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Acute and chronic pain syndrome of moderate and significant severity (pre-and postoperative periods, malignant tumors, injuries, neuralgia). Conducting painful diagnostic and therapeutic manipulations.
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Hypersensitivity to the active substance or other components of the drug. Acute alcohol intoxication, acute poisoning with sleeping pills, analgesic or psychotropic drugs a severe liver failure, severe renal failure (creatinine clearance less of than 10 ml/min), epilepsy with frequent seizures. The period of treatment with MAO inhibitors and the next 14 days after their cancellation. It is not used for the treatment of opioid addiction. Pregnancy or breastfeeding. Age up to 14 years.
Dosage and administration
Doses and duration of treatment are set by the doctor individually taking into account the intensity of the pain syndrome:
• Adults and children over 14 years of age are prescribed 1 capsule (50 mg) orally (with a small amount of liquid regardless of food intake). If it is severe pain, then a single dose may be 2 capsules (100 mg).
• The daily dose should not exceed 8 capsules (400 mg).
• The drug should not be used for longer than the period justified from a therapeutic point of view.
• Patients with moderate liver/kidney function disorders, as well as the elderly, doses are selected individually.
• In moderate hepatic insufficiency, it is recommended to reduce the dose or increase the interval between doses.
In moderate renal failure, it is advisable to extend the interval between doses. Patients with creatinine clearance less than 30 ml/min, should have the interval between doses extended to 12: 00. In such cases, the maximum recommended daily dose is 200 mg.
On the part of the nervous system: often- increased sweating, headache, dizziness rarely-weakness, lethargy, decreased reaction speed, sleep disorders, nightmares, euphoria, hallucinations, anxiety, emotional lability, depression, amnesia, paresthesia, drowsiness, epileptic seizures, tremor, respiratory depression, impaired coordination and speech, fainting, confusion, anxiety.
From the sensory organs: rarely-impaired vision, taste, mydriasis.
From the gastrointestinal tract: often-nausea, vomiting, dry mouth, changes in appetite, constipation, flatulence, epigastric pain, diarrhea; in some cases, there was an increase in the activity of liver enzymes.
From the cardiovascular system: infrequently-tachycardia, palpitations, decrease in blood pressure up to collapse (orthostatic collapse) rarely - bradycardia, increased blood pressure.
Allergic reactions: urticaria, itching, rash, bullous rashes, angioedema, anaphylactic reactions.
From the urinary system: difficult urination, dysuria, urinary retention.
Other: menstrual disorders, fatigue.
Symptoms: vomiting, miosis, circulatory disorders, depression of consciousness (up to coma), convulsions, depression of the respiratory center to complete respiratory arrest.
Treatment is aimed at ensuring the patency of the respiratory tract, maintaining respiration, and the function of the cardiovascular system. The antidote for respiratory depression is naloxone, for convulsions - benzodiazepine.
Tramadol is poorly excreted by dialysis, so a separate application of hemodialysis or hemofiltration is not enough.
Use during pregnancy or lactation
Tramadol penetrates the placental barrier, so it is not recommended to use the drug during pregnancy. If there are indications for analgesic therapy with opiates during pregnancy, it is necessary to limit the use of a single application.
A small amount of tramadol hydrochloride penetrates into breast milk, so do not use the drug during breastfeeding. Breast-feeding cannot be interrupted with a single application.
The ability to influence the speed of reaction when driving vehicles or working with other mechanisms. When using the drug, you should refrain from driving vehicles and working with mechanisms that require increased attention and rapid mental and motor reactions.