Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Proper storage of Xenical:
Store Xenical at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xenical out of the reach of children and away from pets.
Overdose of Xenical in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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Single doses of Xenical 800 mg and multiple doses of up to 400 mg 3 times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg 3 times daily have been administered to obese patients for 6 months without significant increase of adverse findings.
Xenical overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
Should a significant overdose of Xenical occur, it is recommended that the patient be observed for 24 hrs. Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of Xenical should be rapidly reversible.
What should I avoid while taking Xenical?
Avoid a diet that is high in fat. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.
If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take Xenical.
If you also take levothyroxine (such as Synthroid), do not take it within 4 hours before or 4 hours after you take Xenical.
Xenical warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
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Concomitant Drug and Vitamin Use
Data from a Xenical and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when Xenical was coadministered with cyclosporine. Therefore, Xenical and cyclosporine should not be simultaneously coadministered. To reduce the chance of a drug-drug interaction, cyclosporine should be taken at least 3 hours before or after Xenical in patients taking both drugs. In addition, in those patients whose cyclosporine levels are being measured, more frequent monitoring should be considered.
Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because Xenical has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene. In addition, the levels of vitamin D and beta-carotene may be low in obese patients compared with non-obese subjects. The supplement should be taken once a day at least 2 hours before or after the administration of Xenical, such as at bedtime.
Table 2 illustrates the percentage of adult patients on Xenical and placebo who developed a low vitamin level on two or more consecutive visits during 1 and 2 years of therapy in studies in which patients were not previously receiving vitamin supplementation.
Table 2 Incidence of Low Vitamin Values on Two or More Consecutive Visits (Nonsupplemented Adult Patients With Normal Baseline Values - First and Second Year)
Placebo*
Xenical*
*
Treatment designates placebo plus diet or Xenical plus diet
Vitamin A
1.0%
2.2%
Vitamin D
6.6%
12.0%
Vitamin E
1.0%
5.8%
Beta-carotene
1.7%
6.1%
Table 3 illustrates the percentage of adolescent patients on Xenical and placebo who developed a low vitamin level on two or more consecutive visits during the 1-year study.
Table 3 Incidence of Low Vitamin Values on Two or More Consecutive Visits (Pediatric Patients With Normal Baseline Values*)
Placebo†
Xenical†
*
All patients were treated with vitamin supplementation throughout the course of the study
†
Treatment designates placebo plus diet or Xenical plus diet
Vitamin A
0.0%
0.0%
Vitamin D
0.7%
1.4%
Vitamin E
0.0%
0.0%
Beta-carotene
0.8%
1.5%
Weight-loss may affect glycemic control in patients with diabetes mellitus. A reduction in dose of oral hypoglycemic medication (eg, sulfonylureas) or insulin may be required in some patients.
Liver Injury
There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with Xenical, with some of these cases resulting in liver transplant or death. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while taking Xenical. When these symptoms occur, Xenical and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
Increases in Urinary Oxalate
Some patients may develop increased levels of urinary oxalate following treatment with Xenical. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function when prescribing Xenical to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
Cholelithiasis
Substantial weight loss can increase the risk of cholelithiasis. In a clinical trial of Xenical for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2.9% (47/1649) for patients randomized to Xenical and 1.8% (30/1655) for patients randomized to placebo.
Miscellaneous
Organic causes of obesity (eg, hypothyroidism) should be excluded before prescribing Xenical.
Patients should be advised to adhere to dietary guidelines. Gastrointestinal events may increase when Xenical is taken with a diet high in fat (>30% total daily calories from fat). The daily intake of fat should be distributed over three main meals. If Xenical is taken with any one meal very high in fat, the possibility of gastrointestinal effects increases.
What should I discuss with my healthcare provider before taking Xenical?
You should not take Xenical if you are allergic to it, or if you have:
gallbladder problems;
chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or
if you are pregnant.
To make sure you can safely take Xenical, tell your doctor if you have any of these other conditions:
an underactive thyroid;
a history of gallstones or kidney stones;
a history of pancreatitis;
liver disease;
kidney disease;
type 1 or type 2 diabetes;
an eating disorder (anorexia or bulimia); or
if you take any other weight-loss medications (prescription or over-the-counter).
FDA pregnancy category X. Do not use Xenical if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese. Stop taking Xenical and tell your doctor right away if you become pregnant.
Taking Xenical can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give over-the-counter Xenical (alli) to a child younger than 18 years old. Prescription Xenical should not be used by anyone age 12 to 18 without the advice of a doctor.
Xenical should be used only by the person for whom it was prescribed. Never share Xenical with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.
Xenical precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
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Drug Interactions And Decreased Vitamin Absorption
XENICAL may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs.
Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. Therefore, XENICAL and cyclosporine should not be simultaneously coadministered. To reduce the chance of a drug-drug interaction, cyclosporine should be taken at least 3 hours before or after XENICAL in patients taking both drugs. In addition, in those patients whose cyclosporine levels are being measured, more frequent monitoring should be considered.
Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene. In addition, the levels of vitamin D and beta-carotene may be low in obese patients compared with non-obese subjects. The supplement should be taken once a day at least 2 hours before or after the administration of XENICAL, such as at bedtime.
Weight-loss may affect glycemic control in patients with diabetes mellitus. A reduction in dose of oral hypoglycemic medication (e.g., sulfonylureas) or insulin may be required in some patients.
Liver Injury
There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with XENICAL, with some of these cases resulting in liver transplant or death. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while taking XENICAL. When these symptoms occur, XENICAL and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
Increases In Urinary Oxalate
Some patients may develop increased levels of urinary oxalate following treatment with XENICAL. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function when prescribing XENICAL to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
Cholelithiasis
Substantial weight loss can increase the risk of cholelithiasis. In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2.9% (47/1649) for patients randomized to XENICAL and 1.8% (30/1655) for patients randomized to placebo.
Miscellaneous
Organic causes of obesity (e.g., hypothyroidism) should be excluded before prescribing XENICAL.
Patients should be advised to adhere to dietary guidelines. Gastrointestinal events may increase when XENICAL is taken with a diet high in fat ( > 30% total daily calories from fat). The daily intake of fat should be distributed over three main meals. If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects increases.
Patient Counseling Information
Patients should not take XENICAL if they are pregnant, have chronic malabsorption syndrome, cholestasis or hypersensitivity to XENICAL or to any component of this product.
Concomitant Medications
Patients should be asked if they are taking cyclosporine, beta carotene or vitamin E supplements, levothyroxine, warfarin, antiepileptic drugs, amiodarone, or antiretroviral drugs due to potential interactions.
Commonly Observed Adverse Events
Patients should be informed of the commonly-observed adverse events associated with the use of XENICAL which include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation, fecal incontinence.
Potential Risks And Benefits
Patients should be informed of potential risks which include lowered absorption of fat-soluble vitamins and potential liver injury, increases in urinary oxalate, and cholelithiasis. Treatment with XENICAL may result in weight loss and improvement in obesity-related risk factors due to weight loss.
Dosing Instructions
Patients should be counseled to take XENICAL as directed with meals or up to one hour after a meal. Patients should also be advised to take multivitamin supplementation at least two hours before or after the administration of XENICAL, or at bedtime.
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity studies in rats and mice did not show a carcinogenic potential for Xenical at doses up to 1000 mg/kg/day and 1500 mg/kg/day, respectively. For mice and rats, these doses are 38 and 46 times the daily human dose calculated on an area under concentration vs time curve basis of total drug-related material.
Xenical had no detectable mutagenic or genotoxic activity as determined by the Ames test, a mammalian forward mutation assay (V79/HPRT), an in vitro clastogenesis assay in peripheral human lymphocytes, an unscheduled DNA synthesis assay (UDS) in rat hepatocytes in culture, and an in vivo mouse micronucleus test.
When given to rats at a dose of 400 mg/kg/day in a fertility and reproduction study, Xenical had no observable adverse effects. This dose is 12 times the daily human dose calculated on a body surface area (mg/m²) basis.
Use In Specific Populations
Pregnancy
Pregnancy Category X
XENICAL is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. No embryotoxicity or teratogenicity was seen in animals that received Xenical at doses much higher than the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.
Animal Data
Reproduction studies were conducted in rats and rabbits at doses up to 800 mg/kg/day. Neither study showed embryotoxicity or teratogenicity. This dose is 23 and 47 times the daily human dose calculated on a body surface area (mg/m²) basis for rats and rabbits, respectively.
Nursing Mothers
It is not known if XENICAL is present in human milk. Caution should be exercised when XENICAL is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
The safety and efficacy of XENICAL have been evaluated in obese adolescent patients aged 12 to 16 years. Use of XENICAL in this age group is supported by evidence from adequate and well-controlled studies of XENICAL in adults with additional data from a 54-week efficacy and safety study and a 21- day mineral balance study in obese adolescent patients aged 12 to 16 years. Patients treated with XENICAL in the 54-week efficacy and safety study (64.8% female, 75% Caucasians, 18.8% Blacks, and 6.3% Other) had a mean reduction in BMI of 0.55 kg/m² compared with an average increase of 0.31 kg/m² in placebo-treated patients (p=0.001). In both adolescent studies, adverse effects were generally similar to those described in adults and included fatty/oily stool, oily spotting, and oily evacuation. In a subgroup of 152 XENICAL and 77 placebo patients from the 54-week study, changes in body composition measured by DEXA were similar in both treatment groups with the exception of fat mass, which was significantly reduced in patients treated with XENICAL compared to patients treated with placebo (-2.5 kg vs -0.6 kg, p=0.033). Because XENICAL can interfere with the absorption of fatsoluble vitamins, all patients should take a daily multivitamin that contains vitamins A, D, E, K, and betacarotene. The vitamin supplement should be taken at least 2 hours before or after XENICAL.
Plasma concentrations of Xenical and its metabolites M1 and M3 were similar to those found in adults at the same dose level. Daily fecal fat excretions were 27% and 7% of dietary intake in XENICAL and placebo treatment groups, respectively.
Geriatric Use
Clinical studies of XENICAL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients.
What happens if I miss a dose of Xenical?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
If you miss a meal, or if you have a meal without fat, you can skip your dose of Xenical for that meal also.
References
DailyMed. "ORLISTAT: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
