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TRAMADOL HCl

TDL®




FORMULATION:
Each capsule contains: Tramadol HCl ....................................................... 50mg
Each mL of solution for injection contains: Tramadol HCl ...................... 50mg

INDICATIONS:
Moderate to severe acute and chronic pain, painful diagnostic procedures and surgery.

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 active metabolite O- desmethyltramadol is dependent on the cytochrome P450 isoenzyme CUP2D6, 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 are unclear.

INCOMPATIBILITIES:
An injection of tramadol hydrochloride 50mg per 5mL is reported to be incompatible with injections of diazepam, diclofenac sodium, indocetacin, midazolam and piroxicam if mixed in the same syringe.

DEPENDENCE AND WITHDRAWAL:
Tramadol may have lower potential for producing dependence than morphine.

ADVERSE EFFECTS:
Common side effects of opoid 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 opoid adverse effects such as respiratory depression and constipation. In addition to hypotension, hypertension has occasionally occurred. Anaphylaxis, hallucinations and confusions 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 does of morphine, pentazocine, pethidine, peritramide and tramadol were compared.

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.

INTERACTIONS:
Carbazepine is reported to diminish the analgesic activity of tramadol by reducing the 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 off nonadrenaline and serotonin and enhances serotonin release and there is the possibility that it may interact with other drugs that enhances monoaminergic neurotransmission including lithium, tricyclic antidepressants and selective serotonin reuptake inhibitors; it should not be given to patient receiving MAOIs or within 114 days of discontinuation.

CAUTION:
Foods, Drugs, Devices And Cosmetics Act prohibits dispensing without prescription.

USES AND ADMINISTRATION:

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 400mg.
Usual doses by mouth are 50 to 100mg every 4 to 6 hours.

TDL AMPOULE
A dose of 50 to 100mg 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 100mg followed by 50mg every 10 to 20 minutes if necessary to a total maximum (including the initial dose) of 250mg in the first hour. Thereafter, doses are 500 to 100mg every 4 to 6 hours to total daily dose of 600mg

The dosage interval should be increased to 12 hours in patients with a creatinine clearance less than 30mL per minute. The maximum dose by mouth should not exceed 200mg daily in these patients.

Tramadol should not be given to patients with more severe renal impairment (creatinine clearance less than 10mL per minute). A dosage interval of 12 hours is also recommended in severed hepatic impairment.

AVAILABILITY:
TDL Capsule: Box of 50mg capsules
TDL ampoule: Box of 10 x 2mL ampoules

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