Monograph Details
|
|
Ob/Gyn
> Menopause and HRT
|
|
DIVIGEL |
| Manufacturer |
|
Upsher-Smith Laboratories, Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Estrogen |
| Generic Name |
|
Estradiol 0.25mg, 0.5mg, 1mg; per packet; topical gel. |
| Indications |
|
Moderate to severe vasomotor menopausal symptoms. |
| Children |
|
Not applicable. |
| Adults |
|
Apply contents of 1 packet once daily to 5" x 7" area of dry skin on upper thigh; alternate thighs daily. Initially 0.25g/day; individualize. Allow gel to dry before dressing; do not wash area for at least 1 hr after application; wash hands after use. |
| Contraindications |
|
Undiagnosed abnormal genital bleeding. Breast or other estrogen-dependent neoplasias. Hypercoagulability. Thrombophlebitis or thromboembolic disorders. Hepatic dysfunction or disease. Pregnancy. |
| Precautions |
|
Patients with intact uterus should receive a progestin to avoid endometrial hyperplasia. Do initial complete physical and repeat annually (include BP, mammogram, Pap smear). Reevaluate periodically; use lowest effective dose. Endometriosis. Severe hypocalcemia. Bone disease associated with hypercalcemia. Discontinue if jaundice or hypercalcemia occurs, and during immobilization or at least 2 weeks before surgery associated with increased risk of thromboembolism. Hypertriglyceridemia. Porphyria. Hepatic hemangioma. SLE. Discontinue if sudden visual changes occur pending evaluation. Product is flammable. Nursing mothers. |
| Interactions |
|
May be potentiated by CYP3A4 inhibitors. May be antagonized CYP3A4 inducers. May be affected by application of sunscreen. |
| Adverse Reactions |
|
Hypertension, edema, chloasma, mastodynia, headache, glucose intolerance, vaginitis, changes in bleeding patterns, weight changes, intolerance to contact lenses, increased risk of gallbladder disease, thromboembolic events. |
| How Supplied |
|
Packets—30 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
