DIVIGEL
Manufacturer Details
WIN-MEDICARE
Compositions:
Estradiol hemhydrate 1mg gel in single dose units,
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Strength
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Rate
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Packing Style
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1mg gel
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615.00
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gel in single dose units
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List of Related Indications:
- Hormone replacement therapy
- Post menopausal phase
List Of Drugs:
- Estradiol- @-Estrogen- Sex hormones - ( FDC- List )- (Mar 2007)
Indication Type Description:
Drug Interaction:
Hepatic-enzyme inducing drugs like rifampicin, barbiturates and phenytoin have been reported to
increase the rate of estrogen metabolism.
Indication:
LIST OF DRUGS DURING 2007
Sr.No- 36
Name of the Drug- Estradiol topical emulsion 2.5mg/gm
Pharmacological Classification- Vasomotor symptoms associated with menopause
Date of Approval- 16-03-07
Approved by U.S.FDA on 30-12-2007 (Ref- FDA approved List- 2007)
Menopause syndrome
Proprietary Name- Natazia
Established Name - Estradial valerate /Dienogest
Applicant- Bayer Health Care Pharmaceuticals Inc.
Indication-
Indication for prevention of pregnancy
Approved by FDA on 6-5-2010 (Ref- FDA approved List- 2010)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Estradiol Topical emulsion 16-03-2007
2.5mg/gm
Vasomotor symptoms associated with menopause
2. Estraiol TTS 25,50,100mcg/day Feb 1994
Estrogen
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Combipack of 1 tablet of Estradiol 2mg & 01-02-2000
1 Tablet of Estradiol 2mg +
Dyhyrogesterone 10mg
For treatment of women intact uterus for symptoms of estrogen
deficiency as consequence of the menopause or after overectomy
and for the prevention of post menopausal osteoporosis
Adverse Reaction:
Unopposed estradiol replacement in postmenopausal women may be associated with an
increased risk of endometrial cancer, the magnitude of the risk depending on the dosage and the
duration of treatment.
Other undesirable effects are nausea, vomitting, tender breasts, weight gain, fluid retention,
headache, depression, abdoninal bloating & increase in the size of uterine fibroids
Contra-Indications:
Undiagnosed vaginal bleeding. Endometrial hyperplasia, Known or suspected cancer of the
breast in appropriately selected patients being treated for metastatic disease.
Known or suspected estrogen-dependent neoplasia.
Active thrombophlebitis or thrmbo-embolic disorders. Acute liver disease
Special precautions:
Complete medical history should be taken before initiating treatment. Periodic physical
examination of blood pressure, breasts, abdomen, and pelvic organs, including pap smear.
Estrogen should not prescribed for more than one year without prior examination
Dosages/ Overdosage Etc:
Indication-
Indication for prevention of pregnancy
Menopause syndrome
1 - 2 tabs daily. Alternately, 1ml i.m. every 3 - 4 weeks
Patient Information:
Strong skin care products should not used until one hour after apllication of gel
