Full Prescribing Info
Tramadol HCl.
Each capsule contains: Tramadol hydrochloride 50 mg.
Each mL of Solution for Injection contains: Tramadol hydrochloride 50 mg.
Pharmacology: Pharmacokinetics: Tramadol is readily absorbed following oral administration but is subject to first-pass metabolism. Tramadol is metabolized by N- and O- demethylation and 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.
Metabolism: Production of the active metabolite O-desmethyltramadol is dependent on the cytochrome P450 isoenzyme CYP2D6, which exhibits genetic polymorphism. Concomitant administration with specific inhibitors of this enzyme, such as quinidine, may increase concentrations of tramadol and lower concentrations of its active metabolite but the clinical consequence of this effect is unclear.
Moderate to severe acute and chronic pain, painful diagnostic procedures and surgery.
Dosage/Direction for Use
TDL capsule: The dosage depends on the intensity of the pain and the sensitivity of the individual patient. The total daily dosage by mouth should not exceed 400 mg.
Usual doses by mouth are 50 to 100 mg every 4 to 6 hours.
TDL ampoule: A dose of 50 to 100 mg may be given every 4 to 6 hours by intravenous injection over 2 to 3 minutes, or by intravenous infusion.
For treatment of postoperative pain, the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a total maximum (including the initial dose) of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours to total daily dose of 600 mg.
The dosage interval should be increased to 12 hours in patients with a creatinine clearance less than 30 mL per minute. The maximum dose by mouth should not exceed 200 mg daily in these patients.
Tramadol should not be given to patients with more severe renal impairment (creatinine clearance less than 10 ml per minute). A dosage interval of 12 hours is also recommended in severe hepatic impairment.
Special Precautions
Tramadol should be used with caution in patients with renal or liver impairment and should be avoided if renal impairment is severe. Removal by haemodialysis is reported to be very slow.
Tramadol should be used with care in patients with a history of epilepsy or those susceptible to seizures.
Anesthesia: Do not take tramadol during light planes of general anesthesia because of possible intra-operative awareness, although it may be used intra-operatively provided anesthesia is maintained by the continuous administration of a potent volatile or intravenous anesthetic.
Dependence and withdrawal: Tramadol may have lower potential for producing dependence than morphine.
Adverse Reactions
Common side effects of opioid analgesics like tramadol are nausea, vomiting, constipation, drowsiness and confusion; tolerance of these (except confusion) generally develops with long-term use.
Tramadol may produce fewer typical opioid adverse effects such as respiratory depression and constipation. In addition to hypotension, hypertension has occasionally occurred. Anaphylaxis, hallucinations and confusion have also been reported.
Effects on the respiratory system: Respiratory depression has been reported after tramadol infusion anesthesia although in a postoperative study tramadol had no significant respiratory depressant effect when equianalgesic doses of morphine, pentazocine, pethidine, piritramide and tramadol were compared.
Drug Interactions
Carbamazepine is reported to diminish the analgesic activity of tramadol by reducing serum concentration. The risk of seizures is increased if tramadol is administered concomitantly with other drugs that have the potential to lower the seizure threshold.
Tramadol inhibits reuptake of nonadrenaline and serotonin and enhances serotonin release and there is the possibility that it may interact with other drugs that enhance monoaminergic neurotransmission including lithium, tricyclic antidepressants and selective serotonin reuptake inhibitors; it should not be given to patients receiving MAOIs or within 114 days of their discontinuation.
Caution For Usage
Incompatibilities: An injection of tramadol hydrochloride 50 mg per mL is reported to be incompatible with injections of diazepam, diclofenac sodium, indometacin, midazolam and piroxicam if mixed in the same syringe.
Store at temperatures not exceeding 30°C.
MIMS Class
Analgesics (Opioid) / Supportive Care Therapy
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
TDL cap 50 mg
50's (P1,215.2/pack)
TDL inj 50 mg/mL
(amp) 2 mL x 10 × 1's (P1,242.59/box)
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