Xenical Generic 120 mg Slimtop

Orlistat is prescribed for adults only. Consult with your doctor for complete dosing and side effect information.

Orlistat does not aid in weight loss by appetite suppression as most other weight loss aids. Rather, Orlistat inhibits fhe absorbtion of lipids (fats) in foods that are eaten. People with a high BMI should use Orlistat as an effective part of a health diet and exercise to aid in weight loss.

What is Xenical?

Xenical is a weight loss medication that uses the active ingredient orlistat to help you to lose weight. If you have a BMI of 30 or above and are looking to boost your weight loss, Xenical could be the perfect companion to your calorie-controlled diet, that could help you to meet your weight loss goals.

 

How will the 120mg orlistat in Xenical capsules help me to lose weight?

The active ingredient in Xenical capsules is orlistat, which is included in many weight loss medications. Orlistat works by attaching to the fat enzymes in your food and keeping it from being digested, helping to reduce the amount of fat you absorb from your food by around a third. This is how Xenical works alongside a low-fat diet to help you to lose more weight than you would through dieting alone.

 

Do I have to have a certain BMI to take Xenical?

Xenical should only be taken by those with a BMI of 30 or above, or those with weight related risks (such as diabetes) who have a BMI of 28 or above. To work out your BMI, you can use a BMI calculator, like the one found on the NHS website, to see if this medication will be right for you. If you have a BMI that’s lower than 30 and have concerns about your weight, we’d recommend speaking to your doctor for advice.

 

Do I have to diet while taking this medication?

Xenical is designed to be used alongside a balanced, calorie-controlled diet. For best results, you should aim for your diet to contain an average of 30% calories from fat, with your fat intake spread evenly over all 3 of your daily meals. If you eat fatty foods while taking Xenical, you may find that you are more likely to experience side effects such as oily discharge or fatty stools.

 

Can I buy Xenical online without a prescription?

You need a prescription to buy Xenical, but you can get a prescription online from a qualified doctor. If you click on the ‘begin consultation’ button on this page, you’ll be taken to our sister site, doctor 4 u, where you’ll be asked to complete a short questionnaire set by our doctors. Once you’ve answered, our doctors will review your answers and write a prescription for you, if they agree that this product is right for you. They’ll send this prescription to our pharmacists, so we can fulfil and deliver it as soon as possible.

 

Can I take this product if I’m taking other medication?

If you’re taking any other medication, including those that you obtained without a prescription, speak to your doctor or pharmacist before taking this product. This especially applies if you are already taking:

• Anticoagulants, or blood thinners, such as warfarin
• Ciclosporin, you should not take this product at the same time as ciclosporin
• Iodine salts and/or levothyroxine
• Amiodarone
• Medications used to treat HIV
• Medications used for depression, psychiatric disorders, or anxiety
• Medications used to treat epilepsy
• Acarbose, which is used to treat type 2 diabetes. You should not take this product at the same time as acarbose

 

Can I take this medication if I’m pregnant or breastfeeding?

If you’re pregnant or breastfeeding, you should not take this product. If you’re concerned about your weight during pregnancy, speak to your doctor or pharmacist for advice.

 

Will this product affect my contraception?

You may experience diarrhoea as a side effect of taking Xenical, especially if your diet has a high fat content. This can sometimes cause the failure of oral contraceptives like the pill, so we would advise using a second method of contraception while taking Xenical, to make sure that you’re well protected from unwanted pregnancy.

 

How to take these capsules

Always take Xenical exactly as your doctor has told you to, following their dosages carefully. You will usually take one 120mg Xenical capsule three times a day, along side your main meals. You can take this product immediately before or during a meal, or up to one hour after finishing your meal. Swallow the capsule with a glass of water. You will usually stop taking this product after 12 weeks if you have not lost at least 5% of your body weight after this time.

 

When should this product not be used?

Xenical is not suitable for use in children. Do not take this product if you are allergic to orlistat or any of the other listed ingredients. Do not take this product if you have:

• Chronic malabsorption syndrome, which causes insufficient absorption of nutrients from the alimentary tract
• Cholestasis, or liver disorder

 

Does Xenical have any side effects?

Like all medications, Xenical can have side effects, although not everyone will experience them. The most common side effects of this product include:

• Headaches
• Abdominal pain or discomfort
• Urgent or increased need to pass a bowel movement
• Flatulence (wind) with discharge
• Oily discharge
• Oily, fatty stools
• Liquid stools
• Low blood sugar levels, which is experienced by some people with type 2 diabetes
• Rectal pain or discomfort
• Soft stools
• Incontinence
• Bloating, which is experienced by some people with type 2 diabetes
• Tooth/gum disorder
• Irregularity of menstrual cycle
• Tiredness

For a full list of potential side effects of this medication, please see the patient information leaflet included with your medication. If you experience these or any other side effects while you are taking this product, stop use and speak to your doctor or pharmacist right away. For more information about reporting the side effects of medication, please see the

 

How to store this product

Store in a cool, dry place which is below 25 degrees C. Do not use this product if the expiry date printed on the original packaging has passed. Keep out of sight and reach of children.

 

Important information

This product is a medicine; make sure to speak to your doctor or Chemist 4 U pharmacist before taking this product if you have an underlying medical problem or are taking any other medicine or complementary therapy. If your symptoms get worse or continue after taking this product, contact us or your doctor. For medical services in your area, please refer to

If you are pregnant, trying to become pregnant, or breastfeeding, speak to your doctor or our pharmacist before taking this product. If you suffer from any allergies, ask your doctor or our pharmacist if this medicine is right for you.

Store all medicines out of sight and reach of children.

Please read the included leaflet carefully before using this product.

Please contact your GP if appropriate regarding this product.

Orlistat is a drug designed to treat obesity. It is marketed as a prescription drug under the trade name Xenical by Roche in most countries, and is sold over-the-counter as Alli^[2] by GlaxoSmithKline in the United Kingdom and the United States.^[3] Its primary function is preventing the absorption of fats from the human diet by acting as a lipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervised reduced-calorie diet.^[4]

Orlistat is the saturated derivative of lipstatin, a potent natural inhibitor of pancreatic lipases isolated from the bacterium Streptomyces toxytricini.^[5] However, due to its relative simplicity and stability, orlistat was chosen over lipstatin for development as an anti-obesity drug.^[6]

The effectiveness of orlistat in promoting weight loss is definite but modest. Pooled data from clinical trials suggest that people given orlistat in addition to lifestyle modifications, such as diet and exercise, lose about 2–3 kilograms (4.4–6.6 lb) more than those not taking the drug over the course of a year.^[7] Orlistat also modestly reduces blood pressure and appears to prevent the onset of type 2 diabetes, whether from the weight loss itself or other effects. It reduces the incidence of diabetes type II in people who are obese around the same amount that lifestyle changes do.^[8]

Benefits aside, however, orlistat is noted for its gastrointestinal side effects (sometimes referred to as treatment effects), which can include steatorrhea (oily, loose stools). They decrease with time, however, and are the most frequently reported adverse effects of the drug.^[4] In Australia, the United States and the European Union, orlistat is available for sale without a prescription.^[9] Over-the-counter approval was controversial in the United States, with consumer advocacy group Public Citizen repeatedly opposing it on safety and efficacy grounds.^[10] Generic formulations of orlistat are available in some countries. In Australia it has been listed as an S3 medication—available from a pharmacist without a prescription—since 2000.^[11]

Medical uses

Orlistat is used for the treatment of obesity. The amount of weight loss achieved with orlistat varies. In one-year clinical trials, between 35.5% and 54.8% of subjects achieved a 5% or greater decrease in body mass, although not all of this mass was necessarily fat. Between 16.4% and 24.8% achieved at least a 10% decrease in body fat.^[4] After orlistat was stopped, a significant number of subjects regained weight—up to 35% of the weight they had lost.^[4] It reduces the incidence of diabetes type II in people who are obese around the same amount that lifestyle changes do.^[8] Long-term use of orlistat also leads to a very modest reduction in blood pressure (mean reductions of 2.5 and 1.9 mmHg in systolic and diastolic blood pressure respectively).^[12]

Contraindications

Orlistat is contraindicated in:^[4]

• Malabsorption
• Hypersensitivity to orlistat
• Reduced gallbladder function (e.g. after cholecystectomy)
• Pregnancy and breastfeeding
• Anorexia and Bulimia
• Use caution with: obstructed bile duct, impaired liver function, and pancreatic disease

Side effects

The primary side effects of the drug are gastrointestinal-related, and include steatorrhea (oily, loose stools with excessive flatus due to unabsorbed fats reaching the large intestine), fecal incontinence and frequent or urgent bowel movements.^[13] 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.^[14] The manual for Alli makes it clear that orlistat treatment involves aversion therapy, encouraging the user to associate eating fat with unpleasant treatment effects.^[15]

Side effects are most severe when beginning therapy and may decrease in frequency with time;^[4] It has also been suggested that the decrease in side effects over time may be associated with long-term compliance with a low-fat diet.^[16]

On 26 May 2010, the U.S. Food and Drug Administration (FDA) approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication.^[17]

An analysis of over 900 orlistat users in Ontario showed that their rate of acute kidney injury was more than triple that of non-users.^[18] The putative mechanism for this effect is postulated to be excessive oxalate absorption from the gut and its subsequent deposition in the kidney, with excessive oxalate absorption being a known consequence of fat malabsorption.

An April 2013 study published in the British Medical Journal ^[19] looked at 94,695 patients receiving orlistat in the UK between 1999 and 2011. This study showed no evidence of an increased risk of liver injury during treatment. They concluded:

The incidence of acute liver injury was higher in the periods both immediately before and immediately after the start of orlistat treatment. This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug.

Long-term

Despite a higher incidence of breast cancer amongst those taking orlistat in early, pooled clinical trial data—the analysis of which delayed FDA review of orlistat^[20]—a two-year study published in 1999 found similar rates between orlistat and placebo (0.54% versus 0.51%), and evidence that tumors predated treatment in 3 of the 4 participants who had them.^[21] There is evidence from an in vitro study to suggest that the introduction of specific varied preparations containing orlistat, namely the concurrent administration of orlistat and the monoclonal antibody trastuzumab, can induce cell death in breast cancer cells and block their growth.^[22]

Fecal fat excretion promotes colon carcinogenesis. In 2006 the results of 30-day study were published indicating that orlistat at a dosage of 200 mg/kg chow administered to rats consuming a high-fat chow and receiving two 25 mg/kg doses of the potent carcinogen 1,2-dimethylhydrazine produced significantly higher numbers of aberrant crypt foci (ACF) colon lesions than did the carcinogen plus high-fat chow without orlistat.^[23] ACF lesions are believed to be one of the earliest precursors of colon cancer.^[24]

Precautions

Absorption of fat-soluble vitamins and other fat-soluble nutrients is inhibited by the use of orlistat. A multivitamin tablet containing vitamins A,^[25] D, E, K, and beta-carotene should be taken once a day, at bedtime, when using orlistat.^[4]

Interactions

Orlistat may reduce plasma levels of ciclosporin (also known as “cyclosporin” or “cyclosporine”, trade names Sandimmune, Gengraf, Neoral, etc.), an immunosuppressive drug frequently used to prevent transplant rejection; the two drugs should therefore not be administered concomitantly.^[4] Orlistat can also impair absorption of the antiarrhythmic amiodarone.^[26] The MHRA has recently suggested that Orlistat could theoretically reduce the absorption of antiretroviral HIV medications.^[27]

Mechanism of action

Orlistat works by inhibiting gastric and pancreatic lipases, the enzymes that break down triglycerides in the intestine. When lipase activity is blocked, triglycerides from the diet are not hydrolyzed into absorbable free fatty acids, and instead are excreted unchanged. Only trace amounts of orlistat are absorbed systemically; the primary effect is local lipase inhibition within the GI tract after an oral dose. The primary route of elimination is through the feces.

Orlistat was also recently found to inhibit the thioesterase domain of fatty acid synthase (FAS), an enzyme involved in the proliferation of cancer cells but not normal cells. However, potential side effects of Orlistat, such as inhibition of other cellular off-targets or poor bioavailability, might hamper its application as an effective antitumor agent. One profiling study undertook a chemical proteomics approach to look for new cellular targets of orlistat, including its off-targets.^[29] Orlistat also show potential activities mycobacteria and Trypanosoma brucei parasite (see further reading).

At the standard prescription dose of 120 mg three times daily, before meals, orlistat prevents approximately 30% of dietary fat from being absorbed.^[30] Higher doses do not produce more potent effects.^[4]

Legal status

Orlistat has historically been available by prescription only, and this situation continues in Canada. In Australia, the European Union,^[31] and the United States, certain formulations of orlistat have been approved for sale without a prescription.

Australia and New Zealand

In Australia and New Zealand, orlistat has been available as a “Pharmacist Only Medicine since 2000.^[11] In 2007 the Committee 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”.^[32]

United States

On 23 January 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 /ˈælaɪ/ by GlaxoSmithKline.^[33] Approval was granted on 7 February 2007,^[34] and alli became the first weight loss drug officially sanctioned by the U.S. government for over-the-counter use.^[35] Consumer advocacy organization Public Citizen opposed over-the-counter approval for orlistat.^[10]

Alli became available in the U.S. in June 2007. It is sold as 60 mg capsules—half the dosage of prescription orlistat.^[10][35]

European Union

On 21 January 2009, the European Medicines Agency granted approval for the sale of orlistat without a prescription.^[31][36]

Generic formulations

U.S. patent protection for Xenical, originally to end on 18 June 2004, was extended by five years (until 2009) by the U.S. Patent and Trademark Office. The extension was granted on 20 July 2002,^[37] and expired on 18 June 2009.^[38]

Generic orlistat is available in Iran under the brand Venustat manufactured by Aburaihan Pharmaceutical co., in India, under the brands Orlean (Eris), Vyfat, Olistat, Obelit, Orlica and Reeshape.^[39] In Russia, orlistat is available under the brand names Xenical (Hoffmann–La Roche), Orsoten/Orsoten Slim (KRKA d. d.) and Xenalten (OBL-Pharm). In Austria, orlistat is available under the brand name Slimox. In Malaysia, orlistat is available under the brand name Cuvarlix and is marketed by Pharmaniaga.

Society and culture

Cost

At times, such as in spring 2012, orlistat has come into short supply, with consequent price increases because of nonavailability of one of the drug’s components.^[40]

Counterfeit products

In January 2010, the U.S. Food and Drug Administration issued an alert stating that some counterfeit versions of Alli sold over the Internet contain no orlistat, and instead contain the weight-loss drug sibutramine. The concentration of sibutramine in these counterfeit products is at least twice the amount recommended for weight loss.^[41]