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: & nbspThe tablets of the prolonged action covered with a cover. Composition:tablets 10 mg: 10 mg of morphine sulfate as an active substance and ancillary substances - anhydrous lactose, hydroxyethylcellulose, cetostearyl alcohol, magnesium stearate, talc, hypromellose 5mPa.s, hypromellose 15mPa.s, macrogol 400, Oprasprey M-1-3705B (hypromellose, macrogol 400, titanium dioxide);tablets 30 mg: 30 mg of morphine sulfate as an active ingredient and ancillary substances - anhydrous anhydrous, hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc, Opadrai OY-6708 (hypromellose, macrogol 400, titanium dioxide, yellow El 10 sunset, indigo carmine E132, erythrosin E127);tablets 60 mg: 60 mg of morphine sulfate as an active substance and ancillary substances - anhydrous lactose, hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc, Opadrai OY-3508 (hypromellose, macrogol 400, titanium dioxide, quinoline yellow E104, yellow E110, E127);tablets 100 mg: 100 mg of morphine sulfate as an active substance and auxiliary substances - hydroxyethyl cellulose, cetostearyl alcohol, magnesium stearate, talc, Opadrai OY-8215 (hypromellose 5mPa.s, hypromellose 15mPa.s, macrogol 400, titanium dioxide). Description:tablets 10 mg: smooth, film-coated, golden brown biconvex tablets. On one side the marking is "10 mg", the other side is smooth. tablets 30 mg: smooth, film-coated, dark-lilac biconvex tablets. On one side the marking is "30 mg", the other side is smooth. tablets 60 mg: smooth, film-coated, orange-colored biconvex tablets. On one side the marking is "60 mg", the other side is smooth. tablets 100 mg: smooth, film-coated, gray biconvex tablets. On one side the marking is "100 mg", the other side is smooth. Pharmacotherapeutic group:Analgesic narcotic. ATX: & nbspN.02.A.A.01 Morphine Pharmacodynamics:Opioid receptor agonist (mu, kappa, delta). Oppresses the transmission of painful impulses in the central nervous system, reduces the emotional evaluation of pain, causes euphoria,which contributes to the formation of drug dependence (mental and physical).In high doses has a hypnotic effect. It inhibits conditioned reflexes, reduces the excitability of the cough center, causes excitation of the center of the oculomotor nerve (miosis) and n.vagus (bradycardia). Increases the tone of the smooth muscles of the internal organs (including the bronchi, causing bronchospasm), causes a spasm of bile duct sphincter and sphincter of Oddi, increases the tone of the sphincter of the bladder, weakens the intestinal peristalsis (leads to the development of constipation). Reduces the secretory activity of the gastrointestinal tract, the main exchange and body temperature. Inhibits the respiratory and vomiting centers, so repeated administration of morphine or the use of vomitive drugs against the background of its introduction, do not cause vomiting. May depress the respiratory center, stimulate the chemoreceptors of the vomiting center and cause nausea and vomiting. The duration of the action is about 12 hours. Pharmacokinetics:When ingested, the maximum concentration in the blood plasma is reached 4 hours after admission. Penetrates through blood-brain and placental barriers. The volume of distribution is 4 l / kg.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. Indications:Pronounced pain (mainly chronic) syndrome (posttraumatic, malignant neoplasms, postoperative period). It is not used for relief of acute pain syndrome. Contraindications:Hypersensitivity, depression of the respiratory center, severe central nervous system depression, paralytic intestinal obstruction, children under 7 years of age, use of MAO inhibitors less than 2 weeks before the start of treatment, application immediately before surgery and the first 24 hours after them, traumatic brain injury , bronchoobstructive diseases, acute liver disease. 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 on the background of chronic lung diseases, arrhythmia, conditions after surgery on the bile-excreting or urinary tract, severe inflammatory bowel disease, chronic respiratory disease, hyperthyroidism, drug abuse or drug dependence, emotional lability , suicidal thoughts or attempts (including anamnesis), general severe condition. Pregnancy and lactation:Not recommended during pregnancy. For the duration of treatment it is necessary to stop breastfeeding. Dosing and Administration:Inside, swallowing whole and not chewing. It is applied 2 times a day with 12 hour intervals.To reduce persistent pain.AdultsDosage depends on the severity of the pain syndrome, the age of the patient and the previous use of analgesics. With increasing pain, gradually increasing doses of the drug (10, 30, 60 and 100 mg) can be used. In patients with severe pain syndrome, who have not previously received narcotic analgesics, or with pain syndrome,which is not stopped by weaker opioids, treatment usually starts with 30 mg every 12 hours, if necessary, increasing the dose to 60 mg every 12 hours. If a higher dose is required, the dose increase is 25% -50%, while a 12-hour interval between doses is maintained. In exhausted and debilitated patients, the initial dose should be reduced. In patients who previously received the usual dosage forms of morphine or diamorphine, the same daily dose of MCT Kontinus should be applied, dividing it into 2 doses. In patients who switch from parenteral administration of morphine to oral administration of MCT Kontinus, the dosage should initially be increased in order to avoid a decrease in the analgesic effect. Usually, this increase should be 50-100% of the applied dose. In such patients, the dose should be selected individually.Elderly: as with the use of other narcotic analgesics, it is recommended to reduce the dose.Children from the age of 7: single dose should be 0.2-0.8 mg / kg body weight every 12 hours. Postoperative pain syndromeAdults: patients up to 70 kg - 20 mg 2 times a day, patients from 70 kg - 30 mg 2 times a day.Taking the drug in children is not recommended. Side effects:From the digestive system: nausea and vomiting (often at the beginning of therapy), constipation, dry mouth, anorexia, biliary tract spasm, cholestasis, gastralgia, hepatotoxicity (dark urine, pale stool, icteric sclera and skin), with severe inflammatory bowel disease - intestinal atony, paralytic intestinal obstruction, toxic megacolon.From the cardiovascular system: decrease or increase in blood pressure, tachycardia or bradycardia.From the respiratory system: oppression of the respiratory center, bronchospasm, atelectasis. From the nervous system: dizziness, fainting, drowsiness, unusual fatigue, general weakness, headache, tremor, involuntary muscular twitching, discoordination, paresthesia, confusion (hallucinations, depersonalization), increased intracranial pressure with the probability of subsequent cerebral circulatory disorders, insomnia, restless sleep. Against the backdrop of high doses - rigidity of the muscles (especially respiratory), in children - paradoxical agitation, anxiety, seizures,nightmares, sedative or stimulating effects (especially in elderly patients), delirium, decreased ability to concentrate.From the genitourinary system: decreased urine output, ureteral spasm, decreased libido, reduction of potency, spasm of the sphincter of the bladder, impaired outflow of urine or aggravation of the condition in prostate hyperplasia and stenosis urethra.Allergic reactions: hyperemia of the face, skin rash, face swelling, edema of the trachea, laryngospasm, chills.Other: increased sweating, dysphonia; violation definition of visual perception (including diplopia), miosis, eye, imaginary feeling of well being, discomfort; tinnitus, drug dependence and tolerance, "cancellation" syndrome (muscle pain, diarrhea, tachycardia, mydriasis, pyrexia, rhinitis, sneezing, sweating, yawning, anorexia, nausea, vomiting, nervousness, fatigue, irritability, tremors, stomach cramps , dilated pupils, fatigue, hypoxia, muscle contraction, headache, increased blood pressure, and others. vegetative symptoms).Drug dependence, tolerance, withdrawal syndrome. Overdose:Symptoms: bradycardia, lowering of arterial pressure, hypothermia, anxiety, dry mouth, delirium, increased intracranial pressure (with the probability of subsequent cerebral circulation disorders), hallucinations, miosis, muscle rigidity, convulsions, in severe cases - respiratory arrest, coma.Treatment: gastric lavage, restoring breathing and maintaining cardiac activity. Intravenous introduction of a specific antagonist opioid analgesics - naloxone in a single dose 0.2-0.4 mg, with repeated administration 2-3 minutes before the total dose of 10 mg, symptomatic therapy. Interaction:Strengthens the effect of hypnotics, sedatives, general and local anesthetic drugs, anxiolytics.With the systematic administration of barbiturates, especially phenobarbital, the likelihood of reducing the analgesic effect of narcotic analgesics is high, it stimulates the development of cross-tolerance.At simultaneous reception with monoamine oxidase inhibitors (because of possible overexcitation or inhibition with the appearance of hyper- or hypotensive crises), the dosage should be reduced by% of the initial dose.With simultaneous admission with beta-blockers, it is possible to intensify the inhibitory effect on the central nervous system, with dopamine - decrease the analgesic effect of morphine, with cimetidine - increase respiratory depression.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 restores breathing, eliminates analgesia after the application of morphine. Nalorphine eliminates the respiratory depression caused by morphine.Preparations with anticholinergic activity, antidiarrhoeal agents (including loperamide) increase the risk of constipation (up to intestinal obstruction), urinary retention and central nervous system depression.Ethanol, muscle relaxants and drugs, depressing the central nervous system, enhance the depressant effect and respiratory depression.Buprenorphine (including the previous therapy) reduces the effect of other opioid analgesics; on the background of the use of high doses of agonists of mu-opioid receptors reduces respiratory depression,and the background of the use of low doses of agonists of mu-or kappa-opioid receptors - enhances; accelerates the appearance of the symptoms of "withdrawal syndrome" when discontinuing the admission of agonists of mu-opioid receptors against the background of drug dependence, with a sudden withdrawal of them partially reduces the severity of these symptoms.Naloxone reduces the effect of opioid analgesics, as well as the respiratory depression and central nervous system caused by them; may require large doses to level the effects of butorphanol, nalbuphine and pentazocine, which have been prescribed to eliminate the undesirable effects of other opioids; can accelerate the appearance of symptoms of "withdrawal syndrome" against the background of drug dependence.Naltrexone accelerates the appearance of symptoms of "withdrawal 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, antitussive); does not affect the symptoms caused by the histamine reaction.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).Reduces the effect of metoclopramide. Effect on the ability to drive transp. cf. and fur:During the period of treatment, it is necessary to refrain from driving motor vehicles and practicing other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions, and avoid the use of alcohol-containing beverages. Form release / dosage:Tablets of prolonged action, coated with 10, 30, 60 and 100 mg. Packaging:By 10 or 20, or 30 tablets in a blister of PVC, coated with PVDC and aluminum foil. For 1 blister for 20 tablets or 1 or 2 blisters for 10 tablets, or 1 or 2 blisters of 30 tablets together with the instructions for use are placed in a cardboard box. Storage conditions:At a temperature of no higher than 25 ° C.It refers to the List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation (approved by RF Government Resolution No. 681 of June 30, 1998). Accounting and storage is carried out in accordance with the requirements of the instructions RD - 64-008-87. Keep out of the reach of children. Shelf life:5 years. Do not use after the date shown on the package. Terms of leave from pharmacies:On prescription Registration number:П N014264 / 01 Date of registration:03.08.2010 Expiration Date:Unlimited The owner of the registration certificate: Mundifarma GmbH, Germany Mundifarma GmbH, Germany Germany Manufacturer: & nbspBARD PHARMACEUTICALS, Ltd. United KingdomMOSCOW ENDOCRINE FACTORY, FSUE Russia Representation: & nbspMundifarma Gesm.b.XMundifarma Gesm.b.X Information update date: & nbsp2016-10-03 Illustrated instructions × Illustrated instructions Instructions