Medication

Tramadol

Structure

In one milliliter oral solution (corresponding to 40 drops) contains: 100 mg of Tramadol hydrochloride, sucrose (Saccharose), glycerin (Glicerin), propylene glycol (Propylene glycol), polysorbate 20 (Polysorbate 20), potassium sorbate (Rot sorbate), sodium saccharin (Sodium saccharin), peppermint oil (Peppermint oil), anise oil (Oleum anisi), purified water (Aqua purificatae).

One capsule contains: 50 mg Tramadol hydrochloride, lactose monohydrate (Lactose monohydrate), magnesium stearate (Magnesium stearate). The composition of the gelatin capsule contains the dye diamond black PN (E151).

In the composition of one pills Tramadol Retard the film membrane contains 100, 150 or 200 mg of Tramadol hydrochloride, hypromellose (Hypromellose), microcrystalline cellulose (Microcrystalline cellulose), silicon dioxide colloidal (Silicii dioxydum colloidale) anhydrous, magnesium stearate (Magnesium stearate).

The composition of the film membrane: hypromellose (Hypromellose), lactose monohydrate (Lactose monohydrate), macrogol 6000 (Macrogol 6000), talc (Talcum), titanium dioxide (Titanium dioxide), propylene glycol (Propylene glycol).

One milliliter solution contains 50 mg of Tramadol hydrochloride, sodium acetate (Sodium acetate) anhydrous, water for injection (Aqua pro injectionibus).

To make one rectal suppository100 mg Tramadol hydrochloride, solid fat is required.

Release form

Tramadol is available in the form of:

  • drops for oral administration;
  • capsules;
  • pills
  • sustained release tablets (retard);
  • solution for injection;
  • rectal suppositories.

Pharmachologic effect

INN of the drug is Tramadol. The drug belongs to the group opioid analgesic (analgesic) drugs and is a strong central analgesic.

With an increase in the duration of administration of Tramadol, the analgesic effect of the drug decreases, as a result of which patients who are shown long-term therapy need to gradually increase the dose to maintain pain relief.

Pharmacodynamics and pharmacokinetics

Analgesic effect carried out in two ways:

  • by binding to opiate receptors (μ-, δ- and κ-) on the presynaptic and postsynaptic membranes of afferent (centripetal) nerve fibers of the pain perception system (nociceptive system) in the spinal cord and brain, as well as in the digestive tract (due to this property, the intensity decreases pain);
  • by suppressing the reuptake of norepinephrine and stimulating downward noradrenergic effects (as a result, the processes of transmission of pain impulses in the spinal cord are inhibited).

In addition, Tramadol:

  • initiates the opening of potassium (K) and calcium (Ca) channels;
  • increases the imbalance of ions on both sides of the cell membranes;
  • transmission brakes nerve impulses;
  • inhibits destruction catecholamines (norepinephrine, dopamine, epinephrine and others);
  • normalizes level catechoamines in the central nervous system.

Substance inhibits the activity of the cerebral cortex, as well as respiratory centR and cough centerthus having a sedative (calming) and antitussive effects; excites the nucleus of the oculomotor nerve and chemoreceptor trigger (start) zone of the center of vomitingthrough which pupillary reflex; provokes fromsmooth muscle sphincter.

Analgesic effect manifests itself 15-30 minutes after oral administration and lasts up to 6 hours. Of digestive tract approximately 90% of the dose taken is absorbed. Bioavailability indicator:

  • 68% when taken orally (increases with repeated use of the drug);
  • 70% - when using the drug in the form of rectal suppositories;
  • 100% - with the introduction of the solution into the muscle.

The therapeutic concentration reaches its maximum:

  • two hours after taking the tablet form of Tramadol;
  • 60 minutes after taking the drops;
  • 45 minutes after intramuscular injection.

Tramadol biotransformation occurs in liver with education 11 metabolites, one of which (mono-O-desmethyltramadol) is pharmacologically active.

The elimination half-life for Tramadol and its metabolites ranges from 6 to 43.2 hours (a very long half-life of the substance in patients with severe forms liver cirrhosis and chronic renal failure).

Excretion of Tramadol and its products metabolization carried out the kidneys (25 to 35% of the substance is eliminated in its pure form), the average cumulative indicator of excretion the kidneys - 94%. Approximately 7% is excreted using hemodialysis.

Indications for use of tramadol

Indications for use of tramadol are strong and moderately pronounced pain syndrome of various nature: post-traumatic pain syndrome (including pain after fractures, surgeries, etc.); pain associated with neuralgia; developmental pain malignant tumor, myocardial infarction, various therapeutic and diagnostic procedures.

Contraindications

The drug is contraindicated in patients with hypersensitivityto Tramadol or auxiliary components of the drug, with acute intoxication with CNS inhibitors (alcohol, psychotropic drugs, psycholeptics, sedatives and anxiolytic drugs, sleeping pills).

Tramadol is also not prescribed for an increased risk of suicide, a tendency to abuse surfactants (psychoactive substances), and severe forms liver and / or renal failurein the first 13 weeks of pregnancy, to patients who are undergoing treatment using iMAO (monoamine oxidase inhibitors).

In pediatrics, parenteral administration of the drug and the administration of drops are contraindicated in children under one year of age; capsules and tablets for oral administration are prohibited for patients younger than 14 years of age.

Side effects

The most common side effects of Tramadol are disorders that occur from digestive tract and central nervous system. When taking the drug in therapeutic doses, they are noted in approximately every third to twentieth case out of a hundred.

Adverse reactions observed in approximately 5% of cases are nausea, dizziness, constipationincreased drowsiness, headachevomiting itching, diarrhea, astheniasweating enhancement dyspneaincreased dry mouth.

More than 1% of patients with Tramadol use show the following symptoms:

  • increased anxiety, confusion, motor coordination disorders, emotional lability, euphoria, sleep disturbances;
  • abdominal pain, loss of appetite, flatulence;
  • the appearance of a rash on the skin;
  • urinary retention (ischuria), increased urination;
  • changes similar to those that occur with the onset of menopause;
  • vasodilatation;
  • visual impairment.

Less than 1% of patients:

  • convulsive activity increases;
  • cognitive function is impairedI (higher brain functions), concentration, gait;
  • arise hallucinations and paresthesia;
  • appears tremor;
  • is developing amnesia;
  • appears hives (skin blisters);
  • arise urination disorders and menstrual disorders;
  • reactions from heart and vascular system (syncope, orthostatic hypotension, palpitation, high blood pressure, cardiovascular collapse, tachycardia);
  • muscle tone increases;
  • difficulty swallowing;
  • body weight decreases.

Instructions for use Tramadol (Method and dosage)

The treatment regimen is selected depending on the intensity of the pain and the general condition of the patient. Tramadol should not be taken longer than the period during which the use of the drug is absolutely justified.

Moderate kidney and / or liver dysfunction, as well as people of advanced age, the dose is selected individually. The maximum allowable daily dose for patients older than 75 years is considered to be a dose of 0.3 g (corresponding to 3 ml or 120 drops).

With moderate liver failure reduce the dose or increase the interval between doses of capsules.

Patients with renal and / or liver failure Tramadol is recommended in a lower dose and at longer intervals. Patients with clearance creatinine (CC) does not exceed 30 ml per minute; at the initial stages of treatment, it is recommended to double the interval between doses of the solution; the maximum daily dose for them should not exceed 0.2 g.

Drops for oral administration: instructions for use

For patients over the age of 14 for pain relief a single dose of the solution is 20 drops (corresponding to 50 mg). Drops are taken with a small amount of liquid or on sugar.

If after half an hour or an hour there is no expected effect, the dose is repeated.

For children from one to fourteen years of age, the drug is prescribed at a rate of 1-2 mg per kilogram of body weight. The daily dose is from 4 to 8 mg / kg.

A repeated dose is allowed to be taken no earlier than after 4-6 hours.

Do not use Tramadol in a daily dose exceeding 0.4 g (corresponding to 4 ml or 160 drops). The exception is cases when pain relief is required for cancer patients with severe postoperative pain. For this category of patients, the daily dose, if necessary, is increased to 0.6 g.

Instructions for Tramadol capsules

Patients over the age of 14 are prescribed to take one 50 mg capsule (by mouth, with a small amount of liquid, without being attached to the meal time). With a pronounced pain syndrome a single dose is allowed to increase to 0.1 g (2 capsules).

The maximum daily dose is 0.4 g (8 capsules).

Tramadol tablets: instructions for use

Tramadol in 50 mg tablets is taken in the same manner as capsules.

Retard tablets are taken orally at 0.1-0.2 g every 12 hours. The daily dose is 0.4 g. A reduction in the interval between doses up to 6 hours and an increase in the daily dose is acceptable for patients with cancer.

Tramadol injections: instructions for use

For patients over the age of 14, Tramadol in ampoules is injected into a vein, muscle or under the skin.

A single dose - from 50 mg to 0.1 g (contents of 1-2 ampoules of 50 mg or 1 ampoule of 0.1 g).

For children aged one to fourteen, the dose is selected depending on the weight (1-2 mg / kg). The methods of administration are the same as for older patients. Tramadol in / in should be administered very slowly, after diluting it in an infusion solution.

The maximum allowable daily dose is 0.4 g, for patients with oncological diseases - 0.6 g.

Repeated Tramadol iv, v / m or s / c is allowed to enter no earlier than 4-6 hours.

Instructions for Tramadol in the form of suppositories

For patients over the age of 14, a single dose is 0.1 g (1 suppository), the intervals between applications are from 4 to 6 hours.

Overdose

A significant excess of the therapeutic dose may be accompanied by the development of symptoms of intoxication:

  • impaired consciousness (up to coma);
  • generalized seizures;
  • hypotension;
  • narrowing or dilating pupils;
  • respiratory depression;
  • tachycardia.

With a strong overdose of Tramadol, which is accompanied by defeat of the center of consciousness and shallow breathingadministered as an antidote Naloxone. For relief of seizuresintroduction to the patient is shown Diazepam.

Interaction

Concomitant use of Tramadol with MAO inhibitors. When combining the drug with drugs that affect CNS, or with alcoholic beverages, may be noted synergistic effect, expressed in increased sedation or increased analgesic effect.

Carbamazepine raises metabolism drug, as a result - the patient needs an increase in the dose of Tramadol.

Against the background of simultaneous administration of the drug with SSRIs, tricyclic depressants or psycholeptics the patient may be at increased risk of seizures.

Terms of sale

Prescription drug. You cannot buy Tramadol without a prescription.

Storage conditions

Store in a dry, dark place at room temperature (not more than 25 degrees Celsius).

Shelf life

It is suitable for use within 5 years from the date of release.

Special instructions

Tramadol - what is it?

Wikipedia states that Tramadol is powerful analgesic from the group of partial opioid receptor agonists.

Narcopedia (an encyclopedia that describes psychoactive substances) to the question “What is Tramadol?” answers that this substance is synthetic opiate analogue (narcotic alkaloids of opium), and causes effects similar to those of opium.

All known today opioids depending on the nature of their interaction with receptors, they belong to one of four main classes.

The main group is opioid agoniststo which Tramadol belongs. The analgesic power of this drug is much weaker than the power of substances such as heroin, morphine, Fentanyl, pyritramide.

Side effects from taking drugs of this group are associated with depression of stem structures and centers of the medulla oblongata. They appear in the form sedation (may be noted less frequently euphoria), increase general weakness, oppression of the cough reflex.

When taking high doses may develop bradypnea (rare breath) and apnea (respiratory arrest) bradycardia, circulatory disorders, hypotension.

Along with the opioid agonists activate activity emetic centers (which may be accompanied by bouts of nausea and vomiting), and also affect smooth muscles of hollow internal organsas a result of which the patient's motor skills may be impaired (against the background of these disorders constipation, Ishuria, stagnation of biletrend towards bronchospasm).

Tramadol - a drug or not?

All opioid agonists (Tramadol is an exception to this list), provoke physical and mental dependence, therefore the International Convention on Drugs classifies them narcotic drugsthat should be controlled.

These drugs are subject to the specific rules for the appointment, vacation, transportation, reporting, storage determined by special permits of the Ministry of Health of a particular country.

Among others opioid agonists Tramadol is non-narcotic single drugThere are no clear data on the development of dependence on it.

A prescription for Tramadol can be written on the prescription form for potent drugs by any doctor after agreement with the head of the department if necessary to remove from the patient pain syndromethat cannot be fixed with non-opioid pain medication.

When and from what tablets, injections and drops should be prescribed with extreme caution

Tramadol should not be prescribed with a predisposition to the development of alcohol, drug or drug dependence in patients.

During the period of treatment with the drug, as well as for a certain period of time after its completion, special monitoring of the condition of patients with cerebral spasms.

In patients with opioid addiction Tramadol is not used as replacement therapy.

If necessary, prolonged use of the drug does not exclude the possibility of drug dependence.

The drug is allowed to be prescribed (but with caution) to patients with increased (for example, with a head injury) intracranial pressure and serious lung disease.

High doses glycerin may cause headaches digestive tract.

In patients who are taking Tramadol while taking drugs that lower the threshold of convulsive readiness, the risk of seizures.

The solution includes sucrose. Therefore, when prescribing this dosage form, it should be borne in mind that from one dose of the drug from 0.1 to 0.2 g of sucrose enters the body.

The composition of the capsules includes lactose, and therefore they should not be prescribed to patients with fructosemiadeficiency sucrose-isomaltosemalabsorption glucose and galactose.

Analogs

Matches for ATX Level 4 code:OmnoponZaldiarTramal RetardTramal

The generics of the drug are Tramadol GR (capsules and injection), Retard, Stad (drops, capsules, injection) Acre (capsules) Plethiko (injection solution) Tramadol-ratiopharm(drops for oral administration, effervescent tablets, capsules, injection solution); Tramaclosidol in tablets and in the form of a solution for injection, Tramal (drops, capsules, injection, rectal suppositories), Tramal Retard, Tramoline (injection solution).

Tramal and Tramadol: the difference between drugs

Tramal and Tramadol are synonyms (or generics). This means that both drugs have the same composition, have the same effect and have the same indications for use, but are produced by various pharmaceutical companies.

A drug Tramal is the trade name of Tramadol, which is produced by Grunenthal GmbH (Grünental GmbH). Method of release of the drug: drops for oral administration, retard tablets, injection, capsules, rectal suppositories.

Analogs of Tramadol by the mechanism of action: Zaldiar, Omnopon, Prosidol, Forsodol, Ramleps, Tramaceta, Palexia.

During pregnancy

An early period (up to 13 weeks) of pregnancy is a contraindication to the appointment of the drug.

The category of action on the fetus according to the FDA classification is C. This means that clinical trials in pregnant women have not been conducted, and there is no exact data on the safety of the drug, however, in experiments in experimental animals, a risk to the fetus was identified.

Starting from week 14, Tramadol is prescribed if the potential benefit of the drug can outweigh the possible harm.

The drug is characterized by the ability to pass through BBB and placental barrier, 0.1% of the substance entering the body is excreted in the milk of a nursing woman. A single use of the drug, as a rule, does not require cessation of lactation.

Tramadol reviews

There are many reviews of Tramadol. Patients consider the advantages of the drug its high effectiveness even in relation to very severe pain and speed. Disadvantages - the presence of side effects, tolerance that develops over time and, in some cases, dependence.

Another group of drug reviews is tramadol reviews for oncology. They are not left by the patients themselves, but by their relatives, since the drug is prescribed in the later stages cancerwhen the purpose of its application is not treatment, but providing a person with painless care.

The main disadvantage of the drug here is that with its systematic use, the time of anesthesia is gradually reduced, and the patient needs a constant increase in dose.

In this regard, even a patient who is shown to take literally several doses of the drug (for example, during a fracture or to relieve postoperative pain) must be aware of how powerful Tramadol is and not allow itself to be taken uncontrollably.

Tramadol price where to buy

At what price to buy Tramadol in Moscow? In pharmacies, the price of Tramadol in ampoules is from 61 rubles, the price of Tramadol tablets is from 68 rubles ...

Selling Tramadol in pharmacies in Moscow and other cities is impossible without a prescription.

Many are interested in where to buy the drug with delivery and whether it is possible at all. In those cases where the company involved in the implementation of orders of medications via the Internet, as well as their delivery to the patient, is authorized to sell prescription drugs, it is possible that, if necessary, you can make an order for Tramadol online, and it will be delivered almost immediately.

In a situation where the need for the use of the drug can be predicted, and the patient does not have the opportunity to independently reach the pharmacy, some online pharmacies practice next-day delivery.

  • Online pharmacies in Kazakhstan

BIOSPHERE

  • Tramadol 50 mg No. 20 caps. Kwality Pharmaceuticals PVT Ltd. (India) 780 tg.order
  • Tramadol 50 mg No. 30 caps. Farmak (Ukraine) 810 tg.order
  • Tramadol 50 mg No. 10 caps. Quality Pharmaceuticals PVT Ltd. (India) 450 tg.order
  • Tramadol Lannacher 100 mg / 2 ml No. 5 solution for in.amp.G.L. Pharma GmbH (Austria) 1 tg.order
  • Tramadol Lannacher 50 mg No. 20 tablet p.p.p.G.L.Pharma GmbH (Austria) 760 tg.order
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