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Medizinisch geprüft von Militian Inessa Mesropovna, Apotheke Zuletzt aktualisiert am 08.04.2022
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Treatment of moderate to severe pain.
Adults
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, use of ULTRAM® tablets is not recommended in patients under 18 years of age.
Treatment of moderate to severe pain.
These tablets are indicated in adults and adolescents aged 12 years and above.
Orozamudol is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
Adults
Orozamudol® (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. Orozamudol® 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 Orozamudol® have not been studied in the pediatric population. Therefore, use of Orozamudol® tablets is not recommended in patients under 18 years of age.
Posology
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected.
Unless otherwise prescribed, Orozamudol drops should be administered as follows:
Adults and adolescents above the age of 12 years:
The usual daily dose is 50 to 100 mg (20 to 40 drops), 3 to 4 times a day. In children from 12 to 14 years, it is recommended to use the lowest dose.
For acute pain an initial dose of 100 mg is usually necessary. In case Orozamudol Drops is used for acute pain, it should be stressed that its activity is somewhat delayed in comparison to that of other analgesics.
For pain associated with chronic conditions an initial dose of 50 mg is advised. It is recommended, when possible in case of chronic treatment, to slowly increase Orozamudol dosage to its final recommended dose (with increments every 2 to 3 days) in order to reduce the incidence of adverse events.
Paediatric population:
Orozamudol drops is not suitable for children below the age of 12 years.
Geriatric patients:
A dose adjustment is not usually necessary in elderly patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary, the dosage interval is to be extended according to the patient's requirements.
Renal insufficiency/dialysis and hepatic impairment:
In patients with renal and/or hepatic insufficiency the elimination of Orozamudol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patients requirements. In cases of severe renal and/or severe hepatic insufficiency Orozamudol drops are not recommended.
Method of administration
The drops should be administered orally and be diluted with water before administration, independent of meals.
The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances.
Orozamudol drops should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Orozamudol drops is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
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 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, total dose should not exceed 300 mg/day.
Pediatric Patients ( < 18 years old)
The safety and effectiveness of ULTRAM® has not been studied in the pediatric population. Therefore, 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®.
Missed Dose
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.
Discontinuation
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 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.
Route of administration
Oral use
Posology
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The correct dosage per individual patient is that which controls the pain with no or tolerable side effects for a full 12 hours. Patients transferring from immediate release tramadol preparations should have their total daily dose calculated, and start on the nearest dose in the Orozamudol SR range. It is recommended that patients are slowly titrated to higher doses to minimise transient side effects. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported.. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances.
Adults and children over 12 years:
The usual initial dose is one 75 mg tablet twice daily. If pain relief is not achieved, the dosage should be titrated upwards until pain relief is achieved.
Geriatric patients:
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient's requirements.
Renal insufficiency/dialysis and hepatic impairment:
In patients with renal and/or hepatic insufficiency the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient's requirements.
As tramadol is only removed very slowly by haemodialysis or by haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.
Paediatric population under 12 years of age:
Orozamudol SR has not been studied in children. The safety and efficacy of Orozamudol SR has not been established and the product should not be used in children.
Method of administration
These tablets should be taken at 12-hourly intervals and must be swallowed whole and not broken, crushed or chewed.
Orozamudol should not be used in patients with:
- creatinine clearance less than 30 mL/min,
- severe hepatic impairment (Child-Pugh Class C) (See PRECAUTIONS, Use in Renal and Hepatic Disease.)
Orozamudol must be swallowed whole and must not be chewed, crushed, or split (see WARNINGS, Misuse, Abuse and Diversion of Opioids and Drug Abuse And Addiction).
Adults (18 years of age and over)
Patients Not Currently on Tramadol Immediate-Release Products
For patients not currently treated with tramadol immediate-release (IR) products, Orozamudol should be initiated at a dose of 100 mg once daily and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. Orozamudol should not be administered at a dose exceeding 300 mg per day.
Patients Currently on Tramadol Immediate-Release Products
For patients maintained on tramadol IR products, calculate the 24-hour tramadol IR dose and initiate a total daily dose of Orozamudol rounded down to the next lowest 100 mg increment. The dose may subsequently be individualized according to patient need. Due to limitations in flexibility of dose selection with Orozamudol, some patients maintained on tramadol IR products may not be able to convert to Orozamudol. Orozamudol should not be administered at a dose exceeding 300 mg per day. The concomitant use of Orozamudol with other tramadol products is not recommended (see WARNINGS).
Individualization Of Dose
Good pain management practice dictates that the dose be individualized according to patient need using the lowest beneficial dose. Start at the lowest possible dose and titrate upward as tolerated to achieve an adequate effect. Clinical studies of Orozamudol have not demonstrated a clinical benefit at a total daily dose exceeding 300 mg.
In general, dosing of an elderly patient (over 65 years of age) should be initiated cautiously, 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. Orozamudol should be administered with even greater caution in patients over 75 years, due to the greater frequency of adverse events seen in this population.
Dosing Considerations
Orozamudol® 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.
Orozamudol® can be administered without regard to food.
Do not co-administer Orozamudol® tablets with other tramadol-containing products.
Due to the differences in pharmacokinetic properties, Orozamudol® tablets are not interchangeable with tramadol extended-release formulations.
The maximum recommended dose of Orozamudol® 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 Orozamudol® can be improved by initiating therapy with the following titration regimen: Orozamudol® should be started at 25 mg/day (half Orozamudol® 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 Orozamudol® 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 Orozamudol® 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, Orozamudol® 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, Orozamudol® 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 Orozamudol® 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, total dose should not exceed 300 mg/day.
Pediatric Patients ( < 18 years old)
The safety and effectiveness of Orozamudol® has not been studied in the pediatric population. Therefore, use of Orozamudol® tablets is not recommended in patients under 18 years of age.
Management of Patients Requiring Rescue Medication
If Orozamudol® 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 Orozamudol®.
Missed Dose
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.
Discontinuation
Withdrawal symptoms may occur if Orozamudol® 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 rarely, hallucinations. Other symptoms that have been seen less frequently with Orozamudol® discontinuation include panic attacks, severe anxiety, and paresthesias. Clinical experience suggests that withdrawal symptoms may be avoided by tapering Orozamudol® at the time of discontinuation.