XENICAL Capsule (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
H2-Pharma LLC
Λέξεις κλειδιά
61269-460
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1. Indications 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 ...
2. Dosage and Administration
The recommended dose of XENICAL is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal). The patient should be on a nutritionally balanced, reduced-calorie ...
3. Dosage Forms and Strengths
XENICAL 120 mg turquoise capsules imprinted with XENICAL 120 in black ink.
4. Contraindications
XENICAL is contraindicated in: Pregnancy <em>[see Use in Specific Populations (8.1)]</em> Patients with chronic malabsorption syndrome Patients with cholestasis Patients with known hypersensitivity to ...
5. Warnings and Precautions
5.1 Drug Interactions and Decreased Vitamin Absorption XENICAL may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during postapproval use of XENICAL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Cyclosporine Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. XENICAL and cyclosporine ...
8.1. 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 ...
8.3. 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.
8.4. 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 ...
8.5. 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 <em>[see Clinical Studies (14)]</em> ...
9.2. Abuse
As with any weight-loss agent, the potential exists for abuse of XENICAL in inappropriate patient populations (e.g., patients with anorexia nervosa or bulimia). See <em>Indications and Usage (1)</em> for ...
10. Overdosage
Single doses of 800 mg XENICAL and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings. Should a significant ...
11. 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, ...
12.1. Mechanism of Action
Orlistat is a reversible inhibitor of gastrointestinal 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 ...
12.2. Pharmacodynamics
Dose-response Relationship The dose-response relationship for orlistat in human volunteers is shown in Figure 1. The effect is the percentage of ingested fat excreted, referred to as fecal fat excretion ...
12.3. Pharmacokinetics
Absorption Systemic exposure to orlistat is minimal. Following oral dosing with 360 mg <sup>14</sup>C-orlistat, plasma radioactivity peaked at approximately 8 hours; plasma concentrations of intact orlistat ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies in rats and mice did not show a carcinogenic potential for orlistat at doses up to 1000 mg/kg/day and 1500 mg/kg/day, respectively. For mice and rats, these doses are 38 and 46 ...
14. Clinical Studies
The long-term effects of XENICAL on morbidity and mortality associated with obesity have not been established. The effects of XENICAL on weight loss, weight maintenance, and weight regain and on a number ...
16.1. How Supplied
XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder. XENICAL 120 mg Capsules: Turquoise, two-piece, No. 1 opaque hard-gelatin capsule imprinted with XENICAL 120 in black ink — bottle ...
16.2. Storage and Handling
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep bottle tightly closed. XENICAL should not be used after the given expiration date.
17. Patient Counseling Information
See FDA-approved patient labeling (Patient Information). Information for Patients Patients should not take XENICAL if they are pregnant, have chronic malabsorption syndrome, cholestasis or hypersensitivity ...