Active substanceCodeine + Morphine + Noscapine + Papaverine hydrochloride + TebainCodeine + Morphine + Noscapine + Papaverine hydrochloride + Tebain
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  • Omnompon
    solution PC 
  • Dosage form: & nbsphypodermic solution
    Composition:

    1 ml of the solution contains:

    active substances:

    codeine monohydrate 0.72 mg or 1.44 mg,

    morphine hydrochloride trihydrate (in terms of morphine hydrochloride) - 5.75 mg or 11.5 mg,

    noscapine 2.7 mg or 5.4 mg, papaverine hydrochloride 0.36 mg or 0.72 mg, thebaine 0.05 mg or 0.1 mg.

    Excipients:

    disodium edetate (ethylenediaminetetraacetic acid disodium salt) - 0.5 mg, glycerol (glycerine distilled) - 60 mg,

    hydrochloric acid 1 M - up to a pH of 2.5-3.5, water for injection - up to 1 ml.

    Description:Transparent colorless or light yellow liquid.
    Pharmacotherapeutic group:Analgesic narcotic drug
    ATX: & nbsp

    N.02.A.A.51   Morphine in combination with other drugs

    Pharmacodynamics:
    Omnopon increases the pain threshold, inhibits conditioned reflexes and causes euphoria has mild sedative and central antitussive effect, increases the tonus of the vagus nerve center, stimulates the vomiting center, depresses the respiratory center, causing constriction of the pupil due to the activation center oculomotor nerve, attenuates intestinal peristalsis,inhibits the secretory activity of the glands of the gastrointestinal tract. Somewhat reduces the basal metabolic rate and body temperature, stimulates the release of antidiuretic hormone. With subcutaneous administration of Omnepona, the analgesic effect develops in 10-15 minutes and persists for 3-5 hours.

    The main pharmacological properties of Omnepone are due to the morphine contained in it. Morphine - an agonist of predominantly mu-opioid receptors, activates the endogenous antinociceptive system and thus disrupts the interneuronal transmission of pain impulses at various levels of the central nervous system, and also changes the emotional color of the pain, affecting the higher parts of the brain.

    Morphine increases the threshold of pain sensitivity with stimuli of different modalities, inhibits conditioned reflexes, has euphoric and moderate hypnotic activity, increases the tone of the center of the vagus nerve. It can stimulate chemoreceptors of the start-up zone of the vomiting center and cause nausea and vomiting, depress respiratory and vomiting centers, cause pupillary narrowing due to activation of the center of the oculomotor nerve, increase bronchial tone and smoothing(intestines, bile ducts, bladder), increases the contractile activity of the myometrium, weakens the intestinal motility, inhibits the secretory activity of the glands of the gastrointestinal tract. Somewhat reduces the basal metabolism 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, reddening of the skin, increased sweating, reddening of the protein coat of the eyes. Enhances the influence on the central nervous system of means for general anesthesia, hypnotics, sedatives, H blockers1 histamine receptors with a central component of action, anxiolytic, antipsychotic and antidepressant drugs.

    Papaverin is a spasmolytic agent that exerts an antihypertensive effect, reduces tone and relaxes the smooth muscles of the internal organs and vessels. Due to the content of papaverine, Omnipon is to a lesser extent than morphine, causes spasms of smooth muscles of internal organs.

    Codeine is a natural narcotic analgesic from the group of opioid receptor agonists. Anesthetic activity is caused by the excitation of opioid receptors in various parts of the central nervous system and peripheral tissues, leading to stimulation of the antinociceptive system and changes in emotional perception of pain.

    Thebaine is the smallest in number of components of the drug. According to its chemical structure, thebaine is similar to morphine and codeine. Tebain has an analgesic effect, affecting opioid receptors in the central nervous system. According to its pharmacological properties, thebaine differs from morphine and codeine in that it produces an exciting, not depressing, effect on the nervous system. Tebain in small doses has a weak hypnotic effect. Potentiates the effect of codeine and morphine.

    Noscapine is an alkaloid poppy dormant, a benzylisoquinoline derivative; is an agonist predominantly σ-opioid receptors, has almost no analgesic properties, has antitussive effect. Noscapin's Eyehas a spasmolytic effect on smooth muscle.Has a potentiating effect on the spasmolytic activity of papaverine.

    Pharmacokinetics:

    The volume of distribution of morphine is 4 l / kg. With proteins of blood plasma, 30-35% of morphine is associated.

    Morphine is excreted from the body in the form of glucuronide metabolites (up to 80%) or unchanged mainly through the kidneys; A small part is excreted with bile and excreted with feces. The drug passes through the placental barrier and is found in breast milk.

    Papaverine in the liver undergoes biotransformation. It is excreted by the kidneys mainly in the form of metabolites. Plasma binds to proteins.

    Codeine undergoes biotransformation in the liver, 10% by demethylation being converted into morphine. Excreted by the kidneys 5-15% in the form of codeine and 10% in the form of morphine and its metabolites. The connection with plasma proteins is insignificant.

    Thebaine has pharmacokinetic properties similar to codeine. The main metabolite of thebaine is oripavine.

    Noscapine after administration into the body quickly disappears from the blood and passes into tissues. During the first six hours after ingestion, it is excreted unchanged in the urine, and after this time, noscapine is excreted from the body in the form of conjugates. Decay products are found in the urine for a long time (up to 1 month).

    Indications:

    Severe pain of various etiologies (postoperative period, trauma, pain in cancer patients, myocardial infarction, renal, hepatic, intestinal colic, etc.).

    Anesthesia in the conduct of painful diagnostic and therapeutic measures.

    Contraindications:

    Hypersensitivity to the components of the drug.

    Conditions accompanied by respiratory depression or severe depression of the central nervous system. Convulsive conditions. Increased intracranial pressure. Craniocerebral injury. Acute alcoholic conditions, including alcoholic psychosis.

    Bronchial asthma. Pulmonary heart failure. Heart rhythm disturbances.

    Acute surgical diseases of the abdominal cavity before diagnosis.

    Conditions after surgical interventions on the biliary tract. Paralytic ileus.

    Joint reception with monoamine oxidase inhibitors and within 14 days after their cancellation.

    Children up to 2 years.

    If you have any of these diseases, consult a doctor before taking the drug.

    Carefully:

    Patients of advanced age, with general exhaustion, with adrenal insufficiency; Patients with an anamnesis indicating an addiction to opioids.Alcoholism, suicidal tendencies, emotional lability, epileptic syndrome, chronic obstructive pulmonary disease, hypothyroidism, surgicalor gastrointestinal interventions, urinary system, hepatic or renal insufficiency, cholelithiasis, severe inflammatory bowel diseases, urethral stricture, prostatic hyperplasia.

    If you have any of these diseases, consult a doctor before taking the drug.

    Pregnancy and lactation:

    In pregnancy, childbirth and during breast-feeding, application of Omnepona is permissible only for vital indications (it is possible to develop drug dependence in the fetus and newborn).

    Dosing and Administration:

    Doses of the drug are selected individually depending on the severity of the pain syndrome, age and condition of the patient.

    - Adult patients are injected subcutaneously with 1 ml of the solution at a dosage of 0.72 + 5.75 + 2.7 + 0.36 + 0.05 mg / ml. Periodicity of appointment 4-5 hours. The highest single dose is 3 ml of the solution. The highest daily dose is 10 ml.

    - If necessary, increase the dose prescribed 1 ml of the solution with a dosage of 1.44 + 11.5 + 5.4 + 0.72 + 0.1 mg / ml. If necessary, repeat the drug after 4-5 hours. The highest single dose is 1.5 ml of solution.The highest daily dose is 5 ml.

    - Children older than 2 years: the drug at a dosage of 0.72 + 5.75 + 2.7 + 0.36 + 0.05 mg / ml onmean a dose of 0.1 ml (age 2-3 years) to 0.75 ml (age 12-14 years) taking into account the general condition and the required degree of anesthesia.

    Side effects:

    Euphoria, urination disorders, allergic reactions, depression, hallucinations, nausea, less often vomiting, dizziness, muscle weakness, constipation. Drowsiness or agitation, exacerbation of brain diseases due to increased intracranial pressure, spasms of the bile duct and sphincter of the bladder, moderate respiratory depression are also possible.

    To reduce the side effects on the intestines, a laxativefunds.

    Strengthens the depressing effect on the central nervous system of means for general anesthesia, hypnotics, sedatives, blockers H1-gistaminovyh receptors with the central component of action, antidepressants, anxiolytic and antipsychotic drugs.

    It is addictive and drug (opioid) dependence (physical and mental). Causes the widening of the peripheral blood vessels and the release of histamine,which can lead to bronchospasm, lower blood pressure, reddening of the skin, increased sweating, reddening of the protein coat of the eyes.

    With the repeated application of Omnepona for 1-2 weeks (sometimes within 2-3 days), it is possible to develop addiction (weakening of the analgesic effect) and opioid drug dependence. 1-2 days after discontinuation of the drug, signs of withdrawal syndrome (mydriasis, yawn, muscle contractions, headache, sweating, vomiting, diarrhea, tachycardia, hyperthermia, increased blood pressure and other vegetative symptoms) may appear, which requires treatment in conditions of a specialized department.

    If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

    Overdose:

    Symptoms: stuporous or coma, hypothermia, lowering of arterial pressure, respiratory depression. A characteristic feature is a pronounced narrowing of the pupils (with significant hypoxia the pupils can be enlarged).

    Treatment: maintenance of adequate pulmonary ventilation.Intravenous injection of a specific opioid antagonist - naloxone in a dose of 0.4 to 2 mg quickly restores breathing. In the absence of effect after 2-3 minutes, the administration of naloxone is repeated. The initial dose of naloxone for children is 0.01 mg / kg. It should take into account the short-term effect of naloxone. It is also necessary toa thread about the possibility of the development of the "withdrawal" syndrome with the administration of naloxone to patients with dependence on opioids - in such cases, the doses of the antagonist should be increased gradually.

    Interaction:
    Under careful supervision and in reduced doses, Omnopon should be used against the background of the means for general anesthesia, hypnotics, anxiolytics, antidepressants and antipsychotics in order to avoid excessive central nervous system depression and inhibition of respiratory center activity. Omnupon should not be combined with narcotic analgesics from the group of partial agonists (buprenorphine, tramadol) and agonystov-antagonists (nalboufine, butorphanol) opioid receptors because of the danger of weakening analgesia and the possibility of provoking a withdrawal syndrome.The analgesic effect and undesirable effects of opioid agonists (trimeperidine, fentanyl) in the therapeutic dose range are summarized with the effects of Omniphone.
    Effect on the ability to drive transp. cf. and fur:

    During the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

    Form release / dosage:The solution for subcutaneous administration is 0.72 + 5.75 + 2.7 + 0.36 + 0.05 mg / ml and 1.44 + 11.5 + 5.4 + 0.72 + 0.1 mg / ml.

    Packaging:AT ampoules of 1 ml. 5 ampoules in the outline of the cell. 1 or 2 contourcell packs with instructions for use in a pack of cardboard. 20, 50 or 100 contour mesh packages together with an equal number of instructions for use in a cardboard box or in a box of corrugated cardboard (for inpatient).
    Storage conditions:

    List II. "List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation", in specially equipped premises with a license for the specified type of activity.

    In the dark place at a temperature of no higher than 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001052
    Date of registration:12.08.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia
    Manufacturer: & nbsp
    Information update date: & nbsp07.06.2017
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