Promedol side effects. Promedol injection solution

It is important to follow the instructions for using the drug Promedol literally, since this drug belongs to opioid analgesics (narcotic painkillers) and any violation in the established order of use can lead to serious health consequences.
The international non-proprietary name of the drug is Trimeperidine (Trimeperidine). In Latin, the medicine is called "Promedolum"

Release form

1. Tablets, white, embossed in the form of the letter "P". One blister contains 10 tablets, the package includes one or two blisters
2. Promedol for injection in the form of ampoules with a solution. Ampoules contain 1 ml of solution, the package can contain from 5 to 10 ampoules
3. Syringes that also contain 1 ml of solution

Compound

Tablets

1. Active ingredient - Promedol (Trimeperidine hydrochloride) - 25 mg
2. Potato starch
3. Stearic acid
4. Sugar

Solution

• Current infectious diseases (high risk of infection spreading through the central nervous system)
• Slowing down the elimination of toxins from the body, and, as a result of this condition, acute and prolonged diarrhea
• Diarrhea that occurred against the background of pseudomembranous colitis, which was caused by taking drugs from the penicillin, cephalosporin, lincosamide groups
• Poor blood clotting (including if the disease occurred after anticoagulant therapy for spinal or epidural anesthesia)
• Taking monoamine oxidase inhibitors and the 21-day period after stopping these drugs
• Children's age up to 2 years

Relative contraindications (with caution)

• Hypothyroidism
• Myxedema
• Renal or liver failure
• Depression of the central nervous system
• Traumatic brain injury with psychosis
• Respiratory failure
• Urethral stricture
• prostate dysplasia
• Adrenal insufficiency
• Elderly age
• Alcoholism
• Suicidal tendencies
• convulsions
• Severe emotional lability
• Traumatic brain injury
• Drug addiction (including history)
• Severe inflammatory bowel disease
• Arrhythmia
• Arterial hypotension
• Bronchial asthma and chronic obstructive pulmonary disease
• Surgical interventions on the organs of the urinary system and gastrointestinal tract
• Chronic heart failure
• Weakened condition of a sick person
• Promedol should also be prescribed with caution during pregnancy and lactation.

Side effects

Nervous system:

1. Drowsiness
2. Weakness
3. Vertigo
4. Headache
5. Diplopia
6. Blurred vision
7. Nightmares
8. unusual dreams
9. restless sleep
10. Nervousness
11. Fatigue
12. General discomfort
13. Tremor
14. convulsions
15. Involuntary muscle twitches
16. Depression
17. hallucinations
18. Confusion euphoria
19. Disorientation
20. Deceleration of psychomotor reactions
21. Rigidity of the respiratory muscles
22. Tinnitus

Digestive system:

1. Irritation of the gastrointestinal tract
2. Nausea
3. Vomit
4. Constipation
5. Spasms of the bile ducts
6. Dryness of the oral mucosa
7. Anorexia
8. Toxic megacolon
9. Paralytic ileus
10. Hepatoxicity

The cardiovascular system:

1. Decreased blood pressure (rarely increased blood pressure)
2. Arrhythmia

Urinary system:

1. Spasm of the ureters (pain when urinating, frequent urination)
2. Decrease in the total amount of urine

Respiratory system:

1. Respiratory center depression
2. Apnea

Allergic and local reactions:

1. Angioedema
2. Bronchospasm
3. laryngospasm
4. swelling of the face
5. Rash on the skin
6. Redness, burning and swelling at the injection site

Others:

1. Drug addiction (addiction)
2. Increased sweating

Important! During treatment, it is necessary to abandon the use of alcoholic beverages, the performance of hazardous types of work and driving.

Instructions for use

Tablets

• The maximum daily dose of Promedol tablets is 200 mg (8 tablets)
• The maximum single dose is 50 mg (2 tablets)
• Depending on the diagnosis, take 1-2 tablets 3-4 times a day
• If the pain, for the relief of which the use of the drug is indicated, arose due to a spasm of smooth muscles, the drug is combined with antispasmodics and atropine-like drugs.

Solution

Instructions for using Promedol in ampoules look like this:

• The solution in ampoules is administered intramuscularly and intravenously, in syringe tubes - intramuscularly and subcutaneously
• Depending on the diagnosis, adults are prescribed 10-40 mg of medication (0.5-2 ml of solution)
• For premedication, the solution is administered intramuscularly or subcutaneously 35-40 minutes before surgery. 20-30 mg of the active ingredient are combined with 0.5 mg of Atropine
• If Promedol is used for anesthesia, the drug is administered in fractional doses of 3-10 mg.
• Permissible single dose of solution - 40 mg, daily dose - 160 mg

children

Promedol is prescribed for children from two years, 3-10 mg, depending on the age of the child.

At childbirth

Promedol during childbirth is used to relieve pain and to stimulate labor. In this case, the drug is administered intramuscularly or subcutaneously, in a volume of 20-40 mg. A number of prerequisites for the use of the drug in this case: the normal state of the fetus, the opening of the uterus by 3-4 centimeters, the introduction of the last dose no later than 60 minutes before delivery.

Overdose

Symptoms:

1. Dizziness
2. Lowering blood pressure
3. Confusion
4. Headache
5. Cold clammy sweat
6. Nervousness
7. Fatigue
8. Nausea
9. Vomit
10. Drowsiness
11. Sharp weakness
12. Decrease in body temperature
13. Labored breathing
14. convulsions
15. hypoventilation
16. Cardiovascular insufficiency
17. In severe cases - respiratory arrest, loss of consciousness, coma

Treatment:

• Artificial lung ventilation
• Symptomatic therapy
• Use of the opioid antagonist Nolaxone (0.4-2 mg intravenously for adults, 0.01 mg per kg for children)

Producer: RUE "Belmedpreparaty" Republic of Belarus

ATC code: N02AB

Farm group:

Release form: Liquid dosage forms. Injection.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Get to know the treatment

Dosage and administration:

Application Features:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Leave conditions:

On prescription

Package:

Solution for injections 20 mg/ml in ampoules 1 ml No. 5x2.

Gross formula

Pharmacological group of the substance Trimeperidine

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Trimeperidine

White crystalline powder. Easily soluble in water, soluble in alcohol. Aqueous solutions have a pH of 4.5-6.

Pharmacology

Stimulates opioid receptors in the CNS. With the on / in the introduction of C max (9 μg / ml) is achieved after 15 minutes, then there is a rapid decrease in plasma levels and after 2 hours only trace concentrations are determined. Compared to morphine, it has a weaker and shorter analgesic effect, has less effect on the respiratory, emetic and vagal centers, does not cause smooth muscle spasm (except for the myometrium), and has a moderate antispasmodic and hypnotic effect. With s / c and / m administration, the action begins after 10-20 minutes and lasts 3-4 hours or more; oral administration causes an analgesic effect 1.5-2 times weaker than injection of a similar dose.

Application of the substance Trimeperidine

Severe pain syndrome (unstable angina pectoris, myocardial infarction, dissecting aortic aneurysm, renal artery thrombosis, thromboembolism of the arteries of the limbs and pulmonary artery, acute pericarditis, air embolism, pulmonary infarction, acute pleurisy, spontaneous pneumothorax, peptic ulcer of the stomach and duodenum, perforation of the esophagus, chronic pancreatitis, hepatic and renal colic, paranephritis, acute dysuria, foreign bodies of the bladder, rectum, urethra, paraphimosis, priapism, acute prostatitis, acute attack of glaucoma, causalgia, acute neuritis, sciatica, acute vesiculitis, thalamic syndrome, burns, injuries, protrusion of the intervertebral disc, malignant neoplasms, postoperative period), acute left ventricular failure, pulmonary edema, cardiogenic shock, preparation for surgery (premedication), childbirth (pain relief and stimulation), high fever, post-transfusion complications, poisoning with atropine, barbiturates, barium gasoline, boric acid, strong acids, carbon monoxide, turpentine, formalin, snake bites, karakurt.

Contraindications

Respiratory failure, general exhaustion, early childhood (up to 2 years) and old age.

Side effects of Trimeperidine

Nausea, vomiting, weakness, dizziness, depression of the respiratory center, addiction, physical dependence.

Promedol is a drug with an analgesic effect, the so-called opioid receptor agonist.

What is the composition and form of release of Promedol?

The drug Promedol is produced in a 1% injection solution, where the active compound is represented by trimeperidine in an amount of 10 mg. The pharmaceutical product is sold in ampoules of 1 milliliter, which are packed in plastic boxes.

In addition, the opioid analgesic Promedol is available in a 2% solution, where the active compound is also trimeperidine at a dosage of 20 milligrams. The drug is sold by prescription. It should be stored in a dark place. The shelf life of the ampoules is five years, after which the medication becomes unusable.

What is the action of Promedol?

Promedol activates the endogenous so-called antinociceptive system, thereby disrupting the transmission of pain impulses between neurons at different levels of the central nervous system, in addition, the drug changes the emotional coloring of pain, acting on the higher brain regions.

In terms of its properties, trimeperidine is close to morphine, it significantly increases the threshold of pain sensitivity, inhibits conditioned reflexes in a person, in addition, it has a hypnotic effect, rarely provokes nausea and vomiting, and also during childbirth helps to open the cervix, increases the tone of the myometrium.

With parenteral administration of Promedol, the analgesic effect occurs after 10 minutes, reaching its maximum after forty minutes, the duration of the effect is 4 hours. Communication with proteins - 40%. The drug is metabolized by hydrolysis followed by conjugation. Excreted by the kidneys.

What are the indications for use of Promedol?

Promedol solution instructions for use allows the use for medicinal purposes in pain syndrome in various conditions, some of which I will list: unstable angina pectoris, acute pericarditis, myocardial infarction, symptoms of aortic aneurysm, arterial thromboembolism, air embolism, sciatica, acute pleurisy, perforation of the esophagus, spontaneous pneumothorax, chronic pancreatitis, peptic ulcer, paranephritis, dysuria, paraphimosis, burns, priapism, prostatitis, various colic, glaucoma attack, acute neuritis, thalamic syndrome, oncological diseases, in addition, injuries and other diseases.

In addition, Promedol is prescribed for labor pain relief, the drug is used in the preoperative and postoperative periods, as well as for the implementation of neuroleptanalgesia in conjunction with the use of neuroleptics.

What are the contraindications for Promedol?

The drug Promedol (solution) instructions for use does not allow the use for medicinal purposes in the following cases:

Hypersensitivity to the components of the drug;
When the respiratory function is depressed, the solution is not used;
Until the age of two.

Promedol is used with caution in such situations: hepatic, adrenal, renal and heart failure, convulsions, traumatic brain injury, alcoholism, myxedema, hypothyroidism, cachexia, bronchial asthma, symptoms of CNS depression, pregnancy, obstructive pulmonary disease, arrhythmia, myxedema, arterial hypotension, drug addiction, suicidal tendencies, intracranial hypertension, emotional lability, in addition, debilitated patients, lactation, old age.

What are the uses and dosages of Promedol?

Promedol solution is used parenterally: subcutaneously, intravenously, intramuscularly. Usually, adults are prescribed from 0.01 g to 0.04 g. For premedication, before anesthesia, 0.02-0.03 grams of the drug is injected subcutaneously together with atropine.

Anesthesia of childbirth involves the appointment of 0.02 to 0.04 grams of the pharmaceutical preparation with the opening of the throat by three centimeters and with a satisfactory condition of the fetus. The highest daily dose for adults is 0.16 grams.

Promedol - drug overdose

Symptoms of an overdose of Promedol: miosis, depression of consciousness occurs up to the development of coma. The patient is shown symptomatic treatment.

What are the side effects of Promedol?

The introduction of the pharmaceutical Promedol causes such side effects: constipation, respiratory depression, nausea, vomiting, a change in blood pressure, increased dryness in the mouth, arrhythmia, anorexia, decreased diuresis, laryngospasm, in addition, spasm of the biliary tract, itching, is not excluded urinary retention, paralytic intestinal obstruction, as well as bronchospasm, jaundice.

Among other adverse reactions, one can note: angioedema, increased sweating is characteristic, dizziness is possible, drug dependence develops, in addition, headache, convulsions, decreased visual acuity, weakness, diplopia, tremor, drowsiness, there may be involuntary muscle contractions, confusion, symptoms of disorientation, depression, and euphoria.

Other side effects: anxiety, nightmares are characteristic, ringing in the ears in the head is noted, hallucinations are observed, paradoxical excitement is noted, as well as muscle rigidity, psychomotor reactions may be slowed down. In addition, local reactions in the form of skin hyperemia, swelling, and burning sensation are not excluded.

special instructions

During the period of treatment with Promedol, the patient should stop drinking alcohol and refrain from driving vehicles.

How to replace Promedol, what analogs to use?

Trimeperidine (instructions for using the drug before using it should be studied personally from the official annotation included in the package!).

Conclusion

Promedol should be used strictly according to indications.

N.01.A.H Opioid analgesics

From the side digestive system: more often - constipation, nausea and / or vomiting; less often - dryness of the oral mucosa, anorexia, spasm of the biliary tract, irritation of the gastrointestinal tract; rarely - in inflammatory bowel diseases - paralytic ileus and toxic megacolon (constipation, flatulence, nausea, stomach cramps, gastralgia, vomiting); the frequency is unknown - hepatotoxicity (dark urine, pale stools, hysteria of the sclera and skin).

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

Sosidesrespiratory system: less often - depression of the respiratory center.

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

Sosidesurinary system: less often - decrease in diuresis; spasm of the ureters (difficulty and pain when urinating, frequent urge to urinate).

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

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

Others: less often - increased sweating; frequency unknown - addiction, drug dependence.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not indicated in the instructions, tell your doctor about it.

Treatment: maintaining adequate pulmonary ventilation, symptomatic therapy. Intravenous administration of the specific opioid antagonist "naloxone at a dose of 0.4-2 mg quickly restores breathing. If there is no effect, the administration of naloxone is repeated after 2-3 minutes. The initial dose of naloxone for children is 0.01 mg / kg.