Orlistat alli & Xenical Diet Pills Review

Orlistat, Xenical & alli diet pills, what relation?

Orlistat, also known as tetrahydrolipstatin, 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.

Orlistat is a drug designed to treat obesity. Orlistat is marketed by Roche under the trade name Xenical, and as an over-the-counter under the name alli by GlaxoSmithKline.

Orlistat (alli & Xenical) is primarily used to prevent the absorption of fats from the human diet, hence reducing caloric intake and should be used in combination with a physician-supervised reduced-calorie diet.

How Orlistat (alli & Xenical) works

Orlistat (alli & Xenical) is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to
hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control. Systemic absorption of the drug is therefore not needed for activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibits dietary fat absorption by approximately 30%.

In other words: Orlistat (alli & Xenical) inhibits the absorption of about 30% of dietary fat using the recommended dosage of 120 mg three times a day, the fat which is not absorbed by the body is excreted undigested.

Note: At the standard prescription dose of 120 mg three times daily before meals, Orlistat (alli & Xenical) prevents approximately 30% of dietary fat from being absorbed. Higher doses do not produce more potent effects.

Orlistat (alli & Xenical) side effects

The primary side effects of Orlistat (alli & Xenical) are gastrointestinal-related. Side effects are most severe when beginning therapy, and decrease in frequency with time; in clinical trials, nearly half of side effects lasted less than a week, but some may persist for over six months. Because orlistat's main effect is to prevent dietary fat from being absorbed, the fat is excreted unchanged in the feces and so the stool may become oily or loose (steatorrhea). Increased flatulence is also common. Bowel movements may become frequent or urgent, and rare occurrences of fecal incontinence have been seen in clinical trials. To minimize these effects, foods with high fat content should be avoided; the manufacturer advises consumers to follow a low-fat, reduced-calorie diet. Oily stools and flatulence can be controlled by reducing the dietary fat content to somewhere in the region of 15 grams per meal.

Here are some possible side effects of Xenical? (This is NOT a complete list of side effects reported with Xenical. Your health care provider can discuss with you a more complete list of side effects.)

• Oily spotting
• Gas with discharge
• Urgent need to have a bowel movement
• Oily or fatty stools


• Oily discharge
• Increased number of bowel movements
• Inability to control bowel movements
  

For more detailed information about Xenical, ask your health care provider.

Xenical Description: Color, Capsules & ingredients

XENICAL is available for oral administration in dark-blue, hard-gelatin capsules, with
light-blue imprinting. Each capsule contains 120 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. Each 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.

Xenical Indication and Usage

Xenical is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL is also indicated to reduce the risk for weight regain after prior weight loss. XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

What NOT to take with Orlistat (alli & Xenical)

Absorption of fat-soluble vitamins and other fat-soluble nutrients is inhibited by the use of orlistat. A multivitamin tablet containing vitamins A, D, E, K, and beta-carotene should be taken once a day, at least 2 hours before or after taking the drug.

Orlistat may reduce plasma levels of cyclosporin, an immunosuppressive drug frequently used to prevent transplant rejection; the two drugs should therefore not be administered concomitantly.

General Precautions with Orlistat (alli & Xenical)

• Your daily intake of fat should be evenly divided over 3 main meals.
• Xenical can decrease the absorption some fat-soluble vitamins and beta-carotene. Therefore when being treated with Xenical, take a multivitamin supplement that contains vitamins D, E, K, and beta-carotene. Take your multivitamin once a day at least 2 hours before or after taking Xenical, such as bedtime.
• Review all medications that you are taking with your health care provider, including those that you take without a prescription. If you are taking cyclosporine you may have to be monitored more closely.
• If you are diabetic, Xenical may affect your blood sugar control. See your doctor regularly for monitoring and treatment adjustments.

Pediatric Use: The safety and efficacy of Xenical have been evaluated in obese adolescent patients aged 12 to 16 years. However, the safety and efficacy of Xenical has not been studied in pediatric patients below the age of 12 years.

Orlistat (alli & Xenical) Contraindications

You cannot take Orlistat if you:

• have problems absorbing food

• have reduced gallbladder function (e.g. after cholecystectomy)

• are pregnant, or breast-feeding a child. It is not known if orlistat is secreted in human milk. Therefore, orlistat (alli & Xenical) should not be taken by nursing women.
  

People with certain kidney problems may not be able to take Orlistat.

Orlistat Xenical Drug Interactions

Alcohol
In a multiple-dose study in 30 normal-weight subjects, coadministration of Xenical
and 40 grams of alcohol (eg, approximately 3 glasses of wine) did not result in alteration
of alcohol pharmacokinetics, orlistat pharmacodynamics (fecal fat excretion), or systemic
exposure to orlistat.

Cyclosporine
Preliminary data from a Xenical and cyclosporine drug interaction study indicate a
reduction in cyclosporine plasma levels when Xenical was coadministered with
cyclosporine.

Digoxin
In 12 normal-weight subjects receiving Xenical 120 mg three times a day for 6 days, Xenical did not alter the pharmacokinetics of a single dose of digoxin.

Fat-soluble Vitamin Supplements and Analogues
A pharmacokinetic interaction study showed a 30% reduction in beta-carotene supplement absorption when concomitantly administered with Xenical. Xenical inhibited absorption of a vitamin E acetate supplement by approximately 60%. The effect of orlistat on the absorption of supplemental vitamin D, vitamin A, and nutritionallyderived vitamin K is not known at this time.

Glyburide
In 12 normal-weight subjects receiving orlistat 80 mg three times a day for 5 days, orlistat did not alter the pharmacokinetics or pharmacodynamics (blood glucoselowering) of glyburide.

Nifedipine (extended-release tablets)
In 17 normal-weight subjects receiving Xenical 120 mg three times a day for 6 days,
Xenical did not alter the bioavailability of nifedipine (extended-release tablets).

Oral Contraceptives
In 20 normal-weight female subjects, the treatment of Xenical 120 mg three times a
day for 23 days resulted in no changes in the ovulation-suppressing action of oral
contraceptives.

Phenytoin
In 12 normal-weight subjects receiving Xenical 120 mg three times a day for 7 days, Xenical did not alter the pharmacokinetics of a single 300-mg dose of phenytoin.

Pravastatin
In a 2-way crossover study of 24 normal-weight, mildly hypercholesterolemic patients receiving Xenical 120 mg three times a day for 6 days, Xenical did not affect the pharmacokinetics of pravastatin.

Warfarin
In 12 normal-weight subjects, administration of Xenical 120 mg three times a day for 16 days did not result in any change in either warfarin pharmacokinetics (both R- and Senantiomers)
or pharmacodynamics (prothrombin time and serum Factor VII). Although undercarboxylated osteocalcin, a marker of vitamin K nutritional status, was unaltered with Xenical administration, vitamin K levels tended to decline in subjects taking Xenical. Therefore, as vitamin K absorption may be decreased with Xenical, patients on chronic stable doses of warfarin who are prescribed Xenical should be monitored closely for changes in coagulation parameters.

Xenical & Special Populations

Because the drug is minimally absorbed, studies in special populations (geriatric, different races, patients with renal and hepatic insufficiency) were not conducted.

Xenical Short-term Studies

Adults

In several studies of up to 6-weeks duration, the effects of therapeutic doses of Xenical on gastrointestinal and systemic physiological processes were assessed in normal-weight and obese subjects. Postprandial cholecystokinin plasma concentrations were lowered after multiple doses of XENICAL in two studies but not significantly different from placebo in two other experiments. There were no clinically significant changes observed in gallbladder motility, bile composition or lithogenicity, or colonic cell proliferation rate, and no clinically significant reduction of gastric emptying time or gastric acidity. In addition, no effects on plasma triglyceride levels or systemic lipases were observed with the administration of Xenical in these studies. In a 3-week study of 28 healthy male volunteers, Xenical (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, copper, and
iron.

Pediatrics

In a 3-week study of 32 obese adolescents aged 12 to 16 years, Xenical (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, or copper. The iron balance was decreased by 64.7 μmole/24 hours and 40.4 μmole/24 hours in orlistat and placebo treatment groups, respectively.

Orlistat (alli & Xenical) availability

In most areas, such as the United Kingdom, France, and Canada, orlistat is available by prescription only. In Australia and the United States, certain formulations of orlistat have been approved for sale without a prescription.

United States

On January 23, 2006, a U.S. Food and Drug Administration advisory panel voted 11 to 3 to recommend the approval of an OTC formulation of orlistat, to be marketed under the name alli by GlaxoSmithKline. Approval was granted on February 7, 2007,and alli became the first weight loss drug officially sanctioned by the U.S. government for over-the-counter use. Consumer advocacy organization Public Citizen, through its Health Research Group, opposed over-the-counter approval for orlistat, calling it "the height of recklessness" and "a dangerous mistake" due to questionable benefits and possible adverse effects.

(Becoming available in the U.S. during the summer of 2007, alli will be sold as 60 mg capsules — half the dosage of prescription orlistat.)

As of 2007, no generic formulations of orlistat are legally available in the United States. U.S. patent protection for Xenical, originally to end on June 18, 2004, was extended by five years (until 2009) by the U.S. Patent and Trademark Office. The extension was granted on July 20, 2002.

Australia

In Australia, orlistat is currently available over-the-counter in 120 mg size (84 capsules to the pack). Initially available only with a prescription, it was reclassified as a "Pharmacist Only Medicine" in October 2003. In late 2006, the Australian Consumers' Association complained that Roche was inappropriately advertising the drug to teenagers, and Roche was forced to withdraw its ads. The Association filed further complaints with the Therapeutic Goods Administration — TGA, Australia's regulatory authority for healthcare products — and the TGA's Scheduling Committee agreed to convene on February 20, 2007, to discuss possible revoking of orlistat's over-the-counter status. The Committee ultimately decided to keep orlistat as a Schedule 3 drug, but withdrew its authorization of direct-to-consumer Xenical advertising, stating this "increased pressure on pharmacists to provide orlistat to consumers...this in turn had the potential to result in inappropriate patterns of use".

Some claims!

Despite claims that (alli & Xenical) increases the risk of breast cancer amongst clinical trial participants, there is evidence to suggest that the introduction of specific varied preparations containing orlistat, namely the concurrent administration of orlistat and the monoclonal antibody trastuzumab, can actually induce cell death in tumor cells and block their growth.

A 2006 animal study addressed a connection orlistat (alli & Xenical) shares with aberrant crypt foci (ACF), lesions found in the colon which are believed to be one of the earliest precursors of colon cancer.

Some Alli and Xenical Images

alli, Orlistat 60mg. 90 capsules.


Xenical box and capsules, Orlistat 120 mg.

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