Active substanceMorphineMorphine Similar drugsTo uncover Morphine solution PC MOSCOW ENDOCRINE FACTORY, FSUE Russia Morphine solution for injections MOSCOW ENDOCRINE FACTORY, FSUE Russia Morphine sulfate capsules inwards MOSCOW ENDOCRINE FACTORY, FSUE Russia MST Continus pills inwards Mundifarma GmbH, Germany Germany Dosage form: & nbspCapsules of prolonged action. Composition:Capsules 10 mg:Active substance:Morphine sulfate pentahydrate - 10 mg Excipients:Neutral microgranules (sucrose (sugar), corn starch) - 11.539 mg, macrogol 4000 to 1.798 mg, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol) 1.623 mg, dibutyl sebacate 0.390 mg, talc 0.150 mg, gelatin capsules No. 4 (gelatin, dye quinoline yellow [E 104], titanium dioxide [E 171], iron ferric oxide black [E 172]) - 38.0 mg.Capsules 30 mg:Active substance:Morphine sulfate pentahydrate - 30 mg Excipients:Neutral microgranules (sucrose (sugar), corn starch) - 34.617 mg, macrogol-4000 - 5.394 mg, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol) 4.899 mg, dibutyl sebacate 1.170 mg, talc 0.450 mg, gelatin capsules No. 4 (gelatin, iron oxide red oxide [E 172], titanium dioxide [E 171], ferric oxide black oxide [E 172]) - 38.0 mg.Capsules 60 mg:Active substance:Morphine sulfate pentahydrate - 60 mg Excipients:Neutral microgranules (sucrose (sugar), corn starch) - 69.23 mg, macrogol-4000 -10.79 mg, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol) 9.74 mg, dibutyl sebacate 2.34 mg , talc - 0.90 mg, gelatin capsules No. 3 (gelatin, dye sunset yellow [E110], titanium dioxide [E 171], ferric oxide black oxide [E 172]) - 48.0 mg. Capsules 100 mg:Active substance:Morphine sulfate pentahydrate - 100 mg Excipients:Neutral microgranules (sucrose (sugar), corn starch) - 115.39 mg, macrogol-4000-17.98 mg, ethylcellulose aqueous dispersion (ethylcellulose, sodium lauryl sulfate, cetyl alcohol) - 16.23 mg, dibutyl sebacate - 3.90 mg , talc - 1.50 mg, gelatin capsules No. 2 (gelatin, titanium dioxide [E 171], iron ferric oxide black [E 172]) - 61.0 mg. Description:Dosage of 10 mg. Hard gelatin capsules No. 4, the capsule body is transparent, the lid is opaque yellow, and the inscription "10 mg" is inscribed on the cap of the capsule. Dosage of 30 mg. Hard gelatin capsules No. 4, the capsule case is transparent, the opaque cap is pink or pink-orange in color, on the cap of the capsule is inscribed "30 mg".Dosage of 60 mg. Hard gelatin capsules No. 3, the capsule body is transparent, the lid is opaque orange, the inscription "60 mg" is inscribed on the cap of the capsule. Dosage of 100 mg. Hard gelatin capsules No. 2, the capsule body is transparent, the lid is opaque white, the inscription "100 mg" is inscribed on the cap of the capsule. The contents of the capsules are spherical microgranules, from white to white with a yellowish, gray or creamy hue of color. Pharmacotherapeutic group:Analgesic narcotic. ATX: & nbspN.02.A.A.01 Morphine Pharmacodynamics:Opioid receptor agonist (mu, kappa, delta). It suppresses the transmission of painful impulses in the central nervous system (CNS), raises the threshold of pain sensitivity with stimuli of various modalities, reduces the emotional evaluation of pain, causes euphoria (raises mood, evokes a feeling of peace of mind, complacency, iridescent prospects regardless of the real situation), which contributes to the formation of drug dependence (mental and physical).Morphine in high doses has a hypnotic effect. It inhibits conditioned reflexes, lowers the excitability of the cough center,increases the tone of the center of the vagus nerve (bradycardia), causes excitation of the center of the oculomotor nerve (miosis), depresses the respiratory and vomiting centers (therefore, repeated administration of morphine or the use of drugs that cause vomiting does not cause vomiting), can stimulate chemoreceptors of the vomiting center and cause nausea and vomiting. Increases the tone of the smooth muscles of the internal organs (including the bronchi, causing bronchospasm), causes a spasm of bile duct sphincters and sphincter of Oddi, increases the tone of the sphincter of the bladder, weakens the intestinal sphincter (leads to the development of constipation), increases the peristalsis of the stomach, accelerates its emptying (contributes to better detection of stomach ulcers and duodenal ulcers, spasm of sphincter of Oddi creates favorable conditions for radiographic examination of the gallbladder). Reduces the secretory activity of the gastrointestinal tract (GIT), the main exchange and body temperature, stimulates the release of antidiuretic hormone. Causes the widening of the peripheral blood vessels and the release of histamine, which can lead to lower blood pressure (BP), redness of the skin, increased sweating, reddening of the protein coat of the eyes.Supraspinal analgesia, euphoria, physical dependence, respiratory depression, center excitation n. vagus is associated with an effect on mu receptors. Stimulation of the kappa receptors causes spinal analgesia, as well as sedation, miosis.Excitation of delta receptors causes analgesia.After ingestion of prolonged forms, the maximum effect after 60-120 minutes, the duration of action of the prolonged form is 12 hours.With the regular administration of a therapeutic dose, drug dependence is formed after 2-14 days from the start of treatment. The "cancellation" syndrome can occur several hours after the end of the long course of treatment and reach a maximum after 36-72 hours. Pharmacokinetics:When ingestion, the maximum concentration in the blood plasma is reached in 2-4 hours after administration. The connection with proteins is low (30-35%). The volume of distribution is 4 l / kg. The effect of the "first pass" through the liver is more than 50%.Bioavailability with respect to subcutaneous administration is 50%. Bioavailability with respect to intravenous administration is 30%.Metabolized, forming mainly glucuronides and sulfates.It is excreted by the kidneys (85%): about 9-12% - for 24 hours in unchanged form, 80% in the form of glucuronides; The remaining part (7-10%) is with bile. Small amounts are allocated by all glands of external secretion.Penetrates through the blood-brain and placental barriers (can cause depression of the respiratory center in the fetus), is determined in breast milk. Indications:Applied as an anesthetic for the expressed pain syndrome of various origin, mostly chronic (pain in malignant neoplasms, posttraumatic pain), in the postoperative period (adults only). It is not used for relief of acute pain syndrome. Contraindications:Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.Hypersensitivity, depression of the respiratory center (including against the background of alcohol or drug poisoning), severe CNS depression, paralytic intestinal obstruction, children weighing up to 20 kg.Decompensated respiratory failure, bronchial obstructive diseases, craniocerebral trauma, acute liver failure, lactation, application immediately before surgery and the first 24 hours after them.This remedy should never be used in combination with alcohol and drugs containing alcohol. Carefully:Elderly age, prostatic hyperplasia, urethral stenosis, hepatic or renal insufficiency, insufficiency of the adrenal cortex, intracranial hypertension, epileptic syndrome, acute alcohol intoxication, alcoholic delirium, pulmonary heart failure in the background of chronic lung diseases, arrhythmia, post-surgical conditions on the biliary and urinary tract, cholelithiasis, surgical interventions on the gastrointestinal tract, severe inflammation intestinal diseases, chronic respiratory diseases, hypothyroidism, drug abuse or drug dependence (including history), simultaneous treatment with monoamine oxidase inhibitors and their use less than 2 weeks before the start of morphine treatment, emotional lability, suicidal thoughts or attempts ( including in the anamnesis), the general or difficult serious condition. Pregnancy and lactation:In pregnancy, use is only permissible for life indications (respiratory depression and development of drug dependence in the fetus are possible).Studies conducted on animals did not reveal a teratogenic effect of morphine.During pregnancy, a dose reduction is recommended, since the risk of developmental malformations in the fetus is dose-dependent.At the end of pregnancy, high doses, even during short-term treatment, can cause respiratory failure in the newborn.During the last three months of pregnancy, the regular intake of morphine by the mother, whatever the dose, may cause the withdrawal syndrome in a newborn (irritability, vomiting, convulsions, death).In the case of short-term admission in high doses at the end of pregnancy, or prolonged treatment or abuse, it is necessary to ensure observation of the newborn (risk of developing respiratory failure or withdrawal syndrome in the child).In connection with the penetration into breast milk, the intake of morphine during the lactation period is contraindicated. For the duration of treatment, breastfeeding should be discontinued. Dosing and Administration:Capsules Morphine sulfate is prescribed inside.Usually the drug should be taken one capsule every 12 hours. Capsules should be taken at the same time, before or after eating, without chewing, but swallowing whole with a small amount of liquid. Doses are selected by the attending physician individually depending on the severity of the pain syndrome, age, condition of the patient and previous use of analgesics.To reduce the expressed pains are predominantly chronic.For adult patients with intense pain, not previously treated with narcotic analgesics or pain which is not relieved by the weaker opioids, treatment usually starts with 30 mg every 12 hours. The daily dose is 60 mg per day.If the dose previously prescribed becomes insufficient, a dose adjustment is recommended. If ineffective, the dose is reviewed after 24-48 hours (at the beginning of taking the drug, a daily dose estimate is recommended). Increasing the dose of morphine is recommended at 25-50%, while maintaining a 12-hour interval between doses.When switching from parenteral administration of morphine to oral administrationMorphine sulfate, the dosage should initially be increased, in order to maintain an equivalent amount of morphine, to avoid reducing the analgesic effect.When switching from the intravenous route of administration, the dose is increased 3 times, from the subcutaneous dose 2 times.When switching from oral intake of fast-suction morphine to prolonged forms, the same daily dose should be used, dividing it into 2 doses.For elderly patients, it is recommended to reduce the dosage in half.For children weighing more than 20 kg: the daily dose should be 1 mg / kg. If the capsule can not be swallowed, its contents are mixed with cold soft food (porridge, mashed potatoes, yogurt, ice cream) or injected through a gastric or gastrostomy probe with an internal diameter greater than or equal to 2.5 mm with an open distal end or lateral pores. To wash the probe, 30-50 ml of water is sufficient.For individuals with renal insufficiency, doses should be lower than for patients with normal renal function and adapted to the condition of the patient.It should be remembered that skipping 2-3 doses of the next dose of the drug against its long-term use may lead to the development of the "withdrawal" syndrome, which requires urgent medical involvement.Chronic postoperative pain syndrome Adults: patients with a body weight of up to 70 kg - 20 mg 2 times a day, patients with a body weight of 70 kg - 30 mg 2 times a day.Taking the drug in children is not recommended. Side effects:From the digestive system: more often - nausea and vomiting (often at the beginning of therapy), constipation; less often - dry mouth, anorexia, biliary tract spasm, cholestasis (in the main bile duct), gastralgia, stomach cramps; rarely - hepatotoxicity (dark urine, pale stool, hysterical sclera and skin), intestinal atony, paralytic intestinal obstruction, toxic megacolon (constipation, flatulence, nausea, stomach cramps, vomiting) especially in severe inflammatory bowel diseases.From the cardiovascular system: more often - lowering blood pressure, tachycardia; less often - bradycardia; frequency unknown - increased blood pressure.From the respiratory system: more often - oppression of the respiratory center; less often - bronchospasm, atelectasis.From the nervous system: more often - dizziness, fainting, drowsiness, unusual fatigue, general weakness; less often - headache, tremor, involuntary muscle twitching, discoordination of muscle movements, paresthesia, nervousness,depression, confusion (hallucinations, depersonalization), increased intracranial pressure with the likelihood of subsequent cerebral circulatory disorders, insomnia; rarely - restless sleep, CNS depression, against a background of high doses - rigidity of muscles (especially respiratory), in children - paradoxical agitation, anxiety; frequency unknown - convulsions, nightmares, sedative or stimulating effect (especially in elderly patients), delirium, decreased ability to concentrate.From the genitourinary system: less often - a decrease in diuresis, spasm of ureters (difficulty and pain when urinating, frequent urge to urinate), decreased libido, decreased potency; frequency unknown - spasm of the sphincter of the bladder, a violation of the outflow of urine or aggravation of this condition with prostatic hyperplasia and stenosis of the urethra.Allergic reactions: more often - wheezing, facial hyperemia, skin rash of the face; less often - skin rash, hives, itching, face swelling, edema of the trachea, laryngospasm, chills.Other: more often - increased sweating, dysphonia; less often - a violation of the clarity of visual perception (incl.diplopia), miosis, nystagmus, imaginary feeling of well-being, a feeling of discomfort; frequency is unknown - tinnitus, drug dependence, tolerance, withdrawal syndrome (muscle pain, diarrhea, tachycardia, mydriasis, hyperthermia, rhinitis, sneezing, sweating, yawning, anorexia, nausea, vomiting, nervousness, fatigue, irritability, tremor, spasms in the stomach, general weakness, hypoxia, headache, increased blood pressure, etc. vegetative symptoms). Overdose:Symptoms of acute and chronic overdose: cold sticky sweat, confusion, dizziness, drowsiness, decreased blood pressure, nervousness, fatigue, miosis, bradycardia, severe weakness, slow labored breathing, hypothermia, anxiety, dry mouth, delirious psychosis, intracranial hypertension before the violation of cerebral circulation), hallucinations, muscle rigidity, convulsions, in severe cases - loss of consciousness, respiratory arrest, coma.Treatment: gastric lavage, recovery of respiration and maintenance of cardiac activity and blood pressure; intravenous injection of a specific antagonist opioid analgesics - naloxone in a single dose of 0.2-0.4 mg with repeated administration 2-3 minutes before the total dose of 10 mg; the initial dose of naloxone for children is 0.01 mg / kg.Symptomatic therapy. Interaction:Strengthens the effect of hypnotics, sedatives, local anesthetics, preparations for general anesthesia and anxiolytics.Ethanol, muscle relaxants and drugs that depress the central nervous system, enhance the de-priming effect and respiratory depression.Buprenorphine (including previous therapy) reduces the effect of other opioid analgesics; against the background of the use of high doses of agonists of mu-opioid receptors reduces respiratory depression, and on the background of the use of low doses of agonists of mu or kappa-opioid receptors - enhances; accelerates the appearance of the symptoms of the "cancellation" syndrome when the mu-opioid receptor agonist is discontinued on the background of drug dependence, with sudden withdrawal of symptoms partially reduces the severity of these symptoms.With the systematic administration of barbiturates, especially phenobarbital, there is a possibility of reducing the expression of the analgesic effect of narcotic analgesics, stimulating the development of cross tolerance.When used simultaneously with MAO inhibitors (monoamine oxidase), overexcitement and inhibition can occur with the onset of hyper- or hypotensive crises (first, to assess the interaction effect, the dose should be reduced to! 4 of the recommended dose).With simultaneous admission with beta-blockers, it is possible to increase the inhibitory effect on the central nervous system, with dopamine - decrease the analgesic effect of morphine, with cimetidine - increase respiratory depression, with other opioid analgesics - depression of the central nervous system, respiration, lowering blood pressure.Chlorpromazine enhances the myotic, sedative and analgesic effects of morphine.The derivatives of phenothiazine and barbiturates increase the hypotensive effect and increase the risk of respiratory depression.Naloxone reduces the effect of opioid analgesics, as well as the respiratory depression and central nervous system caused by them; higher doses may be required to level the effects of b-torfanol, nalbuphine and pentazocine, which have been prescribed to eliminate the undesirable effects of morphine; can accelerate the appearance of symptoms of the syndrome of "withdrawal" against the background of drug dependence.Naltrexone accelerates the appearance of symptoms of the "cancel" syndrome against the background of drug dependence (symptoms can appear only 5 minutes after drug administration, continue for 48 hours, are characterized by persistence and difficulty of their elimination); reduces the effect of opioid analgesics (analgesic, antidiarrheal, anti-cough); does not affect the symptoms caused by the histamine reaction.Nalorphine eliminates the respiratory depression caused by morphine.Strengthens the hypotensive effect of drugs that reduce blood pressure (including ganglion blockers, diuretics).Competitively inhibits hepatic metabolism of zidovudine and reduces its clearance (increased risk of their mutual intoxication).Medicines with anticholinergic activity, antidiarrhoeal drugs (incl. loperamide) increase the risk of constipation up to intestinal obstruction, urinary retention and CNS depression.Reduces the effect of metoclopramide. Special instructions:Avoid the use of alcoholic beverages and medicines containing alcohol.Do not use in situations where paralytic ileus may occur. When the threat of paralytic ileus emergence, the use of morphine should be stopped immediately.In patients with presumed heart surgery or another operation with intensive postoperative pain syndrome, the use of morphine should be discontinued 24 hours before the operation. If the therapy is subsequently shown, then the dosing regimen is chosen taking into account the severity of the operation.If there is nausea and vomiting, you can use a combination with phenothiazine.To reduce the side effects of morphine preparations on the intestine, laxatives should be used.Simultaneous use of other drugs acting on the central nervous system (antihistamines, sleeping pills, psychotropic drugs, other pain medications) is allowed only with the permission and under the supervision of a doctor. Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Form release / dosage:Capsules of prolonged action, containing 10 mg, 30 mg, 60 mg or 100 mg of morphine sulfate pentahydrate. Packaging:10 capsules per contour cell package. For 1,2 or 5 contour squares with instructions for use in a pack of cardboard. Storage conditions:List II "List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation".Store in a dry place at a temperature of no higher than 25 ° C.Keep out of the reach of children. Shelf life:3 years. Do not use at the end of the expiration date printed on the package. Terms of leave from pharmacies:On prescription Registration number:LP-001833 Date of registration:13.09.2012 Expiration Date:13.09.2017 The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia Manufacturer: & nbspMOSCOW ENDOCRINE FACTORY, FSUE Russia Information update date: & nbsp2016-10-03 Illustrated instructions × Illustrated instructions Instructions