Acomplia – Indications, Posology, Against indications, Undesirable effects

Acomplia – Indications, Posology, Against indications, Undesirable effects
Source RESIP-BCB
ACOMPLIA 20 Compressed Mg stripped Case of 28
Therapeutic class:   Metabolism and nutrition
Active ingredients:   Rimonabant
Statute:   Conditioning modified or withdrawn of the sale since the 2/28/2008 (other forms for this drug)
Laboratory:   Sanofi-Aventis France

Indications

Treatment of the obese patients (IMC > = 30 kg/m ²), or in overweight (IMC > 27 kg/m ²) with associated risk factors, such as diabetes of the type 2 or dyslipidemy (see heading pharmacodynamic properties), in association with the mode and the physical-activity.

Posology

- In the adult, the posology recommended of 1 is compressed to 20 Mg per day, to take the morning before the breakfast.
- The treatment must be founded with a mode moderately hypocaloric.
- The effectiveness and the tolerance of rimonabant were not evaluated beyond 2 years.
- Special Populations:
. Old subjects:
No posological adaptation is necessary at the old subject (see heading pharmacokinetic properties). ACOMPLIA must be used with prudence at the old subjects of more than 75 years (see heading warning statements and precautions for use).
. Hepatic insufficiency:
No posological adaptation is necessary among patients presenting a light or moderate hepatic insufficiency. ACOMPLIA must be used with prudence among patients having a moderated hepatic insufficiency. ACOMPLIA should not be used among patients having a severe hepatic insufficiency (see headings warning statements and precautions for use and properties pharmacokinetic).
. Impaired renal function:
No posological adaptation is necessary in the event of light impaired renal function to moderate (see heading pharmacokinetic properties). ACOMPLIA should not be used in the event of severe impaired renal function (see headings warning statements and precautions for use and properties pharmacokinetic).
. Pediatry:
In the absence of data of effectiveness and tolerance, the use of ACOMPLIA is not recommended in the children and in lower part 18 year old.

Against indications

CONTRA-INDICATE:
- Over-sensitiveness with the active ingredient or the one of the excipients.
- Breast feeding: rimonabant was detected in the milk of nursing spleens and can inhibit the reflex of suction. The passage of rimonabant in the mother’s milk is not known. ACOMPLIA is contra-indicated for the period of breast feeding.
- Because of the presence of lactose in the tablets of ACOMPLIA, the patients reached of rare hereditary diseases such as: intolerance with galactose, lactase deficit or malabsorption of glucose or galactose should not take this drug.
- The data among patients presenting a moderate impaired renal function are limited and there do not exist data among patients presenting a severe impaired renal function. Rimonabant does not have to be used in the event of severe impaired renal function (see headings posology and mode of administration and properties pharmacokinetic).
DISADVISE:
- Pediatry: in the absence of data of effectiveness and tolerance, the use of ACOMPLIA is not recommended in the children and in lower part 18 year old.
- The pharmacokinetic one and the tolerance of rimonabant was not studied among patients having a severe hepatic insufficiency; its use among these patients is not recommended.
- Pregnancy: there do not exist studies specific or controlled in the expectant mother. The animal data are not conclusive but suggest of possible noxious effects on the embryonic or fetal development. The possible hazard in private clinic is not known. The use during the pregnancy is thus not recommended.

Undesirable effects

- The tolerance of ACOMPLIA 20 Mg was evaluated among approximately 2500 obese patients or in overweights recruited in the studies having evaluated the metabolic effects and the reduction of weight, and among approximately 3800 patients in other indications. In the studies carried out against placebo, 15,7% of the patients receiving rimonabant prematurely stopped the treatment because of an undesirable effect. The most frequent undesirable effects having led to a premature stop are: nausea, disorders of mood with depressive, turbid symptoms depressive, anxiety and feelings vertiginous.
- Depressive disorders were reported at 3,2% of the obese patients or in overweight with factor (S) of associated risk (S), treated by rimonabant 20 Mg. These disorders were usually light or moderate and reversible in all the cases either after corrective treatment or the stop of the treatment by rimonabant, and did not show characteristics different from the cases brought back in the controls groups.
- The following table shows all the undesirable effects appeared under treatment in the 4 studies carried out among patients treated for excess of weight and associated metabolic anomalies, when their incidence was significantly higher than that observed in the placebo group (for the incidences > = 1%) or when they were regarded as clinically relevant (for the incidences < 1%).
- Classification of the undesirable effects according to the awaited frequencies:
Very frequent (> = 10%); frequent (> = 1%, < 10%); not very frequent (> = 0,1%, < 1%); rare (> = 0,01%, < 0,1%); very rare (< 0,01%), unknown (not established by the available data).
- Within each group of frequency, the undesirable effects are presented according to an decreasing order of gravity.
- Infections:
. Very frequent: Infection of the high air routes.
. Frequent: Gastro-enteritis.
- Psychiatric disorders:
. Frequent: Depressive disorders. Disorders of mood with depressive symptoms. Anxiety. Irritability. Nervousness. Sleep disorders. Insomnia. Parasomnie.
. Not very frequent: Attacks of panic. Anger. Dysphorie. Emotional disorders.
. Rare: Hallucinations.
- Central nervous system disorders:
. Frequent: Losses of memory. Vertiginous feelings. Hypo-esthesy. Sciatic nerve.
. Not very frequent: Lethargy.
- Vascular Disorders:
Frequent: Puffs of heat.
- Respiratory, thoracic and médiastinaux Disorders:
Not very frequent: Hoquet.
- Digestive disorders:
. Very frequent: Nausea.
. Frequent: Diarrhea. Vomiting.
- Cutaneous Disorders and of subcutaneous fabrics:
. Frequent: Prurit. Hyperhidrose.
. Not very frequent: Night sweats.
- Hoop nets musculosquelettic and of conjunctive fabric:
Frequent: Tendinitis. Muscular cramps. Muscular spasms.
- General Disorders:
Frequent: Asthenia/tiredness. Cold.
- Accidents and intoxications:
Frequent: Fall. Contusion. Distorsion.
- In the clinical studies carried out in other indications, the other following undesirable effects were frequently reported:
. infections: sinusitis.
. metabolic and nutritional disorders: anorexia, reduction in the appetite.
. anomaly of the nervous system: disorders of the attention.
. digestive disorders: dyspepsia, stops dry.
- Undesirable effects on the biological parameters:
It was not shown of modification of the biological parameters under ACOMPLIA