Promedol (Tablets, Solution) Instructions for Use
ATC Code
N01AH (Opioid analgesics)
Active Substance
Trimeperidine (Rec.INN registered by WHO)
Clinical-Pharmacological Group
Pure opioid receptor agonist. Analgesic
Pharmacotherapeutic Group
Narcotic analgesic agent
Pharmacological Action
Promedol belongs to opioid receptor agonists (primarily mu-receptors).
It activates the endogenous antinociceptive system and thus disrupts the interneural transmission of pain impulses at various levels of the central nervous system, and also changes the emotional coloring of pain by affecting the higher parts of the brain.
In its pharmacological properties, Trimeperidine is similar to morphine: it increases the pain threshold for pain stimuli of various modalities, inhibits conditioned reflexes, and has a moderate hypnotic effect.
Unlike morphine, it depresses the respiratory center to a lesser extent and less frequently causes nausea and vomiting.
It has a moderate antispasmodic and uterotonic effect.
It promotes cervical dilation during childbirth and increases the tone and contractile activity of the myometrium.
When administered parenterally, the analgesic effect develops within 10-20 minutes, reaches a maximum after 40 minutes, and lasts for 2-4 hours.
Pharmacokinetics
Plasma protein binding – 40%.
It is metabolized by hydrolysis to form meperidinic and normeperidinic acids with subsequent conjugation.
It is excreted in small amounts by the kidneys unchanged.
Indications
Moderate to severe intensity pain syndrome (unstable angina, myocardial infarction, dissecting aortic aneurysm, renal artery thrombosis, thromboembolism of limb arteries or pulmonary artery, acute pericarditis, air embolism, lung infarction, acute pleurisy, spontaneous pneumothorax, gastric and duodenal ulcer, esophageal perforation, chronic pancreatitis, paranephritis, acute dysuria, paraphimosis, priapism, acute prostatitis, acute attack of glaucoma, causalgia, acute neuritis, lumbosacral radiculitis, acute vesiculitis, thalamic syndrome, burns, oncological diseases, trauma, intervertebral disc protrusion; foreign bodies of the bladder, rectum, urethra).
In combination with atropine-like and antispasmodic agents for pain caused by spasm of the smooth muscles of internal organs (hepatic, renal, intestinal colic).
Acute left ventricular failure, pulmonary edema, cardiogenic shock.
Preoperative, operative, and postoperative periods.
Childbirth (analgesia and stimulation).
Neuroleptanalgesia (in combination with neuroleptics).
ICD codes
| ICD-10 code | Indication |
| H40 | Glaucoma |
| I20.0 | Unstable angina |
| I21 | Acute myocardial infarction |
| I26 | Pulmonary embolism |
| I30 | Acute pericarditis |
| I50.1 | Left ventricular failure |
| J81 | Pulmonary edema |
| K25 | Gastric ulcer |
| K26 | Duodenal ulcer |
| K80 | Cholelithiasis [cholelithiasis] (including biliary colic) |
| K86.1 | Other chronic pancreatitis |
| M54.1 | Radiculopathy |
| M54.3 | Sciatica |
| M54.4 | Lumbago with sciatica |
| M79.2 | Neuralgia and neuritis, unspecified |
| N23 | Unspecified renal colic |
| N41 | Inflammatory diseases of prostate |
| R10.4 | Other and unspecified abdominal pain (colic) |
| R52.0 | Acute pain |
| R52.2 | Other chronic pain |
| R57.0 | Cardiogenic shock |
| T14 | Injuries to unspecified parts of body |
| T30 | Burns and corrosions of unspecified body region |
| Z51.4 | Preparatory procedures for subsequent treatment or examination, not elsewhere classified |
| ICD-11 code | Indication |
| 8B93.Z | Radiculopathy, unspecified |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| 9C61.Z | Glaucoma, unspecified |
| 9C6Z | Glaucoma or suspected glaucoma, unspecified |
| BA40.0 | Unstable angina |
| BA41.Z | Acute myocardial infarction, unspecified |
| BB00.Z | Thromboembolism in the pulmonary artery system, unspecified |
| BB20.Z | Acute pericarditis, unspecified |
| BD11.Z | Left ventricular failure, unspecified |
| CB01 | Pulmonary edema |
| DA60.Z | Gastric ulcer, unspecified |
| DA63.Z | Duodenal ulcer, unspecified |
| DC11.Z | Cholelithiasis, unspecified |
| DC32.0 | Calcific pancreatitis |
| DC32.1 | Paraduodenal pancreatitis |
| DC32.2 | Hereditary chronic pancreatitis |
| DC32.4 | Chronic idiopathic pancreatitis |
| DC32.5 | Tropical pancreatitis |
| DC32.Z | Chronic pancreatitis, unspecified |
| DC33 | Autoimmune pancreatitis |
| DD93.1 | Infantile colic |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| GA91.Z | Inflammatory and other diseases of prostate, unspecified |
| MD81.4 | Other and unspecified abdominal pain |
| ME84.20 | Lumbago with sciatica |
| ME84.3 | Sciatica |
| MF56 | Renal colic |
| MG30.Z | Chronic pain syndrome, unspecified |
| MG31.Z | Acute pain, unspecified |
| MG40.0 | Cardiogenic shock |
| ND56.Z | Unspecified injury of unspecified part of trunk, limb or body region |
| NE11 | Burn of unspecified body region |
| QB9A | Preparatory procedures for subsequent treatment |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
SC, IM or IV (SC and IM only for the drug in syringe-tubes).
Adults from 0.01 g to 0.04 g (from 1 ml of 1% solution to 2 ml of 2% solution). During anesthesia, the drug is administered IV in fractional doses of 0.003-0.01 g.
Children from two years old 0.003-0.01 g depending on age.
For premedication before anesthesia, 0.02-0.03 g is administered subcutaneously or IM together with atropine (0.0005 g) 30-45 minutes before surgery.
Labor analgesia SC or IM in a dose of 0.02-0.04 g when the cervix is dilated by 3-4 cm and the fetus is in satisfactory condition. The last dose of the drug is administered 30-60 minutes before delivery to avoid narcotic depression of the fetus and newborn.
Maximum doses for adults single – 0.04 g, daily – 0.16 g.
Tablets
Used orally, SC, IM and IV. The dose, method and regimen of administration, duration of therapy are determined individually, depending on the indications, clinical situation, patient’s age, and the dosage form used.
Adverse Reactions
From the gastrointestinal tract: constipation, nausea, vomiting, dry mouth, anorexia, spasm of the biliary tract; in inflammatory bowel diseases – paralytic intestinal obstruction and toxic megacolon; jaundice.
From the nervous system and sensory organs: dizziness, headache, blurred vision, diplopia, tremor, involuntary muscle contractions, convulsions, weakness, drowsiness, confusion, disorientation, euphoria, nightmares or unusual dreams, hallucinations, depression, paradoxical agitation, anxiety, muscle rigidity (especially respiratory muscles), tinnitus, slowing of psychomotor reactions.
From the respiratory system: depression of the respiratory center.
From the cardiovascular system: decrease or increase in blood pressure, arrhythmia.
From the urinary system: decreased diuresis, urinary retention.
Allergic reactions: bronchospasm, laryngospasm, angioedema, skin rash, skin itching, facial edema.
Local reactions: hyperemia, edema, “burning” at the injection site.
Other: increased sweating, habituation, drug dependence.
Contraindications
Hypersensitivity; conditions accompanied by respiratory depression; simultaneous treatment with MAO inhibitors and for 3 weeks after their withdrawal; children under 2 years of age.
With caution: respiratory failure, hepatic and/or renal failure, adrenal insufficiency, chronic heart failure, depression of the central nervous system, traumatic brain injury, 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 tendency, emotional lability, alcoholism, drug dependence (including history), severe inflammatory bowel diseases, debilitated patients, cachexia, pregnancy, lactation period, children, elderly age.
Use in Pregnancy and Lactation
Use with caution during pregnancy and lactation.
Use in Hepatic Impairment
With caution: hepatic insufficiency.
Use in Renal Impairment
With caution: renal insufficiency.
Pediatric Use
Contraindicated in children under 2 years of age. Use with caution in children over 2 years of age.
Geriatric Use
Use with caution in the elderly.
Special Precautions
During treatment, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Consumption of ethanol is not allowed.
Overdose
Symptoms: miosis, depression of consciousness (up to coma), increased severity of side effects.
Treatment maintaining adequate pulmonary ventilation, symptomatic therapy. IV administration of the specific opioid antagonist naloxone at a dose of 0.4-2 mg quickly restores breathing. If there is no effect after 2-3 minutes, the administration of naloxone is repeated. The initial dose of naloxone for children is 0.01 mg/kg.
Drug Interactions
It enhances the depression of the central nervous system and respiration caused by the intake of other narcotic analgesics, sedatives, hypnotics, antipsychotic agents (neuroleptics), anxiolytics, drugs for general anesthesia, ethanol, muscle relaxants. Against the background of systematic use of barbiturates, especially phenobarbital, a decrease in the analgesic effect is possible.
It enhances the hypotensive effect of drugs that lower blood pressure (including ganglion blockers, diuretics).
Drugs with anticholinergic activity and antidiarrheal drugs (including loperamide) increase the risk of constipation (up to intestinal obstruction) and urinary retention.
It enhances the effect of anticoagulants (plasma prothrombin should be monitored).
Buprenorphine (including previous therapy) reduces the effectiveness of Promedol. With simultaneous use with MAO inhibitors, the development of severe reactions due to overexcitation or inhibition of the central nervous system with the occurrence of hyper- or hypotensive crises is possible.
Naloxone restores breathing, eliminates analgesia and reduces the depression of the central nervous system caused by the intake of Promedol. It may accelerate the onset of symptoms of “withdrawal syndrome” against the background of drug dependence.
Naltrexone accelerates the onset of symptoms of “withdrawal syndrome” against the background of drug dependence (symptoms may appear as early as 5 minutes after administration of the drug, last for 48 hours, are characterized by persistence and difficulty in their elimination); reduces the effects of Promedol; does not affect symptoms caused by a histamine reaction.
Reduces the effect of metoclopramide.
Storage Conditions
List II of the “List of Narcotic Drugs, Psychotropic Substances and Their Precursors”.
Store the drug in a place protected from light, inaccessible to children, at a temperature not exceeding 15°C (59°F).
Shelf Life
Shelf life: ampoules – 5 years, syringe-tubes – 3 years. Do not use after the expiration date printed on the package.
Dispensing Status
The drug is dispensed by prescription. The maximum allowable amount of the drug prescribed per one prescription is 0.25 g.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for injection 1% (10 mg/1 ml): amp. 5, 10, 100, 150, 200, 250, or 500 pcs.
Solution for injection 2% (20 mg/1 ml): amp. 5, 10, 100, 150, 200, 250, or 500 pcs.
Marketing Authorization Holder
State Institute of Medical and Biological Problems, FSUE (Russia)
Dosage Forms
 |
Promedol | Solution for injection 1% (10 mg/1 ml): amp. 5, 10, 100, 150, 200, 250, or 500 pcs. |
| Solution for injection 2% (20 mg/1 ml): amp. 5, 10, 100, 150, 200, 250, or 500 pcs. |
Dosage Form, Packaging, and Composition
| Solution for injection 1% | 1 ml |
| Trimeperidine | 10 mg |
1 ml – ampoules (5) – contour plastic packs (1) – cardboard packs.
1 ml – ampoules (5) – contour plastic packs (2) /with amp. knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (20) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (30) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (40) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (50) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (100) /with amp. knife or scarifier as needed/ – cardboard boxes.
| Solution for injection 2% | 1 ml |
| Trimeperidine | 20 mg |
1 ml – ampoules (5) – contour plastic packs (1) – cardboard packs.
1 ml – ampoules (5) – contour plastic packs (2) /with amp. knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (20) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (30) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (40) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (50) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (100) /with amp. knife or scarifier as needed/ – cardboard boxes.
Tablets 25 mg: 10 or 20 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Promedol | Tablets 25 mg: 10 or 20 pcs. |
Dosage Form, Packaging, and Composition
Tablets white, round, flat-cylindrical, with a bevel*.
| 1 tab. | |
| Trimeperidine hydrochloride | 25 mg |
Excipients : sucrose – 50 mg, potato starch – 24.5 mg, stearic acid – 0.5 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
* Each tablet is embossed with the letter “P” (when manufactured at FSUE “Moscow Endocrine Plant”, Russia, 111024, Moscow, Entuziastov shosse, 23, building 4).
Injection solution 10 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Promedol | Injection solution 10 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs. |
Dosage Form, Packaging, and Composition
| Solution for injection | 1 ml |
| Trimeperidine | 10 mg |
1 ml – ampoules (5) – contour plastic packs (1) /with amp. knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) – contour plastic packs (2) /with amp. knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (100) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (20) /with amp. knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – contour plastic packs (50) /with amp. knife or scarifier as needed/ – cardboard boxes.
Solution for injection 20 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs., syringe-tubes 20 or 100 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
|
Promedol | Solution for injection 20 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs., syringe-tubes 20 or 100 pcs. |
Dosage Form, Packaging, and Composition
| Solution for injection | 1 ml |
| Trimeperidine | 20 mg |
1 ml – ampoules (5) – plastic contour packs (1) /with ampoule knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) – plastic contour packs (2) /with ampoule knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) (for hospitals) – plastic contour packs (100) /with ampoule knife or scarifier as needed/ – cardboard boxes.
1 ml – syringe-tubes (100) – cardboard packs.
1 ml – ampoules (5) – contour packs (1) /with ampoule knife or scarifier as needed/ – cardboard packs.
1 ml – ampoules (5) (for hospitals) – plastic contour packs (20) /with ampoule knife or scarifier as needed/ – cardboard boxes.
1 ml – ampoules (5) (for hospitals) – plastic contour packs (50) /with ampoule knife or scarifier as needed/ – cardboard boxes.
1 ml – syringe-tubes (20) – cardboard packs.
![Promedol [Tablets, Solution] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Promedol [Tablets, Solution] 2")