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EDVAL 2 :

 
 
 
   
   
   
 
 



 
   
 
     
     
 
  Composition
   
  Each Tablet of EDVAl 2 contains:
Estradiol Valerate …..........2mg
   
   
  Therapeutic Indications & Usage :
   
  Preparation of endometrium for implantation of fertilized ovum. (Endometrium Priming).
   
   
  Contraindications:
   
  1. Undiagnosed abnormal genital bleeding.
   
  2. Known, suspected or history of cancer of the breast except in appropriately selected patients being treated for metastatic disease.
   
  3. Known or suspected estrogen-dependent neoplasia.
   
  4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
   
  5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction.
   
  6. Liver dysfunction or disease.
   
  7. Estradiol Tablets USP should not be used in patients with known hypersensitivity to its ingredients. Estradiol Tablets, USP 2 mg, contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
   
  8. Known or suspected pregnancy. There is no indication for Estradiol tablets in pregnancy. There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.
   
   
  Precautions:
   
  Addition of a progestin when a woman has not had a hysterectomy,Elevated blood pressure,Hypertriglyceridemia,Impaired liver function and past history of cholestatic jaundice,Hypothyroidism,Fluid retention,Hypocalcemia,Ovarian cancer,Exacerbation of endometriosis, Exacerbation of other conditions,Carcinogenesis, Mutagenesis, Impairment of Fertility.
   
   
  Warning :
   
  In conditions like: Cardiovascular disorders,Coronary heart disease and stroke,Venous thromboembolism (VTE), Endometrial cancer,Breast cancer,Dementia,Gallbladder disease, Hypercalcemia,Visual abnormalities.
   
   
  Adverse Reactions
   
  The following additional adverse reactions have been reported with estrogen theraphy:
Changes in vaginal bleeding pattern and abnormal withdrawal bleeding or flow; breakthrough bleeding, spotting, dysmenorrhea,Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer,Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure,Nausea, vomiting
Abdominal cramps, bloatingCholestatic jaundiceIncreased incidence of gallbladder disease
Pancreatitis Enlargement of hepatic hemangiomas,Increase or decrease in weight
Reduced carbohydrate tolerance,Aggravation of porphyria,Edema,Arthralgias; leg cramps,Changes in libido,Urticaria,Angioedema,Anaphylactoid/anaphylactic reactions,Hypocalcemia,Exacerbation of asthma,Increased triglycerides.
   
   
  Recommended dosage & Administration :
   
  As advised by Physician.
   
   
  Presentation:
   
  ED VAL 2 is available in a Blister Strip of 28 Tablets
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
   
 
         
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