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

Auxiliary substances: microcrystalline cellulose, talc, magnesium stearate, gelatinous starch, silicon dioxide colloid, colorant yellow yellow soda E 110.

Description:Round biconvex tablets of light orange color with the letters TRK and the risk on one side and the logo of the firm on the other.

Pharmacotherapeutic group:An analgesic with a mixed mechanism of action.

ATX: & nbsp

N.02.A.X.02 Tramadol

Pharmacodynamics:

The drug belongs to the list of No. 1 potent substances of the Standing Committee on Drug Control of the Ministry of Health of the Russian Federation.

Tramadol is an opioid synthetic analgesic with central action and action on the spinal cord (contributes to the discovery of K and Ca2 + channels, causes hyperpolarization of membranes and inhibits pain impulses), enhances the action of sedatives. Activates specific opioid receptors (mu-, delta-, kappa-) on the post- and postsynaptic membranes of the afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

Pharmacokinetics:

After oral administration, it is quickly and almost completely absorbed from the gastrointestinal tract (about 90%). The maximum concentration in the blood plasma is achieved 2 hours after ingestion. Bioavailability with a single oral intake is 68% and increases with repeated application. Penetrates through hemato-encephalic and placental barriers; excretion in breast milk is 0.1%. The volume of distribution is 306 liters. Connection with plasma proteins - 20%.

In the liver, it is metabolized by N- and O-desmethylation, followed by conjugation with glucuronic acid. 11 metabolites have been identified, of which mono-O-desmethyltramadol (Ml) has pharmacological activity. T1 / 2 in the second phase -6h (tramadol), 7.9 hours (mono-O-desmethyltramadol); in patients older than 75 years, 7.4 hours (tramadol); with cirrhosis of the liver - 13.3 + 4.9 h (tramadol), 18.5 + 9.4 h (mono-O-desmethyltramadol), in severe cases - 22.3 h and 36 h, respectively; with chronic renal failure (clearance creteinin less than 5 ml / min) -11 + 3.2 h (tramadol), 16.9 ± 3 h (mono-O-desmethyltramadol), in severe cases -19.5 h and 43.2 h respectively.

The drug is excreted by the kidneys (25-35% unchanged), the average cumulative index of renal excretion is 94%. About 7% is excreted by hemodialysis.

Indications:

Pain syndrome of strong and medium intensity including inflammatory, traumatic, vascular origin (postoperative period, trauma, pain in cancer patients, neuralgia).

Anesthesia when performing painful diagnostic or therapeutic manipulations.

Contraindications:

- Hypersensitivity to the drug and other opioids.

- A condition accompanied by respiratory depression or severe central nervous system depression (alcohol poisoning, hypnotics, narcotic analgesics, psychotropic drugs).

- Severe hepatic and / or renal failure (creatinine clearance less than 10 ml / min).

- Simultaneous use of MAO inhibitors (including 2 weeks after their cancellation).

- Children's age (up to 14 years).

Carefully:

With caution and under the supervision of a physician should be used in patients with impaired renal and hepatic function, with craniocerebral trauma, increased intracranial pressure, epilepsy patients, as well as persons with drug dependence for opioids, in patients with abdominal pain of unknown origin ("acute abdomen").

Pregnancy and lactation:In pregnancy and during lactation, use is only possible for life indications, the use should be limited only to one-time administration.

Dosing and Administration:

Tramaklosidol is used according to the doctor's prescription, the dosage regimen is selected individually, depending on the severity of the pain syndrome and the sensitivity of the patient.Duration of treatment is determined individually, should not be prescribed A drug over the term justified from a therapeutic point of view.

Tablets are swallowed without chewing, squeezed with a small amount of liquid, regardless of food intake.

DTo alleviate pain in cancer and severe pain in the postoperative period higher doses may be used.

In the absence of other prescriptions, Tramaclosidol should be administered in the following dosages:

For adults and teenagers over 14 years - 1 tablet (50 mg), if necessary, after 30-60 minutes, you can take another pill; with severe pain, a single dose can be 100 mg (2 tablets). The usual daily dose is not more than 400 mg (8 tablets).

In elderly patients (at the age of 75 and over) due to the possibility of delayed excretion, the interval between administration of the drug can be increased in accordance with individual characteristics.

In patients with kidney and liver disease tramadol may last longer. For such patients, it may be recommended to increase the interval between single dose administration.

Tramaclosydol should not be administered for longer than it is therapeutically necessary.

Side effects:

From the cardiovascular system: tachycardia, orthostatic hypotension, syncope, collapse.

From the digestive system: dry mouth, nausea, vomiting, flatulence, abdominal pain, constipation, diarrhea, difficulty in swallowing.

From the nervous system: sweating, dizziness, headache, weakness, fatigue, lethargy, paradoxical stimulation of the central nervous system (nervousness, agitation, anxiety, tremors, muscle spasms, euphoria, emotional lability, hallucinations), drowsiness, insomnia, confusion, impaired movement coordination, convulsions central origin (with concomitant administration of antipsychotics), depression, amnesia, cognitive impairment, paresthesia, gait instability.

Allergic reactions: urticaria, itching, exanthema, bullous rash.

From the side of the urinary system: dysuria, urinary retention.

From the sense organs: impaired vision, taste.

From the respiratory system: dyspnoea.

Other: violation of the menstrual cycle.

With prolonged use - the development of drug dependence is possible. Prizezkoy canceling - the development of the syndrome of "cancellation" is not ruled out.

Overdose:

Symptoms: miosis, vomiting, collapse, coma, convulsions, respiratory center depression, apnea.

Treatment: ensuring airway patency, maintaining breathing and cardiovascular activity. Opiate-like effects can be stopped with naloxone, convulsions with benzodiazepine.

Interaction:

Tramadol is pharmaceutically incompatible with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin, midazolam.

Strengthens the action of ethanol and drugs that have a depressing effect on the central nervous system.

Inductors of microsomal oxidation (incl. carbamazepine, barbiturates) reduce the severity of the analgesic effect and the duration of action of tramadol. Long-term use of opioid analgesics or barbiturates stimulates the development of cross tolerance.

Anxiolytics increase the severity of the analgesic effect of tramadol, the duration of anesthesia increases when combined with barbiturates.

Naloxone activates breathing, eliminating analgesia after the use of opioid analgesics.

MAO inhibitors, furazolidone, procarbazine, antipsychotics increase the risk of seizures (reduction of the convulsive threshold).

Quinidine increases the concentration of tramadol in the blood plasma and reduces the M1 metabolite content due to competitive inhibition of isoenzyme CYP2D6.

Special instructions:

With increased time intervals apply Tramaklosidol in elderly patients. Under careful medical supervision and in reduced doses should be used Tramaklosidol against the background of the funds for anesthesia, hypnotics and psychotropic drugs.

You should not drink alcohol while treating tramadol. Do not use for the treatment of the syndrome of "withdrawal" of drugs. In the case of a single dose, there is no need to interrupt breastfeeding.

Effect on the ability to drive transp. cf. and fur:When using the drug, it is necessary to refrain from driving the car and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets of 50 mg.

Packaging:For 10 tablets in a blister of PVC / aluminum. For 2 blisters in a cardboard box with instructions for use.

Storage conditions:

In dry, dark place at a temperature of up to 25 ° C. Keep out of the reach of children!

The drug belongs to the list of No. 1 potent substances of the Standing Committee on Drug Control of the Ministry of Health of 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:LSR-004414/09

Date of registration:04.06.2009

The owner of the registration certificate: Laboratorios Bago S.A. Laboratorios Bago S.A. Argentina

Manufacturer: & nbsp

Laboratorios BAGO, S.A. Argentina

Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands

Information update date: & nbsp17.09.2015

Illustrated instructions

Instructions

Tramaclosydol® (Tramaklosidol® )