Xenical

DRUG 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:

 XENICAL (orlistat) Structural Formula Illustration

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 pKa within the physiological pH range.

XENICAL is available for oral administration as a dark-blue or turquoise hard-gelatin capsule. The dark blue capsule is imprinted with light blue and the turquoise 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 dark blue capsule shell contains gelatin, titanium dioxide, and FD&C Blue No. 1, with printing of pharmaceutical glaze NF, titanium dioxide, and FD&C Blue No. 1 aluminum lake. The turquoise capsule shell contains gelatin, titanium dioxide, and FD&C Blue No. 2 with black printing ink containing pharmaceutical grade shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.

What are the possible side effects of orlistat (alli, Xenical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is...

Read All Potential Side Effects and See Pictures of Xenical

What are the precautions when taking orlistat 120 mg (Xenical)?

Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain digestive problem (chronic malabsorption syndrome), certain gall bladder problem (cholestasis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: underactive thyroid (hypothyroidism), kidney stones/problems (e.g., calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia...

Read All Potential Precautions of Xenical


Xenical Consumer (continued)

SIDE EFFECTS: Changes in your bowel function frequently occur because of the unabsorbed fat. Fatty/oily stool, oily spotting, intestinal gas with discharge, a feeling of needing to have a bowel movement right away, increased number of bowel movements, or poor bowel control may occur. These side effects may get worse if you eat more fat than you should. If these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Stop taking this medication and tell your doctor immediately if any of these rare but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin), symptoms of kidney stones (such as back pain, pain when urinating, pink/bloody urine).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain digestive problem (chronic malabsorption syndrome), certain gall bladder problem (cholestasis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: underactive thyroid (hypothyroidism), kidney stones/problems (e.g., calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia nervosa/bulimia).

If you are diabetic, weight loss may improve your blood sugar control. Be sure to check your blood sugar regularly and tell your doctor the results. Your diet or medications may need to be adjusted.

This medication is not recommended for use during pregnancy. Consult your doctor for more details.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Xenical Patient Information Including Side Effects

Brand Names: alli, Xenical

Generic Name: orlistat (Pronunciation: OR li stat)

  • What is orlistat (Xenical)?
  • What are the possible side effects of orlistat (Xenical)?
  • What is the most important information I should know about orlistat (Xenical)?
  • What should I discuss with my healthcare provider before taking orlistat (Xenical)?
  • How should I take orlistat (Xenical)?
  • What happens if I miss a dose (Xenical)?
  • What happens if I overdose (Xenical)?
  • What should I avoid while taking orlistat (Xenical)?
  • What other drugs will affect orlistat (Xenical)?
  • Where can I get more information?

What is orlistat (Xenical)?

Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body.

Orlistat is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).

Orlistat may also be used for other purposes not listed in this medication guide.

What are the possible side effects of orlistat (Xenical)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking orlistat and call your doctor at once if you have severe pain in your upper stomach spreading to your back, nausea and vomiting, and a fast heart rate. These could be signs of pancreatitis.

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with orlistat:

  • oily spotting in your undergarments;
  • oily or fatty stools;
  • orange or brown colored oil in your stool;
  • gas with discharge, an oily discharge;
  • loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;
  • an increased number of bowel movements;
  • stomach pain, nausea, vomiting, diarrhea, rectal pain; or
  • weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).

Other side effects that may occur while taking orlistat include:

  • problems with your teeth or gums;
  • cold symptoms such as stuffy nose, sneezing, cough;
  • fever, chills, sore throat, flu symptoms;
  • headache, back pain; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about orlistat (Xenical)?

Do not take this medication if you are allergic to orlistat, or if you have gallbladder problems, or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).

Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight-loss medications (prescription or over-the-counter).

Do not give over-the-counter orlistat (Alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor.

Orlistat should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a secure place where others cannot get to it.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Take orlistat during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Orlistat is usually taken 3 times daily. If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Your doctor may recommend you take vitamin and mineral supplements while you are taking orlistat. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use. Take the supplement at least 2 hours before or after you take orlistat.

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