tramadol + paracetamol




Full Prescribing Info
Paracetamol, tramadol hydrochloride.
Each film coated tablet contains: Paracetamol 325 mg, Tramadol Hydrochloride 37.5 mg.
Paracetamol is used in the symptomatic management of pain and fever. It possesses weak anti-inflammatory activity.
Tramadol Hydrochloride 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 gastrointestinal 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 cytochrome P450 isoenzyme (mainly CYP2E1 and CYP3A4) in the liver and kidney and which is usually detoxified by conjugation with glutathione may accumulate following paracetamol overdosage and cause tissue damage.
Tramadol 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 is excreted mainly in the urine, predominantly as metabolites. Tramadol 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 pain.
Dosage/Direction for Use
Adults and Children over 16 years: An initial dose of 2 tablets is recommended. Additional doses can be taken a needed, not exceeding 8 tablets per day. The dosing interval should not be less than 6 hours. Or as prescribed by the physician.
Contraindications in patients with history of hypersensitivity ASA or any other NSAIDs.
NSAIDs are contraindicated in patients with previous or active peptic ulceration.
Use with caution in patients with cardiac, liver and renal disease. Dose adjustment like using the lowest effective dose and monitoring of renal and liver functions should be instituted.
Absolute contraindications: Not to be given to those patients who have history of: Stroke: cerebrovascular accident (CVA);
Heart: Myocardial infarction, MI; Coronary artery bypass graft: CABG; Uncontrolled hypertension; Congestive heart failure (CHF) NYHA II-IV.
Special Precautions
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 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 should be used with care in patients with history of epilepsy or those susceptible to seizures.
Adverse Reactions
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 hydrochloride are nausea, vomiting, constipation, drowsiness & 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.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AJ13 - tramadol and paracetamol ; Belongs to the class of opioids in combination with other non-opioid analgesics. Used to relieve pain.
Pradol FC tab
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