Dolzero
Dolzero
Ingredients
Active substances: tramadol – 37,5 mg; paracetamol – 325 mg.
Pharmacological group
Analgesics and anti-inflammatory drugs.
Non-narcotic analgesic, antipyretic, nonsteroidal anti-inflammatory and anti-rheumatic drugs. Analgesics-antipyretics.
Pharmacological Action
Dolzero is a combined analgesics containing tramadol and paracetamol.
Tramadol–synthetic opioids (opioid-receptor agonist) family analgesic. It has an action on ?-, ?-, ?-opioid receptors in nociceptive system of the brain and gastrointestinal tract by activating them in afferent pre- and postsynaptic membranes. Tramadol has an action on membrane polarization, opening potassium and calcium channels that causes hyperpolarization and inhibits pain impulses; potentiates the action of sedative drugs.
Paracetamol – analgesic drug with antipyretic properties; has an action on pain and temperature centers of the brain by deactivating cyclooxygenase. It has no action on prostaglandin, synthetic function of peripheral tissues; therefore paracetamol does not have an irritant effect on the gastrointestinal mucosa and has no action on water-electrolyte metabolism.
Tramadol prolongs the rapid onset of analgesic effect of paracetamol. These two ingredients have synergic action which minimizes the likelihood of side effects.
Indications
- The need for analgesia of painful therapeutic or diagnostic manipulations
- Inflammatory, post-traumatic, vascular pain syndrome (moderate to severe degree)
- Trigeminal neuralgia
- Migraine
- Shingles
- Osteochondrosis accompanied by severe radicular pain
- Renal colic
- Acute prostatitis
- Diabetic polyneuropathy
- Phantom limb pain
- Acute injuries ( of bones, muscles, and ligaments)
- Pain after dental procedures
Use
Dosage and administration mode should be determined by a doctor individually. The drug should not be administered for a period greater than the specified one. Tablets are to be administered orally with a small amount of water, without chewing. There is no correlation between the drug administration and eating.
Initial single dose – 1-2 tablet, maximum dose per day – 300mg tramadol, 2600 mg paracetamol (8 tablets).
Interval between drug intakes – at least 6 hours.
In geriatric patients (over 75 years old) the interval between drug intake should be extended, but the single dose remains the same.
Side Effects
Central and peripheral nervous system: headache, weakness, dizziness, fatigue, paradoxical hyperexcitability (tremor, spastic disorders, anxiety, agitation, nervousness, mood lability, hallucinogenic effects, and euphoria). Insomnia, confusion, drowsiness, convulsion induced by central genesis, discoordinated physical activity, depression, memory loss, memory worsening, taste and vision disorders, and unsteady gait are also possible.
Allergic Reactions
Rash, itching, Kvinke swelling.
The gastrointestinal tract: nausea, vomiting, abdominal pain, excessive gas formation, mouth dryness, difficulty in swallowing, diarrhea, and increased transaminases (without jaundice).
The endocrine system: hypoglycemic state up to development of hypoglycemic (diabetic) coma.
The cardiovascular system: orthostatic hypotension, tachycardia, and syncope arrhythmia.
The urinary system: dysuria, difficulty in urination, and urinary retention. In excess doses and unjustifiably prolonged use - nephrotoxic effects (papillary necrosis and interstitial nephritis).
Skin reactions: erythema, rash, Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrosis), bullous eruption.
The respiratory system: respiratory rhythm disorders.
Hematopoietic function: sulpho- haemoglobinuria, aplastic anemia, agranulocytosis, pancytopenia – in exceeding the recommended dose and using for a long time.
Other effects: menstrual disorders, excessive sweating.
Contraindications
- Administration combined with monoamine oxidase inhibitors (dolzero can be administered if 14 days or more passed since the last MAOIs intake)
- acute intoxication caused by psychotropics, opioid analgesics, sleeping pills, and alcohol
- creatinine clearance less than 10ml/min
- patients under 14 years old
- opiate (narcotic) withdrawal syndrome
- hypersensitivity reactions to the drug ingredients
Беременность
Dolzero is contra-indicated in pregnant and breastfeeding women.
Drugs that suppress the central nervous system (tranquilizers, psychotropic drugs), and ethanol increase tramadol’s side effects.
Dolzero’s analgesic effect fully offset when naloxone (opioid receptor antagonist) is administered.
Tramadol: vomiting, myosis, collapse, convulsions, coma, dyspnea, sleep apnea, and the respiratory center depression.
Supplementary Information
Use with caution in patients with traumatic brain injury, shock, intracranial hypertension, confusion of unknown origin, respiratory function disorders, biliary tract abnormalities, viral hepatitis, benign hyperbilirubinemia, toxic (alcoholic) hepatitis, drug addiction, alcoholism, and glucose-6-phosphate dehydrogenase deficiency.
Use with caution when administering dolzero in combination with psychotropic drugs, analgesics with central action, and local anesthetics.
Do not use when acute abdomen symptoms (that masks the full clinical picture) are observed.
Use with caution in geriatric patients (patients over 75 years old).
Dolzero should be administered based on health reasons in case of increased seizure (epilepsy controlled by the drug).
In patients that are prone to drug-abuse or patients with high potential for dependence syndrome development, tramadol administration should be controlled by a doctor.
When dolzero is administered taking of ethanol (alcohol and alcoholic beverages) is contraindicated. Administration of dolzero in patients with alcoholic steatosis increases the probability of liver function disorders.