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Tuesday, September 13, 2016

الرئيسية side effects of orlistat

side effects of orlistat


Side effects of orlistat
Adverse reactions to orlistat are largely gastrointestinal in nature, the incidence of adverse events decreased with prolonged use of orlistat.
Adverse events are listed below by system organ class and frequency
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
The following grouping undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of >2% and within an incidence > 1% above placebo in clinical trials of 1 and 2 years duration
Nervous system disorders 
very common: Headache
Respiratory, thoracic and mediastinal disorders
 upper respiratory infection Very common
lower respiratory infection Common
Gastrointestinal disorders 
-:very common
  • abdominal pain /discomfort
  • oily spotting from the rectum
Common
  • flatus with discharge
  •  faecal urgency
  •  fatty/oily stool
  •  flatulence
  •  liquid stool
  •  oily evacuation
  • increased defecation
  • rectal pain/discomfort 
  • soft stool 
  • faecal incontinence
  •  abdominal distension 
  • tooth disorde
  •  Gingival disorder 
Renal and urinary disorders
common: urinary tract infection
Metabolism and nutrition disorders
very common: hypoglycemia
Infection and infestations
very common :influenza
General disorders and administration site conditions
common: fatigue
Reproductive system and breast disorders
common: menstrual irregularity
Psychiatric disorders
common: anxiety
Only unique treatment adverse events that occurred at a frequency of >2% and within an incidence >1% above placebo in obese type 2 diabetic patients. 
In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period
The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown
  • increase in liver transaminases and alkaline phosphatase
  • Decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in variations of haemostatic parameters have been reported in patients treated with anticoagulants in association with orlistat 
  • Gastrointestinal disorders: rectal bleeding, Diverticulitis, pancreatitis 
  • Skin and subcutaneous tissue disorders :bulbous eruptions
  • Immune system disorders: hypersensitivity (pruritus, rash, urticarial, angioedema, bronchospasm and anaphylaxis)
  • Hepatobiliary disorders: cholelithiasis hepatitis that mat be serious
  • Renal and urinary disorders: oxalate nephropathy 
Contraindication 
  • Hypersensitivity to orlistat
  • Chronic malabsorption syndrome
  • Cholestasis 
  • Breast feeding
Pregnancy and lactation
  • For orlistat no clinical data on exposed pregnancies are available
  • Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development
  • Caution should be exercised when prescribing to pregnant woman
  • As it is not known whether orlistat is secreted into human milk, orlistat is contraindicated during breast feeding 
Special warning and precautions
  • In clinical trials, the decrease in body weight with orlistat treatment was less in type2 diabetic patients than in non diabetic patients. Ant diabetic medical product treatment may have to be closely monitored when taking orlistat 
  • Co-administration of orlistat with cyclosporine is not recommended
  • Patients should be advised to adhere to the dietary recommendations they are given
  • The possibility of experiencing gastrointestinal adverse reactions may increase when orlistat is taken with a diet high in fat
  • The daily intake of fat should be distributed over three main meals
  • If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase
  • Cases of rectal bleeding have been reported with orlistat
  • Prescribes should investigate further in case of severe and/or persistent symptoms
  • The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in cases of severe diarrhea
  • Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulant 
  • The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy in patient with underlying chronic kidney disease and/or volume depletion
  • Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur
  • The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine 
  • Antiepileptic patient , orlistat may unbalance anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions
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