Xenical - the description, contraindications, application

The latin name: Xenical

Xenical Pharmacological groups: hypolipidemic agents

Xenical Working substance: (Orlistat *)

Xenical Application: On data Physician Desk Reference (2003), it is shown for treatment of an obesity, including decrease and maintenance of mass of a body, in a combination with a diet. also it is shown for decrease of risk of a repeated increase of mass of a body after its initial downstroke. it is shown patients with an obesity at an index of mass of a body (, his calculation - see " Special indicatings ") 30 kg / m2 or 27 kg / m2 at presence of other risk factors (a diabetes, an arterial hypertension, ).

Xenical Contraindications: Hypersensitivity, a set of symptoms chronic , a cholestasia.

Xenical Restrictions to application: Children's age (safety and efficiency are not fixed), a hyperoxaluria in an anamnesis, a nephrolithiasis (calcium oxalic stones).

Xenical Application at pregnancy and a feeding a breast: Adequate well controllable researches at pregnant women it was not carried out. As the data of tests for animals not always can predetermine response at the person, it is not recommended to apply during pregnancy. It is not known, whether in thoracal milk, it is not necessary to apply it at feeding women.

Xenical Side effects: According to double blind, -controllable clinical tests, at the patients accepting on 120 mg of 3 times day on a background of a diet, within the first and second year of observation most frequently (with frequency of 5 %) and at least in 2 times are more often, than in group , were marked by-effects from party ZHKT which reflected the mechanism of action of a preparation. Near to the name on the first / second year of observation frequency of occurrence of the given by-effect is specified in group , in brackets - the similar data in group . On the part of bodies ZHKT: oily allocation of 26,6%/4,4 % (1,3%/0,2 %), a meteorism and allocation of gases of 23,9%/2,1 % (1,4%/0,2 %), imperative desires on a defecation of 22,1%/2,8 % (6,7%/1,7 %), a fat / oily chair of 20,0%/5,5 % (2,9%/0,6 %), oily excrements of 11,9%/2,3 % (0,8%/0,2 %), an acceleration of a defecation of 10,8%/2,6 % (4,1%/0,8 %), an incontience of a feces of 7,7%/1,8 % (0,9%/0,2 %). These and other frequently observable collateral reactions basically were average and transient, their frequency was decreased on the second year of treatment. In general the first episode of occurrence of by-effects was marked during 3 from the beginning of therapy. Duration of 50 % of all gastrointestinal by-effects connected to treatment , made less than 1 , in most cases - no more than 4 . However side effects from party ZHKT at some patients can develop within 6 and more months of therapy. In controllable clinical tests to stop treatment because of by-effects 8,8 % of the patients accepting , in comparison from 5,0 % in group have been compelled. In group most frequently treatment interrupted because of by-effects from party ZHKT. In seven , double blind, -controllable researches at the patients accepting on 120 mg of 3 times day in a combination to a diet within 2 years, with frequency of 2 % and exceeded those in group (in a combination to a diet), were marked the following by-effects. Near to the name on the first / second year of observation frequency of occurrence of the given by-effect is specified in group , in brackets - the similar data in group (N means absence of reports on frequency of an attribute of 2 % and exceeded ). On the part of nervous system and sense organs: a headache 30,6 %/N (27,6 %/N), a giddiness 5,2 %/N (5,0 %/N), fatigability of 7,2%/3,1 % (6,4%/1,7 %), infringement of dream 3,9 %/N (3,3 %/N), uneasiness of 4,7%/2,8 % (2,9%/2,1 %), depression N/3,4 of % (N/2,5 %). On the part of respiratory system: Infections of the top respiratory ways of 38,1%/26,1 % (32,8%/25,8 %), infections of the bottom respiratory ways 7,8 %/N (6,6 %/N), signs on the part of -BODIES 2,0 %/N (1,6 %/N), an otitis of 4,3%/2,9 % (3,4%/2,5 %). On the part of bodies ZHKT: pain / discomfort in a stomach 25,5 %/N (21,4 %/N), a nausea of 8,1%/3,6 % (7,3%/2,7 %), an infectious diarrhea 5,3 %/N (4,4 %/N), pain / discomfort in a rectum of 5,2%/3,3 % (4,0%/1,9 %), diseases of a teeth of 4,3%/3,1 % (2,9%/2,3 %), diseases 4,1%/2,0 % (2,9%/1,5 %), a vomiting 3,8 %/N (3,5 %/N). On the part of genitourinary system: an irregular menstrual cycle 9,8 %/N (7,5 %/N), a vaginitis of 3,8%/2,6 % (3,6%/1,9 %), infections systems of 7,5%/5,9 % (7,3%/4,8 %). On the part of a locomotorium: Dorsodynia 13,9 %/N (12,1 %/N), a pain in bottom extremities N/10,8 of % (N/10,3 %), an arthritis 5,4 %/N (4,8 %/N), 4,2 %/N (3,3 %/N), infringement of function of joints 2,3 %/N (2,2 %/N), tendinitis N/2,0 of % (N/1,9 %). On the part of integuments: an eruption 4,3 %/N (4,0 %/N), a xeroderma 2,1 %/N (1,4 %/N). Other: a flu 39,7 %/N (36,2 %/N), an edema stop N/2,8 of % (N/1,9 %). There are infrequent reports on reactions of hypersensitivity to , including an itch, an eruption, a urticaria, a Quincke's disease and an anaphylaxis.

Xenical Interaction: does not influence a pharmakokinetics , alcohol, digoxin (appointed in a unitary dose) and Phenytoinum (300 mg appointed in a unitary dose), on bioavailability of Nifedipinum (a tablet of prolonged liberation), -activity of peroral contraceptives, a pharmakokinetics (both R-, and S-) and a pharmacodynamics (a prothrombin time and a level of VII factor) . Alcohol did not influence a pharmacodynamics (an egestion of Adepses with a feces) and a systemic exposition . On the preliminary data, at simultaneous application and the level of the last in plasma goes down (and should not be accepted simultaneously; for decrease of probability of medicinal interaction it is necessary to accept for 2 up to or through 2 after reception ). reduces an adsorption of -Carotinum contained in alimentary additives, on 30 % and inhibits an adsorption of vitamin (in the form of a tocopherol of Acetas) approximately on 60 %. Influence on an adsorption of vitamins D, A, contained in additives, for today is not known. Though the level , a marker of entering with nutrition of vitamin To, at reception did not change, at accepting people the tendency to downstroke of the maintenance of vitamin of K.Peredozirovka was taped: Unitary reception of 800 mg or his repeated reception in a dose up to 400 mg 3 times day within 15 days people with normal mass of a body and with an obesity was not accompanied by significant by-effects. If the appreciable overdosage is revealed, it is necessary to observe of a condition of the patient during 24 . According to researches on animals and the person, the systemic effects connected with by properties , should be quickly convertible.

Xenical Way of application and dose: Inside, with each basic reception of the nutrition containing Adepses, during meal or not later than through 1 after meal, on 120 mg 3 times day. The miss of reception if reception of nutrition or nutrition have been missed did not contain Adepses is supposed.

Xenical Safety measures: Before purpose it is necessary to exclude the organic reason of an obesity, for example a hypothyroidism. For the period of treatment recommend the balanced low-calorie diet in which Adepses provide no more than 30 % of calories. The probability of development of by-effects from party ZHKT is enlarged at the high maintenance in nutrition of Adepses (more than 30 % of daily caloric content). Daily reception of Adepses, carbohydrates and fibers should be distributed between three basic receptions of nutrition. As reduces an adsorption of some liposoluble vitamins, for maintenance of their adequate entering in an organism patients should accept the polyvitaminic preparations containing liposoluble vitamins. Besides the maintenance of vitamin D and at patients with an obesity can be lower than -Carotinum, than at people, not suffering an obesity. Polyvitaminums should be accepted for 2 up to or through 2 after reception , for example before dream. Reception in the doses exceeding 120 mg of 3 times day, does not provide additional effect. At the patients simultaneously accepting and , more often monitoring the maintenance in plasma is required. At the patients who were not receiving vitamin additives, at two and more consecutive visits to the doctor during the first and second years of treatment dropping a level of vitamins in plasma in the following interest of cases (in brackets the data are specified in group ) has been fixed: vitamin And 2,2 % (1,0 %), vitamin D of 12,0 % (6,6 %), vitamin of 5,8 % (1,0 %), -Carotinum of 6,1 % (1,7 %). At some patients on a background the maintenance of Sodium oxalatums in urine can be enlarged. As well as for other preparations for decrease of mass of a body, some groups of patients (for example with a nervous anorexia or a bulimia) have probability of abusing . As absorption of vitamin To at reception can be decreased, at the patients receiving on a background of long constant reception , it is necessary to supervise parameters of coagulation of a blood closely. The induction losses of mass of a body can be combined with improvement of the metabolic control of a diabetes, that will demand decrease of doses peroral agents (derivatives , Metforminum, etc.) or an insulin.

Xenical Special indicatings: the Degree of an obesity estimate on an index of mass of body () which expect under the formula: =bodies (kg)/body height () 2.

Trading names of preparations with working substance * (Orlistat *):
(Xenical)