Promedolum

Промедол Drug photo

The description is actual on 18.12.2014

  • Latin name: Promedolum
  • ATH code: N01AH
  • Active ingredient: Trimeperidine (Trimeperidine)
  • Producer: GOSZMP, federal state unitary enterprise (Russia)

Structure

1 tablet includes 25 mg of trimeperidine.

1 ml of injection solution includes 10 mg or 20 mg of trimeperidine.

Release form

The drug Promedolum is issued in the form of tablets on 10 or 20 pieces in packaging, and also in the form of 1% or 2% of injection solution in ampoules on 5, 10, 100, 150, 200, 250 or 500 pieces in packaging.

Pharmacological action

Anesthetic, antishock, spasmolytic, uterotoniziruyushchy, somnolent.

 

Pharmacodynamics and pharmacokinetics

The drug Promedolum belongs to pharmacological group of narcotic (opioid) analgetics, with the main anesthetizing action. Active agent of Promedolum on classification of MNN – trimeperidine, shows agonistic impact on opioid receptors. Activates the endogenous anesthetizing (anti-nociceptive) system, thereby breaking, at the TsNS different levels, transportation of painful impulses between neurons. Trimeperidine also exerts impact on the highest departments of a brain, modifying emotional coloring of a pain syndrome.

Pharmacological effects of Promedolum are similar to effects of Morphine and are expressed by increase of a pain threshold at symptoms of pain of various origin, braking of conditioned reflexes, and also slight somnolent influence. Suppression of a respiratory center, at use of Promedolum, is shown to a lesser extent, in comparison with Morphine. Drug leads to such symptoms less often as nausea and vomiting, strengthens sokratitelny function and a tone of a myometrium a little, possesses spasmolytic efficiency of moderate character in relation to ureters and bronchial tubes, and  also spazmogenny action, conceding to effect of Morphine, in relation to intestines and zhelchevyvodyashchy ways.

Development of analgeziruyushchy action of Promedolum, at its parenteral administration, is observed in 10-20 minutes, quickly accrues and reaches the maximum value in 40 minutes. High analgesic effects proceed for 2-4 hours, when carrying out epidural anesthesia — it is more than 8 hours.

Oral administration provides analgeziruyushchy effect of drug which is 1,5-2 times less, than at introduction parenterally.

At any way of delivery of trimeperidine in an organism, its absorption proceeds quickly enough. TCmax at reception is orally observed in 60-120 minutes. At introduction intravenously, the content of trimeperidine in plasma quickly decreases and in 2 hours only its trace concentration are found.

Trimeperidine contacts proteins of plasma for 40%. The main metabolism passes in a liver by means of process of hydrolysis with release of normeperidinovy and meperidinovy acids and further conjugation. T1/2 borrows from 2,4th to 4 hours, at insufficiency of kidneys increases a little.

It is excreted by kidneys in small amounts, including in not changed view of 5%.

Indications to use

Stopping of a pain syndrome of average and strong intensity at:

  • pains after the carried-out operative measure;
  • pains at oncological patients;
  • myocardial infarction;
  • unstable stenocardia;
  • to the stratified  aortic aneurysm;
  • to fibrinferment of a renal artery;
  • acute pericardis;
  • thromboembolisms of a pulmonary artery and arteries of extremities;
  • air embolism;
  • acute pleurisy;
  • lung heart attack;
  • spontaneous pheumothorax;
  • perforation of a gullet;
  • peptic ulcer;
  • chronic pancreatitis;
  • paranephritis;
  • acute dysuria;
  • to renal and hepatic colic;
  • paraphimosis;
  • bad attack of glaucoma;
  • priapism;
  • acute prostatitis;
  • lumbosacral radiculitis;
  • kauzalgiya;
  • acute vesiculitis;
  • thalamic syndrome;
  • acute neuritis;
  • injuries and burns;
  • protrusions of an intervertebral disk;
  • foreign bodys in an urethra, a rectum, a bladder.

Promedolum is appointed in obstetric practice for the purpose of a labor pain relief and as an easy stimulator of patrimonial activity.

In surgical practice drug is shown at premedication and as a part of the general anesthesia as an analgetic component (for example, carrying out a neuroleptanalgesia in a complex with neuroleptics).

The fluid lungs, acute left ventricular failure and cardiogenic shock, are also among indications to use of Promedolum.

Contraindications

Absolute contraindications to reception of Promedolum are:

  • hypersensitivity of the patient to trimeperidine;
  • age till 2 years;
  • painful states at which respiratory depression is observed;
  • in parallel the carried-out therapy using MAO inhibitors, and also time till 21 days after their cancellation.

Also there is a number of relative contraindications at which use of Promedolum is possible only with extra care, it:

Side effects

TSNS:

Bodies of a gastrointestinal tract:

  • lock;
  • dryness in an oral cavity;
  • nausea;
  • anorexia;
  • vomiting;
  • spasm of zhelchevyvodyashchy ways;
  • toxic megacolon, paralytic intestinal impassability, jaundice (at diseases of intestines of the inflammatory nature).

Respiratory system:

  • suppression of a respiratory center.

Cardiovascular system:

Urinary system:

Allergic manifestations:

Local reactions:

  • burning sensation in the place of an injection;
  • hypostasis;
  • hyperemia.

Others:

  • the increased sweating;
  • development of medicinal dependence, accustoming.

Promedolum, application instruction

The application instruction of Promedolum assumes its delivery in the patient's organism by means of intramuscular (in oil), hypodermic (p / to) and in urgent situations intravenous (in/in) injections in the form of solution, and internal (peroral) reception in the form of tablets.

For stopping of a pain syndrome a pill is recommended to take orally, to adult patients, in doses for 25 mg to 50 mg. The maximum daily dose of Promedolum in tablets equals – 50 mg.

The adult in oil and p / to, as a rule, appoint from 10 mg to 40 mg of Promedolum (from the 1st ampoule of 1% of solution up to 2 ampoules of 2% of solution).

When carrying out an anesthesia recommend in/in introduction by fractional doses, depending on a situation, 3-10 mg.

At a pain syndrome, provoked by spasms of smooth muscles (intestinal, renal, hepatic gripes), appoint Promedolum in a combination with spasmolytic and atropinopodobny drugs, under careful control of a condition of the patient.

For the purpose of premedication, and 30-40 minutes before an operative measure, enter in oil or p / to on 20-30 mg in combination with 0,5 mg of Atropine.

Promedolum at childbirth is appointed for anesthesia and stimulation of patrimonial activity. Injections carry out in oil or p / to in doses of 20-40 mg, at a positive assessment a condition of a fruit and disclosure of a neck of uterus on 3-4 cm. Promedolum promotes a relaxation of muscles of a neck of uterus, thereby accelerating process of its disclosure. The last injection has to be made in 30-60 minutes prior to expected delivery, in order to avoid negative effects at the childbirth connected with suppression of breath of a fruit.

The maximum dose of parenteral administration for adult patients equals 40 mg, and the maximum daily 160 mg.

The nursery, is more senior than 2 years, the dose of Promedolum makes from 0,1 to 0,5 mg/kg, with p / to, in oil and is rare in/in introduction. Repeated injections, for the purpose of stopping of pain, can be carried out in 4-6 hours.

When carrying out the general anesthesia, as its component, Promedolum is entered in/in on 0,5 - 2,0 mg/kg/h. The maximum dose, throughout all time of carrying out operation, has to be no more than 2 mg/kg/h.

Infusionally recommend to enter 10-50 mkg/kg/h.

Epidural anesthesia is carried out in a dose of 0,1 - 0,15 mg/kg, previously divorced Promedolum to 2-4 ml of sodium of chloride for injections. The beginning of effect of procedure is observed in 15-20 minutes, the peak of action comes approximately in 40 minutes, with gradual decrease in efficiency for 8 and more hours.

Overdose

At overdose Promedolum, the main negative effect is oppression of consciousness and suppression of breath, up to a coma . Also various strengthened collateral manifestations can be observed. The miosis (narrowing of pupils) can be a characteristic sign of diagnosing of overdose.

Carrying out lung ventilation and its further support, and also in/in introduction of an antidote Naloxonum and the subsequent symptomatic therapy is recommended.

Interaction

During parallel use of Promedolum with somnolent and sedative drugs, anxiolytics, neuroleptics, muscle relaxants, ethanol, means of the general anesthesia and other narcotic analgetics, suppression of TsNS and breath amplifies.

At systematic reception of barbiturates, in particular Phenobarbital, observed lowering of the anesthetizing effect of trimeperidine.

Promedolum can increase efficiency of hypotensive drugs (diuretics, ganglioblokator, etc.).

Antidiarrheal and anticholinergics can lead to an ischuria, heavy locks, intestinal impassability.

Trimeperidine strengthens effects of medicines with anticoagulating activity, in communication by what, at their combined use control of a prothrombin of plasma is necessary.

The therapy using buprenorphine which is present at present or carried out earlier lowers action of Promedolum.

The combined treatment with MAO inhibitors can cause the serious consequences connected with braking or overexcitation of TsNS and to lead to development of hypotensive or hypertensive crises.

Effects of Metoclopramidum go down at its joint reception with Promedolum.

Naloxonum, being a trimeperidine antidote, eliminates its side effects: suppression breath, analgesia, oppression of TsNS. At drug addiction accelerates development of symptomatology of "a withdrawal ".

Naltrexone also influences acceleration of symptomatology of "withdrawal" at narcotic accustoming. After administration of medicine, resistant and difficult removable symptoms are shown quickly enough, sometimes in 5 minutes, and observed for 2 days.

Terms of sale

Correctly completed recipe of Promedolum in Latin, on the form established by rules, with all applied requisites and the seals is necessary for acquisition of this drug.

Storage conditions

Both injection solution, and tablets of Promedolum belong to the list A. Temperature of storage of drug of 8-15 °C.

Period of validity

For tablets and solution – 5 years.

Special instructions

During therapy by Promedolum it is better to abstain from delicate and dangerous works, and also from driving of the car.

At systematic use of Promedolum dependence similar to narcotic can develop.

To children

It is appointed to children after 2 years, it is strict according to indications, in precisely recommended doses, with extra care and under supervision of the doctor.

Section: Anesthetics
in more detail

Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

PAY ATTENTION! Information on drugs on the website is help generalizing, collected from public sources and can form the basis for making decision on use of medicines it is not aware of treatment. Before medicine use Promedolum surely consult with the attending physician.