Tramadol Hydrochloride 50mg Capsules
Each capsule contains:
Tramadol Hydrochloride BP 50mg
|TRAMA contains size '2' hard gelatin capsule with yellow cap and yellow body.|
Pharmacotherapeutic Group: Opioid analgesics
Pharmacodynamic properties: Tramadol inhibits reuptake of norepinephrine, serotonin and enhances serotonin release. It alters perception and response to pain by binding to mu-opiate receptors in the CNS.
Absorption: Readily absorbed from the GI tract. Bioavailability: Approximately 70-75% (oral), Onset: Approx1 hour; Duration: 9 hours
Distribution: Widely distributed. Crosses the placenta and enters breast milk. Protein binding: 20%
Metabolism: Extensive hepatic first-pass metabolism. Converted to O-desmethyltramadol (active) via N- and O-demethylation by CYP3A4 and CYP2D6 isoenzymes and also via glucorinadation or sulfation.
Excretion: Via urine (as metabolites). Elimination half-life: Approximately 6 hours
Post operative pain, Cancer pain, Arthralgia, Neuralgia, Severe acute and chronic pain
Adults, Moderate to severe pain: 50-100 mg 4-6 hourly. Max: 400 mg/day.
Pregnancy: Category C
Tramadol can pass into breast milk and may harm a nursing baby. Do not breastfeed while using tramadol.
Storage: Store tablets between 15-30 °C.
Hypersensitivity, suicidal patients, acute alcoholism, head injuries, raised intracranial pressure, severe renal impairment, lactation.
Hypothyroidism, adrenocortical insufficiency, renal or hepatic impairment, history of epilepsy or increased risk of seizures, inflammatory or obstructive bowel disease, myasthaenia gravis, respiratory depression, prostatic hyperplasia. Pregnancy
Serious AEs: Respiratory depression
Common AEs: Nausea, dizziness, headache, somnolence, constipation, vomiting, dry mouth, sweating, fatigue, vertigo, euphoria.
Possible increase in anticoagulation with warfarin. Increased risk of seizures with SSRI, TCA. Increased risk of serotonin syndrome with mirtazapine, venlafaxine, SSRI and MAOI. Reduced analgesic efficacy of tramadol with carbamazepine, 5-HT3 receptor antagonist e.g. ondansetron. Increased respiratory and CNS depression with CNS depressants e.g. alcohol, opioids, anaesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics.
Each box is supplied with 10 strips of 10 caps packed in blisters.