Name: Tramadol for injection

Release form, composition and pack

1 ml tramadol hydrochloride 50 mg.

Solution for injection is transparent, colorless.

1 ml 1 amp. tramadol hydrochloride 50 mg 100 mg.

Excipients: sodium acetate, water for injection.

Clinical and pharmacological group

Opioid analgesic with a mixed mechanism of action.

Pharmacological action

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

Tramadol is an opioid synthetic analgesic that has a central effect and an effect on the spinal cord (promotes the opening of K + and Ca 2+ channels, causes hyperpolarization of membranes and inhibits the conduction of pain impulses), enhances the effect of sedatives. Activates opioid receptors (mu-, delta-, kappa-) on the pre- and postsynaptic membranes of afferent fibers of the nociceptive system in the brain and gastrointestinal tract.

Pharmacokinetics

Absorption with intramuscular administration is 100%. The time to reach Cmax after intramuscular administration is 45 minutes. Penetrates the blood-brain barrier and the placenta, 0.1% is excreted in breast milk. Vd - 203 l with intravenous administration.

Metabolized in the liver by N- and O-demethylation with subsequent conjugation with glucuronic acid. 11 metabolites have been identified, of which mono-O-desmethyltramadol (M1) has pharmacological activity.

T1/2 in the second phase - 6 hours (tramadol), 7.9 hours (mono-O-desmethyltramadol); in patients over 75 years old - 7.4 hours (tramadol); for liver cirrhosis - 13.3 ± 4.9 hours (tramadol), 18.5 ± 9.4 hours (mono-O-desmethyltramadol), in severe cases - 22.3 hours and 36 hours, respectively; for chronic renal failure (creatinine clearance less than 5 ml/min) - 11 ± 3.2 hours (tramadol), 16.9 ± 3 hours (mono-O-desmethyltramadol).

Excreted by the kidneys (25-35% unchanged) with an average cumulative renal excretion rate of 94%. About 7% is eliminated by hemodialysis.

Indications for use of the product

pain syndrome of moderate and severe intensity of various etiologies (after the surgical period, trauma, pain in cancer patients);

pain relief during painful diagnostic or therapeutic procedures.

Dosage regimen

Tramadol is used as prescribed by a doctor; the dosage regimen of the product 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 product should not be prescribed beyond the period justified from a therapeutic point of view.

Tramadol is intended for intravenous (administer slowly), intramuscular or subcutaneous administration. Unless otherwise prescribed, Tramadol should be prescribed in the following dosages:

For adults and adolescents over 14 years of age, a one-time dose of 50-100 mg of tramadol hydrochloride (1-2 ml of solution for injection). If satisfactory analgesia does not occur, a repeat single dose of 50 mg (1 ml) may be prescribed after 30-60 minutes. For severe pain, a higher dose (100 mg tramadol hydrochloride) may be prescribed as the initial dose. In general, 400 mg of tramadol hydrochloride per day is usually sufficient to relieve pain.

For the treatment of cancer pain and severe pain in the postoperative period, higher doses can be used.

In elderly patients (aged 75 years or more), due to the possibility of delayed elimination, the interval between administrations of the product can be increased in accordance with individual characteristics.

In patients with kidney and liver disease, Tramadol may take longer to act. For such patients, the doctor may recommend increasing the interval between single doses. Tramadol should not be prescribed for longer than therapeutically necessary.

Side effect

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, sleep disturbance, confusion, impaired coordination of movement, convulsions of central origin (with intravenous administration in large doses or with simultaneous administration of antipsychotic drugs), depression, amnesia, impaired cognitive function, paresthesia, gait instability.

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

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

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

From the urinary system: difficulty urinating, dysuria, urinary retention.

From the senses: impaired vision, taste.

From the respiratory system: dyspnea.

Other: menstrual irregularities.

With long-term use - the development of drug dependence. With abrupt withdrawal - withdrawal syndrome.

Contraindications for use of the product

conditions accompanied by respiratory depression or severe depression of the central nervous system (poisoning with alcohol, sleeping pills, opioid analgesics, psychotropic drugs);

severe liver and/or renal failure (creatinine clearance less than 10 ml/min);

simultaneous use of MAO inhibitors (and 2 weeks after their withdrawal);

children's age (up to 14 years);

high sensitivity to the product and other opioids.

The product should be used with caution and under the supervision of a physician by patients with impaired renal and liver function, with traumatic brain injuries, increased intracranial pressure, patients with epilepsy, as well as persons with drug addiction to opioids, in patients with pain in the abdominal cavity of unknown origin (" acute" stomach).

Pregnancy and lactation

During pregnancy and lactation, use is possible only for health reasons; use should be limited to a single dose only.

Use for liver dysfunction

In patients with liver disease, Tramadol may take longer to act. For such patients, the doctor may recommend increasing the interval between single doses. Tramadol should not be prescribed for longer than therapeutically necessary.

Contraindication: severe liver failure.

Use for renal impairment

In patients with kidney disease, Tramadol may take longer to act. For such patients, the doctor may recommend increasing the interval between single doses. Tramadol should not be prescribed for longer than therapeutically necessary.

Contraindication: severe renal failure (creatinine clearance less than 10 ml/min).

Special instructions

Tramadol is used at increased intervals in elderly patients.

Under close medical supervision and in reduced doses, Tramadol should be used against the background of the effects of anesthesia, hypnotics and psychotropic drugs. It is prohibited to drink alcohol during treatment with Tramadol.

Impact on the ability to drive vehicles and operate machinery

When using Tramadol, you must refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

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

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

Drug interactions

Pharmaceutically incompatible with solutions of diclofenac, indomethacin, phenylbutazone, diazepam, flunitrazepam, nitroglycerin, midazolam.

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

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

Anxiolytics increase the severity of the analgesic effect. Naloxone activates respiration, eliminating the analgesia associated with opioid analgesics. MAO inhibitors, furazolidone, procarbazine, antipsychotics - risk of developing seizures (reduced seizure threshold).

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

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

Store in a place protected from light and moisture, out of reach of children, at a temperature of 15° to 25°C. The drug belongs to list No. 1 of potent substances of the Standing Committee for Drug Control of the Ministry of Health of the Russian Federation. Shelf life - 5 years.

Attention!
Before using the medication "Tramadol for injection" You should consult your doctor.
The instructions are provided for informational purposes only. Tramadol for injection».

Photo of the drug

Latin name: Tramadol

ATX code: N02AX02

Active ingredient:

Manufacturer: KRKA, Slovenia PJSC FARMAK, Astrapharm LLC, Ukraine Gedeon Richter, Poland/Hungary AD Hemofarm, Serbia

Description is valid on: 25.10.17

Tramadol is a synthetic analgesic classified as an opioid drug.

Release form and composition

Available in the form of tablets, capsules and solution for injection. Tablets are sold in 10, 30 and 50 pieces, capsules - 20 pieces per package. The solution for injection is sold in ampoules of 2 ml. There are 5 or 10 ampoules in cardboard packs.

Indications for use

• severe pain of vascular, traumatic and inflammatory etiology;
• therapeutic or diagnostic procedures accompanied by severe pain;
• oncological diseases;
• postoperative period.

Contraindications

Do not prescribe in case of hypersensitivity to the components of the drug, depressed respiration and central nervous system depression.

Instructions for use Tramadol (method and dosage)

A single dose for adults and children over 14 years of age when taken orally is 50 mg, slowly intravenously or intramuscularly – 50-100 mg.

If parenteral administration is ineffective, after 20-30 minutes you can take 50 mg of the drug orally.

• For severe pain, it is recommended to prescribe up to 500 mg every 4 hours. In this case, individual observation of patients and the availability of special equipment are necessary.
• For children from 1 to 14 years of age, the dose is 1-2 mg per 1 kg of body weight.

The maximum daily dose for adults and children over 14 years of age, regardless of the route of administration, is 400 mg.

The duration of the course of therapy is determined by the doctor, taking into account the patient’s individual characteristics.

Side effects

May cause the following side effects:

• orthostatic hypotension, tachycardia, collapse, fainting - from the cardiovascular system;
• from the gastrointestinal tract: diarrhea or constipation, dry mouth, flatulence, abdominal pain, nausea;
• from the urinary system: urinary retention, dysuria, difficulty urinating;
• from the nervous system: headache, dizziness, lethargy, weakness, increased sweating, nervousness, hallucinations, muscle spasms, agitation, tremor, anxiety, emotional lability, euphoria, sleep disturbance, drowsiness, incoordination, confusion, unsteady gait, amnesia, depression, seizures, cognitive impairment;
• allergic reactions: bullous rash, itching, urticaria, exanthema.

May cause problems with taste, vision and the menstrual cycle.

Abrupt cessation of use is manifested by “withdrawal” syndrome: a strong desire to take opioids, sneezing, rhinorrhea, muscle cramps and pain, lacrimation, abdominal cramps, dilated pupils, diarrhea, nausea, vomiting, periodic chills, the formation of “goose bumps”, dysphonia, restless sleep , yawning, arterial hypertension and tachycardia.

Overdose

In case of overdose, symptoms such as:

• convulsions,
• vomit,
• apnea,
• depression of the respiratory center,
• miosis,
• collapse,
• coma.

Treatment of overdose involves maintaining airway patency and cardiovascular function. Benzodiazepine is used for seizures, and Naloxone is used to relieve opiate-like effects.

Analogs

Analogs by ATX code: Protradon, Sintradon, Tramaclosidol, Tramal, Tramolin.

Do not decide to change the drug on your own; consult your doctor.

Pharmacological action

The drug affects the spinal cord and central nervous system, inhibiting the conduction of pain impulses. It has a strong analgesic effect that lasts for a long period of time. Has a sedative and mild antitussive effect.

Activates opiate receptors in the gastrointestinal tract and brain. Stabilizes the concentration and slows down the destruction of catecholamines in the central nervous system. Tramadol is 5-10 times weaker than Morphine. Correct use of the drug does not have a significant effect on hemodynamics, intestinal motility and breathing, and does not change the pressure in the pulmonary artery.

With prolonged treatment, tolerance usually develops. The analgesic effect occurs on average 20-30 minutes after using the drug and lasts for 6 hours.

Special instructions

An analgesic is prescribed with extreme caution to people with intracranial hypertension, drug addiction, traumatic brain injury, confusion, abdominal pain of unknown etiology and epileptic syndrome.

Long-term use of this drug is addictive.

During therapy, alcohol consumption should be avoided.

During pregnancy and breastfeeding

During pregnancy and breastfeeding, use is contraindicated.

In childhood

Tablets can be prescribed to children over 14 years of age.

In old age

Patients over 75 years of age should increase the interval between taking the drug.

For impaired renal function

Not prescribed for severe renal failure.

For liver dysfunction

Contraindicated in patients with severe liver failure.

Drug interactions

• Cannot be combined with monoamine oxidase inhibitors.
• Incompatible with solutions of diazepam, diclofenac, indomethacin, flunitrazepam, phenylbutazone and nitroglycerin.
• The analgesic enhances the effect of ethanol and drugs that depress the central nervous system.
• Combining barbiturates and Tramadol enhances the effect of the anesthetic. The combination of an opioid with furazolidone, antipsychotropic drugs, procarbazine and monoamine oxidase inhibitors leads to seizures.

Opioid analgesic, cyclohexanol derivative. Non-selective agonist of μ-, Δ- and κ-receptors in the central nervous system. It is a racemate of (+) and (-) isomers (50% each), which are involved in various ways 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

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. V d 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%.

Release form

10 pcs. - contour cellular packaging (1) - cardboard packs.
10 pcs. - contour cell packaging (3) - cardboard packs.
10 pcs. - contour cell packaging (5) - cardboard packs.

Dosage

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 the effectiveness of parenteral administration 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.

Interaction

When used simultaneously with drugs that have a depressant effect on the central nervous system, ethanol may increase 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, and other drugs that lower the seizure threshold, the risk of developing seizures increases.

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.

Side effects

From the central nervous system: dizziness, weakness, drowsiness, confusion; in some cases - attacks of convulsions of cerebral origin (with intravenous administration in high doses or with the simultaneous prescription of antipsychotics).

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

From the digestive system: dry mouth, nausea, vomiting.

Metabolism: increased sweating.

From the musculoskeletal system: miosis.

Indications

Moderate and severe pain syndrome of various origins (including malignant tumors, acute myocardial infarction, neuralgia, trauma). Carrying out painful diagnostic or therapeutic procedures.

Contraindications

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.

Features of application

Use during pregnancy and breastfeeding

During pregnancy, long-term use of tramadol should be avoided due to the risk of developing addiction in the fetus and withdrawal syndrome in the neonatal period.

If it is necessary to use it during lactation (breastfeeding), it must be taken into account that tramadol is excreted in breast milk in small quantities.

Use for liver dysfunction

Use with caution in patients with impaired liver function.

Use for renal impairment

Use with caution in patients with impaired renal function.

Use in children

Contraindicated in children under 1 year of age. For children aged 1 to 14 years, the dose is set at the rate of 1-2 mg/kg.

Special instructions

Use with caution in cases of central seizures, drug addiction, confusion, in patients with impaired renal and hepatic function, as well as in patients with 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.

Combination with MAO inhibitors should be avoided.

During the treatment period, avoid drinking alcohol.

Tramadol in extended-release dosage forms should not be used in children under 14 years of age.

Impact on the ability to drive vehicles and operate machinery

Tramadol is a drug belonging to the group of opioid narcotic analgesics. The drug has a powerful analgesic effect that lasts for a long time. The circulation of the drug is carefully controlled by drug control authorities. The drug is dispensed from a network of pharmacies with a prescription.

• pills;
• capsules;
• solution for injection;
• suppositories;
• drops for oral administration.

Regardless of the release form, each form of the drug contains the active substance tramadol hydrochloride and a list of excipients.

Description and composition

40 drops or 1 ml of oral solution contains:

• 100 mg of active substance (tramadol hydrochloride);
• sucrose;
• glycerol;
• propylene glycol;
• polysorbate;
• potassium sorbate;
• sodium saccharin;
• peppermint oil;
• anise oil;
• purified water.

One capsule of opioid analgesic contains:

• 50 mg tramadol hydrochloride;
• lactose monohydrate;
• Magnesium stearate.

The gelatin shell of the capsule is colored black and contains brilliant black dye.

The film-coated tablet contains:

• 100, 150, 200 mg tramadol hydrochloride;
• hypromellose;
• microcrystalline cellulose;
• colloidal silicon dioxide;
• Magnesium stearate anhydrous.

The film shell of the tablet contains the following components:

• hypromellose;
• lactose monohydrate;
• macrogol 6000;
• talc;
• titanium dioxide;
• propylene glycol.

To make suppositories for rectal use, solid fat and active ingredient are required.

The solution for injection contains:

• 50 mg tramadol hydrochloride;
• sodium acetate;
• water for injections.

The active component, immediately after entering the body, is quickly absorbed in the gastrointestinal tract. The maximum concentration of tramadol in the blood can be observed 2 hours after administration. Bioavailability at the first dose is 68%, but it increases with regular consumption of the composition. 90% of the total mass of the substance is excreted by the kidneys, 10% through the intestines. The drug has a sedative effect and, when taken in the dosages indicated in the instructions, does not inhibit the breathing process.

Pharmacological group

Opioid narcotic analgesic. It has a mixed mechanism of action and is classified as a centrally acting analgesic. The component has a pronounced analgesic effect.

Indications for use

The drug is used to eliminate severe pain, which can occur in the following cases:

• post-traumatic period;
• postoperative period;
• pain syndrome due to neuralgia;
• pain that occurs during myocardial infarction;
• pain caused by the development of malignant tumors;
• pain syndrome that manifests itself during some therapeutic and diagnostic procedures.

The optimal form of the drug is determined depending on the type and intensity of the patient's pain. In determining the recommended dosage form and dosage, the cause or source of pain is taken into account.

In most cases, cancer patients are prescribed injection doses of the drug. To achieve a better analgesic effect, the dosage of the drug may be increased. It is not recommended to use an opioid composition with one active substance for a long-term effect; long-term use can cause addiction and the development of dependence. In this case, the therapeutic effect for the patient will not be observed.

for adults

The optimal form of the drug is determined individually by the doctor for each patient. Before determining the optimal dose, the specialist determines the nature of the course and the cause of the pain.

The drug can be addictive, so you should not use the substance after a certain course of action has expired.

for children

The drug in the form of drops for oral administration can be used to relieve acute pain in children over the age of 1 year. The dose of the drug is determined individually. The drug in the form of an injection solution, capsules and tablets is used for patients over 14 years of age.

The drug should not be used during pregnancy. Tramadol hydrochloride has a pronounced negative effect on the process.

Contraindications

Taking the drug is contraindicated:

• with respiratory or central nervous system depression;
• severe renal failure;
• liver failure;
• for the treatment of patients with a tendency to use psychoactive substances;
• simultaneously with monoamine oxidase inhibitors;
• children under 1 year of age;
• period of pregnancy and breastfeeding;
• partial sensitivity of the body to any of the components of the drug.

The drug may be used with caution in patients with the following disorders:

• disorders of the liver and kidneys;
• confusion of consciousness regardless of genesis;
• suffered TBI;
• increased levels of cranial pressure;
• convulsions;
• epileptic syndrome;
• pain in the abdominal area;
• tendency to form dependence.

Applications and dosages

The medicine is used as prescribed by a specialist. The method of use and dosage regimen are determined individually, as is the duration of therapy.

for adults

The standard dosage for oral administration (tablets or capsules) is 1 tablet. It should be taken whole with a sufficient amount of purified still water. If the therapeutic effect is not observed, the drug is repeated after 1 hour.

For severe pain, it is allowed to increase the dose once to 2 tablets. The analgesic effect lasts for 6-8 hours. The maximum daily dose of the product is 8 tablets or capsules.

The injection solution can be administered intravenously, intramuscularly or subcutaneously at a dosage of 50-100 mg. Regardless of the administration method, the solution is poured extremely slowly. The maximum daily dose for the injection form is 400 mg, for cancer patients – 600 mg.

Tramdol rectal suppositories are used to relieve pain exclusively in adult patients. A single dose is 100 mg, a daily dose is 400 mg.

for children

The product is contraindicated in children under 1 year of age. For children aged 1 to 14 years, the dosage is calculated from the ratio of 1-2 mg per 1 kg of body weight. It is prohibited to use Tramadol in the form of long-acting medications for children under the age of 14 years.

The medicine in the form of drops must be taken by the child with a small amount of sugar or liquid.

The maximum daily dose for children of different ages is:

• 1 year – 4-8 drops;
• 3 years – 6-12 drops;
• 6 years – 8-16 drops;
• 9 years – 24-24 drops;
• 12-14 years -18-36 drops.

One drop of the drug contains 2.5 mg of tramadol hydrochloride.

for pregnant women and during lactation

Not for use during pregnancy and breastfeeding. If it is necessary to use the product during lactation, breastfeeding must be stopped. The newborn is transferred to the consumption of an adapted formula on an ongoing basis.

Side effects

The following phenomena may occur in patients taking the drug:

• dizziness;
• headaches;
• nausea;
• weakness;
• itching of the skin;
• asthenia;
• sweating;
• diarrhea or .

The following disorders occur extremely rarely:

• patient weight loss;
• hypotension;
• tremor of the limbs;
• pain in the epigastric region;
• urinary retention;
• visual impairment.

Hallucinations when used in the dosages described in the instructions are extremely rare.

Interaction with other drugs

When taking alcoholic beverages simultaneously with Tramadol, respiratory depression is observed. There is information about the development of epileptic seizures when taking Tramadol in combination with antipsychotics. You should not combine the drug with MAO inhibitors; such a composition can cause the development of life-threatening conditions for the patient.

Special instructions

The list of special instructions is as follows:

1. Tramadol in the form of tablets, capsules and suppositories is not prescribed to children under 14 years of age and to patients weighing less than 25 kg.
2. Elderly people should observe the interval between doses of the drug. This restriction must be strictly observed. This measure helps prevent the development of liver dysfunction.
3. Increasing dosages and reducing intervals between doses of the drug composition is acceptable for cancer patients. The optimal permissible dosage of the medicinal composition is determined by a specialist. Tramadol can be used in combination with other opioid analgesics.
4. The incidence of adverse reactions increases with prolonged use of the composition.

When using the drug for a long period of time, the patient may experience various adverse reactions with varying degrees of intensity.

Overdose

An overdose of the drug is accompanied by respiratory depression and convulsions. Assistance to the victim should be provided in a hospital setting; it consists of supporting active pulmonary ventilation. If the overdose is not accompanied by severe symptoms, gastric lavage is sufficient to stabilize the patient’s well-being. It is possible to use enterosorbent.

Storage conditions

The drug must be stored out of the reach of children, protected from direct sunlight and moisture. The injection solution should be stored at an ambient temperature of 15 to 25 degrees for 5 years from the date of manufacture. Rectal suppositories are stored at a temperature not exceeding 30 degrees for 2 years. The shelf life of tablets and capsules is 5 years at a temperature of no more than 25 degrees. Drops for oral administration must be stored at a temperature of no more than 25 degrees for 3 years.

The drug belongs to the list of prescription compounds.

Analogs

The following drugs can be used instead of Tramadol:

1. is a complete analogue of Tramadol. The analgesic is available in drops for oral administration, suppositories, capsules, and injections. The drug can be prescribed to children over one year of age. It is contraindicated for pregnant and lactating women. After a single use there is no need to stop breastfeeding.
2. contains tramadol and as active ingredients. The drug is available in tablets. An opioid analgesic can be prescribed to patients over 14 years of age, except pregnant women and breastfeeding women.
3. Ramlepsa is a combination drug, one of the active components of which is tramadol. It is produced in tablets, which can be prescribed as an analgesic to children over 14 years of age. Ramlepsa should not be prescribed to pregnant or breastfeeding patients.
4. Tramaceta is a combined analgesic drug, the therapeutic effect of which is explained by tramadol and. The medication is available in tablets, which are approved for use as a painkiller in patients over 14 years of age.

Drug price

The cost of the medicine is on average 92 rubles. Prices range from 85 to 98 rubles.

Tramadol is a narcotic analgesic that is used to relieve pain from serious injuries and tumors. The drug quickly eliminates pain, but is less effective than morphine.

Release form

Tramadol is mainly available as an injection solution. Other forms of the drug are also produced (tablets, capsules, rectal suppositories), but they are less easily absorbed by the body, and therefore are less often used in medical practice.

Tramadol injection solution is packaged in sterile glass bottles hidden in cardboard packaging.

Effect of the drug

Tramadol injections have the effect of an opium analgesic. They produce the following effect on the patient’s body:

• inhibits the conduction of pain impulses through the nervous system;
• opens calcium and potassium channels;
• increases the effect of sedatives;
• activates opioid receptors in the brain and spinal cord.

Important! The complex effect helps to almost completely get rid of pain, because even the spinal cord is susceptible to the influence of the opium analgesic.

Due to its strong narcotic effects, the drug is included in the priority list for drug control in the Russian Federation.

Composition of the substance

For production, auxiliary substances are used to create an injection solution, and the main active component is tramadol hydrochloride.

Pharmacokinetics

The substance is absorbed by cellular tissues by 90%. Of the absorbed tramadol hydrochloride, only 68% is absorbed. With constant use of the drug, the body begins to better perceive the drug and absorb large doses of the substance.

The medication penetrates the placental barrier and affects the embryo, so use during pregnancy is carried out with extreme caution. The active substance also reaches 0.1% into the breast milk of nursing mothers.

At the end of the journey, the substance is excreted by the kidneys, about 35% of tramadol hydrochloride is removed unchanged from its original form.

In general, the analgesic effect lasts no more than 4-8 hours, after which a repeated injection of the drug is required.

Indications for use of the drug

Tramadol is intended to combat severe pain. Therefore, it can be prescribed for any severe pain. Main areas of application:

• pain relief during operations;
• reduction of discomfort during endoscopy;
• combating pain in malignant tumors and cancer;
• decreased sensitivity of the chronically inflamed area;
• treatment of purulent inflammations accompanied by severe pain;
• relief of pain in patients who have suffered serious trauma;
• any other situations when a therapeutic or diagnostic procedure is accompanied by severe pain.

Since the substance is considered a narcotic and its release is strictly controlled in the Russian Federation, the analgesic cannot be used for any mild pain. "Tramadol" is aimed at getting rid of severe pain, which significantly reduces the quality of life, causes insomnia, moral and nervous exhaustion.

Method of use of solution for injection

The dosage should first be determined by the attending physician who prescribed the drug to the patient. The size of the daily dose of the drug depends on the following factors:

• patient weight;
• age;
• level of sensitivity to pain;
• the degree of pain that engulfs him.

Important! The more severe the pain and the harder it is for the patient to cope with it, the higher the dosage of Tramadol will be.

The course of therapy and its duration are also chosen by the doctor. You should not violate the recommendations given to them, as this may result in side effects or a decrease in the effectiveness of treatment.

You can administer the drug:

• subcutaneously;
• intravenously (you need to press the syringe slowly);
• intramuscularly.

To properly administer injections, you must have minimal medical skills.

If the doctor has not prescribed the patient a different course of the drug, the following instructions for using Tramadol injections should be followed:

1. Use 50-100 mg as an initial dose (this corresponds to 1-2 ml of solution).
2. If the effect of using the above dosage is insufficient, then increase the dose. Repeatedly (no earlier than 60 minutes) another 1 ml of solution for injection should be administered.
3. During the day, you can use up to 400 mg (8 ml of solution), if reduced dosages do not allow you to completely get rid of pain. Then the initial dose of the drug is 100 mg.
4. If the drug is used for elderly patients, the interval between doses of the substance should be greater than 60 minutes. This is due to the fact that the metabolism of older people slows down, which is why an overdose can occur if an analgesic is administered frequently.
5. When treating cancer, a dosage of more than 400 mg per day is allowed, but only with the permission of a specialist.

Contraindications for use

The medication has a number of contraindications for use. The main prohibition is under 14 years of age. Children do not tolerate opium analgesics well; they quickly develop dependence, which can result in serious health problems.

Other contraindications:

• use of MAO inhibitors while using an analgesic or 2 weeks before its prescription;
• allergic reactions characteristic of the use of opium drugs;
• risk of respiratory depression in bronchial asthma and similar conditions;
• severe liver and kidney dysfunction;
• CNS disorders.

It is strictly prohibited to prescribe the drug if the patient has recently suffered poisoning with sleeping pills, drugs or alcoholic beverages.

Side effects from using Tramadol

Since the drug is opium, the list of side effects on the patient’s body is quite extensive. The main problems that may arise during the use of an analgesic:

1. Increased sweating of the body. It is expressed even with moderate physical activity.
2. Confusion, slowness or acceleration of thoughts.
3. Headaches and migraines of a prolonged nature.
4. Increased stimulation of the nervous system, which is expressed by a number of side effects - hand tremors, confused speech, pronounced emotions, euphoria.
5. Fatigue quickly even when performing basic actions.
6. Tendency to constant drowsiness (if the opposite effect is not observed - hyperexcitability).
7. Insomnia.
8. Incorrect coordination of movements and limbs.
9. Attacks of rapid heartbeat.
10. Nausea progressing to vomiting.
11. Diarrhea and other temporary gastrointestinal disorders.
12. Depressive or manic states.
13. Memory impairment: amnesia, in which current events are poorly remembered.
14. Allergic reactions - skin itching, redness, rash and hives.
15. Dysfunctions of visual and taste perception, including hallucinations; sometimes – a violation of tactile perception.
16. Urinary excretion disorders: incontinence, painful urination, etc.
17. Changes in the menstrual cycle. Displacement or complete absence of menstruation (temporary).

Due to the wide range of side effects, Tramadol is prescribed only when the benefits of using the drug outweigh the possible harm. A striking example is cases where severe cancer pain does not allow one to move, work, or even eat food.

In case of prolonged use of the drug, which is not recommended for moderate pain, drug addiction may develop. It is expressed by a number of typical symptoms - irritability, sleep disturbances, excessive sweating, withdrawal symptoms, etc. When using Tramadol, you must constantly monitor the patient's condition and try to avoid addiction.

Admissibility of the drug during pregnancy and breastfeeding

Doctors allow the use of the medication both when carrying a child and when breastfeeding the baby. However, in both cases it is important to be careful.

Tramadol affects the baby to a lesser extent during breastfeeding. Then the percentage of the substance that reaches the baby does not exceed 0.1%. However, this percentage can negatively affect the child’s condition. If allergic reactions are noticed in the absence of complementary foods, obvious disturbances in the functioning of the nervous system (insomnia, apathy or increased activity), it is important to consult a specialist.

It is not recommended to use the drug during pregnancy, because in small doses it enters the placenta and can cause addiction in the embryo. A short course of the drug is allowed if the pain causes severe stress in the mother, which is even more dangerous for the child.

Interaction with alcohol

• hallucinations;
• disturbances of consciousness;
• coordination disorders;
• hypertension;
• increased nervous excitability;
• and other effects that are characteristic of a person in a state of alcohol or drug intoxication.

If the patient uses alcohol-based vital medications, it is recommended, if possible, to replace them with alcohol-free analogues. If this cannot be done, you should seek advice from the doctor who prescribed the drug or a similar specialist. He can make one of the following decisions:

• temporarily reduce the dosage of the alcohol-based drug;
• reduce the number of drug doses per month;
• temporarily discontinue the medication and replace it with a similar one.

It is impossible to completely cancel important medications, as this can lead to a sharp deterioration in health and even poses a risk of death.

If a patient who is prescribed Tramadol injections is prone to alcoholism, it is very important to monitor his behavior and not allow him to drink alcohol.

Interaction with other drugs

Do not use simultaneously with drugs that depress the central nervous system (sedatives). Tramadol causes increased sedation, especially if the drug contains ethanol.

It should also not be used simultaneously with Quinidine, as this drug can cause an increase in the concentration of Tramadol and an overdose.

With constant use of a narcotic analgesic simultaneously with a barbiturate, the effectiveness of both drugs may decrease.

Use while driving

It is not recommended to use the drug if the patient is about to drive or will soon perform life-threatening activities (interact with cutting machines in factories, etc.). During the period of use of the medication, it is recommended to take sick leave, abandon mental professional activities and hard work requiring fine motor skills and attention.

When using the medication, the following decreases:

• reaction speed;
• level of concentration;
• coordination of movements;
• fine hand motor skills.

Overdose

An overdose can be achieved if you consume more than 8 mg of the drug per kilogram of body weight. Thus, the maximum permissible dosage of 400 mg, which is used for pain of moderate severity, is contraindicated in patients weighing up to 50 kg: it can cause an overdose.

If the dosages specified by the specialist are observed, only too frequent administration of the drug can lead to an overdose. This is especially true for older people, for whom the duration of removal of the medication from the body is increased (more than 8 hours).

The medication does not immediately lead to the maximum degree of overdose; at first, you may not notice the symptoms of the disorder at all. Depending on how much the permissible dose was exceeded, symptoms of three stages of poisoning develop:

1. First stage. It is expressed by typical symptoms of poisoning: nausea and increased sweating, decreased heart rate and decreased blood pressure. Mild fever rarely occurs. The patient may notice dizziness, headaches, “spots” - black spots, blurred vision.
2. Second stage. Breathing problems begin. The patient breathes shallowly and heavily. The heartbeat continues to worsen, and constriction of the pupils is observed. Severe pain occurs in the abdominal area. Diarrhea may occur. It becomes difficult to move, and a significant slowdown in the body’s reactions is noticeable.
3. Third stage. Seizures and other symptoms of epilepsy may occur, and swelling of the lungs or larynx often occurs. Choking or spasm of the lungs begins, which can lead to loss of consciousness. CNS depression often results in coma. If the patient is not helped, death may occur.

This overdose cannot be compensated for by gastric lavage. If you notice symptoms of exceeding the permissible dose, you must consult a doctor so that he can quickly compensate for the dangerous condition with the help of detoxification and special medications.

Since an overdose can lead to coma and death, you must carefully follow your doctor’s instructions and carefully measure the required dose of the drug. This is especially true for older people. They cannot simply follow the instructions in the package: it is important to visit a specialist so that he can professionally and individually prescribe a course of therapy.

Analogues of the drug

The drug can be changed to similar narcotic analgesics. The use of non-narcotic painkillers for severe pain is not justified.

Possible analogues:

• Tramal;
• Protradon;
• Sintradon;
• Tramolin;
• Tramundin retard;
• Tramolin retard.

Tramadol can be replaced with analogues only with the permission of a doctor.

You can also use different forms of the drug:

• capsules;
• pills;
• solution for internal use.

If it is inconvenient to make constant injections, you can replace the release form with one of the above. But to do this, you need to visit the doctor again and ask for a prescription, otherwise the drug will not be sold even if you have a prescription for the purchase of ampoules.

When changing the release form of the drug, you need to take into account that the degree of absorption of different versions of the drug is different. Therefore, the dosage is slightly different. The doctor will make any necessary changes to the prescription.

Storage conditions, expiration date and release from pharmacies

The drug is released strictly according to prescription. Purchasing without a prescription or using counterfeit prescriptions is punishable by law.

Storage conditions: at temperatures up to 20 degrees, in a dry and dark place. It is advisable not to remove the ampoules from the packaging. Keep away from children.

Shelf life – 2 years.