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Peripherally acting anti-obesity agent.
Active ingredient:Orlistat.
Excipients:

Capsule filling Microcrystalline cellulose, sodium starch glycollate, povidone, sodium lauryl sulphate and talc. Capsule shell Gelatine, indigo carmine (E132) and titanium dioxide (E171).

Appearance:
Xenical 120mg capsules have a turquoise cap and turquoise body with imprint of "Xenical ROCHE 120".

Properties and Effects
Mechanism of Action
Xenical is a potent, specific and reversible long-acting inhibitor of gastrointestinal lipases . It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the serine residue of the active site of gastric and pancreatic lipases. The inactivated enzyme is thus unable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit has a positive effect on the weight control.

Pharmacokinetics
Absorption
In normal weight and obese volunteers, the systemic exposure to orlistat was minimal. Plasma concentrations of intact orlistat were nearly non-measurable (67 g of fat). The daily intake of fat should be distributed over three main meals. If Xenical is taken with any one meal very high in fat, the possibility of gastrointestinal effects may increase. Weight loss induced by Xenical is accompanied by improved metabolic control in type 2 diabetics which might allow or require reduction in the dose of oral hypoglycemic medication (e.g. sulfonylureas). A reduction in cyclosporin plasma levels has been observed when Xenical is co-administered. Therefore it is recommended to monitor more frequently than usual the cyclosporin plasma levels when Xenical is co-administered (see Interactions).

Pregnancy, Nursing Mothers
Pregnancy category B. In animal reproductive studies, no embryotoxic or teratogenic effects were observed with orlistat. In absence of a teratogenic effect in animals, no malformative effect is expected in human beings. However, Xenical is not recommended for use during pregnancy in the absence of clinical data. The secretion of orlistat in human breastmilk has not been investigated. Xenical should not be taken during breastfeeding.

Undesirable Effects
Experience from Clinical Trials
Adverse reactions to Xenical are largely gastrointestinal in nature and related to the pharmacologic effect of orlistat on preventing the absorption of ingested fat. Commonly observed events are oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence. The incidence of these increases the higher the fat content of the diet. Patients should be counselled as to the possibility of gastrointestinal effects occurring and how best to handle them such as reinforcing the diet, particularly the percentage of fat it contains. Consumption of a diet low in fat will decrease the likelihood of experiencing adverse gastrointestinal events and this may help patients to monitor and regulate their fat intake. These adverse gastrointestinal reactions are generally mild and transient. They occurred early in treatment (within 3 months) and most patients experienced only one episode. Treatment-emergent GI-adverse events that occurred commonly among patients treated with Xenical were: abdominal pain / discomfort, flatulence, liquid stools, soft stools, rectal pain / discomfort, tooth disorder, gingival disorder. Other events observed were: upper respiratory infection, lower respiratory infection; influenza; headache; menstrual irregularity; anxiety; fatigue; urinary tract infection.

Post-Marketing Experience
Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, rash, urticaria, angioedema and anaphylaxis.

Interactions
During pharmacokinetic studies no interactions with alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin or warfarin have been observed. Decreases in the absorption of vitamin D, E and b-carotene have been observed when co-administered with Xenical. If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of Xenical or at bedtime.

A reduction in cyclosporin plasma levels has been observed when Xenical is co-administered. Therefore it is recommended to monitor more frequently than usual the cyclosporin plasma levels when Xenical is co-administered (see Precautions).

Overdosage
Overdose of Xenical has not been reported. Single doses of 800 mg Xenical and multiple doses of up to 400 mg t.i.d. for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg t.i.d. have been administered to obese patients for 6 months without significant increase of adverse findings. Should a significant overdose of Xenical occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of orlistat should be rapidly reversible.

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