Tramadol instructions for use in ampoules. Use of tramadol for cancer. Instructions for use of Tramal
Tramal is used as prescribed by a doctor, the dosage regimen of the drug is selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient. The duration of treatment is determined individually; the drug should not be prescribed beyond the period justified from a therapeutic point of view.
Various dosage forms of Tramal suggest the following methods of administration:
- oral (regardless of food intake, swallow whole with sufficient liquid);
- intravenous;
- intramuscular;
- subcutaneous;
- infusion
Intravenous administration is carried out slowly, with 1 ml of Tramal (equivalent to 50 mg of tramadol hydrochloride) per minute.
The dose should be adjusted according to the intensity pain and the individual sensitivity of the patient.
If there are no other instructions, in adults and adolescents over 14 years of age The following dosages of Tramal are used:
If, after administering one dose containing 50-100 mg of the active substance (equivalent to 1-2 capsules or 1-2 ampoules of Tramal 50 mg), satisfactory pain relief is not achieved after 30-60 minutes, a second single dose of 50 mg can be administered.
In case of severe pain, a higher single dose of Tramal (100 mg tramadol) can be administered as an initial dosage.
Depending on the intensity of pain, the effect of Tramal lasts for 4 - 8 hours. The dose of tramadol hydrochloride should not exceed 400 mg per day. To relieve pain syndromes with oncological diseases and severe postoperative pain, significantly higher doses of the drug may be required.
For children over 1 year of age Tramal in the form of an injection solution or drops (1 drop contains 2.5 mg of tramadol - in currently drops are not supplied to Russia) can be prescribed in a single dose at the rate of 1-2 mg/kg of the child’s body weight.
In elderly patients (aged 75 years or more), due to the possibility of delayed elimination, the interval between drug administration can be increased in accordance with individual characteristics.
In people with kidney and liver diseases, Tramal may take longer to act. For such patients, the doctor may recommend increasing the interval between single doses. Tramal should not be prescribed for longer than therapeutically necessary.
Tramal retard is available in the form of film-coated tablets in dosages of 100 mg, 150 mg and 200 mg.
Tramal retard tablets are “long-acting” tablets. It means that active substance tramadol enters the blood slowly but constantly, which leads to a prolonged effect. Therefore, it is enough to take Tramal retard only twice a day (morning and evening).
The dose of the drug should be selected depending on the intensity of pain and the individual sensitivity of the patient. Unless otherwise specified, the following is recommended:
Adults and adolescents over 14 years of age receive 1 tablet of 100 mg twice a day, morning and evening. If the analgesic effect is insufficient, the dose can be increased by taking 1 tablet of 150 mg or 200 mg, also in the morning and evening, the intervals between doses are set individually, but must be at least 6 hours. The daily dose should not exceed 400 mg.
In elderly patients over 75 years of age, elimination of the drug may slow down. In such cases, it is necessary to increase the interval between doses in accordance with the patient's well-being. Tramal retard tablets are swallowed whole, without chewing with a sufficient amount of liquid, regardless of food intake.
Advantages of Tramal retard
- increase in duration of action - convenient dosing of the drug 2 times a day
- maintaining constant plasma concentrations of the drug, resulting in pain peaks being prevented while optimizing chronic pain control
- prevention of high concentrations of the drug in plasma, which reduces the frequency of early-onset side effects
Tramal retard is manufactured based on hydrophilic matrix system, which contains tramadol. When interacting with gastric juice The hydrophilic matrix forms a retarding gel layer, preventing rapid penetration of liquid and thus controlling the release of the drug contained therein. The liquid slowly diffuses from the surface to the center of the tablet, and the drug is released only in dissolved form.
Mode of application: Tramal retard tablets swallowed whole without chewing or breaking with sufficient fluid, regardless of food intake.
Tramal retard should not be used for longer than therapeutically necessary.
Articles on the topic
Use of tramadol hydrochloride for non-cancer pain Ananyeva L.P. The use of centrally acting analgesics in the practice of outpatient rheumatologist Ananyeva L.P. Analgesia of the postoperative period Burov N.E.This article presents the indications and prescribing regimens for analgesics:
- After extracavitary operations
- After moderate abdominal surgeries
- After major thoracic and abdominal surgeries
Here are the indications and prescription schemes for Tramal for rheumatic diseases approved by the President Russian Association rheumatologists academician E.L. Nasonov.
Tramadol (Tramal) in the treatment of acute and chronic pain syndromes Osipova N.A.This article provides information on the possibilities of using Tramal in the treatment of acute and chronic pain syndromes in oncology.
The use of tramadol hydrochloride in wide clinical practice Kirienko P.E. Modern possibilities for optimal treatment of chronic pain in cancer patients Bryuzgin V.V. Features of the treatment of chronic pain syndromes Chichasova N.A., Igolkina E.V.This article provides information about treatment options for fibromyalgia.
Opioid analgesic, cyclohexanol derivative.
Drug: TRAMADOL
Active substance of the drug:
tramadol
ATX encoding: N02AX02
CFG: Opioid analgesic with a mixed mechanism of action
Registration number: P No. 011409/01
Registration date: 09.20.04
Owner reg. cert.: ZENTIVA a.s. (The Slovak Republic)
Tramadol release form, drug packaging and composition.
Capsules white, opaque; The contents of the capsules are white powder. 1 caps. tramadol hydrochloride 50 mg
Excipients: anhydrous calcium hydrogen phosphate, magnesium stearate, colloidal silicon dioxide.
Capsule shell composition: gelatin, titanium dioxide.
10 pieces. - blisters (1) - cardboard packs.
10 pieces. - blisters (2) - cardboard packs.
The solution for injection is transparent, colorless, odorless. 1 ml tramadol hydrochloride 50 mg
1 ml - ampoules (5) - plastic containers (1) - cardboard packs.
1 ml - ampoules (5) - plastic containers (2) - cardboard packs.
1 ml - ampoules (5) - plastic containers (20) - cardboard packs.
The solution for injection is transparent, colorless, odorless. 1 ml 1 amp. tramadol hydrochloride 50 mg 100 mg
Excipients: sodium acetate, water for injection.
2 ml - ampoules (5) - plastic containers (1) - cardboard packs.
2 ml - ampoules (5) - plastic containers (2) - cardboard packs.
2 ml - ampoules (5) - plastic containers (20) - cardboard packs.
DESCRIPTION OF THE ACTIVE SUBSTANCE.
All information provided is provided for information only about the drug; you should consult your doctor about the possibility of use.
Pharmacological action of Tramadol
Opioid analgesic, cyclohexanol derivative. Non-selective agonist of mu-, delta- and kappa receptors in the central nervous system. It is a racemate of (+) and (-) isomers (50% each), which in various ways participate in the analgesic effect. The (+) isomer is a pure opioid receptor agonist, has low tropism and does not have pronounced selectivity for various receptor subtypes. Isomer (-), inhibiting the neuronal uptake of norepinephrine, activates descending noradrenergic influences. Due to this, the transmission of pain impulses to the gelatinous substance of the spinal cord is disrupted.
Causes a sedative effect. In therapeutic doses it practically does not depress breathing. Has an antitussive effect.
Pharmacokinetics of the drug.
After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract (about 90%). Cmax in plasma is achieved 2 hours after oral administration. Bioavailability after a single dose is 68% and increases with repeated use.
Plasma protein binding - 20%. Tramadol is widely distributed in tissues. Vd after oral and intravenous administration is 306 l and 203 l, respectively. Penetrates the placental barrier in a concentration equal to the concentration of the active substance in plasma. 0.1% is excreted in breast milk.
Metabolized by demethylation and conjugation to 11 metabolites, of which only 1 is active.
Excreted by the kidneys - 90% and through the intestines - 10%.
Indications for use:
Moderate and strong pain syndrome of various origins(including when malignant tumors, acute myocardial infarction, neuralgia, trauma). Carrying out painful diagnostic or therapeutic procedures.
Dosage and method of administration of the drug.
For adults and children over 14 years of age, a single dose when taken orally is 50 mg, rectally - 100 mg, slowly intravenously or intramuscularly - 50-100 mg. If at parenteral administration efficiency is insufficient, then after 20-30 minutes oral administration at a dose of 50 mg is possible.
For children aged 1 to 14 years, the dose is set at the rate of 1-2 mg/kg.
The duration of treatment is determined individually.
Maximum dose: adults and children over 14 years of age, regardless of route of administration - 400 mg/day.
Side effects of Tramadol:
From the central nervous system: dizziness, weakness, drowsiness, confusion; in some cases - attacks of convulsions of cerebral origin (with intravenous injection into high doses ah or with the simultaneous prescription of antipsychotics).
From the outside of cardio-vascular system: tachycardia, orthostatic hypotension, collapse.
From the outside digestive system: dry mouth, nausea, vomiting.
Metabolism: increased sweating.
From the outside musculoskeletal system: miosis.
Contraindications to the drug:
Acute intoxication with alcohol and drugs that have a depressant effect on the central nervous system, children under 1 year of age, hypersensitivity to tramadol.
Use during pregnancy and lactation.
During pregnancy, long-term use of tramadol should be avoided due to the risk of addiction in the fetus and withdrawal syndrome in the neonatal period.
If necessary, use during lactation ( breastfeeding) it is necessary to take into account that tramadol is excreted in breast milk in small quantities.
Special instructions for the use of Tramadol.
Use with caution for seizures central genesis, drug addiction, confusion, in patients with impaired renal and liver function, as well as hypersensitivity to other opioid receptor agonists.
Tramadol should not be used longer than is therapeutically justified. When long-term treatment The possibility of developing drug dependence cannot be ruled out.
It is not recommended for use in the treatment of drug withdrawal syndrome.
Combination with MAO inhibitors should be avoided.
During the treatment period, avoid drinking alcohol.
Tramadol in the form dosage forms extended release should not be used in children under 14 years of age.
Impact on the ability to drive vehicles and operate machinery
During the period of using tramadol, it is not recommended to engage in activities that require increased attention and high speed of psychomotor reactions.
Interaction of Tramadol with other drugs.
At simultaneous use With medicines that have a depressant effect on the central nervous system, with ethanol it is possible to enhance the depressant effect on the central nervous system.
When used simultaneously with MAO inhibitors, there is a risk of developing serotonin syndrome.
When used simultaneously with serotonin reuptake inhibitors, tricyclic antidepressants, antipsychotics, other drugs that lower the seizure threshold increase the risk of developing seizures.
When used simultaneously, the anticoagulant effect of warfarin and phenprocoumon is enhanced.
When used simultaneously with carbamazepine, the concentration of tramadol in the blood plasma and its analgesic effect decreases.
When used simultaneously with paroxetine, cases of the development of serotonin syndrome and seizures have been described.
When used simultaneously with sertraline and fluoxetine, cases of the development of serotonin syndrome have been described.
With simultaneous use, there is a possibility of reducing the analgesic effect of opioid analgesics. Long-term use of opioid analgesics or barbiturates stimulates the development of cross-tolerance.
Naloxone activates respiration, eliminating analgesia after the use of opioid analgesics.
Name: Tramadol;
INN: Tramadol / Tramadol
Release form:
Solution for injection 5%
Analogues:
Mabron, Tramal, Tramolin
ATX code:
N02AX02.
Pharmacotherapeutic group
Opioids, their analogs and antagonists
Compound
Each ampoule of the drug contains
Active substance
tramadol hydrochloride 50.0 mg
Excipient:
Sodium acetate trihydrate - 9.96 mg
Water for injections - up to 2 ml.
pharmachologic effect
It has a pronounced analgesic effect, which is due to an agonistic effect on opioid receptors (weak morphine-like effect) and a violation of the reuptake of serotonin and norepinephrine in the central nervous system. At injection the analgesic effect develops within 5-10 minutes and lasts 4-6 hours.
According to its basic pharmacological properties, it has a certain similarity with morphine, but differs from it in its significantly lesser ability to depress the respiratory center and inhibit the motility of the gastrointestinal tract, as well as the absence of a histamine-releasing effect. In therapeutic doses, the drug does not have a significant effect on hemodynamic parameters; with controlled use, addiction and drug dependence develop extremely rarely and are less pronounced in nature compared to morphine. Activates opiate receptors (mu-, delta- and kappa-) on pre- and postsynaptic
Indications for use
- Pain syndrome of moderate intensity during malignant neoplasms;
- Acute myocardial infarction;
- Injuries;
- Diagnostic and therapeutic procedures;
- Neuralgia.
Directions for use and doses
Doses are selected individually (depending on the severity of the pain syndrome and the sensitivity of the patient). The duration of the course of treatment is also determined individually, but the drug should not be prescribed beyond the period justified from a therapeutic point of view.
Adults and teenagers over 14 years old usual dose for a single oral dose is 0.05 g s a small amount liquids. If necessary, in case of insufficient effect, after 30-60 minutes you can repeat the dose at the same dose, the frequency of administration is up to 4 doses per day. The maximum daily dose is 0.4 g (400 mg). IN exceptional cases, for example, in cancer patients, it is possible to reduce the interval to 6 hours and increase the daily dose.
The effect lasts for an average of 4-8 hours depending on the nature and intensity of the pain.
Tramadol is used at increased intervals in elderly patients.
special instructions
For children over 1 year of age, the only indication for the use of tramadol is severe pain caused by acute or chronic pain.
Use during pregnancy is allowed if the expected effect of therapy outweighs the potential risk to the fetus. Breastfeeding should be stopped during treatment.
Side effects
Tramadol is relatively well tolerated, in therapeutic doses does not cause significant respiratory depression and does not significantly affect the circulatory system and gastrointestinal tract. It may, however, cause dizziness, dysphoria, euphoria, hallucinations, decreased cognitive abilities, convulsions, nausea, epigastric pain, vomiting, constipation, difficulty urinating, tachycardia, palpitations, lethargy. In rare cases, usually with long-term use of tramadol, addiction, dependence, and withdrawal syndrome are possible; severe respiratory depression, hypotension, collapse. When using tramadol in patients with a history of allergies, allergic reactions are possible.
The incidence of side effects increases with increasing duration of drug use.
Contraindications
- Hypersensitivity;
- Acute alcohol poisoning and intoxication with depressants and drugs that depress the central nervous system;
- Epilepsy;
- Impaired liver and kidney function;
- Lactation;
- Childhood up to 1 year.
- The use of tramadol is contraindicated in patients taking MAO inhibitor drugs (selegiline, hydrozine sulfate, deprenyl, cognitive, ipraniazide, harmine, pargyline, etc.).
Precautionary measures
The drug is prescribed with caution to patients with impaired renal and liver function, with traumatic brain injuries, increased intracranial pressure, patients with epilepsy. The use of tramadol may complicate the diagnosis of acute pain in the abdominal region.
Under close supervision, tramadol should be used in reduced doses against the background of anesthetic agents, sleeping pills, anxiolytics and antidepressants to avoid excessive depression of the central nervous system and suppression of the activity of the respiratory center.
The use of tramadol makes it difficult to perform work that requires a high speed of mental and physical reactions and increased concentration (driving a vehicle, operating machinery, devices, etc.).
Interaction with other drugs
Enhances the effects of tranquilizers, sleeping pills, sedatives and anesthetics, anxiolytics, alcohol. Activity is reduced by analeptics and psychostimulants, and completely blocked by naloxone and naltrexone (direct antagonists). In combination with antipsychotics and MAO inhibitors, the risk of developing epileptiform seizures increases. In patients receiving carbamazepine for a long time, the metabolism of tramadol is significantly increased, which may require an increase in the dosage of the analgesic. The drug should not be combined with narcotic analgesics from the group of full (promedol, fentanyl) or partial agonists (buprenorphine), as well as agonists-antagonists (nalbuphine, butorphanol) of opioid receptors. Inducers of microsomal oxidation (including carbamazepine, barbiturates) reduce the duration analgesic effect. Long-term use of opioid analgesics and barbiturates stimulates the development of cross-tolerance. Quinidine increases plasma concentrations of tramadol. Tramadol is pharmaceutically incompatible “in one syringe” with solutions of non-steroidal anti-inflammatory drugs.
Overdose
Symptoms:
miosis, convulsions, collapse, coma, depression of the respiratory center, apnea.
Treatment:
Ensuring cross-country ability respiratory tract, maintaining adequate pulmonary ventilation, maintaining the activity of the cardiovascular system, symptomatic therapy (opiate effects can be stopped with naloxone; seizures - with benzodiazepines (diazepam)). At chronic poisoning tramadol may develop withdrawal symptoms.
Release form
Solution for injection 5% in 2 ml ampoules in blister packs No. 5x1, No. 5x2
Manufacturer
RUE "Belmedpreparaty"
APPROVED
By order of the chairman
Pharmaceutical Control Committee
Ministry of Health
Republic of Kazakhstan
From "____" __________ 200__
№ ____________________
Instructions for medical use
medicine
TRAMADOL LANNACHER
Tradename
Tramadol Lannacher
International nonproprietary name
Tramadol
Dosage form
Solution for injection in ampoules 50 mg/ml and 100 mg/2 ml
Compound
1 ml of solution contains
active substance - tramadol hydrochloride 50 mg,
Excipients : sodium acetate, water for injection.
Description
Colorless, transparent liquid.
Pharmacotherapeutic group
Analgesics. Opioids.
ATC code N02AX02.
Pharmacokinetics
Absolute bioavailability at intramuscular injection tramadol is 100%. The absorption half-life is approximately 0.6 hours.
Protein binding is 20%. Tramadol penetrates the blood-brain barrier and the placenta. The drug is found in breast milk only in very small quantities (0.1%).
Tramadol and its metabolites are excreted through the kidneys. Only O-demethyltramadol is pharmacologically active.
The elimination half-life is approximately 6 hours, regardless of route of administration. In case of impaired liver or kidney function, a slight increase in the half-life is expected. In cases of more severe impairment (liver cirrhosis, creatinine clearance< 5 мл/мин) ожидается 2-3-кратное увеличение времени элиминации.
Excreted by the kidneys - 90% and through the intestines - 10%.
Pharmacodynamics
Tramadol Lannacher is a centrally acting analgesic and belongs to the class of opiate agonists. Therefore, opiate-like effects may be counteracted by morphine antagonists.
The binding of tramadol to opiate receptors prevents the release of neurotransmitters from synapses caused by pain impulses and inhibits the transmission of pain impulses to the nociceptive system.
The analgesic effect occurs quickly and lasts for several hours. In addition to the analgesic effect, tramadol has an antitussive effect and the effect of central antidepressants.
Indications for use
Pain syndrome of moderate and severe intensity:
Postoperative period
Myocardial infarction
Neuralgia
Pain in cancer patients
Pain relief during painful diagnostic and therapeutic procedures
Directions for use and doses
Tramadol Lannacher is used as prescribed by a doctor; the dosage regimen of the drug is selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient. The duration of treatment is determined individually; the drug should not be prescribed beyond the period justified from a therapeutic point of view. Tramadol Lannacher is intended for intravenous (administer slowly!), intramuscular or subcutaneous administration. Usual single dose for intravenous administration adults and children over 14 years old is 50-100 mg of tramadol hydrochloride. If necessary, in case of insufficient effect, further injections are possible after 30-60 minutes up to the maximum possible daily dose. When performing an intravenous drip infusion, an initial dose of 50-100 mg of tramadol hydrochloride is administered intravenously slowly (over 20 minutes), then a maintenance drip infusion is started at a rate of 12 mg of tramadol hydrochloride per hour up to the maximum possible daily dose, which is 400 mg. Compatible solutions for tramadol infusion are: saline solution, Ringer's solution or 5% glucose solution. When administered intramuscularly or subcutaneously, the initial dose is usually 50-100 mg, further injections are possible, if necessary, at a dose of 50 mg up to the maximum possible daily dose. The maximum daily dose of the drug should not exceed 400 mg.
Children aged 1 to 14 years Tramadol hydrochloride is recommended to be prescribed in a single dose at the rate of 1-2 mg per 1 kg of child’s body weight, the maximum daily dose should not exceed 4-8 mg per 1 kg of child’s body weight.
Side effects
Sweating, dizziness, headache, weakness, fatigue, lethargy, drowsiness, sleep disturbance, confusion, impaired motor coordination
Stimulation of the central nervous system (nervousness, agitation, anxiety, tremors, muscle spasms, euphoria, emotional lability, hallucinations)
Convulsions of central origin (with intravenous administration in high doses, or with simultaneous prescription of antipsychotic drugs)
Depression, amnesia, cognitive impairment, paresthesia, gait instability
Dry mouth, nausea, vomiting, difficulty swallowing, flatulence, abdominal pain, constipation, diarrhea
Tachycardia, orthostatic hypotension, syncope, collapse, vasodilation
Urticaria, itching, exanthema, bullous rash
Difficulty urinating, dysuria, urinary retention
Impaired vision, taste
Dyspnea
Menstrual irregularities.
The development of drug dependence is possible with long-term use
Withdrawal syndrome is possible when the drug is abruptly discontinued
The incidence of side effects increases with increasing duration of drug use. With long-term use in large doses the possibility of developing drug dependence cannot be ruled out.
Contraindications
Hypersensitivity to tramadol hydrochloride or opiates
Conditions accompanied by respiratory depression or severe depression of the central nervous system (alcohol poisoning, sedatives, narcotic analgesics, psychotropic drugs)
Concomitant use of monoamine oxidase inhibitors and a two-week period after their discontinuation
Impaired consciousness of unknown origin
Dysfunction of the respiratory center, impaired respiratory function
Conditions accompanied by increased cranial pressure, without artificial respiration
Opioid addiction
Pregnancy and lactation
Children's age up to 1 year
Drug interactions
When using Tramadol Lannacher simultaneously with drugs that affect the central nervous system(antidepressants, neuroleptics, sedatives, anxiolytics and drugs used in anesthesiology), as well as with alcohol, the effect of the latter may be enhanced
The use of carbamazepine and other inducers of metabolic enzymes may lead to a weakening of the analgesic effect of tramadol hydrochloride, accordingly, to the need for higher doses of the drug
With systematic use of barbiturates, especially phenobarbital, there is a possibility of reducing the analgesic effect of opioid analgesics. Long-term use of opioid analgesics or barbiturates stimulates the development of cross-tolerance
Concomitant use of tramadol hydrochloride and selective serotonin uptake inhibitors, tricyclic antidepressants and antipsychotics may increase the risk of seizures
Naloxone activates breathing, eliminating analgesia after the use of opioid analgesics
special instructions
Observe precautions when taking the drug for the following conditions:
For convulsions of central origin
For traumatic brain injuries
In patients with impaired liver and kidney function
In case of hypersensitivity to other opioid receptor agonists
Tramadol should not be used longer than is therapeutically justified. In the case of long-term treatment, the possibility of developing drug dependence cannot be excluded.