Composition, form of production and packaging
Solution for injection 1% 1 ml
trimiperidine 10 mg
1 ml - ampoules (5) - contour plastic packaging (1) - cardboard packs.
1 ml - ampoules (5) - plastic contoured packages (2) / with a knife. Ampoules or a scarf. on - is necessary. / - packs cardboard.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (20) / with a knife or a scab. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (30) / with a knife or a scab. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (40) / with a knife or a scribe. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (50) / with a knife. Ampoules or a scarf. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (100) / with a knife. Ampoules or a scarf. as needed. / - cardboard boxes.
Solution for injection 2% 1 ml
trimeperidine 20 mg
1 ml - ampoules (5) - contour plastic packaging (1) - cardboard packs.
1 ml - ampoules (5) - plastic contoured packages (2) / with a knife. Ampoules or a scarf. on - is necessary. / - packs cardboard.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (20) / with a knife. Ampoules or a scarf. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (30) / with a knife or a scab. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (40) / with a knife or a scribe. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (50) / with a knife. Ampoules or a scarf. as needed. / - cardboard boxes.
1 ml - ampoules (5) (for hospitals) - plastic contoured packages (100) / with a knife. Ampoules or a scarf. as needed. / - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Promedol refers to agonists of opioid receptors (mainly mu-receptors). Activates the endogenous antinociceptive system and thus disrupts the interneuronal transmission of pain impulses at various levels of the central nervous system, and also changes the emotional color of the pain, affecting the higher parts of the brain.According to its pharmacological properties, trimeperidine is close to morphine: it increases the threshold of pain sensitivity with pain stimuli of different modalities, inhibits 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 action develops in 10-20 minutes, reaches a maximum after 40 minutes and lasts for 2-4 hours.
PHARMACOKINETICS
Connection with plasma proteins - 40%. Metabolized by hydrolysis with the formation of meperidine and normeperidic acids followed by conjugation. In small amounts it is excreted by the kidneys 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 gullet, perforation of the esophagus, chronic pancreatitis, paranephritis, acute dysuria, paraphimosis, priapism, acute prostatitis, acute attack of glaucoma, causalgia, acute neuritis, lumbosacral sciatica t, acute vesiculitis, thalamic syndrome, burns, oncological diseases, traumas, protrusion of the intervertebral disc, foreign bodies of the bladder, rectum, urethra).
In combination with atropinopodobnymi and antispasmodics with pain caused by a spasm of smooth muscles of the internal organs (hepatic, renal, intestinal colic).
Acute left ventricular failure, pulmonary edema, cardiogenic shock.
Preoperative, operating and postoperative periods.
Childbirth (anesthesia and stimulation).
Neuroleptanalgesia (in combination with neuroleptics).
DOSING MODE
A / c, in / m or in / in (only s / to and in / m for a preparation 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 iv in 0.003-0.01 g.
Children from two years: 0.003-0.01 g, depending on the age.
For premedication, before the anesthesia is injected under the skin or in / m 0.02-0.03 g together with atropine (0.0005 g) for 30-45 minutes before the operation.
Anesthesia of labor: SC or IM in a dose of 0.02-0.04 g with the opening of the pharynx 3-4 cm and with a satisfactory condition of the fetus. 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 EFFECT
From the gastrointestinal tract: constipation, nausea, vomiting, dry mouth, anorexia, biliary tract spasm; with inflammatory bowel diseases - paralytic intestinal obstruction and toxic megacolon; jaundice.
From the side of the nervous system and sensory organs: dizziness, headache, blurred vision, diplopia, tremor, involuntary muscle contractions, convulsions, weakness, drowsiness, confusion, disorientation, euphoria, nightmarish or unusual dreams, hallucinations, depression, paradoxical agitation, anxiety, rigidity of muscles (especially respiratory), ringing in the ears, slowing the speed of psychomotor reactions.
On the part of the respiratory system: depression of the respiratory center.
From the cardiovascular system: a decrease or increase in blood pressure, arrhythmia.
From the side of the 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.
CONTRAINDICATIONS
Hypersensitivity; conditions accompanied by respiratory depression; simultaneous treatment with MAO inhibitors and within 3 weeks after their cancellation; children's age up to 2 years.
With caution: respiratory failure, hepatic and / or renal insufficiency, adrenal insufficiency, chronic heart failure, central nervous system depression, craniocerebral trauma, intracranial hypertension, myxedema, hypothyroidism, prostatic hyperplasia, urethral stricture, surgical interventions on the gastrointestinal tract, gastrointestinal tract or urinary system, bronchial asthma, chronic obstructive pulmonary disease, convulsions, arrhythmia, hypotension suicidal tendencies, emotional lability, alcoholism, drug dependence (including in the anamnesis), expressed inflammatory bowel diseases, weakened patients, cachexia, pregnancy, lactation, children's age, advanced age.
PREGNANCY AND LACTATION
Use with caution in pregnancy, during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution: kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution: liver failure.
APPLICATION FOR CHILDREN
Contraindicated in childhood up to 2 years. Use with caution in children older than 2 years.
APPLICATION IN ELDERLY PATIENTS
Use with caution in old age.
SPECIAL INSTRUCTIONS
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. Do not use ethanol.
OVERDOSE
Symptoms: miosis, depression of consciousness (up to coma), increased severity of side effects.
Treatment: maintenance of adequate pulmonary ventilation, symptomatic therapy. In / in the introduction of a specific opioid antagonist naloxone in a dose of 0.4-2 mg quickly restores breathing. If there is no effect after 2-3 min, the administration of naloxone is repeated. The initial dose of naloxone for children is 0.01 mg / kg.
DRUG 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, a decrease in analgesic effect is possible.
Strengthens the hypotensive effect of drugs that reduce blood pressure (including ganglioblocators, diuretics).
Medicines with anticholinergic activity and antidiarrheal 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 the previous therapy) reduces the effectiveness of promedol. When used simultaneously with MAO 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 breathing, eliminates analgesia and reduces central nervous system depression caused by taking Promedol. 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 can appear only 5 minutes after drug administration, continue for 48 hours, are characterized by persistence and difficulty of their elimination); reduces the effects of promedol; does not affect the symptoms caused by the histamine reaction.
Reduces the effect of metoclopramide.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription. The maximum allowable amount of the drug prescribed for one prescription is 0.25 g.
TERMS AND CONDITIONS OF STORAGE
List II "List of narcotic drugs, psychotropic substances and their precursors".
The drug should be stored in a place out of the reach of children at a temperature of no higher than 15 В° C.
Shelf life: ampoules - 5 years, syringe-tubes - 3 years. Do not use after the expiration date indicated on the package.
