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Tramadol (50 mg): instructions for use, indications. (Other names: Tramadol)
Full description (Tramadol (50 mg)): use, composition, dosage, indications, contraindications, side effects. Other names: Tramadol
International non-proprietary name
Capsules 50 mg
One capsule contains
active ingredient – tramadol hydrochloride 50 mg,
excipients: starch, calcium dihydrophosphate, lactose, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, polyvinylpyrrolidone (PVP K30), talc,
the composition of the capsule shell: gelatin, iron (III) yellow oxide (E172), brilliant blue (E133).
Hard gelatin capsules size “2” light green / light green color. The contents of the capsules are white or almost white.
Analgesics. Opioids. Other opioids. Tramadol.
ATH code N02AX02
Tramadol Vs Oxycodone: the benefits and harm, the use of diabetes instead of sugar
After ingestion, tramadol is rapidly and almost completely absorbed in the gastrointestinal tract. The average oral bioavailability is approximately 68%. Eating does not have a significant impact on the rate and extent of absorption. Serum concentration of 100 ng / l (minimum effective analgesic concentration) is reached approximately 0.7 hours after administration and lasts for 9 hours.
Distribution The distribution after oral and intravenous administration is approximately 306 and 203 liters, respectively. Plasma protein binding is about 20%. Tramadol penetrates through the placenta and its concentration in umbilical cord blood is 80% of the concentration in the mother’s blood.
Metabolism Approximately 85% of tramadol is metabolized. Tramadol is metabolized by N- and O-demethylation. With the exception of the O-demethylated metabolite (M1), all metabolites are pharmacologically inactive.
90% of tramadol and its metabolites are excreted through the kidneys, the rest is excreted with feces. The half-life is 5-6 hours and is the same as in tramadol and its metabolites.
In cases of impaired renal function, the volume and rate of excretion decreases, therefore, in patients with creatinine clearance less than 0.5 ml / s, a reduction in dosage and an increase in the intervals between dosing is recommended.
Metabolism of tramadol and M1 is reduced in patients with severe cirrhosis of the liver, and therefore the dosage must be adjusted.
In patients older than 75 years, the peak concentration of tramadol in the blood plasma slightly increases and the half-life is longer, so dose adjustment is required.
Tramadol is a centrally acting analgesic. He is a non-selective opioid receptor agonist. µ, δ and κwith higher affinity for µ-receptors. Tramadol inhibits neuronal uptake of norepinephrine, and also increases the release of serotonin, which leads to the analgesic effect of the drug.
Tramadol in therapeutic doses has almost no effect on the cardiovascular system (does not have a suppressive effect and does not increase the pressure in the pulmonary artery), does not cause smooth muscle spasm, histamine release, therefore, anaphylactic reactions occur rarely. The effect on breathing is minimal and can only manifest at higher doses. The development of addiction and addiction are also very rare.
Indications for use
– pain syndrome of medium and strong intensity
Dosage and administration
The dose is selected individually depending on the intensity of pain and sensitivity of the patient. The smallest effective analgesic dose is usually used. The maximum permissible dose of the drug per day is 400 mg.
If not stated otherwise, the drug should be taken as follows:
Acute pain: 1-2 tablets (50-100 mg) 3-4 times a day. For patients with low body weight, the dose is calculated at a rate of 0.7 mg / kg. The duration of treatment depends on the clinical need.
Pain associated with chronic diseases: The recommended starting dose is 50 mg or 100 mg, followed by a dose titration every 4-6 hours, depending on the intensity of the pain. It is important to regularly assess the need for continuation of treatment, since there is evidence of the onset of withdrawal symptoms and the development of dependence.
The drug is not intended for the treatment of children and adolescents under 18 years of age.
Usually in the treatment of patients under the age of 75 years, a dose adjustment is not required if they have no clinical manifestations of hepatic or renal failure. In patients older than 75 years, the elimination period may be increased. Therefore, if necessary, increases the interval between doses of the drug in accordance with the needs of the patient.
In patients with renal insufficiency, drug elimination may be delayed. The initial dose may be standard. These patients need to consider the need to lengthen the interval between doses of the drug in accordance with the individual characteristics of the patient.
For patients with creatinine clearance <30 мл/мин интервал между приемом препарата должен быть увеличен до 12 часов.
Tramadol is not recommended for patients with severe renal insufficiency with creatinine clearance <10 мл/мин. При гемодиализе или гемофильтрации трамадол выводится очень медленно и поэтому пост-диализное назначение трамадола для поддержания анальгезирующего эффекта нецелесообразно.
In patients with impaired liver function, prolonged elimination of the drug is noted. The standard dose should be divided into 2 parts or the interval between doses of the drug should be increased to 12 hours.
These patients need to consider the need to lengthen the interval between doses of the drug in accordance with the individual characteristics of the patient. Tramadol is not recommended for patients with severe liver failure.
Mode of application
Capsules must be taken whole, without breaking and chewing, with a sufficient amount of liquid, with or without food.
Under no circumstances should the duration of treatment with tramadol exceed a period of extreme need for its administration. If necessary, long-term administration of tramadol for anesthesia due to the nature and severity of the disease should be regularly monitored (if necessary with interruptions in the treatment process) to determine the further need and scope of therapy.
The most common side effects such as nausea and vomiting, which develop in 10% of patients.
The following frequency is observed:
Often: ge; 1/10
Often: ge; 1/100, <1/10
Infrequently: ge; 1/1000, <1/100
Seldom: ge; 1/10 000, <1/1000
Very rarely: <1/10 000
Violations of the cardiovascular system:
– heart palpitations, tachycardia, orthostatic hypotension, cardiovascular collapse. Such adverse reactions can occur, in particular, when administered intravenously, as well as in physically weakened patients.
– bradycardia, increased blood pressure
– respiratory depression, shortness of breath
With a significant excess of the recommended dose and the simultaneous use of other drugs that depress the central nervous system, respiratory depression can develop. There is evidence of increased asthma symptoms, although a causal relationship has not been established.
The nervous system
– headache, drowsiness
– change in appetite, speech disorders, paresthesia, tremor, epileptiform seizures, involuntary muscle contractions, impaired coordination, syncope.
Convulsions developed, mainly, after taking high doses of tramadol or after the simultaneous use of drugs that reduce seizure threshold.
– hallucinations, sleep disturbances, delirium, anxiety and nightmares. After the introduction of tramadol, a variety of adverse psychological phenomena can occur, the intensity of which varies in each case (depending on the individual characteristics and duration of treatment). These include mood changes (usually euphoria, in some cases dysphoria), changes in motor activity (usually depression, in some cases amplification), and cognitive impairment and sensory perception (for example, impaired decision-making ability and impaired perception). May develop drug dependence. Symptoms associated with withdrawal syndrome may develop, just as with the abolition of tramadol vs oxycodone opiates :: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor, and gastrointestinal disturbances. Very rarely, when discontinuation of tramadol, symptoms such as panic attacks, severe anxiety, hallucinations, paresthesia, tinnitus and central nervous system disorders (ie confusion, delusions, depersonalization, derealization, paranoia) are encountered.
– pupillary constriction, dilated pupils, blurred vision
– constipation, dry mouth, vomiting
– belching, discomfort on the part of the gastrointestinal tract (a feeling of constriction in the stomach, swelling), diarrhea
Diseases of the skin and subcutaneous fat
– skin reactions (eg, itching, rash, urticaria)
Damages of the musculoskeletal system and connective tissues
– motor tramadol vs oxycodone: weakness
From the hepatobiliary system
In several cases not related to each other, an increase in the activity of hepatic enzymes was observed, which coincided with the administration of tramadol.
Kidney and urinary system disorders
– difficulty urinating, urination disturbance (dysuria and urinary retention)
Immune system disorders
– allergic reactions (eg, difficulty breathing, bronchospasm, wheezing, angioedema) and anaphylactic reaction
Metabolic disorders and nutrient absorption
hypersensitivity to tramadol and / or auxiliary ingredients of the drug and other opioid analgesics
acute intoxication with depressants of the central nervous system
Tramadol Effects how to take, reviews
(alcohol, centrally acting analgesics, opioids, psychotropic drugs, hypnotics)
severe renal failure (creatinine clearance less than 10 ml / min)
severe liver failure
simultaneous use of MAO inhibitors (and for 14 days
after their cancellation)
patients with epilepsy, for which can not adequately
children and adolescents up to 18 years
pregnancy and lactation
Tramadol should not be used in combination with MAO inhibitors.
Patients who received MAO inhibitors for 14 days prior to the use of opioid analgesics, life-threatening interactions were observed on the central nervous system, respiratory and cardiovascular systems. Such interactions with MAO inhibitors are not excluded with the simultaneous appointment of tramadol.
With simultaneous use of tramadol with drugs that have a depressant effect on the central nervous system, as well as with ethanol, mutual enhancement of their action is possible.
The use of carbamazepine, barbiturates and other inducers of microsomal enzymes can lead to a weakening of the analgesic action of tramadol.
Prolonged use of tramadol stimulates the development of cross-tolerance to other opioid analgesics.
With the joint or prior use of cimetidine (an enzyme inhibitor), clinically significant interactions are unlikely. The combination of opioid receptor agonists / antagonists (for example, buprenofine, nalbuphine, pentazocine) and tramadol is not recommended because the analgesic effect of a pure agonist is reduced under these conditions.
With simultaneous use of Tramadol with selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenalin serotonin reuptake inhibitors (SNRIs), tri- and tetracyclic antidepressants, antipsychotics and other drugs that reduce seizure threshold, the risk of seizures increases.
When tramadol is used in combination with other serotonergic substances, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline serotonin reuptake inhibitors (SNRIs), MAO inhibitors, tri- and tetracyclic antidepressants may develop serotonin syndrome. Symptoms of serotonin syndrome: confusion, agitation, hyperthermia, sweating, ataxia, hyperreflexia, myoclonus and diarrhea.
Serotonin syndrome is possible if one of the following symptoms is observed:
– Spontaneous convulsions
– Induced seizures or twitching of the eye muscles on the background of excitement and sweating
– Tremor and hyperreflexia
– Hypertension and body temperature> 38 ° C and induced or ocular muscle twitching.
Cancellation of serotonergic drugs causes rapid relief of symptoms. Treatment depends on the type and severity of the symptoms.
Particular caution should be exercised with the simultaneous use of tramadol and coumarins (eg, warfarin) because of the risk of reducing prothrombin time with the development of bleeding and hemorrhages.
Other CYP3A4 inhibitors, such as ketoconazole and erythromycin, can inhibit the metabolism of tramadol (N-demethylation) and active O-desmethyltramadol. The clinical significance of this interaction is not well understood.
In a limited number of studies, it was found that pre-or postoperative use of an antiemetic agent, a 5-HT3 antagonist, ondansetron, increased the need for tramadol for postoperative pain.
Tramadol Vs Oxycodone on the skin: treatment of stretch marks, causes
Tramadol should be used with caution and risk / benefit assessment in the following conditions:
– Symptoms of cancellation. Therapeutic doses of tramadol can cause withdrawal symptoms (message rate is 1/8000 cases)
– Drug addiction. Cases of the development of a symptom of dependence are rare and much less common than withdrawal symptoms. The clinical need for treatment with tramadol must be controlled by a physician. Tramadol has a low potential for developing addiction. However, long-term use may develop addiction, mental and physical dependence. In patients with a penchant for drug abuse or drug dependence, treatment with tramadol should be carried out only for a short period and under the strict supervision of a physician.
– Patients with opioid dependence. Tramadol is not applicable as a substitute for patients with opioid dependence, as it does not suppress the symptoms of morphine withdrawal.
– In patients who are sensitive to opioids, Tramadol should be administered with caution.
– Tramadol should be prescribed with caution when head injuries, increased intracranial pressure, liver failure (reduced metabolism of tramadol and its active metabolites) and renal failure (reduced speed and lengthening elimination of tramadol and its active metabolites), with a reduced level of consciousness and in patients prone to convulsive disorders or in shock.
– Patients with convulsive readiness. There have been cases of convulsive symptoms when prescribing therapeutic doses of tramadol, and the risk of seizures may increase if the recommended daily dose is exceeded. Treatment of tramadol patients with epilepsy or a predisposition to seizures should be considered only if there is a clinical rationale. The risk of developing convulsive syndrome is increased in patients taking both tramadol and drugs that reduce the convulsive threshold.
– The drug should be prescribed with caution in patients with respiratory failure or with simultaneous administration with depressants of the central action or when the doses significantly exceed the recommended doses, because in this case, the development of respiratory depression cannot be ruled out.
– The simultaneous appointment of carbamazepine or alcohol in the treatment of tramadol is not recommended.
– Because of the reported deaths in case of an unintentional overdose of tramadol, associated with the use of mentally active drugs and substances, including alcohol, tramadol should be administered with caution to patients with alcohol dependence and receiving any active psychoactive substances.
With prolonged (more than 3 months) use of analgesics, with an interval of a day or more often, a headache may develop or intensify. In this case, you should not increase the dose of tramadol. After consultation with the doctor, it is necessary to resolve the issue of stopping the use of analgesics.
Pregnancy and lactation period
Animal studies have shown that very high doses of tramadol affect organ development, ossification and infant mortality. Tramadol penetrates the placenta. There is not enough data on the safety of using tramadol for treating people during pregnancy. For this reason, tramadol cannot be used to treat pregnant women.
The introduction of tramadol before or during birth does not affect uterine contractility. In newborns, it can cause changes in respiratory rate, which, as a rule, are clinically insignificant.
Chronic use during pregnancy can lead to the development of a newborn withdrawal syndrome.
Breastfeeding tramadol vs oxycodone:
During lactation, about 0.1% of the dose taken by the mother is excreted in milk. Do not use the drug during breastfeeding.
The results of post-marketing observations did not reveal the effect of tramadol on reproductive functions. The results of studies involving animals did not reveal the effect of tramadol on reproductive functions.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery
Even if used in accordance with the instructions, tramadol can cause drowsiness and dizziness, as a result of which the reaction of the drivers and operators of the mechanisms of tramadol vs oxycodone can worsen: This applies in particular to the simultaneous intake of other psychotropic substances, in particular alcohol.
Symptoms of Tramadol overdose are similar to those that may occur with other analgesics (opioids) of central action.
Symptoms: constriction or dilation of pupils, vomiting, collapse, a drop in blood pressure, heartbeat, depression of consciousness (up to a comatose state), epileptic seizures, difficulty breathing, and stopping (apnea).
Maintaining / restoring the vital functions of respiration and blood circulation in a specialized department. An antidote in the case of respiratory depression is naloxone, for convulsions it is advisable to use diazepam.
In case of overdose with oral administration of the drug, it is necessary to take activated charcoal, gastric lavage is recommended in the first 2 hours after administration of tramadol. After 2 hours, it is necessary to conduct a detoxification event using a large amount of liquid.
Tramadol is slightly excreted by hemodialysis and hemofiltration, therefore the treatment of acute intoxication with tramadol by these types of interventions is not advisable.
Release form and packaging
10 capsules are placed in a blister packaging made from polyvinyl chloride film and aluminum foil.
For 1 or 2 blister packs together with instructions for medical use in the state and Russian languages are placed in a pack of cardboard.
In original packaging, in a dry place at a temperature not higher than 30 ° C.
Keep out of the reach of children!
Do not use after the expiration date
Pharmacy sales terms
Name and country of the manufacturer
Protech Biopharma Pvt. Ltd. India
Name and country of the packer
Protech Biopharma Pvt. Ltd. India
Name and country of registration certificate holder
Protech Biopharma Pvt. Ltd. India
Address of the organization that receives claims from consumers on the quality of products (goods) in the Republic of Kazakhstan
LLP “Denovo Impex, Republic of Kazakhstan, Almaty 050062, ul. Utegen Batyr, 15
tel .: 727 2437415
fax: 727 2437416