Targin - instructions for use, dose, side effects, contraindications

Excipients: Giprolosa - 5.00; 0; 0 or 0 mg, Povidone (K 30) - 0; 5.00; 7.25 or 14.50 mg. Ethyl cellulose (N45) - 20.00; 10.00; 12.00 or 24.00 mg. Stearic alcohol - 25,00; 25.00; 29.50 or 59.00 mg, Lactose monohydrate 71.75; 64.25; 54.50 or 109.00 mg, Talc - 2.50; 2.50; 2.50 or 5.00 mg. Magnesium stearate - 1.25; 1.25; 1.25 or 2.50 mg. Opaprai II blue 85F30569 - 4.00 mg or Opadrai II white 85F18422 - 3.72 mg or Opadrai II pink 85F24151 -4.17 mg or Opadrai II yellow 85F32109 - 8.33 mg.

Description:

Tablets 2.5 mg + 5 mg

Oblong, biconvex tablets covered with a film coating of blue color, engraved "5" on one side and "OXN" on the other side. Hbut a broken white color.

Tablets 5 mg + 10 mg

Oblong, biconvex tablets covered with a white film sheath, engraved "10" on one side and "OXN" on the other side. On a broken white color.

Tablets 10 mg + 20 mg:

Oblong, biconvex tablets covered with a pink film shell, engraved with "20" on one side and "OXN" on the other side. On the fracture is white.

Tablets 20 mg + 40 mg

Oblong, biconvex tablets, covered with a film coating of yellow color, engraved "40" on one side and "OXN" on the other side. On the fracture is white.

Pharmacotherapeutic group:Analgesic narcotic. Opiate receptor agonist-antagonist.

ATX: & nbsp

V.03.A.B.15 Naloxone

Pharmacodynamics:

Naloxone and oxycodone have an affinity for (kappa-), (mu) and (delta) opioid receptors in the brain and spinal cord, peripheral organs (eg, the intestine). Oxycodone serves as an opioid receptor agonist and acts as an analgesic, by binding to endogenous opioid receptors in the central nervous system (CNS). Naloxone, on the contrary, a complete antagonist acting on all types of opioid receptors.

Due to the expressed pre-systemic metabolism (the effect of the first passage), the bioavailability of naloxone for ingestion is less than 3%, so clinically significant systemic effect is unlikely.Due to the local competitive antagonism of the oxycodone effect on opioid receptors in the gut, naloxone reduces the severity of bowel disturbances typical of opioid treatment.

In a 12-week, double-blind, parallel-group study involving 322 patients with opiond-indutsnrovannym constipation in patients treated with a combination of oxycodone hydrochloride, naloxone hydrochloride, encountered one extra complete spontaneous on average (without laxatives) bowel movement in the last week of therapy in comparison with patients who continued application of similar doses of oxycodone hydrochloride in a sustained release tablets (p <0.0001). The use of laxatives in the first four weeks of treatment was significantly lower in the naloxone-oksnkodon compared to oxycodone alone group (31% and 55: respectively, p <0.0001). Similar results were obtained in a study in 265 non-cancer patients treated with an oxycodone hydrochloride / naloksopa hydrochloride at doses of 60 mg / 30 mg to 80 mg / 40 mg compared to the same range of doses of oxycodone hydrochloride.

Opioids can affect the hypothalamic-pituitary-adrenal system or the sex glands. There is an increase in serum prolactin concentration and a decrease in the concentration of cortisol and testosterone in the plasma. Clinical symptoms can be explained by these hormonal changes.

The results of preclinical studies showed multidirectional effects natural opioids on the components of the immune system. The clinical significance of these no observations have been established. It is not known whether oxycodone, semisynthetic opioid, influence on the immune system, similar to natural opioids.

Pharmacokinetics:

Oxycodone hydrochloride

Suction

After oral administration of oxycodone shows a high absolute bioavailability, which reaches 87%.

Distribution

After absorption, oxycodone is distributed throughout the body. About 45% is associated with plasma proteins. Oxycodone penetrates the placenta and is found in breast milk.

Metabolism

Oxycodone is metabolized in the intestine and liver with the formation of noroxycodone, oxymorphone and various metabolites in the form of glucuronides.In the formation of noroxycodone, oxymorphone and noroxymorphone, isofermites of the cytochrome P450 system participate. Quinidine reduces the formation of oxymorphone in humans without a significant effect on the pharmacodynamic effects of oxycodone. The contribution of metabolites to the overall pharmacodynamic effect is negligible.

Excretion

Oxycodone and its metabolites are excreted by the kidneys and intestines.

Naloxone hydrochloride

Suction

Ingestion naloxone has a very low systemic bioavailability - less than 3%. Distribution

Naloxone penetrates the placental barrier. It is not known whether the naloxone in breast milk.

Metabolism and excretion

Metabolised in the liver and excreted by the kidneys. The main metabolites are naloxone glucuronide. 6β-naloxol and its glucuronide.

The combination of oxycodone hydrochloride / naloxone hydrochloride (Targin)

The pharmacokinetic properties of oxycodone, which is part of the Thargin preparation, correspond to the properties of oxycodone in the dosage form of the sustained-release tablet taken with the sustained-release naloxone tablets.

All dosages of the drug Targin are interchangeable.

After taking the drug Targin inside at the maximum dose by healthy volunteers, the concentration of naloxone in the plasma is so low that it is not possible to carry out its pharmacokinetic analysis. Therefore, naloxone-3-glucuronide was used as a surrogate marker, since its plasma concentration is sufficient for measurements.

In general, when eating high-fat foods compared to fasting, the bioavailability and maximum concentration of oxycodone in plasma (Cmax) increase by an average of 16 and 30%, respectively. Nevertheless, tablets can be taken without regard to food intake.

results in vitro studies of metabolism have shown that the development of clinically significant interactions with the components of the drug is unlikely.

Pharmacokinetics in selected patient groups

Elderly patients

Oxycodone

In elderly patients, in comparison with young volunteers, an increase in the area under the concentration-time curve was observed (AUCt) oxycodone on average to 118%. Stam oxycodone increased to an average of 114%. The minimum concentration (Cmin) of oxycodone increased to an average of 128%.

Naloxone

In elderly patients compared with young volunteers, there was an increase in the value AUCt naloxone to an average of 182%. The amount of naloxone increased to an average of 173%. Cmin naloxone increased to an average of 317%.

Naloxone-3-glucuronide

In elderly patients compared with young volunteers, there was an increase in the value AUCt naloxone-3-glucuronide on average to 128%. The amount of naloxone-3-glucuronide increased to an average of 127%. C_min Oxycodone increased to an average of 125%.

Patients with impaired Functions liver

Oxycodone

In patients with mild, moderate and severe hepatic insufficiency, in comparison with healthy volunteers, an increase in the value AUC∞ oxycodone on average to 143, 319 and 310%, respectively. The oxycodone level increased to an average of 120, 201 and 191%, and the values t1 /2z. increased to an average of 108, 176 and 183% respectively.

Naloxone

In patients with mild, moderate and severe severity of liver failure compared with healthy volunteers, an increase in the value AUCt naloxone to an average of 411, 11,518 and 10666%, respectively. The amount of naloxone increased on average to 193, 5292 and 5252%, respectively. Due to the insufficient amount of data, the values t1 /2z and the corresponding values AUC∞ naloxone was not calculated. Therefore, the comparison of the bioavailability of naloxone was based on the values AUCt.

Naloxone-3-glucuronide

In patients with mild, moderate and severe hepatic insufficiency, in comparison with healthy volunteers, an increase in the value AUC∞ naloxone-3-glucuronide on average to 157. 128 and 125%, respectively. The amount of naloxone-3-glucuronide increased to an average of 141. I 18% and decreased to 98%, and the values t1 \ 2z. naloxop-3 were increased to an average of 117%. and decreased - to 77 and 94%, respectively.

Patients with impaired renal function

Oxycodone

In patients with mild, moderate and severe severity of renal failure compared with healthy volunteers, there was an increase in the value AUC∞ oxycodone to an average of 153. 166 and 224%, respectively. Сmах oxycodone increased to an average of 110, 135 and 167%. and the values t1 /2z oxycodone increased to an average of 149, 123 and 142%, respectively.

Naloxone

In patients with mild, moderate and severe renal failure compared to healthy volunteers, there was an increase in the value AUCt naloxone to an average of 2,850, 3,910 and 7612%, respectively.The amount of naloxone increased on average to 1076, 858 and 1675%, respectively. Due to the insufficient amount of data, the values t1/2z. and the corresponding values AUC∞ naloxone was not calculated. Therefore, the comparison of the bioavailability of naloxone was based on the values AUCt. The calculated values of the ratio could be affected by the inability to fully characterize the naloxone profiles in blood plasma in healthy volunteers.

Naloxop-3-glucuronide

In patients with mild, moderate and severe renal failure compared to healthy volunteers, there was an increase in the value AUG∞ naloxone-3-glucuronide on average to 220, 370 and 525%, respectively.

The amount of naloxone-3-glucuronide increased to an average of 148. 202 and 239%, respectively. Significant differences in meaning t1 / 2z naloxone-3-glucuronide in patients with renal failure compared with healthy volunteers, on average, was not observed.

Improper application

In order not to violate the properties of the drug with prolonged release, the tablets should be swallowed whole, not breaking, not chewing or grinding. When breaking, chewing or grinding tablets with prolonged release, the active substances are released faster,which can lead to the absorption of a potentially lethal dose of oxycodone (see "Overdose"). Besides, naloxone has a slower elimination rate with intranasal application. Thus, with the wrong application, the Targa will not have a therapeutic effect. In oxycodone-dependent rats, the intravenous administration of oxycodone hydrochloride / naloxop hydrochloride in a 2: 1 ratio led to the development of withdrawal syndrome.

Indications:

Severe pain syndrome in adults requiring the use of opioid analgesics. The composition of the drug is naloxone, which can reduce the manifestations of opioid-induced constipation by blocking the action of oxycodone on opioid receptors in the intestine.

Contraindications:

- Hypersensitivity to the active ingredients or other components of the drug;

- Any clinical condition of the patient, in which the use of opioids is contraindicated;

- Inhibition of respiration with hypoxia and / or hypercapnia;

- Severe chronic obstructive pulmonary disease (COPD):

- "Pulmonary" heart;

- Severe bronchial asthma:

- Neopioidia paralytic intestinal obstruction;

- Hepatic insufficiency of moderate and severe severity;

- Children under 18 years;

- Lactase deficiency, galactose intolerance, glucose-galactose malabsorption (the preparation contains lactose).

Carefully:not described

Pregnancy and lactation:

Pregnancy

Data on the use of the drug Targi in pregnancy and during breastfeeding are absent. Limited use of oxycodone in pregnant women has not revealed an increased risk of congenital anomalies. Data on the use of naloxone during pregnancy is not enough. Nevertheless, the systemic exposure of naloxone in women after taking the drug Targa is relatively low (see the section "Pharmacokinetics"). Both oxycodope and naloxone penetrate the placenta. Studies of the combination of oxycodone and naloxone in animals have not been conducted. A separate study of the toxicity of oxycodone and naloxone in animals showed no teratogenic or embryotoxic effects.

With prolonged use of oxycodone during pregnancy, a newborn can develop a withdrawal syndrome. When oxycodone is used during labor, a newborn can experience respiratory depression.The use of the drug Targa during pregnancy is possible if the benefit to the mother exceeds the possible risks to the fetus and the newborn.

Breastfeeding period

Oxycodopum penetrates into breast milk. The ratio of its concentration in milk and plasma is 3.4: 1. so it is very likely that oxycodopa will manifest itself in a baby who is breastfed. Data on the penetration of naloxope into breast milk are absent. It was noted that the systemic concentration of naloxone after taking the drug Targin is very small (see section "Pharmacokinetics"). There is no risk for a baby breastfed, especially with repeated use of the drug Targin as a nursing mother. For the period of application of the drug Targin, breastfeeding should be discontinued.

Fertility

Data on the effect of the drug Targin on fertility are absent.

Dosing and Administration:

For oral administration.

The dose of the drug is selected taking into account the intensity of the pain syndrome and the sensitivity of the patient. If not prescribed otherwise, the drug Targin is assigned as follows:

Adult patients

A standard initial dose for patients who had not previously taken an ovoid. is 10 mg / 5 mg of oxycodone hydrochloride / naloxone hydrochloride, respectively, every 12 h.

Patients who took ovaries earlier may require higher doses, depending on the duration of the previous therapy.

The drug Targin at a dosage of 5 mg / 2.5 mg is intended for dose selection at the beginning of treatment, taking into account the individual sensitivity of the patient.

The maximum daily dose of the drug Targin is 80 mg of oxycodone hydrochloride and 40 mg of naloxone hydrochloride.

After the end of treatment with the drug Targin and the subsequent appointment to the patient of another opioid, a disruption of the function of the gastrointestinal tract is possible.

For relief of acute pain, some patients who regularly take the drug Thargin requires an additional fast acting analgesic. Because the drug Thargin is presented in a sustained release dosage form, it is not is intended for the treatment of acute pain syndrome. For relief of acute pain fast acting analgesics should be prescribed at a dose of approximately 1/6 day dose of oxycodone hydrochloride.If necessary, more than two additional rapid analgesic, it is recommended to consider increasing the dose of the drug Targin. Increasing the dose of the drug Targin should be gradual - every 1-2 days with a double admission the dose of the drug can be increased by 5 mg / 2.5 mg. and, if necessary, 10 mg / 5 mg oxycodone hydrochloride / naloxone hydrochloride, respectively, until then. a stable therapeutic dose will not be reached. The goal of a step-by-step dose increase is to achieve the dose of the drug necessary for each patient when taken 2 times a day, which will provide sufficient anesthesia with minimal need for additional rapid analgesic.

The drug Targin in an individually selected dose is intended for a fixed two-time intake per day. While for the majority of patients fixed morning and evening intake of the drug (every 12 hours) provides a sufficient analgesic effect, for some patients an individual, uneven schedule of taking the drug is required, based on residual pain.It is necessary, in general, to select the minimum effective dose of the drug.

In the treatment of non-oncological patients, the therapeutic dose of Targin usually does not exceed 40 mg / 20 mg of oxycodone hydrochloride / naloxone hydrochloride, but a higher dose may be required.

Children and teens

The safety and effectiveness of the drug Thargin in children under the age of 18 years has not been studied.

Elderly patients

As well as in younger adult patients, the dose of the drug is selected taking into account the intensity of pain and individual sensitivity to the drug.

Patients with impaired hepatic function

results clinical research They showed, what plasma concentration oxycodone and naloxone in patients with hepatic insufficiency rises, with this effect being expressed to a greater extent with respect to naloxone (see the section "Pharmacokinetics"). The clinical significance of a relatively higher exposure of naloxone in patients with hepatic insufficiency is not known. The drug Targin should be used with caution in patients with mild hepatic insufficiency.Targin is contraindicated in patients with moderate to severe hepatic impairment.

Patients with impaired renal function

results clinical research They showed, what plasma concentration oxycodone and naloxone in patients with renal insufficiency increases, and this effect is more pronounced for naloxone (see the section "Pharmacokinetics").

The clinical significance of a relatively higher exposure of naloxone in patients with renal insufficiency is not known. Caution is advised to use the drug Targin in patients with renal insufficiency (see section "Special instructions").

Mode of application

The drug Targin should be taken in the morning and evening, at the same time, in an individually selected dose.

Tablets with prolonged release can be taken with or without food, with a sufficient amount of liquid. The tablet should be swallowed whole, not breaking and not chewing.

Duration of therapy

The use of the drug Targin should not be longer than absolutely necessary. If a patient needs a long course of analgesic therapy, taking into account the type and severity of the disease,careful and regular monitoring should be organized to address the need, in general, and the intensity of the planned treatment. If treatment with opioids is no longer indicated, the dose should be reduced gradually (see section "Special instructions").

Side effects:

The frequency of undesirable reactions listed below was determined according to the following gradation: very often (> = 1/10): often (> = 1/100. <1/10): infrequently (> = 1/1000. <1/100) rarely (> = 1/10000. <1/1000) and very rarely (<1/10000). the frequency is unknown (can not be determined from available data).

Infringements from immune systems Infrequently: hypersensitivity reaction Disorders from the metabolism and nutrition Often: loss of appetite until its loss Disorders of the psyche Often: insomnia

Infrequently: anxiety, unusual thoughts, anxiety, confusion, depression, nervousness

Frequency unknown: euphoria, hallucinations, nightmares

Disorders from the nervous system Often: dizziness, headache, drowsiness

Infrequently: convulsive seizures¹, decreased attention, speech disorder, loss of consciousness, tremor

Frequency unknown: paresthesia, inhibition Disturbances on the part of the organ of sight Infrequently: visual impairment Hearing impairment and labyrinthine disorders Often: vertigo Heart Disease Infrequently: angina pectoris², a feeling of heartbeat Rarely: yawn

Hfrom outside vessels Often: "tides" of blood

Infrequently: lowering blood pressure (BP), increasing blood pressure

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently: shortness of breath, runny nose, cough

Rarely: tachycardia

The frequency is unknown, respiratory depression

Disorders from the gastrointestinal tract

Often: abdominal pain, constipation, diarrhea, dryness of the oral mucosa, dyspepsia, vomiting, nausea, flatulence

Infrequently: bloating

Rarely: dental disease

Frequency unknown: burp

Disturbances from the liver and bile excretory ways

Infrequently: increased activity of hepatic enzymes, biliary colic

Violations of the genitals and mammary gland

Frequency unknown: erectile dysfunction

Disturbances from the skin and subcutaneous tissues

Often: itching, rash, hyperhidrosis

Disturbances from the musculoskeletal and connective tissues Infrequently: Muscle spasms, muscle twitching, myalgia

Disorders from the kidneys and urinary bladder

Infrequently: imperative urge to urinate Frequency unknown: retention of urine General disorders and disorders at the site of administration Often: asthenia

Infrequently: abstinence syndrome, chest pain, chills, malaise, pain, peripheral edema, weight loss

Rarely: weight gain

Trauma, intoxication and complications of manipulation

Infrequently: injury due to accidents

¹- typical for patients with epilepsy or with increased convulsive activity

²- characteristic of patients with coronary artery disease in history

For the active substance - oxycodone hydrochloride - it is known about the following additional undesirable drug reactions:

Due to its pharmacological action, oxycodopic hydrochloride can cause respiratory depression, miosis, bronchial spasm and smooth muscle spasm, and also suppress the cough reflex.

Infectious and parasitic diseases Rarely: herpes simplex Infringements from immune systems Frequency unknown: anaphylactic reactions Disorders from the metabolism and nutrition Infrequently: dehydration Rarely: increased appetite, mental disorders

Often: disturbances in mood and personality changes, decreased activity, increased p ischomotor activity

Infrequently: agitation, impaired perception of the surrounding reality (for example, loss of sense of reality of what is happening), decreased libido, drug dependence Frequency unknown: euphoria, hallucinations, nightmares

Disturbances from the nervous system

Infrequently: decreased attention, migraine, dysgeusia, increased LD. involuntary twitching of muscles, hypoesthesia. coordination disorder Hearing impairment and labyrinthine disorders

Infrequently: hearing loss Vascular disorders

Often: vasodilation

Disturbances from the respiratory system, chest and mediastinal organs Infrequently: dysphonia

Disorders from the gastrointestinal tract

Often: hiccough

Infrequently: Dysphagia, intestinal obstruction, ulcer of the oral mucosa, stomatitis

Rarely: melena, bleeding gums

Disturbances from the liver and bile ducts

The frequency is unknown, cholestasis

Disturbances from the skin and subcutaneous tissues

Infrequently: dry skin

Rarely: rashes

Disorders of the kidneys and urinary tract Often: dysuria

Violations of the genitals and mammary gland

Frequency unknown: amenorrhea

General disorders and disorders at the site of administration

Infrequently: edema, thirst, drug tolerance

Trauma, intoxication and complications of manipulation

Infrequently: injury from accidents.

Overdose:

Symptoms of intoxication

Depending on the characteristics of the patient's disease, an overdose of the drug Targin may manifest symptoms typical for an overdose of oxycodone (an opioid receptor agonist) or naloxone (an antagonist of the opinoid receptors).

Symptoms of an overdose of oxycodone include miosis. respiratory depression, drowsiness, stuttering, lethargy of skeletal muscles, bradycardia and arterial hypotension. Severe cases of overdose can be manifested by coma, non-cardiogenic pulmonary edema and circulatory shock with a probability of death.

Development of symptoms of an overdose only naloxoy is unlikely.

Treatment of intoxication

Treatment of withdrawal symptoms as a consequence of an overdose of naloxone should be symptomatic in the conditions of constant medical supervision.

Clinical symptoms suggesting an overdose of oxycodone can be remedied by the administration of opioid receptor antagonists (eg, intravenous administration of 0.4-2 mg of naloxone hydrochloride). If necessary, the introduction can be repeated with a 2-3 minute interval. It is possible to administer the drug as an intravenous infusion: 2 mg of naloxone hydrochloride is added to 500 ml of a 0.9% solution of sodium chloride or 5% solution of dextrose (naloxone concentration 0.004 mg / ml) and administered at a rate corresponding to the dosage of the drug when injected and clinical response from the patient.

It is necessary to consider the possibility of gastric lavage.

Supportive therapy in the form of artificial ventilation, oxygen administration, vasoconstrictive drugs and intravenous infusion of solutions is used according to indications, including circulatory shock as a result of an overdose. Cardiac arrest or arrhythmia may require the use of heart massage and defibrillation.Also, the water-electrolyte balance should be maintained.

Interaction:

Drugs that depress CPF (other opioids, sedatives and hypnotics, antidepressants, phenothiazines, antipsychotics, antihistamines and antiemetics) may increase the depressive effect of the drug Targin on CPV.

Alcohol can enhance the pharmacodynamic effects of the drug Targin. so you should avoid using the drug Targin simultaneously with alcohol.

Patients concurrently taking oxycodones and coumarin anticoagulants showed clinically significant changes in the values of the international normalized ratio (MPO) in both directions.

The metabolism of oxycodone occurs predominantly with the involvement of the cytochrome P450 isoenzyme CYP3A4 and. partially. CYP2D6 (see section "Pharmacokinetics"). The activity of these metabolic pathways can be reduced or increased due to the influence of other drugs or food products used simultaneously. Thus, the dose of the drug Targin is subject to appropriate correction.

Inhibitor inhibitors CYP3A4. such as macrolide antibiotics (clarithromycin, erythromycin, tsethromycin), antifungal drugs from the group of azoles (ketoconazole, voriconazole. itraconazole, posaconazole), HIV protease inhibitors (ritovirus, indinavir, nelfinavir, saquinavir), cimetidine and grapefruit juice can reduce the clearance of oxycodone and lead to an increase in its plasma concentration. In this case, you may need to reduce the dose of the drug Targin and re-select it.

Inductors of isoenzyme CYP3A4. such as rifampicin, carbamazepine, phenytoin and St. John's wort, can activate the metabolism and increase the clearance of the drug, which results in a decrease in the concentration of oxycodone in the plasma. Care should be taken and, in addition, in order to properly control the pain syndrome, an additional dose adjustment may be necessary.

Theoretically, medical preparations, inhibitors of isoenzyme CYP2D6. such as paroxxine. fluoxetine and quinidine. can reduce the clearance of oxycodone and. accordingly, to increase the concentration of oxycodone in plasma. Combined use with isoenzyme inhibitors CYP2D6 had an insignificant effect on the elimination of oxycodone and its pharmacodynamic effects.

Results of metabolic studies in vitro testify that between oxycodone and naloxone one should not expect clinically significant interactions. The likelihood of clinically significant interactions between paracetamol, acetylsalicylic acid or naltrekeone and the combination of oxycodone and naloxone in therapeutic concentrations is minimal.

Special instructions:

The most serious consequence of opioid overdose is respiratory depression. Caution should be exercised when prescribing Thargin to elderly or weakened patients, patients with paralytic intestinal obstruction caused by opioids, severe breathing disorders, myxedema, hypothyroidism, Addison's disease (adrenal insufficiency), toxic psychosis, cholelithiasis, prostatic hyperplasia, alcoholism and alcoholic delirium, pancreatitis, increased or decreased blood pressure, if there is an anamnesis of coronary heart disease, head trauma (the risk of an increase nutricherepnogo pressure) predisposition to epilepsy or seizures, or patients receiving both inhibitors of monoamine oxidase (MAO).

The drug is administered with caution to patients with mild renal and hepatic insufficiency. Patients with severe renal insufficiency should be carefully monitored.

Diarrhea can be considered as the expected unwanted reaction of paloxon.

The transfer of patients who took long doses of oiioids for a drug called Targin can cause withdrawal symptoms at the beginning of treatment. Such patients should be given special attention.

The drug Targin is not intended to treat the symptoms of "withdrawal".

During the long-term use of the drug, the patient may develop resistance, in this connection. to maintain the analgesic effect will require higher doses of the drug Targin. Long-term use of the drug Targin can cause physical dependence. With sudden discontinuation of therapy, abstinence syndrome may develop. If the need for therapy with the drug Targin is over, in order to avoid the development of withdrawal symptoms it is recommended to reduce the dose gradually. There is a danger of developing psychological dependence (addiction) from onioid analgesics, including the drug Targin.Therefore, the drug Targin should be used extremely cautiously in patients with alcohol or drug dependence in the anamnesis.

The profile of drug dependence development to oxycodone is similar to other potent agonists of the onioid receptors.

It is necessary to avoid simultaneous use of alcohol, since it is possible to increase the undesirable reactions of the drug Targin.

The clinical experience of the use of the drug Targin in patients with complications of malignant tumors in the form of peritoneal carcinomatosis or with a syndrome of partial occlusion in common tumors of the gastrointestinal tract or pelvic region is absent, so it is not recommended for these patients to prescribe the drug.

The drug Targin is not recommended to be used before the operation or during the first 12-24 hours after the operation. The subsequent application of the drug is possible after a careful assessment of the relationship of benefit and risks for each patient, taking into account the type and extent of the surgery performed, the type of anesthesia, other concurrent drugs and the general condition of the patient.

Any abuse of the drug Thargin by patients with drug dependence edge is undesirable.

In patients with opioid dependence (parenteral, ipantransal and oral route of administration), such as heroin, morphine or methadone, the drug Targin will cause an abstinence syndrome caused by an antagonist of opioid receptors - paloksoiom, or strengthen existing symptoms of withdrawal (see the section "Overdose").

The drug Targin is a double polymeric matrix, designed exclusively for oral administration. Parenteral administration of drug components (especially talcum) in patients with drug dependence can lead to the development of local tissue necrosis and lung granulomagosis or other serious, fatal undesirable reactions.

An empty matrix providing sustained release of the active substance from the tablet can be detected in the patient's stool.

Against the background of the use of the drug Targin, the results of doping control can be positive. Taking Targin as a dope can be harmful to your health.

Effect on the ability to drive transp. cf. and fur:

Targin can affect the ability to drive vehicles and work with mechanisms.In particular, it is likely at the beginning of therapy with Thargin, after increasing the dose or after switching to other drugs, and also when used with other drugs that depress CNS activity. It is necessary to have a preliminary consultation with the attending physician before driving vehicles or working with other mechanisms.

Form release / dosage:

Tablets, prolonged action, film-coated 2.5 mg + 5 mg, 5 mg + 10 mg, 10 mg + 20 mg, 20 mg + 40 mg.

For 10 tablets in Aluminum / PVC blister, 2 blisters together with instructions for use in a pack of cardboard.

Packaging:blisters (2), cardboard tacks

Storage conditions:

Store at a temperature of ns above 25 ° C.

Keep out of the reach of children.

Refers to list II of the "List of narcotic drugs, psychotropic substances and their precursors subject to control in the Russian Federation ".

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002880

Date of registration:25.02.2015

The owner of the registration certificate:Mundifarma Mundifarma Switzerland

Manufacturer: & nbsp

BARD PHARMACEUTICALS, Ltd. United Kingdom

Representation: & nbspMundifarma Gesm.b.XMundifarma Gesm.b.X

Information update date: & nbsp25.02.2015

Illustrated instructions

Instructions

Targin® (Targin®)