Clinical and pharmacological group: & nbsp

Opioid narcotic analgesics

Included in the formulation
  • Promedol
    solution for injections 
  • Promedol
    pills inwards 
  • Promedol
    solution for injections 
  • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    ONLS

    АТХ:

    N.01.A.H   Opioid analgesics

    Pharmacodynamics:

    Agonist opioidnyh μ-, δ- and φ-receptors (activation of μ-receptors is 2 times stronger than δ and κ): suppression of interneuronal transmission of pain impulses in the afferent ways of the central nervous system, reducing the emotional assessment of pain and reaction to it.

    Pharmacokinetics:

    Absorption is good. Relationship with plasma proteins 40%. Penetrates through the placenta and the blood-brain barrier. Biotransformation in the liver. The half-life is 2,4-4 h, increases with chronic renal failure. Elimination by the kidneys (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, lung infarction, acute pleurisy, spontaneous pneumothorax, peptic ulcer and 12-finger guts, 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).

    VII.H40-H42   Glaucoma

    IX.I20-I25.I20.0   Unstable angina

    IX.I20-I25.I21   Acute myocardial infarction

    IX.I26-I28.I26   Pulmonary embolism

    IX.I30-I52.I30   Acute pericarditis

    X.J80-J84.J81   Pulmonary edema

    XI.K20-K31.K25   Stomach ulcer

    XI.K20-K31.K26   Duodenal ulcer

    XI.K80-K87.K80   Gallstone disease [cholelithiasis]

    XI.K80-K87.K86.1   Other chronic pancreatitis

    XIII.M50-M54.M54.1   Radiculopathy

    XIII.M50-M54.M54.3   Sciatica

    XIII.M50-M54.M54.4   Lumbago with sciatica

    XIII.M70-M79.M79.2   Neuralgia and neuritis, unspecified

    XIV.N20-N23.N23   Renal colic, unspecified

    XIV.N40-N51.N41   Inflammatory diseases of the prostate

    XVIII.R10-R19.R10.4   Other and unspecified abdominal pain

    XVIII.R50-R69.R52.0   Acute pain

    XVIII.R50-R69.R52.2   Another constant pain

    XVIII.R50-R69.R57.0   Cardiogenic shock

    XIX.T08-T14   Injuries to the unspecified part of the trunk, limb or body region

    XIX.T20-T32   Thermal and chemical burns

    XXI.Z40-Z54.Z51.4   Preparatory procedures for subsequent treatment, not elsewhere classified

    Contraindications:

    Hypersensitivity, depression of the respiratory center; with epidural and spinal anesthesia: a clotting disorder (including anticoagulant therapy), infection (the 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 MAO inhibitors (including during the 21st day after their application).

    Carefully:

    Pain in abdomen of unclear etiology, surgical interventions on the gastrointestinal tract, urinary system; bronchial asthma, chronic obstructive pulmonary disease, convulsions, arrhythmias, arterial hypotension, chronic heart failure,respiratory insufficiency, hepatic and / or renal failure, myxedema, hypothyroidism, adrenal insufficiency, CNS depression, intracranial hypertension, head trauma, prostatic hyperplasia, suicidal tendencies, emotional lability, drug dependence (including in history), severe inflammatory bowel disease , urethral stricture, alcoholism, seriously ill, weakened patients, cachexia, pregnancy, breast-feeding, elderly and children.

    Pregnancy and lactation:

    Adequate and well-controlled studies in humans and animals have not been conducted. Use with caution in pregnancy and lactation.

    Category of recommendations FDA is not defined.

    Dosing and Administration:

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

    Adults: from 0.01 g to 0.04 g (from 1 ml of a 1% solution to 2 ml of a 2% solution). During anesthesia with fractional doses, the drug is administered intravenously to 0.003-0.01 g.

    Children from two years: 0.003-0.01 g, depending on age.

    For premedication, under the skin or intramuscularly, 0.02-0.03 g, together with atropine (0.0005 g) for 30-45 minutes before the operation, is administered before anesthesia.

    Anesthesia of childbirth: subcutaneously or intramuscularly at a dose of 0.02-0.04 g when the opening of the throat is 3-4 cm and with a satisfactory fetal condition. The last dose of the drug is administered for 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 - 0.04 g, daily - 0.16 g.

    Side effects:

    From the side gastrointestinal tract: constipation, nausea, vomiting, dry mouth, anorexia, spasm of bile ducts; with inflammatory bowel diseases - paralytic intestinal obstruction and toxic megacolon; jaundice.

    From the side nervous system and sense organs: dizziness, headache, blurred vision, diplopia, tremor, involuntary muscle contraction, convulsions, weakness, drowsiness, confusion, disorientation, euphoria, nightmarish or unusual dreams, hallucinations, depression, paradoxical agitation, restlessness, rigidity of muscles (especially respiratory) , ringing in the ears, slowing the speed of psychomotor reactions.

    From the side respiratory system: depression of the respiratory center.

    From the side of cardio-vascular system: decrease or increase of arterial pressure, arrhythmia.

    From the side urinary system: decreased urine output, urine retention.

    Allergic reactions: bronchospasm, laryngospasm, angioedema, skin rash, skin itch, face swelling.

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

    Other: increased sweating, addiction, drug dependence.

    Overdose:

    Symptoms acute and chronic overdose: cold sticky sweat, confusion, dizziness, drowsiness, decreased blood pressure, nervousness, fatigue, miosis, bradycardia, severe weakness, slow labored breathing, hypothermia, anxiety, dry mouth, delirious psychosis, intracranial hypertension (up to disorders of cerebral circulation), hallucinations, muscle rigidity, convulsions, in severe cases - loss of consciousness, respiratory arrest, coma.

    Treatment: gastric lavage, recovery of respiration and maintenance of cardiac activity and blood pressure; intravenous injection of a specific antagonist opioid analgesics - naloxone in a single dose of 0.2-0.4 mg with repeated administration 2-3 minutes before the total dose of 10 mg; the initial dose of naloxone for children is 0.01 mg / kg.

    Interaction:

    Alcohol, drugs that depress the central nervous system - potentiation of oppressive effects on the central nervous system, including the respiratory center.

    Anticholinergics, antidiarrheals - the risk of severe constipation and acute retention of urine.

    Antihypertensive drugs, especially ganglion blockers and diuretics - potentiation of the hypotensive effect.

    Buprenorphine - a decrease in the therapeutic effect of other μ-receptor agonists, including a reduction in respiratory depression, the emergence of withdrawal syndrome in dependent individuals.

    Other drugs that cause drug dependence are an increased risk of developing drug dependence.

    Zidovudine - morphine competitively inhibits biotransformation in the liver of zidovudine, combined use increases the toxicity of each drug.

    Metoclopramide - decreased prokinetic activity of metoclopramide.

    Miorelaxants - potentiation of respiratory depression.

    Naltrexone, naloxone, nalorfin - antidotes of narcotic analgesics, eliminate all their pharmacological effects, including cause withdrawal syndrome in patients with drug dependence to them.

    Narcotic analgesics - mutual potentiation of effects.

    Phenotiazine neuroleptics - some increase, and some reduce the effect of morphine.

    Special instructions:

    Synthetic narcotic analgesic, piperidine derivative. 2-4 times weaker than morphine.

    The drug is necessary Store in a dark place out of the reach of children at a temperature not exceeding 15 ° C.

    List II "List of narcotic drugs, psychotropic substances and their precursors".

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