Omnopon injections intravenously. Instructions for use Omnopon (solution)

Registration number : LS-001052

Trade name of the drug: Omnopon

Dosage form: solution for subcutaneous administration

Compound: 1 ml of solution contains:
Active substances : morphine hydrochloride - 5.75 mg or 11.5 mg. narcotine - 2.7 mg or 5.4 mg, papaverine hydrochloride - 0.36 mg or 0.72 mg, codeine - 0.72 mg or 1.44 mg, thebaine - 0.05 mg or 0.1 mg.
Excipients: disodium salt of ethylenediaminetetraacetic acid (disodium edetate), glycerin (glycerol), 1M hydrochloric acid solution, water for injection.

Description: Transparent colorless or light yellow liquid

Pharmacotherapeutic group: Analgesic narcotic
ATX code N02AX

PHARMACOLOGICAL PROPERTIES
Omnopon- Refers to List II of the List narcotic drugs, psychotropic substances and their precursors subject to control in Russian Federation.
Basic pharmacological properties omnopona due to the content contained in it morphine. 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 coloring of pain, affecting higher departments brain.

Pharmacodynamics
Omnopon raises the threshold pain sensitivity, inhibits conditioned reflexes, causes euphoria and has a moderate hypnotic and central antitussive effect, increases the tone of the center vagus nerve, stimulates the vomiting center, depresses respiratory center, causes constriction of the pupil due to activation of the center oculomotor nerve, weakens intestinal motility, inhibits the secretory activity of glands gastrointestinal tract. Slightly reduces basal metabolism and body temperature. Stimulates the release of antidiuretic hormone. When omnopon is administered subcutaneously, the analgesic effect develops within 10-15 minutes and lasts for 3-5 hours.
Papaverine hydrochloride - antispasmodic, providing hypotensive effect, reduces tone and relaxes smooth muscles internal organs and vessels. Due to the content of papaverine, omnopon causes spasms of the smooth muscles of internal organs to a lesser extent than morphine. Codeine is a natural narcotic analgesic from the group of opiate receptor agonists. Analgesic activity is due to stimulation of opiate receptors in various parts of the central nervous system and peripheral tissues, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain. Drug- an opioid alkaloid that suppresses the cough center.

Pharmacokinetics
Volume of distribution morphine is 4 l/kg. 30-35% of the drug is bound to plasma proteins.
Morphine excreted from the body in the form of glucuronide metabolites (up to 80%) or unchanged, mainly through the kidneys; a small part is excreted in bile and excreted in feces. The drug crosses the placental barrier and is found in breast milk.
Papaverine undergoes biotransformation in the liver. It is excreted by the kidneys mainly in the form of metabolites. In plasma it binds to proteins.
Codeine undergoes biotransformation in the liver, with 10% becoming mofin by demethylation. Excreted by the kidneys 5-15% in the form of codeine and 10% in the form of morphine and its metabolites. Communication with plasma proteins is insignificant.

Indications for use
Severe pain syndrome of various origins, both acute and chronic (myocardial infarction, trauma, post-traumatic period, malignant neoplasms, in preparation for surgery and in postoperative period and so on.). Pain syndrome (renal, liver, intestinal colic combinations with myotropic antispasmodics or atropine-like drugs).

Contraindications
Increased sensitivity to the components of the drug.
Conditions accompanied by respiratory depression or severe depression of the central nervous system. Convulsive states. Increased intracranial pressure. Head injury.
Bronchial asthma. Paralytic ileus. Heart failure due to chronic diseases lungs. Cardiac arrhythmias.
Acute surgical diseases organs abdominal cavity before diagnosis is made. Conditions after surgical interventions on the biliary tract. Joint reception with monoamine oxidase inhibitors and for 14 days after their discontinuation.
Children under 2 years old.
During pregnancy, childbirth and during breastfeeding the use of omnopon is permissible only for health reasons (possible development drug addiction in the fetus and newborn).
Carefully - elderly patients, with general exhaustion, with liver and kidney disease, insufficiency of the adrenal cortex, patients with a history of indication of addiction to opioids.

Directions for use and doses
Doses of the drug are selected individually depending on the severity pain syndrome, age and condition of the patient.
Typically, adults are administered subcutaneously 1 ml of a 1% or 2% solution. If necessary, the drug is re-administered after 4-5 hours. The highest single dose is 30 mg (3 ml of 1% solution or 1.5 ml of 2% solution), highest daily dose- 100 mg (10 ml of 1% solution or 5 ml of 2% solution).
For children over 2 years of age, the drug is prescribed in a dose of 1 mg (age 2-3 years) to 7.5 mg (age 12-14 years), taking into account general condition and the required degree of pain relief.

Side effect
Euphoria, urinary 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 biliary tract and sphincter are also possible. Bladder, moderate respiratory depression. For decreasing side effect laxatives should be prescribed for the intestines
Strengthens the inhibitory effect on the central nervous system of anesthetics, hypnotics, sedatives, antihistamines with a central component of action, antidepressants, anxiolytics and antipsychotic drugs. Causes addiction and drug (opioid) dependence (physical and mental). Causes expansion of peripheral blood vessels and histamine release, which can lead to bronchospasm and hypotension. redness of the skin, increased sweating, redness of the white membrane of the eyes.
At reuse omnopona within 1-2 weeks (sometimes within 2-3 days), addiction (weakening of the analgesic effect) and opioid drug dependence may develop. 1-2 days after stopping the use of the drug, signs of withdrawal syndrome may appear (mydriasis, yawning, muscle contractions, headache, sweating, vomiting, diarrhea, tachycardia, hyperthermia, hypertension and others autonomic symptoms), which requires treatment in a specialized department.

Overdose
Symptoms: stuporous or coma, hypothermia, decreased blood pressure, respiratory depression is observed. A characteristic feature is a pronounced constriction of the pupils (with significant hypoxia, the pupils can be dilated).
Treatment: maintaining adequate pulmonary ventilation. Intravenous administration The specific opioid antagonist naloxone in a dose of 0.4 to 2 mg quickly restores breathing. If there is no effect, the administration of naloxone is repeated after 2-3 minutes. The starting dose of naloxone for children is 0.01 mg/kg. The short duration of action of naloxone should be taken into account. It is also necessary to remember about the possibility of developing withdrawal syndrome when administering naloxone to patients with addiction to morphs and similar drugs - in such cases, the dose of the antagonist should be increased gradually.

Interaction with others medicines
Under close supervision and in reduced doses, OMNOPON should be used against the background of the effects of anesthesia, sleeping pills, anxiolytics. antidepressants and antipsychotics to avoid excessive depression of the central nervous system and suppression of the activity of the respiratory center. OMNOPON should not be combined with narcotic analgesics from the group of partial agonists (buprenorphine, tramadol) and agonists-antagonists (nalbuphine, butorphanol) of opioid receptors due to the risk of weakening analgesia and the possibility of provoking withdrawal syndrome.
Analgesic effect and unwanted effects opioid agonists (promedol, fentanyl) in the therapeutic dose range are cumulative with the effects of OMNOPON.

special instructions
During the treatment period, it is necessary to refrain from potentially active activities dangerous species activities requiring increased concentration attention and speed of psychomotor reactions.

Release form
Solution for subcutaneous administration. Ampoules of 1 ml containing 1% or 2% solution.
5 ampoules in a blister pack. 1-2 blister packs per cardboard box or 20, 50 or 100 blister packs (for hospital use).

Storage conditions
Store in a place protected from light at a temperature not exceeding 15 degrees List II. List of narcotic drugs, psychotropic substances and their precursors subject to control of the Russian Federation.
Keep out of the reach of children!

Best before date
3 years. It is prohibited to use the drug after the date indicated on the package.

Vacation conditions
Dispensed from pharmacies on prescription with the same restrictions as other narcotic analgesics.

Manufacturer:
Federal State Unitary Enterprise "Moscow Endocrine Plant",
Moscow city. 109052. st. Novokhokhlovskaya, 25.

In some situations, the pain syndrome is so intense that the use of fairly intense painkillers is mandatory. In such cases, doctors often use the drug Omnopon. The instructions created by the manufacturer contain data that this medication really helps to cope with pain.

Considering the fact that the medicine belongs to the group of narcotic drugs, patients are interested in any available information. What is the drug "Omnopon"? Instructions for use, reviews, analogues, possible complications These are the points that definitely need to be considered.

Composition information

This drug is available in the form of a solution intended for subcutaneous administration. It is a clear, colorless liquid, although it is allowed presence of lung yellowish tint. The medicine is placed in glass ampoules.

What does the composition of the drug "Omnopon" look like? The instructions contain information that active ingredients medications are morphine hydrochloride, narcotine, as well as codeine, thebaine and papaverine hydrochloride. In addition, the composition also contains some excipients, including glycerol, purified water for injection, sodium edetate, and hydrochloric acid solution.

Pharmacological properties

What properties does the medicine “Omnopon” have? Instructions for use, reviews, indications and limitations are important points which should not be ignored. However, first, it is better to familiarize yourself with the general information.

This drug belongs to the group of psychotropic, narcotic substances, the distribution of which is controlled at the state level. One of active ingredients is morphine, which affects the higher parts of the brain and disrupts the natural transmission of pain impulses.

This medicine increases the threshold of sensitivity to pain, and also causes euphoria and inhibits conditioned reflexes. The drug has hypnotic and sedative properties, partially inhibits the functioning of the respiratory center, and also stimulates the synthesis of antidiuretic hormone and slows down the peristalsis of the digestive tract.

Narcotine belongs to the group of opioid alkaloids and acts on the cough center of the brain, suppressing its activity. Papaverine is known to be an antispasmodic - this substance reduces the tone of smooth muscle fibers of blood vessels and internal organs. Codeine belongs to the group of fairly powerful narcotic analgesics.

Brief information about pharmacodynamics

The active components spread quite quickly throughout the body along with the blood. Approximately 30-35% of the drug is bound to plasma proteins.

Morphine is excreted from the body by the kidneys almost unchanged. Codeine and papaverine are metabolized in liver tissue. Their metabolites also leave the body in urine.

When should you take the medicine?

In what cases do patients need such an intensive drug as Omnopon? The instructions contain information about the main indications.

• The medicine is used to relieve severe pain, regardless of its origin. It is prescribed to patients with trauma, myocardial infarction, and malignant neoplasms. We are talking about both acute and chronic pain.
• The drug is used in the pre- and postoperative period.
• In combination with antispasmodics and atropine-like drugs this medicine prescribed for renal, intestinal and hepatic colic.

The drug "Omnopon": instructions for use (in ampoules)

It is worth noting that you should never use this medicine on your own. Only a doctor can prescribe the drug "Omnopon". Instructions for use are intended for informational purposes only. In any case, the medicine is dispensed at the pharmacy only with a prescription.

In most cases, patients are given 1 ml of a 1% or 2% solution, although the dose is determined individually. In some cases, the procedure is repeated after 4-5 hours. The maximum single dose is 3 mg of 1% or 1.5 mg of 2% solution. A patient can be administered no more than 10 mg of 1% or 5 mg of 2% medication per day.

Information about contraindications

This is a rather serious medicine that cannot always be taken. It is worth familiarizing yourself with a fairly impressive list of contraindications before starting treatment.

• The drug is not prescribed to patients if there is a risk of developing an allergic reaction (a history of hypersensitivity to any components of the drug).
• It should not be taken by people in conditions that are accompanied by suppression of the activity of the nervous system and the respiratory center, in particular.
• Contraindications include convulsive conditions and various injuries heads.
• The medicine is not used in the presence of bronchial asthma, arrhythmia, as well as those forms of heart failure, the development of which is associated with chronic pathologies lungs.
• Injections are not performed for surgical diseases of the abdominal organs until the patient has an accurate diagnosis.
• The medicine has age restrictions - children under 2 years old should not take the drug.
• Pregnancy is relative contraindication. If intense pain occurs, the expectant mother may be prescribed injections, but it is worth keeping in mind that such therapy is sometimes accompanied by the development of drug dependence ( we're talking about both about the woman and the fetus).

Is it always safe to take this drug? Description of possible complications

In most cases, the treatment is well tolerated. But we cannot exclude the possibility of side effects.

• In some cases, treatment is associated with reactions from the nervous system. The drug may cause drowsiness or, conversely, agitation. To the list adverse reactions include euphoria, dizziness, hallucinations, and depression.
• The medicine may cause muscle weakness.
• Since the drug affects smooth muscles, during therapy it is possible various disorders urination, as well as persistent spasms of the bladder sphincter.
• Administration of medication may cause problems with performance digestive system. Patients often complain of constipation. That is why laxatives are often included in the treatment regimen.
• Other complications include allergic reactions different types, increased intracranial pressure and exacerbation of existing brain diseases, spasms of the biliary tract.

It is also worth saying that long-term use Taking such a powerful drug is often accompanied by the development of dependence with the further appearance of withdrawal syndrome. That is why the drug must be used very carefully.

Overdose information

Are too large doses of Omnopon solution dangerous? The instructions contain information and possibilities of overdose. This condition accompanied by sharp decline blood pressure. Respiratory depression is also observed. Using too large dose the drug can lead to a coma.

Patients with similar symptoms urgently needs to be taken to the first aid station. The specific antagonist is Naloxone, which is administered intravenously. The doctor's task is also to maintain normal pulmonary ventilation.

What to replace the medicine with?

Many patients are faced with the need to take the drug Omnopon. Instructions for use, analogues, reviews - this important information. So, what can replace the drug described above?

Drugs such as Sompon and Domopon will help cope with pain. The list of effective painkillers includes “Pantopon” and “Papaverat”. In any case, you cannot look for analogues on your own - this matter can only be entrusted to the attending physician.

Photo of the drug

Latin name: Omnopon

ATX code: N02AX

Active substance:

Analogues: Zaldiar, Tramal Retard 200, Tramal, Tramadol

Manufacturer: Moscow Endocrine Plant (Russia), Health of the People Pharmfabrika (Ukraine)

Updating instructions: 06.06.2015

Instructions for medical use

medicine

OMNOPON

Tradename

International nonproprietary name

Dosage form

Solution for injection, 2% 1 ml

Compound

1 ml of solution contains

active substances: morphine hydrochloride 11.50 mg

noscapine 5.40 mg

papaverine hydrochloride 0.72 mg

codeine 1.44 mg

thebaine 0.10 mg

Excipients: disodium edetate, glycerin, 1 M hydrochloric acid solution, water for injection

Description

Transparent colorless or yellowish color liquid

Pharmacotherapeutic group

Analgesics Opioids Natural alkaloids opium Morphine in combination with other drugs

ATX code N02AA51

Pharmacological properties

Pharmacokinetics

When administered subcutaneously, it is quickly absorbed into the systemic circulation.

Penetrates through histohematic barriers, including blood-brain, placental (can cause depression of the fetal respiratory center), in breast milk. Plasma protein binding of morphine is approximately 35%, codeine - about 7%, papaverine - almost 90%. Morphine is metabolized in the liver to form the main inactive metabolite morphine-3-glucuronide, as well as the active morphine-6-glucuronide. Codeine is metabolized by O- and N-demethylation in the liver to form morphine and norcodeine. Papaverine is rapidly metabolized in the liver to form phenolic metabolites. The half-life is 2-3 hours. It is excreted in the form of metabolites mainly by the kidneys - 90%, the rest - with bile. In case of impaired liver and kidney function, as well as in elderly patients, an increase in the half-life is possible.

Pharmacodynamics

Morphine hydrochloride is an opioid analgesic. Has a pronounced analgesic effect. The mechanism of action is due to the stimulation of various subtypes of opioid receptors of the central nervous system (delta, mu and kappa). Excitation of delta receptors causes analgesia; mu receptors - supraspinal analgesia, euphoria, physical dependence, respiratory depression, stimulation of the vagus nerve centers; kappa receptors - spinal analgesia, sedation, miosis.

Inhibits the interneuronal transmission of pain impulses in the central part of the afferent pathway, reduces the emotional assessment of pain, causes euphoria, which contributes to the formation of dependence (physical and mental). By reducing the excitability of pain centers, it has an anti-shock effect. In high doses it exhibits sedative activity and causes hypnotic effect. Inhibits conditioned reflexes, reduces the summative ability of the central nervous system, and potentiates the effect of depressants. Reduces the excitability of the thermoregulation center, stimulates the release of vasopressin. It has virtually no effect on vascular tone. It depresses the respiratory center, reduces the excitability of the cough center, excites the vagus nerve centers, causing bradycardia, stimulates the neurons of the oculomotor nerves, and constricts the pupil (miosis). May stimulate trigger zone chemoreceptors medulla oblongata and induce nausea and vomiting. It inhibits the vomiting center, therefore the use of the drug in repeated doses and emetics administered after it do not cause vomiting. Increases the tone of the smooth muscles of internal organs: sphincters of Oddi, bladder, antrum of the stomach, intestines, biliary tract, bronchi. Weakens peristalsis, slows down the movement of food masses, and contributes to the development of constipation.

Papaverine hydrochloride is an antispasmodic agent that has a hypotensive effect, reduces tone and relaxes the smooth muscles of internal organs and blood vessels. Due to the content of papaverine, Omnopon causes spasms of the smooth muscles of internal organs to a lesser extent than morphine.

Codeine is a natural narcotic analgesic from the group of opiate receptor agonists. Analgesic activity is due to stimulation of opiate receptors in various parts of the central nervous system and peripheral tissues, leading to stimulation of the antinociceptive system and a change in the emotional perception of pain.

Noscapine (narcotine) is an opioid alkaloid that suppresses the cough center.

Indications for use

• pain syndrome of severe intensity, incl. for malignant neoplasms, myocardial infarction, severe injuries
• preparation for surgery
• postoperative period.

Directions for use and doses

The drug is administered subcutaneously. The dosage regimen is individual. As a rule, adults are administered 1 ml.

The appropriate dose is prescribed every 12-24 hours depending on the severity of the pain syndrome.

Maximum doses for adults: single - 1.5 ml, daily - 5 ml.

The dose should be reduced for elderly people and patients with disorders mental state and patients with liver and kidney failure.

Children from 2 to 7 years old are administered subcutaneously 0.05 ml per year of life, children 8-10 years old - 0.3 ml, over 10 years old - 0.4 ml.

Side effects

• with prolonged use, bradycardia or tachycardia is possible
• violations heart rate
• orthostatic hypotension
• respiratory depression
• bronchospasm
• sedative or stimulating effects (especially in elderly patients)
• delirium
• hallucinations, euphoria
• increased intracranial pressure with the likelihood of subsequent impairment cerebral circulation
• headache
• hypothermia
• depression
• constriction of the pupils
• when using high doses it is possible muscle rigidity
• dry mouth
• nausea
• vomit
• constipation
• spasm of the biliary tract with a subsequent increase in the level of bile enzymes
• disturbance of the outflow of urine or aggravation of this condition with prostate adenoma and urethral stenosis
• allergic reactions (including urticaria)
• decreased libido
• with repeated use, addiction, drug dependence (physical and mental), and withdrawal syndrome are possible.

Contraindications

• respiratory failure due to depression of the respiratory center
• bronchial asthma
• heart failure due to chronic lung diseases
• cardiac arrhythmias
• heavy liver failure
• traumatic brain injury
• intracranial hypertension
• stroke
• status epilepticus
• general severe exhaustion, cachexia
• stomach ache unknown etiology
• acute diseases internal organs before diagnosis
• acute alcohol intoxication
• simultaneous treatment monoamine oxidase inhibitors
• fever
• individual hypersensitivity to the components of the drug
• children under 2 years old
• pregnancy, breastfeeding period

Use with caution in elderly patients and patients with a history of opioid addiction.

Drug interactions

At simultaneous use: with other drugs that have a depressive effect on the central nervous system, increased depression of the central nervous system is possible; with beta-blockers - increased inhibitory effect on the central nervous system; with butadione - accumulation of morphine is possible; with dopamine - a decrease in the analgesic effect of Omnopon; with cimetidine - increased respiratory depression; with phenothiazine derivatives and barbiturates - enhancement hypotensive effect and respiratory depression. Long-term use barbiturates (especially phenobarbital) or narcotic analgesics cause the development of cross-tolerance. Chlorpromazine enhances analgesic, as well as miotic and sedative effects Omnopona.

special instructions

Not used for pain relief during labor, since morphine penetrates the placental barrier and can cause respiratory depression in the newborn.

Use with caution in cases of impaired liver and kidney function, hypothyroidism, adrenal insufficiency, prostate hypertrophy, shock, myasthenia gravis, inflammatory diseases gastrointestinal tract, as well as in patients over 60 years of age.

During the treatment period, avoid drinking alcohol.

The ability to influence the speed of reaction during control vehicle or potentially dangerous mechanisms

During the treatment period, you should not drive vehicles or engage in other potentially hazardous activities that require rapid psychomotor reactions.

Overdose

Symptoms: respiratory depression and hypotension with the development of circulatory failure and coma, miosis. Children may also have seizures and may develop renal failure. The toxicity of the drug depends on the amount administered and individual sensitivity to morphine.

Treatment: maintaining adequate pulmonary ventilation, general resuscitation measures, transfusion therapy, oxygen therapy, peritoneal dialysis. Intravenous administration of the specific antagonist naloxone in a dose of 0.4 to 2 mg (initial dose for children - 0.01 mg/kg intravenously), if necessary - every 20-30 minutes, then with a 2-hour break - intramuscularly until breathing is restored . The use of naloxone in drug addicts can lead to the development of withdrawal syndrome; in such cases, the dose of the antagonist should be increased gradually. Analeptics are contraindicated.

Release form and packaging

1 ml in glass ampoules.

5 ampoules per blister pack made of polyvinyl chloride film and printed varnished aluminum foil.

20 blister packs along with instructions for medical use in the state and Russian languages ​​and a ceramic cutting disc or ceramic ampoule knife are placed in a cardboard box.

Release form: Liquid dosage forms. Injection.

General characteristics. Compound:

Pharmacological properties:

Indications for use:

Important! Get to know the treatment

Directions for use and dosage:

Features of application:

Side effects:

Interaction with other drugs:

Contraindications:

Overdose:

Storage conditions:

Store in a place protected from light at a temperature not exceeding 15 degrees List II. List of narcotic drugs, psychotropic substances and their precursors subject to control of the Russian Federation. Keep out of the reach of children! Shelf life - 3 years. It is prohibited to use the drug after the date indicated on the package.

Vacation conditions:

On prescription

Package:

Solution for subcutaneous administration. Ampoules of 1 ml containing 1% or 2% solution.5 ampoules in a blister pack. 1-2 blister packs per cardboard box or 20, 50 or 100 blister packs (for hospital use).