Generic Medicine Info
Should be taken with food. Take immediately before or during or up to 1 hr after each main meal. If a meal is missed or contains no fat, the dose may be omitted.
Cholestasis and chronic malabsorption syndrome. Pregnancy and lactation.
Special Precautions
Patients with diabetes, thyroid disease, epilepsy, anorexia nervosa, bulimia, history of hyperoxaluria or Ca oxalate nephrolithiasis. Renal and hepatic impairment. Monitoring Parameters Monitor BMI, weight, diet (calorie and fat intake), LFT, renal function, serum glucose (in patient with diabetes), thyroid function (in patient with thyroid disease), INR (patient taking warfarin). Rule out other causes of obesity (e.g. hypothyroidism) prior to initiation of therapy.
Adverse Reactions
Significant: Rectal bleeding, decreased prothrombin and increased INR, cholelithiasis, oxalate nephropathy that may lead to renal failure. Gastrointestinal disorders: Oily spotting, flatus with discharge, faecal urgency and incontinence, fatty/oily stool, oily evacuation, flatulence, soft or liquid stools, abdominal pain, increased defaecation, diverticulitis, pancreatitis, rectal discomfort, abdominal distension (patient with type 2 diabetes), tooth and gingival disorder. General disorders and administration site conditions: Fatigue. Immune system disorders: Hypersensitivity reactions (e.g. anaphylaxis, bronchospasm, angioedema, pruritus, rash, urticaria). Infections and infestations: Influenza. Investigations: Increased transaminases and alkaline phosphatase. Metabolism and nutrition disorders: Hypoglycaemia (patient with type 2 diabetes), pedal oedema. Musculoskeletal and connective tissue disorders: Back or leg pain, myalgia. Nervous system disorders: Headache. Psychiatric disorders: Anxiety. Reproductive system and breast disorders: Menstrual irregularity, vaginitis, UTI. Respiratory, thoracic and mediastinal disorders: Upper and lower respiratory infection. Skin and subcutaneous tissue disorders: Bullous eruption.
Potentially Fatal: Severe liver injury with hepatocellular necrosis or acute hepatic failure and hepatitis.
Drug Interactions
Reduces the plasma levels of ciclosporin thereby may decreasing immunosuppressive efficacy. May decrease efficacy of antiretroviral drugs (e.g. atazanavir, ritonavir, tenofovir). May decrease the absorption of fat-soluble vitamins (A, D, E, K), β-carotene, anticoagulants (e.g. warfarin), iodine salts and/or levothyroxine and antiepileptic drugs (e.g. valproate, lamotrigine). May cause hormonal contraceptive failure. May decrease the plasma levels of amiodarone.
CIMS Class
Anti-Obesity Agents
ATC Classification
A08AB01 - orlistat ; Belongs to the class of peripherally acting antiobesity products.
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