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Fentanyl - instructions for use, reviews, analogs and formulations (injections in ampoules for injection 1 ml and 2 ml, transdermal therapeutic system or patch) medications for premedication and anesthesia in adults, children and pregnancy. Composition

Fentanyl - instructions for use, reviews, analogs and formulations (injections in ampoules for injection 1 ml and 2 ml, transdermal therapeutic system or patch) medications for premedication and anesthesia in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Fentanyl. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Fentanyl in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Fentanyl in the presence of existing structural analogues.Use for premedication and anesthesia during surgery in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Fentanyl opioid analgesic. The opioid receptor agonist interacts predominantly with the mu receptors. The analgesic effect is significantly superior to morphine. Has a depressing effect on the respiratory center, slows the heart rate, has little effect on blood pressure. Analgesic effect with intravenous administration develops after 1-3 minutes, and with intramuscular injection, after 10-15 minutes; duration of action with a single injection of not more than 30 minutes.

 

Composition

 

Fentanyl + auxiliary substances.

 

Pharmacokinetics

 

Metabolism of fentanyl occurs predominantly in the liver. About 75% is excreted in urine mainly in the form of metabolites, less than 10% - in unchanged form. About 9% is excreted with feces mainly in the form of metabolites.

 

Indications

  • Neuroleptanalgesia (in combination with droperidol);
  • premedication (as part of certain schemes).

 

As an anesthetic:

  • during short-term extra-cavitary operations;
  • as an additional tool for operations under local anesthesia;
  • with severe pain with myocardial infarction, lung infarction, renal and hepatic colic;
  • with postoperative pain.

 

For dermal application:

  • chronic pain in cancer;
  • unrestrained pain;
  • severe chronic pain in children older than 2 years who took opioid analgesics.

 

Forms of release

 

Solution for intravenous and intramuscular injection (injections in ampoules for injection).

 

Transdermal therapeutic system (TTS) or patch.

 

Instructions for use and how to use them

 

Ampoules

 

Intravenous, intramuscular, adult, in preparation for surgery: in / in - 0,05-0,1 mg (in combination with 2,5-5 mg of droperidol) for 10-15 minutes before anesthesia; for surgical anesthesia: in / in - 0,05-0,2 mg every 20-30 minutes. Children in preparation for surgery - 0.002 mg / kg body weight; for surgical anesthesia: in / in - 0,01-0,15 mg / kg or in / m 0,15-0,25 mg / kg; to maintain surgical anesthesia: in / m - 0,001-0,002 mg / kg.

 

Patch

 

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 cm2.

 

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.

 

Dose selection and maintenance therapy

 

The transdermal patch should be replaced with a new one every 72 hours. The dose is selected individually until the required level of anesthesia is reached. 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.

 

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

 

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

  • drowsiness;
  • headache;
  • dizziness;
  • confusion of consciousness;
  • depression;
  • anxiety;
  • nervousness;
  • hallucinations;
  • anorexia nervosa;
  • involuntary muscle contractions;
  • euphoria;
  • amnesia;
  • insomnia;
  • tremor;
  • speech disorders;
  • rave;
  • asthenia;
  • sexual dysfunction;
  • ataxia;
  • myoclonic cramps;
  • a feeling of palpitations;
  • bradycardia, tachycardia;
  • arterial hypotension;
  • arterial hypertension;
  • arrhythmia;
  • yawn;
  • rhinitis;
  • respiratory depression (including respiratory failure, apnea and bradypnea);
  • hemoptysis;
  • obstructive pulmonary disease;
  • pharyngitis;
  • laryngospasm;
  • nausea, vomiting;
  • constipation, diarrhea;
  • abdominal pain;
  • dyspepsia;
  • hiccough;
  • intestinal obstruction;
  • painful flatulence;
  • itching;
  • anaphylactic shock;
  • anaphylactic reactions;
  • anaphylactoid reactions;
  • rash;
  • sweating;
  • skin reaction at the place of application (change in skin appearance, peeling, exudation, petechial erosion, microcracks, scab);
  • rash;
  • erythema;
  • retention of urine;
  • urinary tract infections;
  • pain in the bladder;
  • spasm of ureters;
  • conjunctivitis;
  • fatigue;
  • malaise;
  • influenza-like symptoms;
  • edema;
  • feeling of cold.

 

With long-term administration of fentanyl, tolerance, physical and mental dependence, short-term stiffness of the muscles (including those of the chest) may develop.

 

Contraindications

  • bronchial asthma;
  • addiction;
  • Conditions accompanied by depression of the respiratory center;
  • obstetrical operations;
  • irritated, irradiated or damaged skin at the place of application;
  • toxic dyspepsia;
  • simultaneous use of MAO inhibitors or admission within 14 days after their withdrawal;
  • severe lesions of the central nervous system;
  • hypersensitivity to fentanyl.

 

Application in pregnancy and lactation

 

The use of Fentanyl during pregnancy is only possible if the intended benefit to the mother exceeds the potential risk to the fetus.

 

Fentanyl is excreted in breast milk, so if you need to use during lactation, you should decide whether to stop breastfeeding.

 

During the use of fentanyl in women of childbearing age, reliable means of contraception should be used.

 

Use in children

 

Contraindicated in children and adolescents under 18 years.

 

Application in elderly patients

 

Caution should be used in elderly patients.

 

special instructions

 

The use of fentanyl is recommended in the presence of an anesthesiologist and under conditions of intensive care.

 

When intravenously administered at a dose of 100-500 mcg, acute respiratory depression, up to apnea, is possible.

 

With simultaneous use with insulin preparations, correction of the dosing regimen of fentanyl is required.

 

Refers to narcotic and potent drugs. May be addictive.

 

Drug Interactions

 

With simultaneous use with other drugs that exert a depressing effect on the central nervous system, there may be a mutual enhancement of effects.

 

With the systematic administration of barbiturates, especially phenobarbital, there is a likelihood of reducing the analgesic effect of opioid analgesics. Long-term use of barbiturates or opioid analgesics stimulates the development of cross tolerance.

 

Nitrous oxide enhances the muscle rigidity caused by fentanyl.

 

Naloxone activates breathing, eliminating analgesia after the use of opioid analgesics.

 

Analogues of the drug Fentanyl

 

Structural analogs for the active substance:

  • Durogezik Matrix;
  • Lunaldin;
  • Fendivia;
  • Fentadol Matrix;
  • Fentadol Reservoir.

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