Promedol (Promedolum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceTrimiperidineTrimiperidine
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  • Promedol
    solution for injections 
    MOSCOW ENDOCRINE FACTORY, FSUE     Russia
  • Promedol
    pills inwards 
    STATE FACTORY OF MEDICAL PREPARATIONS, FSUE     Russia
  • Promedol
    solution for injections 
    STATE FACTORY OF MEDICAL PREPARATIONS, FSUE     Russia
    • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    active substance:

    trimiperidine hydrochloride (promedol) - 10 mg or 20 mg

    Excipients:

    hydrochloric acid 1 M - to a pH of 4.0 to 6.0,

    water for injection-up to 1 ml.

    Description:clear colorless liquid
    Pharmacotherapeutic group:analgesic narcotic
    ATX: & nbsp

    N.01.A.H   Opioid analgesics

    Pharmacodynamics:

    Trimeperidine refers to agonists of opioid receptors (mainly - mu-receptors). Activates the endogenous antinociceptive system and such,

    way violates the inter-neural transmission of pain impulses at various levels of the central nervous system, and also changes the emotional color of pain, affecting the higher parts of the brain. By pharmacological properties trimeridine is close to morphine: it increases the threshold of pain sensitivity with pain stimuli of different modalities, depresses conditioned reflexes, and has a moderate hypnotic effect.Unlike morphine, it lessens the respiratory center to a lesser degree and causes nausea and vomiting less often. Has moderate spasmolytic and uterotonic effect. Promotes the opening of the cervix during labor, increases the tone and contractile activity of the myometrium.

    With parenteral administration analgesic effect develops in 10-20 minutes, reaches a maximum after 40 minutes and lasts 2-4 hours.
    Pharmacokinetics:

    Absorption is rapid in any mode of administration. After intravenous administration, a rapid decrease in plasma concentration is observed and after 2 hours only trace concentrations are determined. Connection with plasma proteins - 40%. Metabolized mainly in the liver by hydrolysis with the formation of meperidine and normeperidic acids followed by conjugation. The half-life (T1 / 2) is 2.4-4 hours, increases with renal insufficiency. In small amounts is excreted by the kidneys (including 5% - unchanged).

    Indications:

    Pain syndrome of moderate to severe intensity (unstable angina, myocardial infarction, exfoliating aneurysm of the aorta, thrombosis of the renal artery, thromboembolism of the arteries of the extremities or pulmonary artery,acute pericarditis, air embolism, pulmonary infarction, acute pleurisy, spontaneous pneumothorax, peptic ulcer and 12 duodenal ulcer, perforation of the esophagus, chronic pancreatitis, paranephritis, acute dysuria, Paraphimosis, priapism, acute prostatitis, acute glaucoma attack, causalgia, acute neuritis, sciatica, acute vesicles, thalamic syndrome, burns, cancer, trauma, disc protrusion; foreign bodies of the bladder, rectum, urethra).

    In combination with atropine and antispasmodics for pain caused by spasm of smooth muscles of internal organs (liver, kidney, intestinal colic).

    Acute left ventricular failure, pulmonary edema, cardiogenic shock.

    Preoperative, operating and postoperative periods.

    Childbirth (anesthesia and stimulation).

    Neuroleptanalgesia (in combination with neuroleptics).

    Contraindications:

    Hypersensitivity, depression of the respiratory center; with epidural and spinal anesthesia - a violation of blood clotting (including on the background of anticoagulant therapy),infection (risk of infection in the central nervous system); diarrhea against pseudomembranous colitis caused by cephalosporins, lincosamides, penicillins, toxic dyspepsia (delayed elimination of toxins and related exacerbation and prolongation of diarrhea); simultaneous treatment with monoamine oxidase inhibitors (including within 21 days after their use).

    The drug in this dosage form is contraindicated for use the children under the age of 2 years.

    If you have any of these diseases, consult a doctor before taking the drug.

    Carefully:

    FROM caution: respiratory failure, hepatic and / or renal insufficiency, adrenal insufficiency, chronic heart failure, central nervous system abnormality, craniocerebral trauma, intracranial hypertension, myxedema, hypothyroidism, prostatic hyperplasia, urethral stricture, surgical interventions on the gastrointestinal tract or urinary system, bronchial asthma, chronic obstructive pulmonary disease, convulsions, arrhythmia, arterial hypotension,suicidal tendencies, emotional lability, alcoholism, drug dependence (including history), severe inflammatory bowel disease, weakened patients, cachexia, pregnancy, lactation, children's age, and advanced age.

    If you have One of the listed diseases, before taking the drug must consult with your doctor.

    Dosing and Administration:

    Subcutaneously, intramuscularly or intravenously (only subcutaneously and intramuscularly for the drug in syringe tubes).

    Adults - from 10 mg to 40 mg. (from 1 ml of a solution with a concentration of 10 mg / ml to 2 ml of a solution with a concentration of 20 mg / ml). During anesthesia with fractional doses of the drug - administered intravenously for 3 - 10 mg.

    Children from two years: 3-10 mg, depending on age.

    For premedication, injected under the skin or intramuscularly 20 - 30 mg together with atropine (0.5 mg) for 30-45 minutes before the operation.

    Anesthesia of childbirth: subcutaneously or intramuscularly at a dose of 20-40 mg with the opening of the pharynx 3-4 cm and with a satisfactory fetal condition. The last) dose of the drug is administered 30-60 minutes before the delivery in order to avoid a drug depression of the fetus and the newborn.

    Higher doses for adults: single dose - 40 mg, daily -160 mg.

    Side effects:

    Co hand digestive system: more often - constipation, nausea and / or vomiting; less often - dryness of the oral mucosa, anorexia, biliary tract spasm, irritation of the gastrointestinal tract; rarely - with inflammatory bowel diseases - paralytic intestinal obstruction and toxic megacolon (constipation, flatulence, nausea, stomach cramps, gastralgia, vomiting); frequency unknown - hepatotoxicity (dark urine, pale stool, hysterical sclera and skin).

    Co hand nervous system and sense organs: more often - dizziness, weakness, drowsiness; less often - headache, blurred vision, diplopia, tremor, involuntary muscle twitching, euphoria, discomfort, nervousness, fatigue, nightmares, unusual dreams, restless sleep, confusion, convulsions; rarely - hallucinations, depression, in children - paradoxical agitation, anxiety; frequency unknown - convulsions, rigidity of muscles (especially respiratory), ringing in the ears; frequency is unknown - slowing down the speed of psychomotor reactions,disorientation.

    Co hand respiratory system: less often - oppression of the respiratory center.

    Co hand of cardio-vascular system: more often - lowering blood pressure; less often - arrhythmias; frequency unknown - increased blood pressure.

    Co hand urinary system: less often - decreased diuresis; spasm of ureters (difficulty and pain when urinating, frequent urge to urinate).

    Allergic reactions: less often - bronchospasm, laryngospasm, angioedema; rarely - skin rash, itchy skin, swelling of the face.

    Local reactions: hyperemia, edema, burning at the injection site.

    Other: less frequent - increased sweating; frequency is unknown - addiction, drug dependence.

    If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects of the instructions not indicated, inform your doctor.

    Overdose:Symptoms: nausea, vomiting, cold sticky sweat, confusion, dizziness, drowsiness, lowering of blood pressure, nervousness, fatigue, bradycardia, severe weakness, slow labored breathing, hypothermia, anxiety,miosis (with pronounced hypoxia, the pupils can be enlarged), convulsions, hypoventilation, cardiovascular failure, in severe cases - loss of consciousness, respiratory arrest, coma.
    Treatment: maintenance of adequate pulmonary ventilation, symptomatic therapy. Intravenous administration of a specific opioid antagonist "naloxone at a dose of 0.4 to 2 mg quickly restores breathing." In the absence of the effect after 2-3 minutes, the administration of naloxone is repeated. "The initial dose of naloxone for children is 0.01 mg / kg.

    Interaction:

    Strengthens the inhibition of the central nervous system and respiration caused by the use of other narcotic analgesics, sedatives, hypnotics, antipsychotics (antipsychotics), anxiolytics, drugs for general anesthesia, ethanol, muscle relaxants.

    Against the background of the systematic use of barbiturates, especially phenobarbital,

    it is possible to reduce the analgesic effect.

    Strengthens the hypotensive effect of drugs that reduce blood pressure (including ganglion blockers, diuretics).

    Medicines with anticholinergic activity and antidiarrhoeal drugs, including loperamide) increase the risk of constipation (up to intestinal obstruction) and urinary retention.

    Strengthens the effect of anticoagulants (should monitor prothrombin plasma). Buprenorphine (including previous therapy), reduces the effectiveness of promedol.

    When used simultaneously with monoamine oxidase inhibitors, it is possible to develop severe reactions due to overexcitation or inhibition of the central nervous system with the emergence of hyper- or hypotensive crises.

    Naloxone restores, breathes, eliminates analgesia and reduces central nervous system depression caused by admission, promedola. It can accelerate the appearance of symptoms of "withdrawal syndrome" against the background of drug dependence. Naltrexone accelerates / the appearance of symptoms of "withdrawal syndrome" against the background of drug dependence (symptoms may appear as early as 5 minutes after drug administration, continue for 48 hours, are resistant and difficult to eliminate), reduces effects of promedol, does not affect symptoms, caused by a histamine reaction.

    Reduces the effect of metoclopramide.

    Special instructions:Do not use ethanol.
    Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:Solution for injection 10 mg / ml and 20 mg / ml.
    Packaging:

    Solution for injection 10 mg / ml and 20 mg / ml in ampoules of 1 ml, in syringe tubes of 1 ml (cm3). 5 ampoules in the outline of the cell. 1 or 2 contoured cell packs with instructions for use in a pack or bundle with a slot from two front sides, provided by the control of the first cardboard opening. 20, 50 or 100 contour packagings with 20, 50 or 100 instructions for use in a cardboard box or in a box of corrugated cardboard (for inpatient).

    20, 50 or 100 syringes-tubes with instructions for the use of the drug and a syringe-tube in a box of cardboard.

    Storage conditions:

    List II of the "List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation" in specially equipped premises with a license for the specified type of activity.

    In the dark place at a temperature of no higher than 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    Ampoules - 5 years, syringe-tubes - 3 years. Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N000368 / 01
    Date of registration:27.10.2011
    The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.10.2015
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