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OVIPAUZ L:

 
 
 
   
   
   
 
 


 
   
 
     
     
 
  Composition
   
  Each tablet of OVIPAUZ-L contains
  Levonorgestrel.........0.15 mg
Ethinyl oestradiol.....0.03 mg
   
   
  Therapeutic Indications & Usage
   
  OVIPAUZ-L is indicated in women for:
 
  • Increasing menstrual cycle regularity.
  • Decreasing menstrual blood loss and thereby incidence of iron-deficiency anemia.
  • Decreasing occurrence of dysmenorrhea.
  • Decreasing incidence of functional ovarian cysts.
  • Decreasing chances of ectopic pregnancy.
  • Decreasing risk of fibroadenomas and fibrocystic disease of breast.
  • Decreasing possibility of acute pelvic inflammatory disease.
   
  Contraindications
 
  • Thrombophlebitis or thromboembolic disorders.
  • Past history of deep vein thrombophlebitis or thromboembolic disorders.
  • Cereberovascular or coronary artery disease (current or past history).
  • Thrombogenic valvulopathies.
  • Thrombogenic rhythm disorders.
  • Major surgery with prolonged immobilization.
  • Diabetes with vascular involvement.
  • Headaches with focal neurological symptoms.
  • Uncontrolled hypertension.
  • Known or suspected carcinoma of the breast or personal history of breast cancer.
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia.
  • Undiagnosed abnormal genital bleeding.
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use.
  • Hepatic adenomas or carcinomas, or active liver disease, as long as liver function has not returned to normal.
  • Known or suspected pregnancy.
  • In less than 4 weeks following delivery in women who do not elect to breastfeed, or a midtrimester pregnancy termination.
  • Testing for pregnancy by inducing withdrawal bleeding.
  • Period before menarche.
  • Lactation.
  • Individuals above the age of 65 years.
  • Hypersensitivity to any of its ingredients.
   
  Precautions
   
  OVIPAUZ-L must be advocated with caution in women with cardiovascular disease risk factors such as hypertension, diabetes, hyperlipidemias, obesity and in elderly. It is also to be given with care in depression, gall bladder disease, porphyria, as well as migraine - particularly migraine headache with focal neurological symptoms due to an enhanced risk of stroke.
   
  OVIPAUZ-L must be given with caution in diarrhea and / or vomiting since the latter may reduce the absorption resulting in decreased concentrations of its ingredients.
   
   
  Warnings
   
  Breakthrough bleeding and spotting are sometimes encountered whilst taking oral contraceptives (OVIPAUZ-L), especially during the first three months of use. If the bleeding persists or recurs, non-hormonal causes should be considered and adequate diagnostic measures taken to rule out malignancy or pregnancy. Some women may develop post-pill amenorrhea or oligomenorrhea (possibly with ovulation), especially when such a condition is pre-existent.
   
  The risk of thromboembolic disease is not related to the length of use of oral contraceptives and gradually disappears after OVIPAUZ-L is stopped. If there is unexplained partial or complete loss of vision, onset of proptosis or diplopia, papilledema, or retinal vascular disease, OVIPAUZ-L should be discontinued.
   
  Oral contraceptives (OVIPAUZ-L) have been demonstrated to cause glucose intolerance as well as hyperinsulinism. An increase in blood pressure can occur with oral contraceptives but this is more likely in elderly users and those who take OVIPAUZ-L for prolonged periods. If there is significant elevation of blood pressure, OVIPAUZ-L must be discontinued; for most women the raised blood pressure will gradually thereafter normalize.
   
  A periodic personal and family medical history and complete physical examination are appropriate for all women especially using OVIPAUZ-L. Women treated for hyperlipidemias must be closely followed since progestogens (in OVIPAUZ-L) can elevate the low density lipoprotein levels.
   
  OVIPAUZ-L must be discontinued if jaundice develops whilst it is being taken, or if the woman develops significant depression. Contact-lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
   
  Conception may be delayed by 1-2 months among women stopping oral contraceptives (OVIPAUZ-L) compared to women stopping non-hormonal contraceptive methods. If the patient has adhered to the regimen, and misses two consecutive periods, pregnancy should be ruled out before continuing OVIPAUZ-L therapy.
   
  Safety and efficacy of oral contraceptives (OVIPAUZ-L) in children and adolescents postpubertal are expected to be similar to those in women of reproductive age.
   
  OVIPAUZ-L must be advocated with caution along with antibiotics, anticonvulsants, and other drugs (like St John's Wort), anti-HIV protease inhibitors, acetaminophen, ascorbic acid, CYP 3A4 inhibitors (indinavir, itraconazole, ketoconazole, fluconazole and troleandomycin), cyclosporin, prednisolone and other corticosteroids, temazepam, salicylic acid, morphine and clofibric acid.
   
   
  Adverse Reactions
   
  Oral contraceptives (OVIPAUZ-L) can cause thromboembolic and thrombotic disorders and other vascular problems, carcinoma of the reproductive organs and breasts, hepatic neoplasia, ocular lesions, gallbladder disease, carbohydrate and lipid effects, elevated blood pressure and headache. It can also cause menstrual disturbances, breast changes, skin lesions and hair changes, hypersensitivity reactions, gastrointestinal symptoms, libido changes and temporary infertility, deepening of corneal curvature, appetite deviation, liver / renal dysfunction, edema / fluid retention, mood changes including depression, nervousness and exacerbation of porphyria.
   
   
  Drug Interactions
   
  OVIPAUZ-L in combination with antibiotics, anticonvulsants, and other drugs (like St John's Wort) that increase the metabolism of contraceptives must be with due precaution, or it would result in breakthrough bleeding. The safety and efficacy of OVIPAUZ-L may be affected by co-administration of anti-HIV protease inhibitors.
   
  OVIPAUZ-L in combination with antibiotics, anticonvulsants, and other drugs (like St John's Wort) that increase the metabolism of contraceptives must be with due precaution, or it would result in breakthrough bleeding. The safety and efficacy of OVIPAUZ-L may be affected by co-administration of anti-HIV protease inhibitors.
   
  Increase in plasma concentrations of oral contraceptives can occur if OVIPAUZ-L is taken along with acetaminophen, ascorbic acid, and CYP 3A4 inhibitors such as indinavir, itraconazole, ketoconazole, fluconazole and troleandomycin. On the other hand, concomitant intake of OVIPAUZ-L with cyclosporin, prednisolone and other corticosteroids can enhance their blood concentrations; oral contraceptives (OVIPAUZ-L) can decrease serum levels of temazepam, salicylic acid, morphine and clofibric acid when both are taken together.
   
  Binding proteins concentrations are elevated by OVIPAUZ-L; serum folate levels may also be depressed by oral contraceptives.
   
   
  Recommended Dosage & Administration
   
  FEMALES
  One OVIPAUZ-L Tablet once daily for 21 consecutive days at the same time each day.
   
  Therapy with OVIPAUZ-L is to be initiated on day one of menstrual cycle (i.e. first day of menstrual bleeding).
   
  When the patient is switching over from another oral contraceptive regimen, she must wait for 7 days (and not more) before starting OVIPAUZ-L.
   
  To derive the maximum efficacy of OVIPAUZ-L, it must be taken exactly as directed and at intervals not exceeding 24 hours.
   
  A withdrawal bleed may start usually after 2-3 days after last OVIPAUZ-L Tab has been taken, and may not have finished before the next pack is started. Further, if spotting or breakthrough bleeding occurs during the treatment period, the regimen recommended for OVIPAUZ-L must continue.
   
   
  Presentations
   
  OVIPAUZ-L Tablets: Blisters of 21s.
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
   
 
         
 
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