Dologesic

Paracetamol, tramadol hydrochloride.

Each film-coated tablet contains: Paracetamol 325 mg, Tramadol HCl 37.5 mg.
Paracetamol is used in the symptomatic management of pain and fever. It possesses weak anti-inflammatory activity.
Tramadol HCl is an opioid analgesic. It also has noradrenergic and serotonergic properties that may contribute to its analgesic activity.

Pharmacology: Pharmacokinetics: Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentration occurring about 10-60 minutes after oral administration. Paracetamol is distributed into the most body tissues. It crosses the placenta and is present in the breast milk. Plasma-protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations. The elimination half-life of Paracetamol varies from about 1 to 3 hours.
Paracetamol is metabolized predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates less than 5% is excreted as unchanged Paracetamol. A minor hydroxylated metabolite (N-acetyl-p-benzoquinoneimine), which is usually produced in very small amounts by mixed function oxidases in the liver and kidney and which is usually detoxified by conjugation with glutathione may accumulate following paracetamol overdosage and cause tissue damage.
Tramadol HCl is readily absorbed following oral administration but is subject to first-pass metabolism. Tramadol is metabolized by N- and O-demethylation glucuronidation or sulfation in the liver. The metabolite O-desmethyltramadol is pharmacologically active. Tramadol HCl is excreted mainly in the urine, predominantly as metabolites. Tramadol HCl is widely distributed, crosses the placenta, and appears in small amounts in breast milk. The elimination half-life following oral administration is about 6 hours.

Indicated for moderate to severe acute pain.

Adults and Children over 16 years: 1 to 2 tablets every 4 to 6 hours up to a maximum of 8 tablets per day or as prescribed by the physician.

Paracetamol should be given with care to patients with impaired kidney and liver functions. It should also be given with care to patients with alcohol dependence.
Tramadol HCl should be used with caution in patients with renal or liver impairment and should be avoided if renal impairment is severe. Removal by hemodialysis is reported to be very slow. Tramadol HCl should be used with care in patients with history of epilepsy or those susceptible to seizures.

Paracetamol are rare and usually mild, although haematological reactions including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Skin rashes, and other hypersensitivity reactions occur occasionally. Overdosage with Paracetamol can result in severe liver damage and sometimes acute renal tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential. The common side effects of tramadol HCl are nausea, vomiting, constipation, drowsiness and confusion; tolerance to these (except constipation) generally develops with long-term use. Micturition may be difficult and there may be ureteric or biliary spasm; there is also an antidiuretic effect. Dry mouth, dizziness, sweating, facial flushings, headache, vertigo, bradycardia, tachycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, decreased libido or potency, hallucinations, and miosis also occur. These effects tend to occur more commonly in ambulant patients than in those at rest in bed and in those without severe pain. Raised intracranial pressure occurs in some patients. Muscle rigidity has been reported following high doses. The euphoric activity of opioids has led to their abuse.

Store at temperatures not exceeding 30°C.

Analgesics (Non-Opioid) & Antipyretics / Analgesics (Opioid)

N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.

Rx