Generic drug of the therapeutic class: Metabolism and nutrition
active ingredients: Rimonabant
laboratory: Sanofi-Aventis France
Case of 70
Treatment of obese patients (BMI> = 30 kg / m²), or overweight (BMI> 27 kg / m²) with associated risk factors, such as type 2 diabetes or dyslipidemia (see section on pharmacodynamic properties), in combination with diet and physical activity.
Dosage ACOMPLIA 20 mg Film-coated tablet Case of 70
- In adults, the recommended dosage is 1 tablet at 20 mg per day, to be taken in the morning before breakfast.
- Treatment should be started with a moderately low calorie diet.
- The efficacy and safety of rimonabant have not been evaluated beyond 2 years.
- Special populations:
No dose adjustment is necessary in the elderly (see section 5.2). ACOMPLIA should be used with caution in patients over 75 years of age (see section cautionary statements and precautions for use).
. Hepatic insufficiency :
No dose adjustment is required in patients with mild or moderate hepatic impairment. ACOMPLIA should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be used in patients with severe hepatic impairment (see sections cautionary and precautions for use and pharmacokinetic properties).
. Renal insufficiency :
No dose adjustment is necessary in patients with mild to moderate renal impairment (see section 5.2). ACOMPLIA should not be used in cases of severe renal impairment (see sections cautionary and precautions for use and pharmacokinetic properties).
. Pediatrics :
In the absence of efficacy and safety data, the use of ACOMPLIA is not recommended in children and under 18 years of age.
- Hypersensitivity to the active substance or to any of the excipients.
- Breast-feeding: Rimonabant has been detected in the milk of lactating rats and may inhibit the sucking reflex. The passage of rimonabant in breast milk is not known. ACOMPLIA is contraindicated during the breastfeeding period.
- Due to the presence of lactose in ACOMPLIA tablets, patients with rare hereditary diseases such as: galactose intolerance, lactase deficiency or glucose or galactose malabsorption should not take this medicine.
- Data in patients with moderate renal impairment are limited and there are no data in patients with severe renal impairment. Rimonabant should not be used in cases of severe renal impairment (see section on dosage and method of administration and pharmacokinetic properties).
NOT RECOMMENDED :
- Pediatrics: In the absence of efficacy and safety data, the use of ACOMPLIA is not recommended for children under 18 years of age.
- The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended.
- Pregnancy: There are no specific or controlled studies in pregnant women. The animal data are inconclusive but suggest possible deleterious effects on embryonic or fetal development. The potential risk in clinic is not known. Use during pregnancy is not recommended.
Acomplia side effects
- The safety of ACOMPLIA 20 mg has been evaluated in approximately 2500 obese or overweight patients enrolled in studies that evaluated metabolic effects and weight reduction, and in approximately 3800 patients in other indications. In placebo-controlled studies, 15.7% of patients receiving rimonabant discontinued prematurely due to an adverse event. The most common side effects leading to premature withdrawal are: nausea, mood disorders with depressive symptoms, depressive disorders, anxiety and dizziness.
Depressive disorders were reported in 3.2% of obese or overweight patients with risk factor (s), treated with rimonabant 20 mg. These disorders were usually mild or moderate and reversible in all cases either after corrective treatment or at discontinuation of rimonabant treatment, and did not show any characteristics different from the cases reported in the control groups.
- The following table shows all treatment-emergent adverse events in the 4 studies performed in patients treated for excess weight and associated metabolic abnormalities, when their incidence was significantly greater than that observed in the placebo group (for incidences> = 1 %) or when considered clinically relevant (for incidences <1%).
- Classification of adverse reactions according to expected frequencies:
Very common (> = 10%) frequent (> = 1%, = 0.1%, = 0.01%, <0.1%); very rare (<0.01%), unknown (not established by available data).
- Within each frequency group, adverse effects are presented in descending order of severity.
. Very common : Infection of high airways.
. Common : Gastroenteritis.
- Psychiatric disorders:
. Frequent : Depressive disorders. Mood disorders with depressive symptoms. Anxiety. Irritability. Nervousness. Sleeping troubles. Insomnia. Parasomnia.
. Uncommon : Attacks of panic. Anger. Dysphoria. Emotional disorders.
. Rare : Hallucinations.
- Neurological disorders:
. Frequent : Memory loss. Dizzying sensations. Hypoaesthesia. Sciatica.
. Uncommon : Lethargy.
- Vascular disorders:
Frequent : Hot flashes.
- Respiratory, thoracic and mediastinal disorders:
Uncommon : Hoquet.
- Digestive disorders :
. Very common : Nausea.
. Common : Diarrhea. Vomiting.
- Skin and subcutaneous tissue disorders:
. Frequency : Pruritus Hyperhidrosis.
. Uncommon : Sweats at night.
- Musculoskeletal and Connective Tissue Disorders:
Common : Tendinitis. Muscle cramps. Muscle spasms.
- General disorders:
Common : Asthenia / fatigue Cold.
- Accidents and intoxications:
Frequency : Fall. Contusion. Sprain.
- In clinical studies in other indications, the following other adverse reactions have been frequently reported:
. infections: sinusitis.
. metabolic and nutritional disorders: anorexia, decreased appetite.
. Nervous system abnormality: attention disorders.
. digestive disorders: dyspepsia, dry mouth.
- Undesirable effects on biological parameters:
It has not been shown any change in biological parameters under ACOMPLIA.