- Approval Id
- c104f4c9e2254790
- Drug Name
- DIVIGEL GEL 0.5mg/dose
- Product Name
- DIVIGEL GEL 0.5mg/dose
- Approval Number
- SIN11644P
- Approval Date
- 2001-08-22
- Registrant
- ORION PHARMA (SG) PTE. LTD.
- Licence Holder
- ORION PHARMA (SG) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- GEL
- Dosage
- **Dosage and Administration**
Divigel can be used for continuous or cyclical treatment. The dose can be adjusted individually from 0.5 g to 1.5 g per day, corresponding to 0.5 to 1.5 mg estradiol per day. The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily and can be readjusted after 2 to 3 cycles.
In patients with an intact uterus, it is recommended to combine Divigel with an adequate dose of progestin for adequate duration, e.g. 12–14 consecutive days per cycle.
Estrogen with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual women.
The Divigel dose is applied once daily, on the skin of the lower trunk or the right or left thighs, on alternate days. The application surface should be 1–2 times the size of the hand. Divigel should not be applied on the breasts, on the face or irritated skin. After application the gel should be allowed to dry for a few minutes and the application site should not be washed within one hour. Accidental contact of the gel with the eyes should be avoided. Hands should be washed after application.
If the patient forgets to apply a dose, it should be applied as soon as possible, unless the dose is more than 12 hours late. If the dose is more than 12 hours late, it should be skipped. Missed doses may induce breakthrough bleeding.
- Route Of Administration
- TOPICAL
- Indication Info
- **Therapeutic Indications**
Treatment of the climacteric syndrome associated with natural or artificial menopause (estrogenic deficiency, e.g. hot flushes, night sweatings, urogenital atrophy and prevention of postmenopausal (type 1) osteoporosis).
- Contraindications
- **Contraindications**
Undiagnosed vaginal bleeding. Confirmed active venous thromboembolism (deep venous thrombosis (DVT), pulmonary embolism) within the last 2 years. A history of recurrent venous thromboembolism (VTE) or known thrombophilic disease in a patient who is not lately on anticoagulant treatment (See Special warnings and special precautions for use – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Severe hepatic disease (including Dubin-Johnson and Rotor’s syndrome). Known or suspected malignant conditions, especially breast cancer and/or endometrial cancer, if sex steroid influenced. Hypersensitivity to the constituents of the preparation.
- Atc Code
- G03CA03
- Atc Item Name
- estradiol
- Pharma Manufacturer Name
- ORION PHARMA (SG) PTE. LTD.
- Company Detail Path
- /organization/orion-pharma-sg-pte-ltd
