Tramadol

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There is hardly a person whom are not familiar feeling of pain. Even the ancient Greeks said: “pain - is the health of guard dog.” Indeed, it warns the pain of impending organism.

Today, the pharmaceutical market large number of pain medication foreign and domestic production. Among them - TRAMADOL, issued recently mastered the Kharkov pharmaceutical company OAO “” Health “.

Edited by the business TRAMADOL is determined by the domestic technology using imported substances (tramadol hydrochloride) firms “Heumann Pharma Gmbh” (Austria).

TRAMADOL - highly nenarkotichesky central analgesic action, intended for oral intake with acute or chronic pain diverse etiology. TRAMADOL is classed as moderately toxic means, has good portability.

As an agonist-antagonist Opiate receptors, the drug has expressed analgesic activity. Its effect comes through 20 minutes after ingestion and lasts until 5 pm

The drug effectively eliminates Moderate pain syndrome in the post-operative period, with injuries, gall colic, myocardial infarction, during the execution of painful diagnostic procedures. In addition, TRAMADOL has protivokashlevoe effect.

When you receive therapeutic doses TRAMADOL is breathing oppression, and does not affect motorized bowel function.

The drug produced in gelatine capsules for the city of 0.05 Adults and children over 14 years of drug appoint 1 capsule with a small amount of liquid.

During treatment TRAMADOLOM some precautions should be observed: abandon the drive and perform a potentially hazardous activities that require greater attention and speed of mental and motor responses.

Patients with violation of the functions of the kidneys or liver drug treatment should begin with a minimum dose. Particular caution when receiving TRAMADOLA be followed for the appointment of his patients with drug and alcohol dependency.

More than 20 - year clinical experience with drugs tramadol abroad and clinics in Ukraine showed the drug under modern requirements for the safe and effective drug to eliminate pain syndrome.

It should be noted that production TRAMADOL “Pharmaceutical companies” Health “is available at a price of a wide range of consumers. His value is below any foreign analogues.

«Preparation of tramadol after modern classification behaves to the anodynes of the mixed (opiyno-neopiynogo) mechanism of action. It follows to apply preparation under strict control of doctor. A show to his application is a pain syndrome of moderate and expressed intensity, which accompanies the row of diseases, in particular traumas, oncologic diseases (terminal stages). There is the settled opinion that tramadol must low ability form dependence and he is not included to the list of preparations which are subject the special control. In actual fact this preparation forms strong physical and psychical dependence. Being partial of opiynim next to an anaesthetic action, he must ability influence on consciousness, emotions, cause zvikannya and narcotic dependence (drug addiction), even at medical application (to protracted). At his unmedical application (abuse), dependence arises up considerably quick. Actually through this ability there is a group of medications which tramadol belongs to.

Tramadol is an insidious drug, a child quickly zvikae to him. He gives feeling boldness, to the confidence, complexes disappear. Parents do not notice changes in the conduct of child which at the beginning looks wholly healthy, symptoms show up only on the late stages. But then to rescue a child very difficultly. The system use of this preparation draws the heavy forms of epilepsy, exhausts an organism. For parents which use tramadol regularly, so-called «tramadol’ni» give birth to put - mentally and physically underdeveloped. Uzalezhneniy from tramadolu in course of time certainly passes to the use of heavy injection drugs.

The Coordinating Council for forensic analysis at the Ministry of Justice proposes to include tramadol drugs.

This was discussed during a meeting of the Board held at the Ministry with the participation of representatives of the Ministry of Justice, Ministry of Internal Affairs, Ministry of Health, the General Prosecutor’s Office, the Security Service of Ukraine, as well as research institutions, judicial expertise.

Tramadol - medicine, and if the proposal is accepted Coordinating Board, it will become a synthetic narcotic substances origin.

The Coordinating Council, which is composed of specialists in the field of expertise to ensure justice, plans to hold in January 2007 workshop on the study tramadol for his classification as a drug. In connection with this planned to contact the SBU had requested help in obtaining samples tramadol produced by domestic pharmaceutical enterprises to conduct relevant studies. According to the results of such studies Coordinating Council plans to initiate changes in the relevant ruling Cabinet of Ministers of Ukraine, which identified a list of medicines that attributed to the drug “in Ukraine. After that the illicit spread tramadol will be covered under Article 321 of the Criminal Code of Ukraine ( “illegal production, manufacture, acquisition, transport, forwarding, storage for sale or the sale of toxic or potent or toxic substances or hard drugs”).

The Coordinating Council for forensic analysis at the Ministry of Justice was established in November 1994. The Council is a permanent, advisory body, which aims at the development of joint approaches to the forensic examination of activities and address critical development issues forensic analysis, which is an inter-ministerial nature. The Board is composed of experts in the field of forensic analysis of the Ministry of Justice, Ministry of Internal Affairs, Ministry of Health, Prosecution, the Security Service, Defense Ministry, the State Border Service, as well as research institutions, UNIAN reported.

Lineup:
Tablets
1 tablet contains 50 mg of tramadol hydrochloride.
Supporting substances:
Lactose, mikrokristallicheskaya cellulose, magnesium stearate, krospovidon, makrogol 4000, sodium saccharin, colloidal silicon anhydride, flavour.

Description: white, or almost white round tablets dvoyakovypuklye nasechkoy on one side and a characteristic smell of strawberries.

Capsules
1 capsule contains 50 mg of tramadol hydrochloride.
Supporting substances:
Lactose, Calcium gidrogenfosfat, glikolyat sodium starch, magnesium stearate, gelatin, stain E 132, E-171, E 172.

Description: Solid gels capsules, kryshechka green hull yellow. The contents of the capsule - a white powder or almost white and odourless.

Pharmacological properties:
Indications Group: mixed opioid analgesic mechanism of action. N02 AH02

Pharmacodynamics:
It belongs to the means of the central analgesic action. Has pronounced sedative effect.

Selective antagonist opioid mu-, delta and kappa receptors in the central nervous system-with the highest affinity for the mu-receptors. Inhibits reverse neyronalny seizure increases noradrenaline and serotonin release. Has also protivokashlevoe the action did not violate the motor diarrhoeal - gut tract. Duration of - about 4-8 hours.

Pharmacokinetics:
Suction: After receiving tramadol quickly and almost completely absorbed from diarrhoeal - gut tract (about 90%). The maximum concentration in plasma is determined in about 2 hours. The value of the biological availability is about 70%, does not depend on eating and increased use of multiple drugs.

Distribution: Tying with plasma proteins was about 20%. Tramadol penetrates through the blood and placenta-entsefallichesky barriers. Approximately 0.1% is allocated to breast milk.

Metabolism: Metaboliziruetsya by demethylation and metabolites conjugation to 11, only one of whom (O-demetiltramadol) has expressed pharmacological activity (2-4 times higher than tramadol activity).

Derivation: Tramadol and its metabolites derived mainly kidneys (90%) and through the bowel (about 10%). The half-regardless of the introduction of the road at about 6 hours.

Patients in old age, with liver cirrhosis and kidney failure, with the value of half-growing period.

Indications for use:
Pain Syndrome moderately to severely intensity diverse etiology (post-operative period, trauma, pain from cancer patients).

With the aim of pain in painful diagnostic or therapeutic manipulation.

Contraindications:
Increased sensitivity to the drug.

Condition, accompanied by oppression of breath or oppression pronounced central nervous system (alcohol poisoning, hypnotics drugs, narcotic analgesics, psychotropic means). The simultaneous use of MAO inhibitors (and two weeks after the repeal). Pregnancy and lactation period (possible only by the application lifecycle testimony). Age up to 14 years.

Pregnancy and breast-feeding period:
If pregnancy should avoid prolonged application of tramadol because of the risk of adjusting from the fetal syndrome outbreak in the neonatal lifting.

If necessary, the admission during lactation should be aware that a small number of tramadol allocated to breast milk.

Dosing and dose:
The dose medication and doctor o dbiraetsya individually depending on the intensity and nature of complaints.

Adults and young people over the age of 14.
Usually, the initial dose - 1 tablet or capsule (50 mg) inside a small amount of liquid regardless of the time eating, with no effect within 30 - 60 minutes, you can still take 1 tablet or capsule, with a one-time dose of strong pain may soon compile 100 mg (2 tablets or capsules). The effect, depending on the degree of pain, kept within 4-8 hours. We should not exceed daytime tramadol 400 mg dose (8 tablets or capsules).

Children.
We should not take this drug-shape children weighing less than 25 kg and at the age of less than 14 years.

Older patients, patients with violations of the functions of the liver and kidneys.
If necessary, the reception should increase the interval between drug tricks.

The duration and application identifies doctor

Capsules should not swallow doctor, the required quantity of liquid melon, regardless of the meal.

Tablets can not swallow doctor, the required quantity of liquid melon, regardless of the meal, or pre-dissolved in 1 / 2 cup of water.

Adverse actions:
The most characteristic dizziness, nausea, constipation, headache, drowsiness (these side effects occur from 30 - 15% of patients receiving tramadol), vomiting, skin itching, symptoms psihostimuliruyuschego action, asthenia, sweating, dyspepsia, dry mouth, diarrhea (meet The 15 - 5% of patients).

With a frequency of less than 5% weight loss is possible, hypotension and tachycardia, paresthesia, hallucinations, tremors, pain in the abdomen, visual impairment, the delay urination.

The frequency of side effects of development increases with increasing duration of the admission of medication. With long-term use in high doses is not possible to the development of drug dependence.

All side effects, including those not listed above, the doctor should be reported.

Overdose drug (intoxication):
The most dangerous overdoses are tramadolom pupillary, vomiting, convulsions and respiratory depression. When suspected poisoning should immediately seek medical help.

First aid with poisoning - maintaining adequate pulmonary ventilation and symptomatic therapy in a specialized department. In light enough cases of stomach washing. Naloksona The application is not critical, because , to overcome all the symptoms of poisoning and can cause convulsions. Hemodialysis little effective. In convulsions appropriate intravenous diazepam.

Hints:
With the increased use of time intervals tramadol in patients older. With caution and under the supervision of a doctor to use the drug to patients with impaired kidney and liver function, with craniocerebral injury, elevated intracranial pressure, epilepsy patients, and those with drug addiction to opioids.

A careful medical supervision and in small doses to be applied against the backdrop of tramadol action means for anaesthesia, hypnotics and psychotropic substances. The drug should not be combined with narcotic analgesics because of poor predictability synergies.

Against the backdrop of a lengthy application karbamazepina effect of tramadol may be weaker. Not recommended to drink alcohol in the treatment tramadolom.

In applying tramadol should not drive a car or do other jobs requiring greater attention.

Interaction with other means:
Together with tramadol use drugs, providing a depressing effect on the central nervous system, as well as with ethanol, possibly strengthening their actions.

Together with the application trmadola karbamazepinom inductors and other metabolic enzymes possibly weakening analgeziruyuschego action tramadol.

With systematic admission barbiturates, especially phenobarbital, it is probable decrease sedative action opioid analgesics. Long-term use of opioid analgesics or barbiturates encourages the development of cross-tolerance.

Naloxone activates breathing, eliminating analgesia after applying opioid analgesics.

Form release:
For 10 tablets or capsules containing 50 mg of tramadol g / s, blisters in the PVC / aluminum foil. At 1, 2, 3 or 5 blisters along with instructions on the application of carton.

Side effects:
Side effects of 5 years.

We should not use the drug after the expiration of the period of validity on the package.

Storage conditions:
Store at temperatures above 25o C is not out of reach of children.

In the Donetsk region about 20 thousand Young people are already dependent on narcotic drugs “Tramadol”. “During a press conference in Donetsk Oblast chief doctor said narcological clinic Igor Tsyba on Friday, 9 December.

“As of today, the real statistics, we do not have. Even the possibility to convert these poor, wretched patsanyat who use “Tramadol”. But when we have a blind questionnaires, in the Donetsk region, at a very conservative estimate, about 20 thousand depend on “Tramadola” - said Tsyba, Obkom writes.

He expressed his conviction that “Tramadol” without any evidence - is the purest narcotics. ”

“He raised the same dependence of the physical, mental, like all classic drugs. Opinion two may not be “- noted Tsyba.

According to his data, today in Ukraine there is not less than 7 companies producing “Tramadol”. (The largest of these - “gorlovsky Styrene)

In particular, Tsyba also noted that, despite the fact that “gorlovsky Concern Stirol” in the past year did not produce the drug “Tramadol”, “this is great value has no because consumers switched to the Russian preparation for the German, Slovenian , Kiev, Kharkov, Odessa and others. ”

Chief ails also reported that medical field, together with law enforcement authorities have decided to appeal once again to the President of Ukraine and the Verkhovna Rada, “the proposal specifically localize this drug in the group of those who fall under the criminal responsibility”.

It is known that pain syndrome in the structure of the lifting of opioids syndrome differs gravity, and therefore requires effective therapy. Its main components are the intense pain in the skeletal muscles, pain in joints, abdominal pain spasticheskogo nature, rarely - a pain localization [4].

With a view to controlling pain in the asthma drug Ukrainian practice widely used various spasmodicals and analgesics. Among the latter are increasingly used opioid analgesic tramadol, formally attributable to the number of nenarkoticheskogo [3, 5]. However, it is known that all set up so far opioid analgesics, to a greater or lesser extent, have addictive properties, ie, the ability to cause dependence, and tramadol is no exception to this rule.

There are numerous empirical evidence to support this view. Thus, while in the hospital, patients opiomaniey not only willingly take tramadol, but actively encouraged the doctor to his appointment, as a rule, arguing request strong feelings of pain. Indeed, in combination with benzodiazepines tramadol rapidly facilitates condition of patients at an altitude syndrome lifting. However, in most cases, patients are asked, but doctors tramadol designate up to 2 - weeks or more, that hardly can be considered justifiable, even in people with high drug doses per diem and narkotizatsii great timing. Such a lack of doctors “drug” presumably against the tramadolu, in our view, is due to the paucity of available literature information on addictive properties of this compound.

To obtain the necessary clinical information and fill the gap, we have undertaken this study.

The study investigated the clinical picture of mental and behavioural disorders due to the non-use of nenarkoticheskogo Opioid analgesic tramadol from 24 patients. All the patients had been diagnosed with a syndrome of dependence on this drug.

All of the patients were male. Age-dependent patients with tramadol was 18-35 years. Experience various non-consumption of psychotropic substances and stupefying fluctuated in the range of 2 to 10 years, including the use of tramadol experience was equal to 2-3 years. U fourteen patients first stupefying means adopted to achieve euphoria was named hashish, the four - inhalants, two - tramadol, two - opiates handicraft manufacturing, one - cyclodol and another one - efedron. All patients at the time of the survey tramadol used without medical supervision in order to achieve euphoria.

Nine patients had a history of the period in a systematic reception opiates. The first reception was tramadol they resulted from an attempt to alleviate the condition of lifting, as a result of a suspension of the use of hoods handicrafts produced from poppy straw. In the future, these patients have shifted to the systematic use of tramadol, although allowed occasional use of hoods of poppy straw (about 1 per month). U of persons dependent on opiates handicraft manufacturing, dependence on tramadol evolved through stages vikarnoy (substitution) narkotizatsii tramadolom. Samy patients were told that “soskochili” (ie cease narkotizatsiyu another Opioid Drugs like heroin) with the help of tramadol. All patients at the time of the survey were aware that became dependent on tramadol, and the motive for treatment to a doctor, it was precisely the desire to stop the use of tramadol. Thus, there is a distinctive dynamics motives use tramadol. First, the aim is to facilitate the use of opioids syndrome lifting, and then formed vikarnaya alcoholism, finally, the patients come to receive tramadol as the main psychoactive substance that causes euphoria.

All the patients surveyed preferred tramadol capsules. Even patients who practiced intravenous tramadol (sometimes in combination with sibazonom), usually used for the manufacture of injection solution tramadol contained in the capsules.

In order to achieve euphoria patients are usually used for a reception from 2 to 10 capsules tramadol (at 0,05). This daily dose capsules can reach 18-20 tramadol (two observation).

Most of the patients who ate tramadol noted improving mood, comfort, a sense of ease. Some patients reported feeling increased activity on the tide of forces of energy.

Five patients were examined (for admission to a hospital) directly to the state of intoxication caused by the use of tramadol 6-8 capsules. It is noted: propulsion and voice arousal, increased kontaktnost, sociability, gaiety, fidgeting, mobility. It was fast, loud, incoherent, but clear. However, the patients were sintonny, quite subtly sensed the mood interlocutor understand jokes, reacted to them. There has been reinforced by gestures.

There were immediate vegetative tramadolovogo manifestations of intoxication: flushing person reduction of blood pressure to an average of 109 ± 5 mm Art. Art., a slight tachycardia (± 8 to 86 strokes per minute), the decline in pupil reaction to light.

So the words of patients know that the systematic use of tramadol accompanied by pain in the abdomen and constipation. Many patients are not elaborating, complained of discomfort in zagrudinnoy area, said that was the “bad heart”.

All patients reported that on the background of the use of tramadol also occasionally used other means stupefying: tranquilizers, drugs cannabis, opiates handicraft manufacturing. Especially narkogennogo steps to strengthen its reception tramadol combined with tranquilizers benzodiazepinovogo series.

Those Users mostly tramadol, noted growing tolerance: from two to three capsules a day tramadol (at 0,05) in the early narkotizatsii, to twenty such capsules a day at the time of inspection.

All the patients surveyed when it is not possible to use tramadol noted mental discomfort, the decreased mood, a sense of internal tension, anxiety, irritability, conflict, aggressive behaviour towards relatives. Vlechenie drug to be generally obsessivny nature (for JH Pyatnitsky, 1975) [4]. When tramadolom systematic abuse over a period of three or four months, forming a typical syndrome lifting. The main signs were vegetative its manifestations: sweating, chills, “murashek feeling,” running on the skin, moderate tachycardia (heart rate up to 90 per minute), tremor-hand fingers, general malaise, “muscular discomfort”, the inability to find a comfortable working posture. There have sleep disorders. The time somatosensory vegetative disorders in a position to repeal ranged from 5 to 7 days. The most emotional maintained long-term violations in the form of a sense of internal tension, anxiety, irritability, conflict.

The systematic use of tramadol is accompanied by characteristic changes in behavior. Some of the patients surveyed recognized stealing money from relatives and Sales made things out of the house with a view to acquiring tramadol, which is usually immediately used for the purpose of intoxication. In other instances of such behavior became aware of patients with the words of their relatives, who, moreover, pointed to negative changes in the nature of the sick. According relatives, as the dependence on tramadol, patients become increasingly insensitive, crude and prone to deception. Thus, we may conclude that, with the use of tramadol is typical of all drug abuse regress personality known in the literature as the Broytigama syndrome (W. Brautigam) [1].

It should also be noted that happens under the influence of the use of tramadol Giving premorbidnyh psychological backgrounds of the individuals predisposed to disease drug Profile [2].

Patients with established dependence on tramadol often practiced occasional use of other opiates, primarily the various extracts from poppy straw handicraft manufacturing. Only a small number of substance abuse can be diagnosed tramadolovuyu in pure form (only three patients categorically denied the use of other opiates). It should be emphasized that the sick, which in the past has repeatedly transferred syndrome lifting other opioids, comparing it to the lifting of the state of tramadol, celebrated their similarities.

Along with the general features of the syndrome during the lifting of opioids, with the use of tramadol has been a number of differences. Thus, the speed of development and intensity of somatosensory vegetative manifestations of the syndrome from lifting people ate tramadol, objectively lower than that of patients who ate homemade preparations of opium produced. In addition, persons consuming tramadol, in a position to cancel it lacked diarrhoea, so characteristic of the syndrome lifting opioids. Despite this, an estimated majority of the members surveyed our group of patients with doses of equivalence and comparability narkotizatsii seniority, the duration and severity of subjective lifting of the state of tramadol was greater than in the lifting of the state of other opioids.

As a nonopioid analgesic, tramadol can be used recreationally. It can, via agonism of μ opiate receptors, produce effects similar to those of opioids (e.g., morphine or hydrocodone), although not nearly as intense due to tramadol’s much lower affinity for the receptor. However, the metabolite m1 is produced after demethylation of the drug in the liver. The m1 metabolite has an estimated 200x greater affinity for the mu1, and mu2 opioid receptors. In addition to acting as an opioid, tramadol is also a very weak but rapidly acting serotonin-norepinephrine reuptake inhibitor. When taken in amounts larger than normal therapeutic doses, tramadol can cause seizures (typically tonic-clonic) and severe nausea, which could deter abuse to some extent. Tramadol has been known to produce severe withdrawal symptoms with abrupt cessation after prolonged use. In addition, tramadol can help alleviate withdrawal symptoms from more addictive opiates, and is much easier to lower quantity of usage compared to opiates such as hydrocodone and oxycodone.