Control of moderate and severe relieving pains after analgesics with weaker effects.
Composition:
1 tabl powl. contains 10 mg or 20 mg of morphine sulphate. The drug contains lactose; in addition, tabl. 20 mg contain sunset yellow.
Action:
A strong opioid analgesic, selective agonist of opioid receptors (strong agonist of mi receptors, weaker kappa and delta receptors). The main therapeutic action of morphine is analgesic and sedative (ie sleeping pills and decreasing anxiety levels). After oral administration, morphine is absorbed relatively quickly - mostly in the upper part of the small intestine and also in the small stomach. Low absolute bioavailability (20-40%) is due to the prolonged first pass effect. After a single dose, the maximum serum concentration appears after 10-30 minutes. Approx. 20-35% of morphine is bound to plasma proteins, mainly with albumin fraction. It penetrates well into tissues, poorly to o.u.n. (distribution coefficient c. 0.4) and does not tend to accumulate in the system. In children, penetration to o.u.n. is much more severe than in adults. High tissue concentrations were observed in the liver, kidneys, gastrointestinal tract and muscles. Morphine is glucuronidated into the active metabolites: morphine-3-glucuronide (M3G) and to a lesser extent morphine-6-glucuronide (M6G). T0,5 glucuronides are much longer than free morphine. In addition to liver, morphine is also metabolised in the kidneys and intestinal mucosa. Metabolism in children over 3 years is not significantly different from metabolism in adults. Both metabolites are removed from the body by the kidneys in 85%, in 9-12% in unchanged form, in 7-10% in the bile.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Obstruction of intestinal obstruction or its suspicion. Abdominal pain syndrome. acute liver disease. Uncontrolled convulsions. Co-administration with MAO inhibitors and 2 weeks from discontinuation of MAO inhibitors. Breast-feeding.
Precautions:
Take special care with the drug in case of: opioid addiction; the occurrence of disturbances of consciousness; occurrence of respiratory center disorders and lung function or a condition that leads to the occurrence of the above disorders; breathing inhibition; severe pulmonary heart; conditions with elevated intracranial pressure when no mechanical ventilation is carried out; hypotension associated with hypovolaemia; hypertrophy of the prostate gland with residual urine in the bladder (risk of bladder rupture due to urinary retention); narrowing of the urethra; renal colic; disorders of bile duct activity; inflammation of the gut or the presence of mechanical bowel obstruction; pheochromocytoma; pancreatitis; severe kidney or liver problems; hypothyroidism; epilepsy or increased convulsions; severe bronchial asthma; advanced (severe) chronic obstructive pulmonary disease. Depression of the respiratory system is the most important risk in the case of opioid overdose. Long-term use of the drug may lead to the development of tolerance to the drug, causing the need to gradually apply higher doses of morphine to maintain control of the pain. Long-term use of the drug may lead to physical dependence, and withdrawal may occur with abrupt cessation of treatment. Morphine may be abused and misused by addicts or addicts - the drug should be prescribed with extreme caution to patients abusing alcohol or medication. Due to the risk of intestinal obstruction or depression of the respiratory center, the drug should be used with caution both before and after surgery. The drug is not recommended before surgery and for 24 hours after surgery. The medicine may make it difficult to recognize and darken the clinical picture of acute abdominal diseases, such as intestinal perforation.In rare cases hyperalgesia may occur, which persists after increasing the dose, especially in patients who have been treated with high doses. It may be necessary to reduce the dose of morphine or change to another opioid. In patients with a history of epilepsy, morphine may lower the seizure threshold. In patients with adrenal insufficiency (eg Addison's disease), cortisol levels in the blood plasma should be monitored and if necessary, corticosteroid substitution should be performed. The drug in the form of tabl. powl. 20 mg is not intended for children under 6 years of age and may not be appropriate for children under 12 years of age due to the high content of active substance in the tablet in relation to the need for morphine in this age group. Morphine has a breath-taking effect - at the start of treatment, it is necessary to keep prophylaxis of constipation at the same time. The drug contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Table. 20 mg contain sunset yellow which may cause allergic reactions.
Pregnancy and lactation:
It is not recommended for women who are pregnant, unless in the doctor's opinion the benefit for the mother outweighs the potential risk to the fetus. Animal studies have shown reproductive toxicity. Morphine sulphate crosses the placenta, inhibits uterine systolic function. In newborns whose mothers received opioid analgesics for prolonged periods of pregnancy, symptoms of withdrawal syndrome may occur. Morphine may prolong or shorten the duration of labor. Newborns whose mothers received opioid analgesics during labor should be monitored for symptoms of respiratory depression or withdrawal syndrome and, if necessary, the appropriate opioid antagonist should be used. Morphine is excreted in milk, where it reaches concentrations higher than in maternal plasma - do not use during breastfeeding. Due to the mutagenic properties, morphine should be given to women and men of childbearing age only if they use effective contraception.
Side effects:
Very often: mood variability, mainly euphoria but also mood depression, constipation (during long-term treatment), nausea. Common: decreased appetite until loss of appetite, changes in activity level (usually lowering, but also increased level of activity or arousal states), insomnia, cognitive and sensory changes (eg thinking disorders, perception disorders, hallucinations, confusion), pain and dizziness, drowsiness, uncontrollable muscle spasms, vomiting (especially at the beginning of treatment), abdominal pain, anorexia (anorexia), dry mouth, excessive sweating, rash, urination disorders, weakness, pruritus. Uncommon: hypersensitivity reactions, fits, increased tension, paresthesia, fainting, blurred vision, vertigo, tachycardia, bradycardia, clinically significant increase or decrease in blood pressure, facial flushing, non-cardiac edema (also as a result of hastening the dose) ), bronchial spasm, respiratory depression, intestinal obstruction, indigestion, dysgeusia, increased liver enzymes, urticaria, urinary retention, peripheral edema. Rare: increased pancreatic enzyme activity or pancreatitis, biliary colic, renal colic, physical dependence manifesting in withdrawal syndrome. Very rare: ADH syndrome (SIADH syndrome, dominant symptom: hyponatremia), psychological dependence, tremor, blurred vision, double vision, nystagmus, dyspnea, teeth changes, other rashes such as rash, muscle cramps, muscle stiffness, erection, lack of menstruation, chills. Not known: anaphylactic reactions, anaphylactoid reactions, dysphoria, hyperalgesia (hyperalgesia) or allodynia, miosis, palpitations, heart failure, decreased cough reflex, gallbladder pain, decreased libido, tolerance to the drug.
Dosage:
Orally. The dose should be selected individually depending on the intensity of pain, age of the patient and response to previously used analgesics, so as to bring the pain down and maintain the analgesic effect to the Next dose.Adults and adolescents over 12 years: 10 mg or 20 mg every 4 hours. Children from 6 to 12 years: 5 mg or 10 mg every 4 hours. Children from 3 to 5 years: 5 mg (half table 10 mg) every 4 h. The severity of pain or the occurrence of tolerance to the drug may require increasing the dose. In patients with impaired liver or kidney function and if the patient is suspected of prolonged gastrointestinal transit, the drug should be dosed with extreme caution. Elderly patients (aged 75 years and over) and patients with generally poor health may be more susceptible to morphine - greater caution and / or longer intervals should be used when adjusting the dose; if necessary, reduce the dose. Table. the preparation can be used in the initial dose setting process and also as a supplement to ongoing treatment using tablets. prolonged release. It is a rule to set individual dosing in such a way that the selected dose at the same time is the lowest effective analgesic dose for a given patient. In the treatment of chronic pain, the therapy should be carried out based on a fixed schedule. In patients undergoing additional analgesic treatment (eg perioperative, nerve plexus block), the dose should be re-established based on the re-measurement of the pain intensity. The doctor will decide on the duration of treatment based on the degree of pain intensity in the patient. If necessary, change the medicine to a more appropriate form of treatment. In the treatment of chronic pain, a fixed dosage schedule should be maintained. Table. should be swallowed whole, without chewing, breaking or crushing, with a sufficient amount of liquid, regardless of meals. Table. can be divided into halves along the dividing line.