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Tramadol Hydrochloride orally disintegrating tablets is a centrally acting analgesic in an orally disintegrating formulation using a tablet formulation base. The chemical name for tramadol hydrochloride is (±) cis -2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is:
Tramadol Hydrochloride is supplied as orally disintegrating tablets containing 50 mg of tramadol hydrochloride for oral administration.
Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7.
The tablets are white in color and contain the inactive ingredients aspartame, copovidone, crospovidone, ethylcellulose, magnesium stearate, mannitol, mint flavor, and silicon dioxide.
Do NOT chew, break, or split the tablet.
Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of tramadol hydrochloride tablets can be improved by initiating therapy with a titration regimen. The total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg q.i.d.). After titration, Tramadol Hydrochloride 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.
For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, Tramadol Hydrochloride 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.
Place Tramadol Hydrochloride tablet on the tongue until it completely disintegrates and then swallow it. It may take approximately one minute for the tablet to disintegrate on the tongue. Tablet may be taken with or without water.
In a post-marketing-surveillance study the use of a sustained-release tramadol preparation (Tramal long 100, 150, 200 mg) was investigated in 3153 patients. The intention was to comply with the legal obligation to carry out product surveillance and to collect data on prescribing behaviour. We focused our attention on drug safety and efficacy. Tramal long was used mainly for severe and very severe pain. The most frequently reported causes of pain were diseases of the locomotor system (49.9%), tumours (24.3%), traumas and fractures (10.1%), and neurogenic (9.3%). The mean daily dose was 235.7 mg, usually divided into two doses. The analgesic effect was described as very good or good by 82.5% of the patients. Adverse events occurred in 6.5% of the patients, mostly in the form of typical opioid side-effects such as nausea (3.4%), dizziness (1.5%) and vomiting (1.1%). Severe or unknown side-effects were not reported.
Individualization of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Studies with tramadol in adults have shown that starting at the lowest possible dose and titrating upward will result in fewer discontinuations and increased tolerability.
- In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of ULTRAM® be increased to 12 hours, with a maximum daily dose of 200 mg. Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.
- The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours.
- In general, dose selection for an elderly patient over 65 years old should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy. For elderly patients over 75 years old, total dose should not exceed 300 mg/day.
DOSING: The recommended dose of tramadol is 50-100 mg (immediate release tablets) every 4-6 hours as needed for pain. The maximum dose is 400 mg/day. To improve tolerance patients should be started at 25 mg/day, and doses may be increased by 25 mg every 3 days to reach 100 mg/day (25 mg 4 times daily). Thereafter, doses can be increased by 50 mg every 3 days to reach 200 mg day (50 mg 4 times daily). Tramadol may be taken with or without food.
Recommended dose for extended release tablets is 100 mg daily which may be increased by 100 mg every 5 days but not to exceed 300 mg /day. Extended release tablets should be swallowed whole and not crushed or chewed.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal.
Overdose symptoms may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma. please check tramadol overdosage