(Tramadol Capsules BP 50 mg)
Each Capsule Contains
Tramadol Hydrochloride BP 50mg
MECHANISM OF ACTION
Tramadol Hydrochloride is a centrally acting synthetic analgesic compound. Although its mode of action is not completely understood, from animal tests, at least two complementary mechanisms appear applicable: binding of parent and M1 metabolite to µ-opioid receptors and weak inhibition of reuptake of norepinephrine and serotonin. Opioid activity is due to both low affinity binding of the parent compound and higher affinity binding of the O-demethylate metabolite M1 to µ-opioid receptors. In animal models, M1 is up 106 times more potent than tramadol in producing analgesia and 200 times more potent in µ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound.
Nkoyo Tramadol-50 Capsule is indicated for the treatment of severe acute and chronic pain, diagnostic procedures and surgical pains.
Nkoyo Tramadol-50 Capsule Is contraindicated in hypersensitivity, acute Central Nervous system intoxications due to alcohol, analgesics, or psychotropics.
Concomitantly administered tranquilisers, hypnotics intensifies sedative effects. Fatal interaction with MAOls.
Opioid analgesics like buprenophine, butorphanol, and pentazocine precipitate withdrawal symptoms.
Sweating nausea, vomiting, animation stupor.
Alcohol, not to drive or operate machinery.
Paediatrics: Should not be used in children below 16 years.
Pregnancy: Safety not established
Lactation: Not recommended.
Elderly: Reduced dose maybe necessary.
50mg to 100mg 2 to 3 times daily. Maximum should not exceed as 400mg total daily dose.
Cases of overdose with Tramadol have been reported. Estimates of ingested dose in foreign fatalities have been in the range of 3 to 5 g. A 3 g intentional Overdose by a patient in the clinical studies produced emesis and no sequelae.
The lowest dose reported to be associated with fatality was possibly between 500 and 1000mg in a 40kg woman. But details of the case are not completely known.
Serious potential consequences of overdosage are respiratory depression and seizure. In treating an overdose, Primary attention should be given to maintaining adequate ventilation along with general supportive treatment. While naloxone will reverse some, but not all. Symptoms caused by overdosage with tramadol HCL the risk of seizures is also increased with naloxone administration. In animals convulsions following the administration of toxic doses of tramadol could be suppressed with barbiturates or benzodiazepines but were increased with naloxone. Naloxone administration did not change the lethality of an overdose in mice. Hemodialysis is not expected to be helpful in an overdose because it removes less than 70% of the administered dose in a 4-hour dialysis period.
Dispense in a tight container. Store at controlled room temperature (up to 25oC, 77oF).
Keep all medicines away from the reach of children.
Blister of 10 Capsules
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