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Drug details for : ACOMPLIA
| Drug class description : | Other |
| Generic Name : | Rimonabant |
| Drug description : | 20 mg Film-coated tablet Biconvex, teardrop-shaped, white tablets debossed with “20” on one side. |
| Presentation : | Each tablet contains 20 mg rimonabant. Excipients: The tablets contain approx. 115 mg lactose. |
| Indications : | As an adjunct to diet and exercise for the treatment of obese patients (BMI 30 kg/m2), or overweight patients (BMI > 27 kg/m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia. |
| Adult Dosage : | In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. The treatment should be introduced with a mildly reduced calorie diet. The safety and efficacy of rimonabant have not been evaluated beyond 2 years. Special Populations Patients with hepatic insufficiency: No dosage adjustment is required for 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 Special Precautions). Patients with renal impairment: No dosage adjustment is required for patients with mild and moderaterenal impairment. ACOMPLIA should not be used in patients with severe renal impairment (See Special Precautions). |
| Child Dosage : | Paediatrics: ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety. |
| Elderly Dosage : | Elderly: No dosage adjustment is required in elderly. ACOMPLIA should be used with caution in patients over 75 years of age (See Special Precautions). |
| Contra Indications : | Hypersensitivity to the active substance or to any of the excipients Lactation. |
| Special Precautions : | Rimonabant is metabolised by the liver, thus caution is advised in patients with moderate hepatic impairment. The pharmacokinetics and safety of rimonabant have not been studied in patients with severe hepatic impairment; its use in these patients is not recommended. There are limited data in patients with moderate renal impairment and no data in patients with severe renal impairment. Rimonabant should not be used in patients with severe renal impairment (See Adult Dosage). The efficacy and safety of rimonabant treatment in patients over 75 years of age has not sufficiently been established. Rimonabant should be used with caution in this population. Rimonabant has not been studied in patients being treated for epilepsy. In clinical trials no difference in the incidence of seizures was seen in patients receiving rimonabant or placebo. Rimonabant, however, should be used with caution in these patients. The clinical effect (weight loss) of rimonabant in Black patients was lower than in Caucasians. This could be caused by a higher rimonabant clearance than in Caucasians resulting in a lower exposure. Rimonabant should be used with caution in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone)(See Interactions). Since ACOMPLIA tablets contain lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine. Patients should be instructed not to increase their dose of ACOMPLIA. Obesity is a condition that can be associated with depression or other psychiatric conditions. Depressive disorders have been reported in patients receiving rimonabant 20 mg (See Adverse Reactions). Therapy with rimonabant should not be initiated in patients with uncontrolled serious psychiatric illness such as a major depression. Appropriate treatment of this condition should be initiated first and therapy with rimonabant considered once this psychiatric condition is controlled. As there is limited data in patients with antidepressant medication in combination with rimonabant, use of rimonabant is not recommended in these patients. Patients who had a cardiovascular event (myocardial infarction, stroke, etc.) less than 6 months ago were excluded in the studies for rimonabant. |
| Interactions : | Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro. Co-administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant. Co-administration of CYP3A4 inducers is expected to reduce the exposure of rimonabant. Potential for other medicinal products to affect rimonabant: Concomitant administration of ketoconazole (apotent CYP3A4 inhibitor) increased rimonabant AUC by 104% (95% prediction interval: 40% - 197%). A similar increase in exposure is expected with other potent CYP3A4 inhibitors. Caution is advised during concomitant use of ACOMPLIA and potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone). Although concomitant administration of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St John's wort) has not been studied, it is expected that concomitant administration of potent CYP3A4 inducers may reduce the plasma concentration of rimonabant and may result in loss of efficacy. Co-administration of orlistat, ethanol or lorazepam had no significant effect on the plasma levels of rimonabant. Potential for rimonabant to affect other medicinal products: The in vivo inhibitory effect on CYP2C8 has not been studied. However, in vitro, rimonabant had a mild inhibitory effect on CYP2C8. The potential for inhibition of CYP2C8 in vivo appears to be low.Rimonabant does not inhibit or induce other CYP enzymes or P-glycoprotein (P-gp) in vitro. This was confirmed clinically with specific probe studies using midazolam (CYP 3A4 substrate) and warfarin (CYP 2C9 substrate) and digoxin (a P-gp substrate). The steady-state pharmacokinetics of an ethinyl estradiol/levonorgestrel combination oral contraceptive were not significantly altered by concomitant administration of rimonabant. Pregnancy and lactation There are no adequate or well-controlled studies in pregnant women. Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development. The potential risk for humans is unknown.Use in pregnancy is, therefore, not recommended. Patients should notify their physician if they become pregnant during treatment with ACOMPLIA. Rimonabant has been detected in the milk of lactating ratsand rimonabant may inhibit the suckling reflex. It is not known if rimonabant is excreted in human milk. ACOMPLIA is contraindicated during breast-feeding (See Contraindications). |
| Adverse Reactions : | ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately 3800 patients in other indications. In placebo-controlled studies, the discontinuation rate due to adverse reactions was 15.7 % for patients receiving rimonabant. The most common adverse reactions resulting in discontinuation were: nausea, mood alteration with depressive symptoms, depressive disorders, anxiety and dizziness. Depressive disorders were reported in 3.2% of obese patients, or overweight patients with associated risk factor(s) treated with rimonabant 20 mg. These were usually mild or moderate in severity and resulted in recovery in all cases either after corrective treatment or discontinuation of rimonabant and did not exhibit any differentiating characteristics compared to cases reported in the control groups. The following table shows all treatment-emergent adverse reactions from four placebo-controlled studies in patients treated for weight loss and related metabolic disorders when these incidences were statistically significantly greater than the corresponding placebo rate (for events 1 %) or considered clinically relevant (for events < 1 %). Classification of expected frequencies of undesirable effects: Very common (10%); Common ( 1, <10%); Uncommon (0.1, <1%); Rare (0.01, <0.1%); Very rare (<0.01%), Not known (cannot be established from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Infections and infestations: Very common - Upper respiratory tract infection, Common - Gastroenteritis. Psychiatric disorders: Common - Depressive disorders, Mood alterations with depressive symptoms, Anxiety, Irritability, Nervousness, Sleep disorders, Insomnia and Parasomnias. Uncommon - Panic symptoms, Anger, Dysphoria and Emotional disorder. Rare - Hallucinations Nervous system disorders: Common - Memory loss, Dizziness, Hypoaesthesia and Sciatica. Uncommon - Lethargy Vascular disorders: Common - Hot flush. Respiratory, thoracic and mediastinal disorders: Uncommon - Hiccups. Gastrointestinal disorders: Very common - Nausea. Common - Diarrhoea and Vomiting. Skin and subcutaneous tissue disorders: Common - Pruritus and Hyperhidrosis. Uncommon - Night sweats Musculoskeletal and connective tissue disorders: Common - Tendonitis, Muscle cramp and Muscle. spasms General disorders: Common - Asthenia/fatigue and Influenza Injury, Poisoning and procedural complications: Common - Fall, Contusion and Joint sprain. In clinical studies for other indications, the following additional adverse reactions were commonly reported: - infections and infestations: sinusitis - metabolism and nutrition disorders: anorexia, decreased appetite - nervous system disorders: disturbance in attention - gastrointestinal disorders: stomach discomfort, dry mouth. Laboratory adverse events ACOMPLIA has not been shown to alter laboratory test values. |
| Manufacturer : | Sanofi-Aventis |
| Drug Availability : | (POM) |
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