Prosidol (Tablets, Solution) Instructions for Use

ATC Code

N02AB (Phenylpiperidine derivatives)

Clinical-Pharmacological Group

Opioid analgesic

Pharmacotherapeutic Group

Analgesics; opioids; phenylpiperidine derivatives

Pharmacological Action

Opioid analgesic agent. It also has sedative, antitussive, and antispasmodic effects. It activates the antinociceptive system and alters the emotional perception of pain. By stimulating opioid receptors in the gastrointestinal tract, it reduces intestinal motility. It does not affect the sphincters. It causes miosis. It has an activating effect on the vomiting center and possesses tocolytic action. It depresses the respiratory center (significantly weaker than morphine).

The duration of analgesic action after oral administration is 4-6 hours, after parenteral administration – 1.5-6 hours (depending on individual sensitivity and dose), 15-30 minutes – after intramuscular administration.

With long-term use (more than 3 months), the analgesic activity decreases (due to the development of tolerance).

Pharmacokinetics

It is well absorbed by any route of administration. Plasma protein binding is 40%.

It is metabolized in the liver to form inactive glucuronidated metabolites.

It is excreted mainly by the kidneys, both as metabolites and in active form.

Indications

Pain syndrome (severe and moderate intensity): malignant neoplasms of various locations; trauma; myocardial infarction; acute pancreatitis; gastric and duodenal ulcer; biliary colic; renal colic; intestinal colic; postoperative period; Leriche’s syndrome; obliterating endarteritis; premedication; general anesthesia (as an analgesic component); painful diagnostic procedures.

ICD codes

Dosage Regimen

Tablets, Solution

For pain syndrome in oncological patients – orally, 25-50 mg 2-3 times/day; daily dose – 50-250 mg (depending on the intensity of pain and previous therapy).

For traumatic pain, gastric ulcer, hepatic, renal and intestinal colic, in the postoperative period – subcutaneously or intramuscularly, 10-40 mg or intravenously – 5-10 mg; daily dose – 20-60 mg.

For premedication – intramuscularly or intravenously by drip, 5-10 mg; for general anesthesia as an analgesic component – intravenously, 0.2-0.7 mg/kg/h.

For acute myocardial infarction – intravenously, 0.1 mg/kg (diluted in 20 ml of 0.9% sodium chloride solution) or intramuscularly 5-10 mg.

For Leriche’s syndrome and obliterating endarteritis – intramuscularly 10-15 mg. Buccally, 10-20 mg, orally – 25 mg. Daily dose – up to 250 mg.

Adverse Reactions

From the central nervous system dizziness, weakness, headache; convulsions, narcolepsy.

From the digestive system dryness of the oral mucosa, nausea, vomiting, impaired liver function, intestinal atony.

From the cardiovascular system decreased blood pressure, bradycardia.

From the genitourinary and urinary system bladder atony, impaired renal function, amenorrhea, decreased libido.

Other allergic reactions, habituation, withdrawal syndrome, with intravenous administration – respiratory depression.

Local reactions pain and hyperemia at the injection site.

Contraindications

Hypersensitivity; depression of the respiratory center; hepatic and/or renal failure; coma; alcohol intoxication; arterial hypotension; organic diseases of the central nervous system; epilepsy and tonic-clonic seizures in history; bronchial asthma; respiratory failure.

With caution pregnancy, lactation period.

Use in Pregnancy and Lactation

With caution pregnancy, lactation period.

Use in Hepatic Impairment

Contraindication — hepatic failure.

Use in Renal Impairment

Contraindication — renal failure.

Special Precautions

It has significant narcotic potential, drug dependence cannot be completely excluded.

Drug Interactions

It enhances the effect of antihypertensive drugs.

Tranquilizers, hypnotics, ethanol, antipsychotic drugs enhance its effect.

Naloxone and naltrexone are specific antagonists.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.