Pain of high intensity, including those associated with surgical procedures, obstetrics and premedication.
Composition:
1 ml of solution contains 50 mg of pethidine hydrochloride.
Action:
A synthetic, opioid analgesic that works primarily on o.u.n. It works shorter than morphine - 2-4 h. The drug is absorbed quickly after subcutaneous and intramuscular administration. The maximum plasma concentration usually occurs after 45 min. In 30-50% it is bound to plasma proteins. Metabolized in the liver. A significant part of the drug is excreted unchanged by the kidneys and as an active metabolite - norpethidine. T0,5 pethidine is 3-6 h, T0,5 norpetidine is about 20 hours.
Contraindications:
Hypersensitivity to pethidine hydrochloride or to any of the excipients. Severe kidney problems. Impaired respiratory center and respiratory function. Concomitant use of MAO inhibitors (including moclobemide and phenelzine) and a period of 2 weeks from their discontinuation, because severe agitation or inhibition of o.u.n. (hypertension or hypotension). Concomitant use of ritonavir - due to the risk of toxic effects of norpethidine. Concomitant use of selegiline - due to the risk of very high fever and toxic effects on o.u.n. Phaeochromocytoma tumor. Coma. Increased intracranial pressure or head injuries - due to an increased risk of respiratory depression, which may lead to an increase in cerebrospinal fluid pressure; sedation and changes in the appearance of the pupil may disturb the patient's observation. acute alcohol intoxication. Cases where there is a risk of paralytic ileus or severe diarrhea associated with pseudomembranous antibiotics caused by the use of antibiotics or diarrhea caused by poisoning (until the toxic agent is removed).
Precautions:
Repeated administration of pethidine may lead to the development of tolerance. Abrupt discontinuation in patients with developed tolerance may result in withdrawal symptoms. Caution use in patients who are abusing medication or are prone to drug abuse. Pethidine administered for a long time may induce a morphine type addiction. Use with caution or dose reduction in patients with biliary system anomalies, hypothyroidism, adrenocortical insufficiency, asthma, hypotension, shock, hypertrophy of the prostate gland, inflammation or intestinal obstruction, myasthenia gravis, supraventricular tachycardia, seizure disorders. Pethidine neurotoxicity may occur in patients with renal insufficiency, cancer, sickle cell anemia, during concomitant administration of cholinolytic drugs or during prolonged administration of increasing doses of pethidine. Caution should be used the drug in children, the elderly, patients debilitated, with impaired liver and kidney function.
Pregnancy and lactation:
The preparation can be used during pregnancy only in cases where the benefit for the mother outweighs the potential risk to the fetus. Pethidine is widely used in the treatment of pain during childbirth, penetrates the placenta and may cause respiratory depression in the newborn. In children of mothers who have used pethidine during pregnancy, withdrawal symptoms may occur. Pethidine is excreted in human milk - this should be taken into account when used in breast-feeding women.
Side effects:
The most serious side effect is respiratory depression. The most common are: sedation, nausea, constipation, vomiting, excessive sweating. There may also be: dizziness, confusion (high doses), mood changes (including dysphoria, euphoria), anxiety, hallucinations, headache, dry mouth, bile spasm, orthostatic hypotension, facial flushing, bradycardia, tachycardia (more frequently after intravenous administration), miosis, blurred or double vision, other visual disturbances, urinary retention, difficulty urinating, ureteral contraction, anti-diuretic action, urticaria,pruritus, rash, reactions at the injection site. Rare: anaphylactic reactions after intravenous administration. Long-term use of the drug may cause physical and mental addiction. Tolerance to the drug develops with prolonged use, which does not apply to constipation. Tolerance to bladder opioid analgesia may develop.
Dosage:
Intramuscularly, subcutaneously or intravenously (in the form of a slow injection).premedication (30-90 min before surgery). Adults: 50-100 mg intramuscularly or subcutaneously. Elderly patients are more sensitive to pethidine. Children: 1-2 mg / kg intramuscularly or subcutaneously.Maintenance of anesthesia: inject small repeated doses of the diluted preparation (eg 10 mg / ml) slowly intravenously or infused continuously (eg diluted to 1 mg / ml). The dose should be adjusted to the patient's condition, type of premedication and anesthesia, and the type and duration of the surgery.Obstetrics: 50-100 mg intramuscularly or subcutaneously - administered when there are cramps at regular intervals. If necessary, the dose can be repeated after 1-3 hours, not exceeding the 400 mg dose within 24 hours.Treatment of severe pain, e.g. pain in acute myocardial infarction, hepatic and renal colic, postoperative pain. Adults: 25-100 mg intramuscularly or subcutaneously. Doses can be repeated every 4 hours. If necessary, the preparation can be given slowly intravenously at a dose of 25 - 50 mg, preferably after previous dilution. In elderly patients, the starting dose should not exceed 25 mg; with multiple dosing, reduce the total daily dose. Children: 0.5-2 mg / kg intramuscularly or subcutaneously every 4 h. In patients with impaired liver and kidney function, the dose should be reduced. Before intravenous administration, the contents of the ampoule may be diluted to 10 ml with 10% Glucose solution or 0.9% NaCl solution or water for injections; the solution obtained has a concentration of 5 mg / ml (at a dilution of 1 ml) or 10 mg / ml (at a dilution of 2 ml).