Source: European Medicines Agency (EU)
Severe pain in adults.
Levomethadone must be titrated individually. In general, the lowest effective analgesic dose should be chosen. The following recommended doses should be used as guidance. In case of severe pain conditions (e.g. cancer pain) doses may vary.
It is recommended that the patient should rest during levomethadone’s duration of action.
For adults a single dose of 7.5 mg levomethadone hydrochloride is recommended. In certain cases the initial dose might be 2.5 mg levomethadone hydrochloride.
In case of decreasing efficacy, administration can be repeated after 4-6 hours. In order to avoid a cumulative effect generally the second and all following doses should be lower than the initial dose.
For the total daily dose it is recommended not to exceed 4 to 6 times the single dose.
For the treatment of chronic pain administration following a fixed dose schedule should be preferred.
Notes: Levomethadone is roughly twice as effective as the methadone racemate. There are indications that levomethadone degradation is enhanced when the methadone racemate is administered, thereby possibly altering this ratio. This must be taken into account when dosing.
Dose reduction is recommended in the elderly, patients with renal disorders, patients with severe chronic hepatic disorders or patients with reduced general condition.
The safety and efficacy of levomethadone in children and adolescents aged below 18 years have not been established. No recommendation on a posology can be made.
Oral use. The tablets should be taken with a sufficient amount of liquid (e.g. ½ glass of water).
Particularly in opiate-naïve persons (especially children), serious intoxication can be induced even by lower doses. In children up to 5 years, this is possible from about 0.5 mg, in older children from about 1.5 mg and in opiate-naïve adults from about 10 mg levomethadone.
A dose reduction is recommended if patients show signs and symptoms of an excessive levomethadone-effect, characterised by symptoms such as “feeling strange”, poor concentration skills, drowsiness and possibly dizziness upon standing.
Furthermore, cases of overdose are characterised by respiratory depression (reduced respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme drowsiness tending to impaired consciousness and even coma, miosis, musculoskeletal flaccidity, cold and clammy skin and sometimes bradycardia and hypotension. Massive overdoses can cause apnoea, circulatory failure, cardiac arrest and death.
Emergency medical care or, if necessary, intensive-care measures are required immediately (e.g. intubation and ventilation). For treating symptoms of intoxication, specific opiate antagonists (e.g. naloxone) can be used. The dose of individual opiate antagonists varies (refer to the product information). In particular, it should be considered that levomethadone can have long-lasting respiratory-depressant effects (up to 75 hours), whilst opiate antagonists have a much shorter duration of action (1 to 3 hours). Subsequent injections may therefore be required after the antagonistic effects have subsided. Measures to maintain body warmth and volume replacement may be necessary.
In the event of oral intoxication with levomethadone, gastric lavage may be performed only after antagonism has taken place. It is particularly important to protect the airways by intubation both when performing gastric lavage and prior to administering antagonists (vomiting may be induced). In the treatment of intoxication, alcohol, barbiturates, bemegride, phenothiazines and scopolamine must not be used.
Levomethadone is not dialysable.
Blister: 2 years.
HDPE bottles:
2.5 mg/20 mg/30 mg: 1 year.
5 mg: 18 months.
After first opening: 1 month.
Store in the original package in order to protect from light.
Child resistant aluminium//PVC/PE/PVDC unit-dose peel-off or push-through blisters with 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 tablets.
HDPE bottles with child-resistant polypropylene screw cap with 28, 56, 98, 100, 250 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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