In the event of "breakthrough" pain, patients may occasionally need additional doses of short-acting narcotic analgesics.
If the required dose of the drug Fentadol® Tank exceeds 300 μg / h, consideration should be given to the use of additional or alternative methods of analgesia or alternative methods of administering narcotic analgesics. Use of the drug Fentadol® Tank in special patient groups In elderly, debilitated and impaired patients, as well as in patients with renal or hepatic insufficiency, the dose should be reduced if necessary. Discontinuation of treatment with Fentadol® Tank
If it is necessary to interrupt the use of TTS, then substitution for any other narcotic analgesics should be carried out gradually, starting with a low dose and slowly increasing it.
This is due to the fact that the content of fentanyl in the blood serum after removal of the TTS decreases gradually; it takes at least 17 hours to reduce the serum fentanyl concentration by 50%. The abolition of narcotic analgesics should be gradual in order to avoid the withdrawal syndrome (nausea, vomiting, diarrhea, anxiety and muscle tremor).
SIDE EFFECT

According to the WHO, the undesirable effects are classified according to their frequency of development as follows: very often (> 1/10), often (> 1/100, 1/1000, 1/10000, <1/1000), very rarely (<1 / 10000, including individual cases).

From the nervous system and sensory organs:

Very often: headache, dizziness, drowsiness (including those in newborns);

Often: sedation, anorexia, confusion, anxiety, nervousness, involuntary muscle contraction, hypoesthesia;

Infrequently: euphoria, amnesia, insomnia, hallucinations, agitation, tremor, paresthesia, speech impairment;

Rarely: amblyopia;

Very rarely: violation of coordination of movements, convulsions (including clonic convulsions and a large epileptic fit), depression, anxiety, delirium, exertion, asthenia, sexual dysfunction, withdrawal syndrome.

From the respiratory system:

Often: yawning, rhinitis;

Infrequent: shortness of breath, hypoventilation;

Very rarely: respiratory depression (including respiratory failure, apnea and bradypnoea), dyspnea.

From the cardiovascular system:

Often: a feeling of palpitations;

Infrequent: tachycardia, bradycardia, increase or decrease in blood pressure;

Rarely: arrhythmia, vasodilation.

From the digestive system:

Very often: nausea, vomiting, constipation;

Often: dry mouth, dyspepsia, pain in the abdomen;

Infrequently: diarrhea;

Rarely: hiccough;

Very rarely: intestinal obstruction, painful flatulence.

From the side of the urinary system :

Infrequent: retention of urine, urinary tract infection, spasm of ureters;

Very rarely: oliguria, cystalgia.

Allergic reactions:

Infrequently: itching;

Very rarely: anaphylaxis.

Dermatological reactions:

Very often: increased sweating;

Often: skin reaction at the place of application;

Infrequent: rash, erythrema.
The rash, erythema and itching at the site of application in most cases disappear within one day after removal of the TTS.
Other:

Infrequently: conjunctivitis, fatigue, malaise, flu-like symptoms;

Rarely: chills, peripheral edema.

With long-term use of fentanyl, as with the use of other narcotic analgesics, tolerance, physical and mental dependence, short-term stiffness of the muscles (including the thoracic) can develop.
When switching from previously taken narcotic analgesics to the use of the drug Fentadol Tank or in the event of a sudden discontinuation of therapy, a "cancellation" syndrome is possible, which is characterized by nausea, vomiting, diarrhea, anxiety and chills.
CONTRAINDICATIONS

- depression of the respiratory center, including acute respiratory depression;

- TTS should not be used for the treatment of acute or postoperative pain due to the lack of the possibility of selecting an adequate dose in a short period of time and the likelihood of developing a life-threatening respiratory depression;

- simultaneous use with monoamine oxidase (MAO) inhibitors, both during the entire period of application of MAO inhibitors, and within 14 days after their cancellation;

- irritation and violation of the integrity of the skin, radiation dermatitis in the place of the intended application;

- diarrhea on the background of pseudomembranous colitis, caused by the intake of cephalosporins, lincosamides, penicillins;

- toxic dyspepsia;

- severe CNS lesions;

- intestinal obstruction;

- severe bronchial asthma or an acute attack of bronchial asthma;

- the period of labor contractions and childbirth (including cesarean section), due to the probability of fetal / newborn respiratory depression;

- age up to 18 years;

- Hypersensitivity to the active substance or excipients of TTS.

With caution: respiratory failure (pneumonia, atelectasis and lung infarction, bronchial asthma, chronic obstructive bronchitis, propensity to bronchospasm), intracranial hypertension, brain tumors, traumatic brain injury, bradyarrhythmia, arterial hypotension, renal and hepatic insufficiency, renal or hepatic colic (including in the anamnesis), cholelithiasis, hypothyroidism, elderly, debilitated and weakened patients, acute surgical diseases of the abdominal cavity organs until diagnosis, general severe
th state of the patient, benign prostatic hyperplasia, urethral stricture, drug dependency (including drug), alcoholism, suicidal tendencies, hyperthermia, simultaneous insulin GCS, antihypertensive drugs.
PREGNANCY AND LACTATION

Information on the use of TTS containing fentanyl in pregnant women is not enough.
Fentanyl during pregnancy should only be used in emergencies when the expected benefit to the mother outweighs the potential risk to the fetus.
Prolonged use of transdermal fentanyl during pregnancy can cause a syndrome of "lifting" the newborn.
Fentanyl is not to be taken during labor and delivery (including caesarean section), because fentanyl crosses the placenta 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. Consequently, discontinue breastfeeding (for the duration of application and for 72 hours after removal of the TTS) if appropriate destination during lactation.
APPLICATION FOR CHILDREN

Contraindicated in children under 18 years.

SPECIAL INSTRUCTIONS

Fentadol drug reservoir may be used only by qualified personnel in a specialized hospital, as part of an integrated treatment of pain in patients provided with adequate medical, social and psychological assessment of their condition.
Fentadol drug reservoir can not be assigned for the relief of acute or postoperative pain, because there is no possibility of selection of adequate doses for short-term use. There is a probability of occurrence and the development of serious and life-threatening lung hypoventilation (or respiratory depression) as a result of the TTS.
Patients who have severe side effects were observed on a background using a TTS requires careful control of their state for an additional 24 hours after removal of the TTS, since fentanyl plasma concentration decreases gradually and its 50% reduction is achieved for about 17 h (13-22 h). Fentadol drug reservoir should be kept out of reach of children both before and after use! TTC Fentadol tank should not be divided or cut into pieces!
Use in patients not previously treated with opioids
In applying the TTS Fentadol reservoir in patients previously treated with narcotic analgesics rarely observed cases of significant respiratory depression and / or death when used as the initial analgesic therapy. The risk of serious or life-threatening hypoventilation exists even in the case of a minimum dose of TTS Fentadol tank as the initial analgesic therapy in patients not previously treated with opioids.
It is recommended to use the drug reservoir Fentadol patients demonstrating tolerance to narcotic analgesics.
respiratory depression
As with other potent opioids, when using the drug reservoir Fentadol some patients may experience respiratory depression expressed. Patients should be carefully monitored to detect such effects. Respiratory depression may continue after the removal of the TTS Fentadol tank. The degree of respiratory depression increases with dose Fentadol reservoir.
Chronic lung disease
TTC Fentadol reservoir may cause a number of severe side effects in patients with chronic obstructive pulmonary disease and other (to reduce the excitability of the respiratory center and reduce breathing).
Intracranial hypertension
TTS Fentadol tank should be used with caution in patients who may be especially sensitive to an increase of CO 2 (patients with increased intracranial pressure, disturbance of consciousness and coma). TTC Fentadol tank should be used with caution in patients with intracranial tumors.
Cardiovascular disease
Fentanyl may cause bradycardia and should therefore be used with caution in patients with bradyarrhythmias. In patients with arterial hypotension TTC Fentadol tank should be used with caution.
liver disease
Because fentanyl is metabolized to inactive metabolites in the liver, the liver disease may slow down the drug elimination from the body. In patients with cirrhosis of the liver after a single application of the drug reservoir Fentadol not observed changes in the pharmacokinetics, although fentanyl concentration in the blood serum tended to increase. Patients with hepatic impairment need to be carefully monitored for signs of fentanyl overdose. In this case, reduction in dose Fentadol reservoir.
Narcotic analgesics can raise the tone of smooth muscles of the gastrointestinal tract and biliary tract. Fentadol tank should be used with caution in patients with hepatic colic history.
kidney disease
Less than 10% of fentanyl excreted by the kidneys in unchanged form, known active metabolites which would not excreted by the kidneys.
The data received at I / fentanyl in patients with renal failure suggest that the volume of distribution of fentanyl may be changed by dialysis, which can affect the concentration of fentanyl in the blood serum. Patients with kidney failure need careful monitoring. When the overdose symptoms should reduce the dose of TTS Fentadol tank.
In the transition from the long-term treatment with morphine for transdermal administration of fentanyl may occur syndrome "cancel" despite adequate analgesic effect of the drug. When the syndrome "cancel" recommended patients administering short acting morphine in low doses.
Interaction with inhibitors of CYP3A4 isoenzyme
When combined with inhibitors of isoenzyme CYP3A4 (e.g., ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefadozon, verapamil, diltiazem and amiodarone) may increase the concentration of fentanyl in the plasma, which can enhance or prolong both therapeutic effects and adverse reactions in particular cause severe respiratory depression. In such situations should be carefully monitored for the patient. Accordingly, the combined use of transdermal fentanyl with inhibitors of CYP3A4 isoenzyme is not recommended in the absence of a careful patient monitoring. Patients who are prescribed TTC Fentadol tank simultaneously with inhibitors of CYP3A4 isoenzyme, should be monitored for signs of the occurrence of respiratory depression; may require dose adjustment.
Use in elderly patients
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 TTS Fentadol tank 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 symptoms of fentanyl overdose, which would require reducing the dose of TTS Fentadol tank.
Use in malnourished and debilitated patients
Since malnourished and debilitated patients clearance may decrease and lengthen T 1/2fentanyl, they need to be carefully monitored to detect possible symptoms of fentanyl overdose, which would require reducing the dose of TTS Fentadol tank.
Drug dependency and abuse potential
Repeated administration of narcotic analgesics is possible development of tolerance and physical and psychological dependence. Iatrogenic dependence in the application of opioids is rare. As with other narcotic analgesics, there are cases of abuse of fentanyl. Abuse or intentional use of the drug Fentadol tank for other purposes could result in overdose and / or death. Patients who are at increased risk of abuse of narcotic analgesics should be monitored carefully.
Hyperthermia / external heat sources
pharmacokinetic model suggests that fentanyl concentration in serum may increase by about 1/3 increase in body temperature to 40 ° C. Therefore patients with hyperthermia should be monitored closely to detect the characteristic side effects of fentanyl, and if necessary, followed by dose correction. All patients during therapy is necessary to avoid the direct action of external heat sources such as heat lamps, sunlamps, intensive sunbathing, hot water bottles, saunas, hot tubs with the water in the place of application Fentadol® reservoir TTS.
Always shoot before visiting TTC sauna. Saunas reception is possible only by replacing TTC (at intervals of 72 hours). New TTC should be superimposed on the cold and completely dry skin.
Termination drug application Fentadol reservoir
if required discontinuation TTC Fentadol reservoir, replacement of the preparation other narcotic analgesics should be carried out gradually, starting with a low dose, due to the gradual reduction of the concentration of fentanyl after removal of the TTS Fentadol reservoir at which 50% reduction in fentanyl concentration in serum is about 17 hours. The elimination of the drug should always be to avoid the development of the syndrome of "cancellation".
Effects on ability to drive and engaging in other activities that require concentration and speed of psychomotor reactions.
TTC Fentadol tank can affect the mental and / or physical functions needed to perform potentially hazardous activities such as driving a vehicle or working with machinery. In the period of treatment should refrain from driving motor vehicles and activities potentially hazardous activities that require high concentration and psychomotor speed reactions.
Instructions for Disposal
It is necessary to tightly fold the sticky side of the used TTS half inside and return the doctor for disposal in accordance with established procedure. Unused TTC also need to return the doctor for disposal. Before you use the TTC Fentadol tank should be stored in its original packaging.
OVERDOSE

Symptoms: dizziness, drowsiness, confusion, nervousness, weakness, depression of the cardiovascular system, lower blood pressure, bradycardia, "sticky" sweat, cramps, muscle tension, depression of the respiratory center with Cheyne-Stokes respiration and / or cyanosis, coma state , bradypnea apnea.
Treatment:TTS removal, physical and verbal stimulation of the patient to recover respiration ( "pat cheeks" reference by name), introduction of a specific antidote - naloxone. Respiratory depression overdose can last longer than the period of the opioid receptor antagonist; therefore may occur in repeated intravenous (i / v) administration of naloxone (or continuous infusion). The use of an opioid receptor antagonist can lead to sharp pain and release of catecholamines.
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 administered as infusion of 2 mg of naloxone 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 assigned intramuscular (i / m) or subcutaneously (s / c). 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.
Symptomatic and supportive therapy vital signs (including administering muscle relaxant, mechanical ventilation, with bradycardia - atropine, with marked decrease in blood pressure - blood volume replenishment).
DRUG INTERACTION

With the simultaneous use of other medications (drugs) that have a depressing effect on the CNS, including other narcotic analgesics, sedatives and hypnotic drugs, agents for general anesthesia, phenothiazines, tranquilizers, central muscle relaxants, antihistamines drug having sedative effects, alcohol, may increase the risk of gipoventylyatsii development and amplification, reduce blood pressure, excessive sedation, coma, or lead to death (the reception of any of the drugs at the same time using Fentado The tank requires special monitoring of the patient).
If it becomes necessary to joint use drug Fentadol tank with one of the aforementioned drugs, a correction of the dose of one or both drugs.
Fentanyl has a high ground clearance, it is rapidly and largely metabolised, mainly with the participation of isoenzyme CYP3A4. Simultaneous reception potent CYP3A4 inhibitors (e.g., erythromycin, ritonavir, ketoconazole, itraconazole, diltiazem, cimetidine, 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 pronounced respiratory depression. Careful monitoring of patients. Combined reception ritonavir or other potent inhibitor of CYP3A4 isoenzyme transdermal administration of fentanyl is not recommended, if not a careful patient monitoring. Fentanyl enhances the effect of antihypertensive drugs.
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 m-anticholinergic activity (including pancuronium bromide) reduce the risk of bradycardia and decrease of blood pressure (especially against the use of beta-blockers, and other vasodilators) and may increase the risk of tachycardia and increase in blood pressure; muscle relaxants, non-m-anticholinergic activity (including suxamethonium) does not reduce the risk of bradycardia and decrease of blood pressure (especially with aggravated Cardiology anamnesis) and increase the risk of severe side effects in the cardiovascular system.
Dinitrogen oxide enhances muscle rigidity.
It is necessary to reduce the dose of fentanyl while the use of insulin, corticosteroids and antihypertensive drugs.
Not recommended joint application of fentanyl with MAO inhibitors, both throughout the period of use of MAO inhibitors and for 14 days after their withdrawal, asthey increase the risk of severe complications in the application of fentanyl (narcotic analgesics enhancement of the effect or enhancement of serotonergic effects).
TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS XPA
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