Tramadol

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Prices in online pharmacies:

from 272 rubles.

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Tramadol is an opioid analgesic with a mixed mechanism of action.

Release form and composition

solution for injection: colorless, transparent (1 and 2 ml each in colorless glass ampoules, 5 ampoules in a blister strip or contour plastic packaging, in a cardboard box 1, 2, 20, 50 or 100 packages);
rectal suppositories: torpedo-shaped, with a smooth surface, white, with a faint odor (10 pcs. in blisters, in a cardboard box 1 or 2 blisters);
capsules: gelatinous hard, size and color varies depending on the manufacturer; contents - almost white or white powder (5, 6, 7, 8 and 10 pcs. in blisters, in a cardboard box 1, 2, 3, 4, 5, 6, 8, 10, 20, 40, 60, 80 or 100 packs; 5, 6, 7, 8, 10, 20, 30, 40 and 50 pcs. In polymer containers, in a cardboard box 1, 5, 10 or 20 containers; 5, 6, 7, 8, 10, 20, 30, 40, 50 and 100 pcs. In polymer bottles, in a cardboard box 1, 5, 10 or 20 bottles);
tablets: round, flat, with a slightly rough surface, white with slightly noticeable inclusions, with a chamfer, with a risk (100 mg tablets), a characteristic strawberry smell is possible (50 mg tablets - 10 pcs. in blisters, in a cardboard box 1, 2, 3 or 5 blisters; 10, 20, 30, 40, 50 and 100 pcs. In containers, in a cardboard box 1 container; 10 pcs. In blisters, in a cardboard box 2 packages; tablets 100 mg - by 10 pcs. In blisters, in a cardboard box 1, 2, 3, 4, 5, 6, 8, 10, 20, 40, 60, 80 or 100 packs; 10, 20, 30, 40, 50 and 100 each pcs. in bottles, in a cardboard box 1, 5, 10 or 20 bottles; 10, 20, 30, 40, 50 and 100 pcs. in containers, in a cardboard box 1, 5, 10 or 20 containers);
drops for oral administration: a transparent, colorless or slightly brownish solution with a characteristic smell of anise and mint (10, 20, 50 and 100 ml each in dark glass dropper bottles, 1 bottle in a cardboard box).

The active substance is tramadol hydrochloride:

1 ml of solution - 50 mg;
1 suppository - 100 mg;
1 capsule - 50 or 100 mg;
1 tablet - 50 or 100 mg;
1 ml drops - 100 mg.

Excipients:

solution: sodium acetate, water for injection;
suppositories: solid fat, glycerol (mono-, di-, tri) alkanoate;
capsules: sodium carboxymethyl starch, magnesium stearate, microcrystalline cellulose; shell composition - gelatin, titanium dioxide, dyes;
tablets: colloidal silicon oxide, magnesium stearate, microcrystalline cellulose, sodium saccharin, macrogol 4000, crospovidone, lactose, flavoring;
drops: purified water, sodium saccharinate dihydrate, propylene glycol, glycerol, sucrose, polysorbate, potassium sorbate, anise flavor, peppermint flavor.

Indications for use

Tramadol is a remedy for the relief of pain syndrome of moderate and severe intensity of various etiologies, including pain in cancer patients, pain in trauma and in the postoperative period.

Also, the drug is used for pain relief during painful diagnostic and therapeutic procedures.

Contraindications

conditions accompanied by respiratory depression or severe depression of the central nervous system (poisoning with opioid analgesics, hypnotics and psychotropic drugs, alcohol);
severe renal and / or hepatic impairment;
as a drug for the treatment of withdrawal symptoms resulting from the use of opioids;
propensity to abuse psychoactive substances;
suicidal tendencies;
epilepsy, not amenable to adequate drug control;
simultaneous use of MAO (monoamine oxidase) inhibitors and 2 weeks after their cancellation;
children under 1 year old - for oral drops, up to 14 years old - for other dosage forms;
pregnancy and lactation (with the exception of vital cases);
hypersensitivity to any component of the drug or other opioids.

With caution and under strict medical supervision, Tramadol is used in the following cases:

impaired renal and / or liver function;
disorders of consciousness of various origins;
traumatic brain injury;
increased intracranial pressure;
epilepsy;
convulsions;
drug dependence on opioids;
pain in the abdominal cavity of unknown origin (the so-called acute abdomen);
tendency to form dependence (alcoholism, drug or drug addiction);
simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors (some antidepressants and appetite suppressants), other tricyclic compounds, anti-migraine drugs (triptans), narcotic analgesics, neuroleptics and other drugs that reduce the threshold of seizure activity.

Method of administration and dosage

Tramadol is used as directed by a physician. The method of administration, dosage regimen and duration of treatment are determined individually, depending on the clinical picture, the severity of the pain syndrome and the sensitivity of the patient.

The drug should not be used longer than therapeutically necessary.

Injection

Tramadol is administered slowly intravenously, intramuscularly, or subcutaneously.

In the absence of other prescriptions, adolescents from 14 years old and adults are prescribed 50-100 mg in 1-2 ml of solution for injection once. If satisfactory analgesia does not occur, a dose of 50 mg is given after 30-60 minutes.

A high dose (100 mg) is used as an initial one for severe pain.

The daily dose is usually 400 mg. It is usually sufficient to relieve pain.

For cancer patients, higher doses may be used.

In patients with kidney and liver diseases, in the elderly over the age of 75 years, the excretion of tramadol hydrochloride may slow down, so an increase in the interval between injections of the drug may be required.

Suppositories for rectal administration

Adolescents from 14 years old and adults are usually prescribed 1 suppository up to 4 times a day.

Elderly people, patients with impaired renal / liver function in acute pain can be used 1 suppository, but with prolonged treatment, the intervals between injections should be increased.

Capsules and tablets

In these dosage forms, Tramadol should be taken orally: swallowed without chewing with a sufficient amount of liquid, regardless of meals. The tablets can be dissolved in ½ glass of water immediately before taking.

The starting dose for adolescents 14 years of age and older is 50 mg. If there is no effect within 30-60 minutes, you can take another 50 mg.

For severe pain, a single dose may be 100 mg.

The maximum daily dose is 400 mg.

Patients with impaired renal / liver function and elderly people should increase the interval between doses of the drug.

Oral drops

In the form of drops, Tramadol should be taken orally with a small amount of liquid or with sugar. Food intake does not affect the effectiveness of the drug.

Teenagers from 14 years old and adults are prescribed 20 drops (50 mg). If after 30-60 minutes there is no effect, you can take another 20 drops. The maximum daily dose is 160 drops (400 mg). The intervals between doses are 4-6 hours.

For children 1-14 years old, a single dose is 1-2 mg / kg.

Approximate dosages for children, depending on age and body weight:

1 year (10 kg) - 4-8 drops;
3 years (15 kg) - 6-12 drops;
6 years (20 kg) - 8-16 drops;
9 years (30 kg) - 12-24 drops;
12-14 years old (45 kg) - 18-36 cap.

1 drop corresponds to approximately 2.5 mg of tramadol hydrochloride.

Patients with impaired renal / liver function and elderly people should increase the interval between doses of the drug.

The bottle is equipped with a protective cap (childproof). To open it, press on the cover and turn it from left to right.

Side effects

on the part of the cardiovascular system: syncope, orthostatic hypotension, tachycardia, collapse;
from the nervous system: impaired cognitive function, confusion, increased fatigue, unsteadiness of gait, impaired coordination of movements, weakness, paresthesia, lethargy, sleep disturbances, drowsiness, dizziness, amnesia, sweating, depression, headache, paradoxical stimulation of the central nervous system (muscle spasms, tremors, emotional lability, anxiety, agitation, hallucinations, nervousness, euphoria), convulsions of central origin (with intravenous administration in high doses or with the simultaneous use of antipsychotics);
from the senses: disturbances in taste and vision;
from the urinary system: difficulty urinating, urinary retention, dysuria;
from the digestive system: difficulty swallowing, dry mouth, abdominal pain, flatulence, constipation, vomiting, diarrhea, nausea;
from the respiratory system: dyspnea;
allergic reactions: itching, urticaria, bullous rash, exanthema;
others: violation of the menstrual cycle; with prolonged use - drug dependence; with an abrupt termination of treatment - withdrawal syndrome.

Overdose symptoms: depression of the respiratory center, vomiting, convulsions, miosis, apnea, collapse, coma. Treatment: ensuring airway patency, maintaining the activity of the cardiovascular system and respiration; opiate-like effects are controlled with naloxone, convulsions with benzodiazepine.

special instructions

It is forbidden to drink alcohol during treatment.

Tramadol should not be used in combination with narcotic analgesics, since the effect of their interaction is difficult to predict.

The effect of tramadol hydrochloride may be weaker in patients receiving long-term carbamazepine.

During treatment, it is necessary to refrain from driving and performing potentially dangerous work that requires increased attention.

Drug interactions

diclofenac, midazolam, indomethacin, diazepam, phenylbutazone, nitroglycerin, flunitrazepam: pharmaceutical incompatibility has been noted;
ethanol and drugs that depress the central nervous system: their effect is enhanced;
quinidine: the plasma concentration of tramadol increases, the concentration of its metabolite (mono-O-desmethyltramadol) decreases;
inducers of microsomal oxidation (including barbiturates and carbamazepine): the severity of the analgesic effect of tramadol and the duration of its action decrease;
barbiturates: with long-term use, cross-tolerance may develop;
anxiolytics: the severity of the analgesic effect of the drug increases;
MAO inhibitors, antipsychotics, procarbazine, furazolidone: the seizure threshold decreases, as a result of which seizures may develop, the risk of severe side effects from the cardiovascular and central nervous systems increases;
naloxone: tramadol analgesia is eliminated, respiratory depression is weakened;
naltrexone: the analgesic effect of the drug may decrease;
inhibitors of the isoenzyme CYP2D6 (for example, amitriptyline, paroxetine, fluoxetine): the metabolism of tramadol decreases;
inhibitors of the isoenzyme CYP3A4 (erythromycin, ketoconazole): the metabolism of tramadol and its active O-demethylated metabolite is inhibited;
antagonists of 5-ITZ-serotonin receptors: reduce the effect of tramadol (if this combination is used in the treatment of postoperative pain, the dose of tramadol should be increased);
coumarin derivatives (including warfarin): an increase in prothrombin time, the development of bleeding and subcutaneous hemorrhage is possible;
agonists-antagonists of opioid receptors (for example, pentazocine, nalbuphine, buprenorphine): may reduce the analgesic effect of tramadol;
selective serotonin reuptake inhibitors (paroxetine, fluvoxamine, citalopram, sertraline, escitalopram), monoamine oxidase inhibitors, narcotic analgesics, some antidepressants and appetite suppressants, tricyclic antidepressants, anti-migraine drugs, other drugs and other drugs that lower the seizure threshold: increase the risk of seizures, possibly the development of serotonin syndrome (increased sweating, fever, confusion, hyperreflexia, ataxia, diarrhea, agitation, myoclonic seizures).

Analogs

Tramadol analogs are:

solutions for injection - Tramadol-Ratiopharm, Tramaclosidol, Tramadol-Pletchiko, Tramadol Lannacher;
suppositories - Tramal, Tramadol Lannacher;
capsules - Tradol, Tramadol-GR, Tramadol-Ratiopharm, Tramadol Stada;
tablets - Tramadol-Ratiopharm, Tramadol Retard, Tramadol Lannacher, Tramaclosidol;
drops for oral administration - Tramal, Tramadol Stada, Tramadol Lannacher, Tramadol-Ratiopharm.

Terms and conditions of storage

Keep out of reach of children, protected from light and moisture.

Expiry dates:

solution - 5 years at a temperature of 15–25 ° С;
suppositories - 3 years at temperatures up to 30 ° C;
tablets and capsules - 5 years at temperatures up to 25 ° C;
drops for oral administration - 3 years at temperatures up to 25 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Tramadol: prices in online pharmacies

Drug name

Price

Pharmacy

Tramadol 100 mg tablets 20 pcs.

272 r

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Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!