Promedol - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Promedol

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Promedol is a narcotic analgesic drug.

Release form and composition

• Tablets: flat-cylindrical, white, chamfered and embossed in the form of the letter "P" (10 tab. In blisters, 1 or 2 packages in a cardboard box);
• Solution for injection 1% and 2%: transparent, colorless (for pharmacies - 1 ml in syringes-tubes, in a carton pack of 20, 50 or 100 syringes; 1 ml in ampoules, 5 ampoules in a blister strip, in a pack cardboard 1 or 2 packs (if necessary, with an ampoule knife or scarifier); for medical institutions - 1 ml in ampoules, 5 ampoules in a blister strip, in a cardboard box or a box made of corrugated cardboard 20, 30, 40, 50 or 100 packs (if necessary with an ampoule knife or scarifier)).

Active ingredient: trimeperidine hydrochloride (promedol):

• 1 tablet - 25 mg;
• 1 ml of solution - 10 or 20 mg.

Excipients of tablets: potato starch, sugar, stearic acid.

Additional components of the solution: hydrochloric acid, water for injection.

Indications for use

Tablets and Promedol solution are prescribed for pain syndrome of moderate to severe severity, resistant to non-narcotic analgesics, including in the following cases:

• Injuries;
• Burns;
• Lumbosacral radiculitis;
• Acute neuritis;
• Thalamic syndrome;
• Protrusion of the intervertebral disc;
• Postoperative period;
• Acute prostatitis;
• Peptic ulcer and 12 duodenal ulcer;
• Pain caused by spasm of smooth muscles of internal organs: renal, hepatic, intestinal colic (in combination with atropine-like and antispasmodic drugs);
• Chronic pancreatitis;
• Oncological diseases.

In the form of a solution, the drug is also prescribed for the following diseases / conditions:

• Myocardial infarction;
• Aortic dissecting aneurysm;
• Unstable angina;
• Thromboembolism of the arteries of the extremities or pulmonary artery;
• Renal artery thrombosis;
• Lung infarction;
• Acute pericarditis;
• Air embolism;
• Acute pleurisy;
• Causalgia;
• Acute attack of glaucoma;
• Acute vesiculitis;
• Paranephritis;
• Perforation of the esophagus;
• Spontaneous pneumothorax;
• Acute dysuria;
• Priapism;
• Paraphimosis;
• Foreign bodies of the urethra, bladder, rectum;
• Pulmonary edema;
• Acute left ventricular failure;
• Cardiogenic shock;
• Preoperative, operational and postoperative periods;
• Childbirth (for pain relief and stimulation);
• Neuroleptanalgesia (in combination with neuroleptics).

Contraindications

For both dosage forms:

• Depression of the respiratory center;
• Hypersensitivity to any component of the drug.

Additionally for tablets:

• Cachexia;
• Children's age (due to the impossibility of accurate dosing).

Additionally for mortar:

• Infectious diseases (due to the risk of infection entering the central nervous system);
• Toxic dyspepsia (slowing down the elimination of toxins and the associated exacerbation and prolongation of diarrhea);
• Diarrhea due to pseudomembranous colitis due to the use of cephalosporins, lincosamides or penicillins;
• Blood clotting disorder, incl. as a result of anticoagulant therapy (for epidural and spinal anesthesia);
• The simultaneous use of monoamine oxidase inhibitors and within 21 days after their withdrawal;
• Children under 2 years of age.

Tablets should be used with caution:

• Hypothyroidism;
• Traumatic brain injury with psychosis;
• Central nervous system depression;
• Myxedema;
• Respiratory failure;
• Stricture of the urethra;
• Hyperplasia of the prostate;
• Adrenal insufficiency;
• Hepatic / renal impairment;
• Alcoholism;
• Elderly age.

The solution should be used with caution:

• Severe inflammatory bowel disease;
• Suicidal tendencies;
• Convulsions;
• Emotional lability;
• Traumatic brain injury;
• Central nervous system depression;
• Intracranial hypertension;
• Alcoholism;
• Drug addiction (including a history);
• Arterial hypotension;
• Arrhythmia;
• Chronic obstructive pulmonary disease;
• Bronchial asthma;
• Cachexia;
• Surgical interventions on the gastrointestinal tract or urinary system;
• Stricture of the urethra;
• Hyperplasia of the prostate;
• Myxedema;
• Adrenal insufficiency;
• Respiratory failure;
• Chronic heart failure;
• Hepatic / renal impairment;
• Hypothyroidism;
• Weakened condition of patients;
• Childhood;
• Elderly age;
• Pregnancy and lactation period.

Method of administration and dosage

In tablets Promedol should be taken orally 1-2 pcs. For pain due to spasm of smooth muscles (intestinal, renal and hepatic colic), the drug is combined with antispasmodic and atropine-like agents, treatment is carried out under the close supervision of the patient. The maximum permissible single dose is 50 mg (2 tab.), Daily - 200 mg (8 tab.).

The Promedol solution is administered intravenously (i / v) and intramuscularly (i / m), in syringe tubes - only intramuscularly and subcutaneously (s / c).

Adults, depending on the clinical situation, are prescribed 10-40 mg (from 1 ml of 1% solution to 2 ml of 2% solution). Children from 2 years old, depending on age - 3-10 mg.

For premedication before anesthesia, the drug is administered subcutaneously or intramuscularly at a dose of 20-30 mg simultaneously with 0.5 mg of atropine 30-45 minutes before the operation.

During anesthesia, Promedol is administered intravenously in fractional doses of 3-10 mg.

For pain relief of childbirth, an intramuscular or subcutaneous injection is prescribed at a dose of 20-40 mg when the pharynx opens by 3-4 cm and the fetus is in a satisfactory condition. In order to avoid drug depression of the fetus and newborn, the last dose should be administered no later than 30-60 minutes before delivery.

The maximum single dose for adults is 40 mg, the daily dose is 160 mg.

Side effects

When taking Promedol tablets, the following are possible:

• From the nervous system: depression of the respiratory center, shortness of breath, disorientation, lethargy, headache, euphoria, slowing down of the speed of psychomotor reactions;
• From the gastrointestinal tract: nausea and vomiting;
• Others: increased sweating, decreased blood pressure, allergic reactions, drug dependence, addiction.

When using the drug in the form of a solution, the following are possible:

• From the digestive system: more often - nausea, vomiting, constipation; less often - irritation of the gastrointestinal tract, anorexia, dryness of the oral mucosa, spasm of the biliary tract; rarely (with inflammatory bowel diseases) - paralytic intestinal obstruction, toxic megacolon (stomach cramps, nausea, vomiting, flatulence, constipation, gastralgia); frequency unknown - hepatotoxicity (pale stools, dark urine, icterus of the skin and sclera);
• From the nervous system and sensory organs: more often - drowsiness, vertigo, weakness; less often - blurred vision, headache, diplopia, restless sleep, unusual dreams, nightmares, nervousness, discomfort, fatigue, involuntary muscle twitching, tremors, convulsions, confusion, euphoria; rarely - depression, hallucinations, in children - anxiety, paradoxical excitement; the frequency is unknown - disorientation, slowing down of the speed of psychomotor reactions, ringing in the ears, muscle rigidity (especially respiratory), convulsions;
• From the side of the cardiovascular system: more often - a decrease in blood pressure (BP); less often - arrhythmias; frequency unknown - increased blood pressure;
• From the urinary system: less often - spasm of the ureters (frequent urge to urinate, pain and difficulty urinating), decreased urine output;
• From the respiratory system: less often - depression of the respiratory center;
• Allergic reactions: less often - angioedema, laryngospasm, bronchospasm; rarely - itchy skin, rash, swelling of the face;
• Local reactions: burning, hyperemia and edema at the injection site;
• Others: less often - increased sweating; frequency unknown - drug dependence, addiction.

special instructions

During treatment, it is forbidden to drink alcoholic beverages, you should refrain from driving and performing potentially dangerous types of work that require speed of reactions and high concentration of attention.

Drug interactions

Promedol increases respiratory and central nervous system depression caused by the use of ethanol, general anesthetics, monoamine oxidase inhibitors, hypnotics and sedatives, anxiolytics, neuroleptics, muscle relaxants and other narcotic analgesics.

Barbiturates (especially phenobarbital), used systemically, can reduce the analgesic effect of Promedol.

Naloxone eliminates the analgesia caused by trimeperidine, restores breathing and reduces central nervous system depression.

Nalorphine eliminates drug-induced respiratory depression while maintaining its analgesic effect.

Trimeperidine reduces the effect of metoclopramide, enhances the antihypertensive effect of antihypertensive drugs, including diuretics and ganglion blockers.

In the case of simultaneous use of antidiarrheal agents (including loperamide) and drugs with anticholinergic activity increase the risk of urinary retention and constipation, up to intestinal obstruction.

Promedol enhances the effect of anticoagulants, therefore, if it is necessary to use this combination, plasma prothrombin should be monitored.

Buprenorphine (including if it was used during previous therapy) reduces the effect of trimeperidine.

Due to overexcitation or inhibition of the central nervous system with the simultaneous use of monoamine oxidase inhibitors, the risk of developing severe reactions with the occurrence of hypo- or hypertensive crises increases.

At the same time, the naltrexone used reduces the effectiveness of Promedol, can accelerate the onset of withdrawal symptoms in patients with drug dependence (these signs may appear as early as 5 minutes after drug administration, persist for 48 hours and are characterized by the difficulty of eliminating them).

Analogs

There is no information about the analogues of Promedol.

Terms and conditions of storage

Store in a dry (tablets), protected from light, out of the reach of children, tablets - at room temperature, solution - at temperatures up to 15 ºС.

Shelf life of tablets and solution in ampoules is 5 years, solution in syringe tubes is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!