In a multiple-dose study in 30 normal-weight subjects, coadministration of XENICAL and 40 grams of alcohol (e.g., approximately 3 glasses of wine) did not result in alteration of alcohol pharmacokinetics, Viplena pharmacodynamics (fecal fat excretion), or systemic exposure to Viplena.
How to use Viplena Capsule
If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication.
If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start taking Viplena and each time you get a refill. Take this medication as directed by your doctor, by mouth with liquid sometime during each meal that contains fat or within 1 hour after the meal, usually 3 times daily. If you miss a meal or your meal contains no fat, skip that dose of the medication. To decrease the chance of unpleasant side effects, it is very important that no more than 30% of the calories in your diet come from fat. Your daily intake of fat, protein, and carbohydrates should be evenly spread over 3 main meals.
Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
Because this drug can interfere with the absorption of certain vitamins (fat-soluble vitamins including A, D, E, K), a daily multivitamin supplement containing these nutrients is recommended. Take the multivitamin at least 2 hours before or 2 hours after taking Viplena (such as at bedtime).
If you take cyclosporine, take it at least 3 hours before or after Viplena to make sure the full dose of cyclosporine is absorbed into your bloodstream. If you take levothyroxine, take it at least 4 hours before or after Viplena.
You should see some weight loss within 2 weeks after you start Viplena. Tell your doctor if your condition does not improve or if it worsens.
XENICAL (Viplena) is a gastrointestinal lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats.
Viplena is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1- 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:
Viplena is a white to off-white crystalline powder. Viplena is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Viplena 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, Viplena, 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.
Más estudios acerca de Viplena
Según otro estudio, la pérdida de peso durante un año en adultos que toman Viplena es de aproximadamente 3.4 kilos más en comparación con el grupo placebo (Referencia).
Sin embargo, el peso no es muy significante representando solo el 3.1% del peso inicial. También se tiene que tomar en cuenta que el peso parece ser recuperado lentamente después del primer año de tratamiento.
Además, un estudio demostró que una dieta baja en carbohidratos libre de medicamentos es tan efectiva como la combinación de una dieta baja en grasas con Viplena (Referencia).
The main side-effects are caused by the fat which is passed out with your stools (faeces). You may have fatty smelly stools, urgency to get to the toilet, oily spotting on your underclothes, and excess wind. These side-effects are less likely if you eat a low-fat diet. They tend to settle with time, possibly because if they occur they remind you that you should be eating a low-fat diet. Other side-effects are rare.
Note: the above is not the full list of side-effects for those taking Viplena. Please see the leaflet that comes with your medicine for a full list of possible side-effects and cautions.
In a pharmacokinetic study conducted in healthy volunteers who received 120 mg Viplena three times daily for 13 days and a single dose of 120 mg Viplena on the morning of Day 14 co-administered with a single dose of 1200 mg amiodarone on Day 4, a 23 – 27% reduction in the systemic exposure to amiodarone and desethylamiodarone was observed . The effect of commencing Viplena treatment in patients on stable amiodarone therapy has not been studied.
Does Viplena work?
Studies have shown that, on average, Viplena, plus a weight-reducing diet and exercise, causes more weight loss than a weight-reducing diet and exercise alone. Some people lose 10% or more of their body weight within six months with the help of Viplena. In others, it is less effective.
One reason why Viplena may not work is that you may think that you can relax your weight-reducing diet, and the Viplena will 'do it all'. This is not true. In order to lose weight you still have to eat less and exercise regularly. Remember, Viplena prevents only some of the fat that you eat from being absorbed (just under a third). But, if you do not keep to a healthy weight-reducing diet, and you eat more fat (chocolates, cakes, etc), the extra fat that you eat will easily cancel out the effect of the Viplena.
What is Viplena?
Viplena is a medicine which can help you to lose weight if you are overweight or obese. Viplena works by blocking chemicals (enzymes) in your gut which digest fat. Nearly a third of the fat that you eat is blocked by Viplena. The undigested fat is not absorbed into your body and is passed out with your stools (faeces). The normal dose is one capsule - 120 mg, three times a day with each meal. However, you do not need to take one if there is no fat in the meal or if you miss a meal.
Liraglutide is a new medicine that was licensed for the treatment of obesity in January 2017. There has been limited experience of this treatment, which is only available in injectable form. It is currently mainly being used in specialist centres for people whose obesity has led them to develop other illnesses such as diabetes.
Two other medicines - sibutramine and rimonabant - previously used to help with weight loss are no longer available in the UK because of concerns over their safety.
During clinical studies, effectiveness, side effects and the action mechanism of Viplena were not the only aspect studied. Researchers also tested the effects of high doses on healthy and obese people.
Some people were administered very high daily doses of Viplena, including up to 1200 mg per day (more than 3 times the recommended dose). It was found out that the frequency and intensity of side effects did not change.
Dr Laurence Knott, Reviewed by Dr Helen Huins | Last edited 1 Mar 2018 | Certified by The Information Standard
Viplena is a medicine which can help you to lose weight if you are overweight or obese.
Based on an oral 14 C-Viplena mass balance study in obese patients, two metabolites, M1 ((the hydrolyzed β-lactone ring product of Viplena) and M3 (sequential metabolite after M1's cleavage of the N-formyl leucine side-chain), accounted for approximately 42% of total radioactivity in plasma. M1 and M3 have an open β-lactone ring and extremely weak lipase inhibitory activity (1000- and 2500-fold less than Viplena, respectively). In view of this low inhibitory activity and the low plasma levels at the therapeutic dose (average of 26 ng/mL and 108 ng/mL for M1 and M3, respectively, 2 to 4 hours after a dose), these metabolites are considered pharmacologically inconsequential. The primary metabolite M1 had a short half-life (approximately 3 hours) whereas the secondary metabolite M3 eliminated at a slower rate (half-life approximately 13.5 hours).
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Viplena only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2019 Cerner Multum, Inc. Version: 12.01.
Viplena Side Effects
Viplena works in the gastrointestinal tract and almost does not enter the bloodstream. Therefore, adverse reactions observed during the drug use are usually associated with a decrease in the absorption of fat from your food.
People treated with Viplena may experience:
- Oily stools;
- Discomfort and pain in the abdomen;
- Increased intestinal motility;
- Higher frequency of bowel movements.
This list does not describe all of the possible side effects.
Important: many reactions are caused not by Viplena, but by the fats that you consume.
Gastrointestinal side effects usually occur in the early stages of treatment and last less than 7 days. Low-fat foods help reduce adverse reactions and increase the treatment effectiveness.
Daños al hígado
Existen casos raros en los que personas han sufrido de daño hepático severo debido al uso de Viplena (Referencia).
Si experimentas cualquier síntoma como piel u ojos amarillentos, orina oscura, pérdida del apetito, dolor en la parte derecha del abdomen o heces claras, comunícate con tu médico de inmediato para una evaluación.