Xenical (Orlistat)

What is Xenical and how is it used?

Xenical is a prescription medicine used to treat the symptoms of obesity management in the presence of other risk factors or diseases such as high blood pressure, diabetes mellitus or hyperlipidemia. Xenical may be used alone or with other medications.

Xenical is a gastrointestinal agent.

It is not known if Xenical is safe and effective in children younger than 12 years of age.

What are the possible side effects of Xenical?

• severe stomach pain,
• severe pain in your lower back,
• blood in your urine,
• painful or difficult urination,
• little or no urination,
• swelling in your feet or ankles,
• feeling tired,
• shortness of breath,
• nausea,
• upper stomach pain,
• itching,
• loss of appetite,
• dark colored urine,
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Xenical include:

• oily or fatty stools,
• oily spotting in your undergarments,
• orange or brown colored oil in your stool,
• gas or oily discharge,
• loose stools,
• urgent need to go to the bathroom,
• inability to control bowel movements,
• increased number of bowel movements,
• stomach pain,
• nausea, and
• rectal pain

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Xenical. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

XENICAL (orlistat) is a gastrointestinal lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.

Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl] methyl]-dodecyl ester. Its empirical formula is C₂₉H₅₃NO₅, and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm. The structure is:

Orlistat is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no pK within the physiological pH range.

XENICAL is available for oral administration as a turquoise hard-gelatin capsule. The capsule is imprinted with black. Each capsule contains a pellet formulation consisting of 120 mg of the active ingredient, orlistat, as well as the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. The capsule shell contains gelatin, titanium dioxide, and FD&C Blue No. 2 with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.