LEVOMETHADONE Tablets
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Περιεχόμενα
Name of the medicinal product
Levomethadone 2.5 mg tablets. Levomethadone 5 mg tablets. Levomethadone 20 mg tablets. Levomethadone 30 mg tablets.
Qualitative and quantitative composition
Levomethadone 2.5 mg: Each tablet contains levomethadone as 2.5 mg levomethadone hydrochloride. Levomethadone 5 mg: Each tablet contains levomethadone as 5 mg levomethadone hydrochloride. Levomethadone ...
Pharmaceutical form
Tablet. Levomethadone 2.5 mg tablets: White to off-white, oblong tablet of 9.0 4.0 mm and break scores on both sides. The tablet can be divided into equal doses. Levomethadone 5 mg tablets: White to off-white, ...
Therapeutic indications
Severe pain in adults.
Posology and method of administration
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 ...
Contraindications
Hypersensitivity to the active substance,or to any of the excipients listed in section 6.1. During the first trimester of pregnancy, levomethadone must not be used. In the second and third trimesters, ...
Special warnings and precautions for use
Strict indication and particularly close medical surveillance are required in case of: presence of impaired consciousness concomitant use of other central nervous system and/or respiratory depressant medicinal ...
Interaction with other medicinal products and other forms of interaction
The effects of levomethadone can be influenced both by pharmacodynamic and pharmacokinetic interactions. Depending on the clinical picture, the dose of levomethadone and/or concomitant medicinal products ...
Fertility, pregnancy and lactation
Pregnancy Levomethadone has not been sufficiently studied. For the evaluation, reference can be made to data on D, L-methadone used during substitution therapy. A number of human studies have shown that ...
Effects on ability to drive and use machines
Even when used as directed, levomethadone can alter responsiveness to such an extent that the ability to drive or use machines is impaired. This particularly applies in combination with alcohol. The decision ...
Undesirable effects
Frequencies of adverse reactions are based on the following categories: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000) Not ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics; opioids; diphenylpropylamine derivatives ATC code: N02AC06 Levomethadone is a fully synthetic opioid analgesic which, as a basic diphenylmethane derivative, can be ...
Pharmacokinetic properties
Absorption Levomethadone is rapidly absorbed after oral administration. The mean absolute bioavailability after oral ingestion of a solution is about 82%. Bioavailability In a relative bioavailability ...
Preclinical safety data
After acute intoxication, death occurs by respiratory arrest. LD<sub>50</sub> values of levomethadone after i.v. administration are 13.6 to 28.7 mg/kg in mice and 8.7 mg/kg in rats. For acute toxicity ...
List of excipients
Microcrystalline cellulose Dextrates (7.8-9.2%) Mannitol Sodium starch glycolate (type A) (Ph.Eur.) Colloidal silicon dioxide Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Shelf life Blister: 2 years. HDPE bottles: 2.5 mg/20 mg/30 mg: 1 year. 5 mg: 18 months. After first opening: 1 month.
Special precautions for storage
Store in the original package in order to protect from light.
Nature and contents of container
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, ...
Special precautions for disposal and other handling
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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