Alphoscet, 250 mg/ml, 4 ml solution for injection
Choline alfoscerate
PHARMACEUTICAL FORM
Solution for injection
Clear, colorless to slightly yellowish solution, practically free from visible particles.
COMPOSITION
- ml solution for injection contains 250 mg choline alfoscerate
For the full list of excipients, see section List of excipients
List of excipients:
Water for injections
PHARMACEUTICAL GROUP AND ATC CODE
Pharmacotherapeutic group: Other nervous system drugs. Other parasympathomimetics.
ATC code N07AX02
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Choline alfoscerate, as a choline transporter and a phosphatidylcholine precursor, has the potential ability to carry out preventive and corrective action on biochemical lesions, and thus it is recognized as a particular value among the pathogenetic factors of the involuntary psycho-organic syndrome, i.e. on the reduced cholinergic tone and on the altered phospholipid composition of the neuronal membranes.
The chemical structure of choline alfoscerate (containing 40.5% of choline) and the related chemical-physical properties guarantee a significant contribution of active and metabolically protected substance to the brain tissue.
The results of the experimental tests of preclinical pharmacology and of the clinical studies have validated the ability of choline alfoscerate to advantageously influence the cognitive and memory functions, as well as the affective and behavioral sphere compromised by involutory brain pathology.
Pharmacokinetic properties
The pharmacokinetic characteristics, determined by the administration of the labeled compound, similar in the different animal species used (rats, dogs, monkeys), are the following: fast and complete gastrointestinal absorption; rapid uptake and distribution in different tissues and organs, including the brain; only renal excretion (approximately 10%, in 96 hours of the administered radioactivity dose); higher availability in the brain than 3H-choline.
THERAPEUTIC INDICATIONS
Degenerative-regressive cerebral psycho-organic syndromes or secondary to cerebrovascular insufficiency, i.e., primary or secondary cognitive disorders of the elderly, characterized by memory deficits, confusion and disorientation, decreased motivation and initiative and reduced attentional capacity.
Changes in the affective sphere and senile behavior: emotional lability, irritability, indifference to the surrounding environment.
Pseudodepression of the elderly.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly
Recommended dose is 1000 mg (one ampoule) per day administered intramuscular or intravenous, slowly.
Clinical benefits of the treatment with choline alfoscerate should be reevaluated at regular intervals. Treatment with choline alfoscerate can be continued as long as the therapeutic benefit is assured.
Treatment should be initiated and monitored by a physician with experience in the diagnosis and treatment of dementia of various causes and stroke with impaired cognitive function. The diagnosis should be made on the basis of applicable guidelines.
Patients with hepatic and renal impairment
Safety and efficacy of choline alfoscerate have not yet been established in patients with renal or hepatic impairment.
Paediatric population
Safety and efficacy of choline alfoscerate in children bellow 18 years have not yet been established.
CONTRAINDICATIONS
- hypersensitivity to choline alfoscerate or to any excipients listed at the section List of excipients
- pregnancy and lactation
UNDESIRABLE EFFECTS
As a precursor of biological constituents the administration, even protracted, of choline alfoscerate does not generally pose tolerability problems.
Frequencies are defined using the following convention: 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 known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Psychiatric disorders
Rare: insomnia, restlessness
Nervous system disorders
Uncommon: nausea (probably due to secondary dopaminergic activation)
Rare: dizziness
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Safety and efficacy of choline alfoscerate in children bellow 18 years have not yet been established.
If the patient complains nausea during treatment, a dose reduction is recommended (see section “Undesirable effects”).
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
There are no or limited amount of data from the use of choline alfoscerate in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Breastfeeding
There is insufficient information on the excretion of choline alfoscerate /metabolites in animal milk.
Alphoscet should not be used during pregnancy and breast-feeding.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
No interaction studies have been performed.
OVERDOSE
In case of overdose, nausea will occur as an adverse reaction. It will disappear after reducing the dose or stopping treatment.
SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
None
INCOMPATIBILITIES
None
PACКAGING
Type I glass colorless ampoules with break ring containing 4 ml solution for injection.
Packs containing 3 ampoules.
Not all pack sizes may be marketed
SPECIAL PRECAUTIONS FOR STORAGE
The drug product is stored at temperatures below 25°C, in original package.
SHELF LIFE
4 years
NAME AND ADDRESS OF MANUFACTURER
S.C. Rompharm Company S.R.L.
Eroilor Street, no. 1A, Otopeni, Ilfov County, 075100, Romania
MARKETING AUTHORISATION HOLDER
Nextra Group Ltd
18 I.Evdoshvili street, zip code 0154, Tbilisi, Georgia.
