Active ingredients: Sodium salt of 4-hydroxybutyric acid
ALCOVER 17,5% Oral Solution Bottle 140ml
ALCOVER 17,5% Oral Solution 12 Bottles 10ml
Why is Alcover used? What is it for?
PHARMACO-THERAPEUTIC CATEGORY
Medicines for the treatment of chronic alcoholism.
THERAPEUTIC INDICATIONS
Adjuvant in the following therapies:
- in the control of ethyl alcohol withdrawal syndrome;
- in the initial stage of multimodal treatment of alcohol addiction;
- in the prolonged treatment of alcoholic dependence resistant to other therapeutic aids, in the coexistence of other pathologies aggravated by the intake of ethyl alcohol.
Contraindications When Alcover should not be used
- Serious organic and mental illnesses, as the short and long term effects of ALCOVER on these physiological conditions are not known;
- epileptic disease and epileptic seizures, to avoid possible effects of potentiation of the sedative action of antiepileptic drugs;
- previous or current addiction to narcotic substances, to avoid the risks of voluntary overdose and pharmacotoxicological synergism inherent in these pathological states, characterized by polydrug intake of psychoactive substances and compulsion to increase the dose;
- hypersensitivity to the components or to other closely related substances from a chemical point of view;
- pregnancy, lactation;
- concomitant treatment with antiepileptic drugs and psychoactive substances.
Precautions for use What you need to know before taking Alcover
ALCOVER must be used under direct medical supervision and must be taken in the presence of a person directly delegated by the doctor when dealing with patients suffering from mental deterioration and severe compulsion to ethyl alcohol, with reduced ability to understand and want and therefore exposed the risk of overdose and acute intoxication.
Interactions Which drugs or foods can modify the effect of Alcover
Synergistic effects are possible with antiepileptic drugs and psychoactive substances, the simultaneous use with these drugs must therefore be avoided.
Warnings It is important to know that:
In women of childbearing age, any pregnancy must always be excluded before the start of treatment and effective contraceptive coverage must be ensured during treatment.
Possible effect on the ability to drive cars
The possible occurrence of undesirable effects may affect the ability to drive or operate machinery.
Dose, Method and Time of Administration How to use Alcover: Posology
- Therapeutic control of ethyl alcohol withdrawal syndrome and initial phase (first 60 days) of multimodal treatment of alcoholic dependence: 50 mg / kg / day, divided into 3 administrations at least four hours apart (eg morning) , afternoon and evening).
- Prolonged multimodal treatment (after the first 60 days) of alcoholic dependence: from a minimum of 50 mg / kg / day to a maximum of 100 mg / kg / day, divided into 3 doses spaced at least four hours apart. .
ALCOVER contains a quantity of active principle equal to 175 mg for each ml of solution, which can be administered with the special measuring cup included in the package.
Duration of the therapeutic cycle
- 7-10 days in the therapeutic control of ethyl alcohol withdrawal syndrome - 60 days in the initial multimodal treatment of alcohol dependence
- over 60 days in prolonged multimodal treatment in alcohol dependence.
Overdose What to do if you have taken too much Alcover
In the event of an overdose, the drug essentially has a depressant action on the central nervous system with possible confusion and difficulty in breathing. Emergency therapeutic procedures: respiratory assistance and increased diuresis.
In case of accidental ingestion of an excessive dose of ALCOVER, notify your doctor immediately or go to the nearest hospital.
Side Effects What are the side effects of Alcover
Clinical trial studies show that the only commonly observed side effect is mild "subjective dizziness" which often appears after the first administration. However, this sensation recedes spontaneously within 15-30 minutes and does not recur. after subsequent administrations.
Some cases were also reported in which the drug caused feelings of nausea.
In the event of unwanted effects - even different from those described - the patient is invited to communicate them to their doctor.
Expiry and Retention
Warning: do not use the medicine after the expiry date indicated on the package. The validity period refers to the product in intact packaging, correctly stored.
SPECIAL STORAGE PRECAUTIONS
No special storage precautions.
Stability after first opening: 30 days.
KEEP THE MEDICINAL PRODUCT OUT OF THE SIGHT AND REACH OF CHILDREN
Composition and pharmaceutical form
COMPOSITION
1 bottle 140 ml contains: Active ingredient: 4-hydroxybutyric acid sodium salt 24,500 g.
Excipients: Sodium saccharin; methyl p-hydroxybenzoate; propyl p-hydroxybenzoate; sorbitol 70%; black cherry aroma; citric acid; purified water.
PHARMACEUTICAL FORM AND CONTENT
17.5% oral solution
1 bottle containing 140 ml of solution, complete with measuring cup.
12 bottles containing 10 ml of solution.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ALCOVER
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 bottle 140 ml contains:
Active principle
Sodium salt of 4-hydroxybutyric acid 24,500 g
(SODIUM OXYBATE)
1 bottle 10 ml contains:
Active principle
Sodium salt of 4-hydroxybutyric acid 1,750 g
(SODIUM OXYBATE)
For excipients see 6.1.
03.0 PHARMACEUTICAL FORM
17.5% oral solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Adjuvant in the following therapies:
• in the control of ethyl alcohol withdrawal syndrome;
• in the initial phase of multimodal treatment of alcohol dependence;
• in the prolonged treatment of alcoholic dependence resistant to other therapeutic aids, in the coexistence of other pathologies aggravated by the intake of ethyl alcohol.
04.2 Posology and method of administration
Therapeutic control of ethyl alcohol withdrawal syndrome and initial phase (first 60 days) of multimodal treatment of alcoholic dependence: 50 mg / kg / day, divided into 3 administrations at least four hours apart (eg morning) , afternoon and evening).
Prolonged multimodal treatment (after the first 60 days) of alcoholic dependence: from a minimum of 50 mg / kg / day to a maximum of 100 mg / kg / day, divided into 3 doses spaced at least four hours apart. .
ALCOVER contains a quantity of active principle equal to 175 mg for each ml of solution, which can be administered with the special measuring cup included in the package.
Duration of the therapeutic cycle
• 7-10 days in the therapeutic control of ethyl alcohol withdrawal syndrome
• 60 days in the initial multimodal treatment of alcohol dependence
• over 60 days in prolonged multimodal treatment in alcohol dependence.
04.3 Contraindications
Contraindications consist of:
• serious organic and mental illnesses, as the short and long term effects of ALCOVER on these pathophysiological conditions are not known;
• epileptic disease and epileptic seizures, to avoid possible potentiating effects of the sedative action of antiepileptic drugs;
• previous or current addiction to narcotic substances, to avoid the risks of voluntary overdose and pharmacotoxicological synergism inherent in these pathological states, characterized by polydrug use of psychoactive substances and compulsion to increase the dose;
• hypersensitivity to the components or to other closely related substances from a chemical point of view;
• pregnancy, breastfeeding;
• concomitant treatment with antiepileptic drugs and psychoactive substances.
04.4 Special warnings and appropriate precautions for use
ALCOVER must be used under direct medical supervision and must be taken in the presence of a person directly delegated by the doctor when dealing with patients suffering from mental deterioration and severe compulsion to ethyl alcohol, with reduced ability to understand and want and therefore exposed the risk of overdose and acute intoxication.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
No interactions with other drugs are known from clinical studies.
Potentially, however, synergistic effects are possible to enhance the sedative action with antiepileptic drugs and pharmacotoxicological synergism with psychoactive substances: simultaneous use with such drugs must therefore be avoided.
04.6 Pregnancy and lactation
Since no specific studies have been conducted and even though the drug does not present embryo-fetal, peri and post-natal toxicity effects in pharmacological studies, its use during pregnancy and lactation is not recommended.
04.7 Effects on ability to drive and use machines
The possible occurrence of undesirable effects may affect the ability to drive and operate machinery.
04.8 Undesirable effects
Clinical trial studies show that the only commonly observed side effect is mild "subjective dizziness" which often appears after the 1st administration. However, this sensation recedes spontaneously within 15-30 minutes and does not recur. after subsequent administrations.
Some cases were also reported in which the drug caused feelings of nausea.
04.9 Overdose
In the event of an overdose, the drug essentially has a depressant action on the central nervous system with possible confusion and difficulty in breathing. Emergency therapeutic procedures: respiratory assistance and increased diuresis.
Antidotes: the aforementioned action regresses spontaneously; gastric lavage is however recommended.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: drugs used in alcohol dependence.
ATC code: N07BB49
The ALCOVER product is an oral formulation containing the sodium salt of 4-hydroxybutyric acid as the active ingredient, proposed as an addict to the use of alcohol and for the treatment of alcohol withdrawal attacks.
This active principle is a normal component of the central nervous system of mammals; it is found in the brain at concentrations ranging from 1.78 nM / g in the rat to 4.1 nM / g in the guinea pig.
The active principle up to doses of 300 mg / kg does not significantly influence the cardiocirculatory effects induced by noradrenaline, isoprenaline and acetylcholine, in the rat it did not cause detectable gastro-intestinal effects up to doses of 500 mg / kg.
As regards the effects on the central nervous system, an increase in spontaneous motor activity was observed at doses of 300 and 600 mg / kg and a marked reduction, with loss of straightening and sleep reflexes, at a dose of 1200 mg / kg.
Special pharmacodynamic studies were conducted on rats made alcohol-dependent by administering ethanol. Already at the dose of 200 mg / kg there was a 40% decrease in ethanol consumption, while at the dose of 400 mg / kg the reduction was 70%. The reduction in ethanol intake is also maintained at significant levels even a few days after stopping treatment.
05.2 Pharmacokinetic properties
Pharmacokinetic studies on healthy volunteers show that the drug is rapidly absorbed and, despite the calculated Tmax being around the 2nd hour after treatment, in reality the maximum values are found already after 20 minutes.
Although sodium gamma-hydroxybutyrate is considered a drug with elimination conditioned by an enzymatic saturation capacity, in the reality of the experimental conditions, which envisaged the use at doses of 25 mg / kg and therefore below the saturation capacity, the curve elimination was substantially straight.
At these doses, an early and prolonged pharmacological action is assumed: the value of t½ of about 4 hours should be substantiated in an action of at least 8 hours.
05.3 Preclinical safety data
The pharmaceutical preparation thus formulated has a very low level of toxicity. In fact, from the pharmacological studies of acute toxicity the following data result:
• LD50 for oral administration in mice = 12.014 g / kg
• DL50 for i.p. administration in mice = 3.21 g / kg
• LD50 for oral administration in the rat = 12.36 g / kg
• DL50 for i.p. administration in the rat = 3.28 g / kg
Chronic toxicity studies were conducted for 26 weeks in the rat (at doses ranging from 125 to 500 mg / kg / day) and in the dog (at doses ranging from 50 to 150 mg / kg / day): the studies showed that administrations were well tolerated and no morphological or functional abnormalities were found in the treated animals.
Effects on fertility were conducted on male and female rats up to doses of 400 mg / kg / day for 4 weeks prior to mating with no effects on fertility and first and second generation products of conception.
Embryo-fetal toxicity and teratogenic action studies were also conducted in rats (doses up to 400 mg / kg / day) and rabbits (doses up to 400 mg / kg / day) and peri and postnatal toxicity studies. in the rat (doses up to 400 mg / kg / day) with no abnormalities.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, 70% sorbitol, black cherry flavor, citric acid, purified water.
06.2 Incompatibility
No particular incompatibilities with other drugs are known, except for the possible synergistic effects with sedatives and psychoactive substances, already mentioned.
06.3 Period of validity
2 years in intact packaging, properly stored.
Stability of the 140 ml bottle after first opening: 30 days.
06.4 Special precautions for storage
No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
• Plastic bottle, with "child-proof" type plastic closure, equipped with measuring cup.
Bottle containing 140 ml of solution for oral use.
• 11 ml amber glass bottle closed by a polyethylene seal and tear-off aluminum cap.
Box containing 12 oral bottles of 10 ml.
06.6 Instructions for use and handling
None.
07.0 MARKETING AUTHORIZATION HOLDER
PHARMACEUTICAL LABORATORY C.T. S.r.l. - Strada Solaro n. 75-77 - Sanremo
08.0 MARKETING AUTHORIZATION NUMBER
• 140 ml bottle: AIC n. 027751066
• Box of 12 10 ml bottles: AIC n. 027751078
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
02/08/1991 01/06/2005
10.0 DATE OF REVISION OF THE TEXT
19/09/2013
