Ultram Tramadol Hydrochloride
Proper name: tramadol hydrochloride
Chemical name: (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride
Molecular formula and molecular mass: C16H25NO2 •HCl and 299.84
Physicochemical properties: Tramadol hydrochloride is a white to off-white, crystalline, odorless powder with a melting point between 180-184°C.
ULTRAM® (tramadol hydrochloride) is indicated for the management of moderate to moderately severe pain in adults.
Geriatrics ( > 65 Years of Age)
Healthy elderly subjects aged 65 to 75 years administered tramadol have plasma concentrations and elimination half-lives comparable to those observed in healthy subjects less than 65 years of age. ULTRAM® should be administered with greater caution in patients older than 75 years, due to the greater potential for adverse events in this population (see WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION).
Pediatrics ( < 18 Years of Age) The safety and effectiveness of ULTRAM® have not been studied in the pediatric population. Therefore, the use of ULTRAM® tablets is not recommended in patients under 18 years of age DOSAGE AND ADMINISTRATION Dosing Considerations ULTRAM® is not recommended for minor pain that may be treated adequately through lesser means where benefit does not outweigh the possible opioid-related side effects. ULTRAM® can be administered without regard to food. Do not co-administer ULTRAM® tablets with other tramadol-containing products. Due to the differences in pharmacokinetic properties, ULTRAM® tablets are not interchangeable with tramadol extended-release formulations.
The maximum recommended dose of ULTRAM® should not be exceeded. Recommended Dose And Dosage Adjustment 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. Adults (18 Years of Age and Over) For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ULTRAM® can be improved by initiating therapy with the following titration regimen: ULTRAM® should be started at 25 mg/day (half ULTRAM® scored tablet) QAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.).
Thereafter 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.) as shown in Table 1.3 below. Table 1.3: Initiation Titration Dose of ULTRAM® by Days Days 1 to 3 Days 4 to 6 Days 7 to 9 Days 10 to 12 Days 13 to 15 Days 16 to 18 Initiate at 25 mg (AM) (half ULTRAM® scored tablet) 25 mg b.i.d. 25 mg t.i.d. 25 mg q.i.d. 50 mg t.i.d. 50 mg q.i.d. After titration, ULTRAM® 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 the 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, ULTRAM® 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. Use in Renal Impairment 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. Use in Hepatic Impairment The recommended dose for adult patients with cirrhosis is 50 mg every 12 hours. Elderly Patients ( > 65 years old) 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, the total dose should not exceed 300 mg/day.
Pediatric Patients ( < 18 years old)
The safety and effectiveness of ULTRAM® have not been studied in the pediatric population. Therefore, the use of ULTRAM® tablets is not recommended in patients under 18 years of age.
Management of Patients Requiring Rescue Medication
If ULTRAM® is used as rescue medication in conjunction with extended-release tramadol tablets, the total daily dose of tramadol should not exceed 400 mg. Fentanyl products should not be used as rescue medication in patients taking ULTRAM®.
If a patient misses a dose, they should take their next dose as soon as they remember. If it is almost time for their next dose, they should not take the missed dose. Instead, they should take the next scheduled dose. They should not make up for the missed dose by taking a double dose.
Withdrawal symptoms may occur if ULTRAM® is discontinued abruptly (see Drug Abuse, Addiction, and Dependence). These symptoms may include anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and also rarely, hallucinations. Other symptoms that have been seen less frequently with ULTRAM® discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering ULTRAM® at the time of discontinuation.
Storage And Stability
Dispense in a tight container. Store at 15 -30°C.
Dosage Forms, Composition, And also Packaging
ULTRAM® tablets contain 50 mg of tramadol hydrochloride. They are white in color, capsule-shaped, coated tablet imprinted “ULTRAM” on one side and “06 59” on the scored side. They are available in HDPE bottles of 100 tablets.
Inactive ingredients in the tablet are carnauba wax, corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide.
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