Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Grünenthal Ltd, Regus Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge, Middlesex, UB11 1BD, United Kingdom
PALEXIA is indicated for the relief of moderate to severe acute pain in children from 2 years of age with a body weight of more than 16 kg and in adults, which can be adequately managed only with opioid analgesics.
The use of PALEXIA in children is restricted to hospital use where appropriate equipment to enable respiratory support is available.
The dosing regimen should be individualised according to the severity of pain being treated, the previous treatment experience and the ability to monitor the patient.
Patients should start treatment with single doses of 50 mg tapentadol as oral solution administered every 4 to 6 hours. Higher starting doses may be necessary depending on the pain intensity and the patient’s previous history of analgesic requirements.
On the first day of dosing, an additional dose may be taken as soon as one hour after the initial dose, if pain control is not achieved. The dose should then be titrated individually to a level that provides adequate analgesia and minimises undesirable effects under the close supervision of the prescribing physician.
Daily doses greater than 700 mg tapentadol on the first day of treatment and maintenance daily doses greater than 600 mg tapentadol have not been studied and are therefore not recommended.
Calculation table for PALEXIA 20 mg/ml oral solution:
| Single dose of tapentadol to be prescribed | Volume (ml) to be administered |
|---|---|
| 25 mg | 1.25 ml |
| 50 mg | 2.5 ml |
| 75 mg | 3.75 ml |
| 100 mg | 5 ml |
The oral solution is intended for acute pain situations. If longer term treatment is anticipated or becomes necessary in adults and effective pain relief in the absence of intolerable adverse events was achieved with PALEXIA, the possibility of switching the patient to therapy with PALEXIA prolonged release formulation should be considered. As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis.
Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol (see section 4.8). When a patient no longer requires therapy with tapentadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
In patients with mild or moderate renal impairment a dosage adjustment is not required (see section 5.2).
PALEXIA has not been studied in controlled efficacy trials in patients with severe renal impairment, therefore the use in this population is not recommended (see sections 4.4 and 5.2).
In patients with mild hepatic impairment a dosage adjustment is not required (see section 5.2).
PALEXIA should be used with caution in patients with moderate hepatic impairment. Treatment in these patients should be initiated at 25 mg tapentadol as oral solution and not be administered more frequently than once every 8 hours. At initiation of therapy a daily dose greater than 150 mg tapentadol is not recommended. Further treatment should reflect maintenance of analgesia with acceptable tolerability, to be achieved by either shortening or lengthening the dosing interval (see sections 4.4 and 5.2).
PALEXIA has not been studied in patients with severe hepatic impairment and therefore, use in this population is not recommended (see sections 4.4 and 5.2).
In general, a dose adaptation in older people is not required. However, as older people are more likely to have decreased renal and hepatic function, care should be taken in dose selection as recommended (see sections 4.2 and 5.2).
Dose recommendation for children is dependent on age and body weight.
For children and adolescents from 2 years to less than 18 years the recommended single dose is 1.25 mg per kg body weight every 4 hours.
The maximum dose per day is 7.5 mg per kg body weight (≙ 6 x single dose).
The maximum dose for children and adolescents with a high BMI (body mass index) must not exceed the calculated maximum dose for a body weight at the 97.5 percentile for the given age.
Dose reductions may be considered over time as acute pain decreases.
Dose recommendation for children with a body weight of more than 16 kg (PALEXIA 20 mg/ml oral solution):
| 2 years to less than 18 years. body weight of more than 16 kg. | |||
|---|---|---|---|
| 1.25 mg/kg every 4 hours | |||
| PALEXIA 20mg/ml oral solution (dosing with provided 5 ml pipette) | |||
| kg (body weight) | ml (Dose Volume) | kg (body weight) | ml (Dose Volume) |
| 16.1-17.5 | 1.0 | 49.6-51.1 | 3.1 |
| 17.6-19.1 | 1.1 | 51.2-52.7 | 3.2 |
| 19.2-20.7 | 1.2 | 52.8-54.3 | 3.3 |
| 20.8-22.3 | 1.3 | 54.4-55.9 | 3.4 |
| 22.4-23.9 | 1.4 | 56.0-57.5 | 3.5 |
| 24.0-25.5 | 1.5 | 57.6-59.1 | 3.6 |
| 25.6-27.1 | 1.6 | 59.2-60.7 | 3.7 |
| 27.2-28.7 | 1.7 | 60.8-62.3 | 3.8 |
| 28.8-30.3 | 1.8 | 62.4-63.9 | 3.9 |
| 30.4-31.9 | 1.9 | 64.0-65.5 | 4.0 |
| 32.0-33.5 | 2.0 | 65.6-67.1 | 4.1 |
| 33.6-35.1 | 2.1 | 67.2-68.7 | 4.2 |
| 35.2-36.7 | 2.2 | 68.8-70.3 | 4.3 |
| 36.8-38.3 | 2.3 | 70.4-71.9 | 4.4 |
| 38.4-39.9 | 2.4 | 72.0-73.5 | 4.5 |
| 40.0-41.5 | 2.5 | 73.6-75.1 | 4.6 |
| 41.6-43.1 | 2.6 | 75.2-76.7 | 4.7 |
| 43.2-44.7 | 2.7 | 76.8-78.3 | 4.8 |
| 44.8-46.3 | 2.8 | 78.4-79.9 | 4.9 |
| 46.4-47.9 | 2.9 | ≥80.0 | 5.0 |
| 48.0-49.5 | 3.0 | ||
PALEXIA 20 mg/ml is not recommended for children with a body weight of 16 kg or less due to the high concentration of tapentadol.
The safety and efficacy of PALEXIA in children younger than 2 years have not yet been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made for children younger than 2 years.
Duration of treatment: The oral solution is intended for acute pain situations. As with all symptomatic treatments, the continued use of tapentadol must be evaluated on an ongoing basis. In children the duration of treatment should not exceed 3 days as safety and efficacy of longer treatment are not yet available.
Discontinuation of treatment: Withdrawal symptoms could occur after abrupt discontinuation of treatment with tapentadol (see section 4.8). When a patient no longer requires therapy with tapentadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
PALEXIA has not been studied in children and adolescents with renal impairment, therefore the use in this population is not recommended (see sections 4.4 and 5.2).
PALEXIA has not been studied in children and adolescents with hepatic impairment, therefore the use in this population is not recommended (see sections 4.4 and 5.2).
PALEXIA is for oral use.
PALEXIA can be taken with or without food.
PALEXIA can be taken either undiluted or diluted in water or any non-alcoholic drink. There is a dosing pipette with an attached adaptor in the pack which is recommended to be used to take the exact volume needed from the bottle corresponding to the prescribed single dose of tapentadol.
PALEXIA may be administered through a nasogastric tube made of polyurethane, silicone, or polyvinyl chloride (these materials were tested and showed no interactions or degradation of tapentadol).
Human experience with overdose of tapentadol is very limited. Preclinical data suggest that symptoms similar to those of other centrally acting analgesics with mu-opioid receptor agonist activity are to be expected upon intoxication with tapentadol. In principle, these symptoms include, referring to the clinical setting, in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.
Management of overdose should be focused on treating symptoms of mu-opioid agonism. Primary attention should be given to re-establishment of a patent airway and institution of assisted or controlled ventilation when overdose of tapentadol is suspected.
Pure opioid receptor antagonists such as naloxone are specific antidotes to respiratory depression resulting from opioid overdose. Respiratory depression following an overdose may outlast the duration of action of the opioid receptor antagonist. Administration of an opioid receptor antagonist is not a substitute for continuous monitoring of airway, breathing, and circulation following an opioid overdose. If the response to opioid receptor antagonists is suboptimal or only brief in nature, an additional dose of antagonist (e.g. naloxone) should be administered as directed by the manufacturer of the product.
Gastrointestinal decontamination may be considered in order to eliminate unabsorbed active substance. Gastrointestinal decontamination with activated charcoal or by gastric lavage may be considered within 2 hours after intake. Before attempting gastrointestinal decontamination, care should be taken to secure the airway.
5 years.
After first opening of the bottle, the solution should not be used for longer than six weeks.
Unopened: This medicinal product does not require any special storage conditions.
After first opening: Store in an upright position.
High density polyethylene (HDPE)-bottles sealed with aluminium foil liner and closed with a high density polyethylene (HDPE)/polypropylene (PP) child-resistant cap.
Each bottle of the oral solution is provided with a dosing pipette and an adapter attached to the dosing pipette.
The scale of the 5 ml dosing pipette is subdivided in 0.1 ml intervals. Additionally, the right scale shows the single doses for adults.
100 ml bottles and 200 ml bottles.
Not all pack sizes may be marketed.
No special requirements for disposal.
For other handling see section 4.2
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