Adult Dosing

Vasomotor symptoms associated with the menopause

• Evamist: Initial 1 spray 1.53 mg/day; Max: 3 spray/day, To be applied on the inner surface of forearm
• Divigel: Start 0.25 g/day; Max: 1 g/day. To be applied right or left upper thigh on the surface area of 5 by 7 inches
• Elestrin: Start 0.87 g/day; titrate dose as per therapeutic response. To be applied on upper arm
• Estrogel: 1.25 g/day. To be applied on arm
• Estrasorb: 3.48 g/day. To apply to the thigh and calf
• Alora, Estraderm: 0.05 mg/day x 2 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Climara: 0.025 mg/day x 1 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Vivelle, Vivelle-dot, Minivelle : 0.0375 mg/day x 2 qwk. To be applied on lower abdomen and buttocks

Vulvar and vaginal atrophy associated with the menopause

• Estrogel: 1.25 g/day, to be applied on arm
• Alora, Estraderm: 0.05 mg/day x 2 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Climara: 0.025 mg/day x 1 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Vivelle, Vivelle-dot: 0.0375 mg/day x 2 qwk. To be applied on lower abdomen and buttocks

Postmenopausal osteoporosis:

• Alora: 0.025 mg/day x 2 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Climara: 0.025 mg/day x 1 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Estraderm: 0.05 mg/day x 2 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Menostar: 0.014 mg/day x 1 q wk. To applied on the lower abdomen
• Vivelle, Vivelle-dot: 0.025 mg/day x 2 qwk. To be applied on lower abdomen and buttocks

Hypoestrogenism due to hypogonadism, castration or primary ovarian failure

• Alora, Estraderm: 0.05 mg/day x 2 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Climara: 0.025 mg/day x 1 qwk. To applied on the lower abdomen or the upper quadrant of the buttocks or outer aspect of the hip
• Vivelle, Vivelle-dot: 0.0375 mg/day x 2 qwk. To be applied on lower abdomen and buttocks

• Discontinue or taper medicine at 3-6 month interval
• Add progestin therapy in postmenopausal women with intact uterus
• Administer in a cyclic regimen 3 wks on and 1 wk off

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

Alora, Climara, Divigel, Elestrin, Estraderm, Estrogel, Evamist, Estrasorb, Minivelle, Vivelle, Vivelle-dot

• Moderate to severe vasomotor symptoms associated with the menopause

Alora, Climara, EstroGel, Estraderm, Vivelle, Vivelle-dot

• Vulvar and vaginal atrophy associated with the menopause

Alora, Climara, Estraderm, Vivelle, Vivelle-dot

• Hypoestrogenism due to hypogonadism, castration or primary ovarian failure

Alora, Climara, Estraderm, Menostar, Vivelle, Vivelle-dot

• Postmenopausal osteoporosis prevention

• Hypersensitivity to any of the ingredients of the product
• Undiagnosed vaginal bleeding
• Active or history of breast cancer
• Estrogen-dependent neoplasia
• Active or history of deep vein thrombosis or pulmonary embolism
• Active or recent arterial thromboembolism within 12 months
• Liver dysfunction/diseases
• Known or suspected pregnancy
• Hx of anaphylactic reaction or angioedema to estradiol
• Hx of protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders

• Estrogen-Alone Therapy
• Estrogen increases the risk of endometrial cancer. Progestin with estrogen therapy may decrease risk of endometrial hyperplasia, a condition which may precedes endometrial cancer. Monitor closely all the women taking estrogen therapy; use adequate diagnostic measures like endometrial sampling to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding
• As per the Women's Health Initiative (WHI) estrogen-alone substudy, oral conjugated estrogens 0.625 mg alone, relative to placebo increased the risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment
• As per the e WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI, oral conjugated estrogens 0.625 mg alone, relative to placebo increased the risk of developing probable dementia in postmenopausal women (=<65 years of age) during 5.2 years of treatment
• Lowest effective doses of estrogens with or without progestins for the shortest duration are recommended to minimize the risks and maximize the benefit

• Estrogen Plus Progestin Therapy
• Estrogen and progestin combination therapy is not indicated for prevention of cardiovascular disease or dementia
• As per the WHI estrogen plus progestin substudy, oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo increased the risk of myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment. The study also demonstrated an increased risk of invasive breast cancer
• As per the WHIMS estrogen plus progestin ancillary study of the WHI, oral conjugated estrogens 0.625 mg combined with medroxyprogesterone acetate 2.5 mg, relative to placebo increased the risk of developing probable dementia in postmenopausal women (=<65 years of age) during 4 years of treatment
• Lowest effective doses of estrogens with or without progestins for the shortest duration are recommended to minimize the risks and maximize the benefit

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Estrogen and estrogen/progestin therapy increases the risk of cardiovascular events like myocardial infarction, DVT and stroke, discontinue the drug immediately if any of these event suspected [US Black Box warning]
• Risk of DVT and pulmonary embolism increases with estrogen alone therapy, discontinue the drug for at least 4-6 weeks before surgery associated with risk of thromboembolism or during prolonged immobilization
• Unopposed use of estrogens in women with intact uteri increases the risk of endometrial cancer [US Black Box warning]
• Estrogen plus progestin therapy in postmenopausal women increases the risk of breast cancer [US Black Box Warning]
• Perform breast examination and mammogram yearly, based on patient age, risk factors and prior mammogram results
• Estrogen and estrogen/progestin therapy increases the risk of dementia in postmenopausal women 65 years of age and older [US Black Box warning]
• Increases the risk of gallbladder diseases by 2 to 4 fold in postmenopausal women receiving estrogen therapy
• Estrogen therapy causes severe hypercalcemia in patients with breast cancer and bone metastases. Discontinue the therapy if hypercalcemia occurs, and provide appropriate measures
• Retinal vascular thrombosis occurs in patients receiving estrogens. Discontinue the drug if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia or migraine. Permanently discontinue if papilledema or retinal vascular lesions is seen on examination
• Estrogen use, causes increases in blood pressure, monitor BP at regular interval
• Use of progestin with estrogen in continuous regimen lowers the incidence of endometrial hyperplasia, than would be induced by estrogen treatment alone. However there is possible increased risk of breast cancer associated with the use of progestins with estrogens compared to estrogen-alone regimens
• Estrogen therapy elevates the plasma triglycerides in patients with preexisting hypertriglyceridemia, leading to pancreatitis and other complications
• Use cautiously in patients with a history of cholestatic jaundice associated with past estrogen use or with pregnancy and in the case of recurrence discontinue the drug
• Estrogen administration causes increased thyroid-binding globulin (TBG) levels. Patients on thyroid hormone replacement therapy receiving estrogen require increased doses of their thyroid replacement therapy. Monitor thyroid function regularly to maintain free thyroid hormone levels in an acceptable range
• Estrogen alone therapy in exacerbate endometriosis in post-hysterectomy, consider addition of progestin to the therapy
• Estrogen therapy may aggravate symptoms of angioedema in women with hereditary condition
• Estrogen causes fluid retention, use cautiously in patients with conditions like asthma, epilepsy, migraine, and cardiac or renal dysfunction
• The WHI estrogen plus progestin substudy has demonstrated a statistically non-significant increased risk of ovarian cancer

Cautions: Use cautiously in

• Cardiovascular diseases
• Hypertension
• Hypertriglyceridemia
• History of Cholestatic Jaundice
• Hypothyroidism
• Asthma
• Diabetes mellitus
• Epilepsy
• Migraine
• Porphyria
• Systemic lupus erythematosus
• Hepatic hemangiomas
• Endometriosis
• Severe hypocalcemia
• Gallbladder Disease
• Obesity
• Patients >65 yrs
• Tobacco use

Supplemental Patient Information

• Advise patients to avoid fire, flame or smoking until the spray/gel has dried

Pregnancy Category:X

Breastfeeding: Limited data on the use of estradiol during breastfeeding indicates that the amount transferred into breastmilk is influenced by route of administration and dosage form. Transdermal maternal doses of up to 100 mcg daily produce low levels in milk and is not expected to cause any adverse effects in breastfed infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 December 2010). Though this drug has found to be compatible with breastfeeding, withdrawal bleeding may occur after drug is withdrawn based upon data from AAP Policy Guidelines (available at http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/3/776)As per manufacturer's data, estrogen administration during breastfeeding interferes with lactation. Detectable amount is secreted in breast milk, use cautiously when estradiol is administered to a nursing woman.

• GU: Abnormal vaginal bleeding, breakthrough bleeding, spotting, dysmenorrhea, abnormal withdrawal bleeding or flow, vaginitis, leukorrhea, ovarian cancer, endometrial hyperplasia, endometrial cancer, breast tenderness, breast enlargement, nipple discharge, galactorrhea, fibrocystic breast changes; breast cancer, change in libido
• CV: Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke, hypertension, increased triglycerides
• GI: Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice, gallbladder disease, pancreatitis, enlargement of hepatic hemangiomas
• DERM: Chloasma or melasma, erythema multiforme, erythema nodosum, hemorrhagic eruption, hirsutism, pruritus, rash, hair loss, urticaria, angioedema, redness and irritation at the application site
• EENT: Retinal vascular thrombosis, steepening of corneal curvature, intolerance to contact lenses
• CNS: Headache, migraine, dizziness, mental depression, chorea, nervousness, mood disturbances, irritability, exacerbation of epilepsy, dementia
• METABOLIC: Hypocalcemia
• MISC: Weight gain, prophyria, carbohydrate intolerance, edema, anaphylactic reactions

• Estrogen; responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. By negative feedback mechanism regulates the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH)
• Metabolized by liver; CYP450: 3A4. Also undergoes enterohepatic recirculation
• Renally excreted as conjugates
• Half-life: 36 hrs
• Divigel: 10 hrs
• Alora: 1.75 +/-2.87 hrs
• Estraderm: approx 1 hr
• Estrogel: 36 hrs
• Vivelle: 4.4 +/- 2.3 hrs
• Vivelle-dot: 5.9 to 7.7 hrs

US Trade Name(s)

• Alora
• Climara
• Divigel
• Elestrin
• Estraderm
• Estrogel
• Evamist
• Estrasorb
• Menostar
• Minivelle
• Vivelle
• Vivelle-dot

US Availability

estradiol(generic)

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.06 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Alora

• TDP: 0.025 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Climara

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.06 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Vivelle-dot

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estraderm, Vivelle

• TDP: 0.05 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Menostar

• TDP: 0.014 mg/24 hrs

Divigel

• GEL: 0.1 % (0.25, 0.5, 1 g/ packet)

Elestrin

• GEL: 0.06 % (0.87 g/metered-dose pump)

Estrogel

• GEL: 0.06 % (1.25 g/metered-dose pump)

Evamist

• SPRAY: 1.53 mg/spray

Estrasorb

• EMULSION: 1.74 g/pouch

Minivelle

• TDP: 0.0375 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Canadian Trade Name(s)

• Climara
• Estraderm
• Etradot
• Estrogel
• Oesclim

Canadian Availability

estradiol(generic)

• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Climara

• TDP: 0.025 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estraderm

• TDP: 0.025 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estradot, Oesclim

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estrogel

• GEL: 0.06 % (1.25 g/ metered-actuation)

UK Trade Name(s)

• Elleste solo MX
• Estraderm MX
• Estraderm TTS
• Estradot
• Evorel
• Fematrix
• Fem seven
• Oestrogel
• Progynova
• Sandrena

UK Availability

Elleste Solo MX, Fematrix

• TDP: 0.04 mg/24 hrs
• TDP: 0.08 mg/24 hrs

Estraderm MX, Evorel

• TDP: 0.025 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estraderm TTS

• TDP: 0.025 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estradot

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Fem seven

• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Progynova, Sandrena

• TDP: 0.05 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Oestrogel

• GEL: 0.06 %

Australian Trade Name(s)

• Climara
• Estraderm
• Estraderm MX
• Estradot
• Femtran
• Sandrena gel

Australian Availability

Climara, Estraderm MX

• TDP: 0.025 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estraderm, Femtran

• TDP: 0.025 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Estradot

• TDP: 0.025 mg/24 hrs
• TDP: 0.0375 mg/24 hrs
• TDP: 0.05 mg/24 hrs
• TDP: 0.06 mg/24 hrs
• TDP: 0.075 mg/24 hrs
• TDP: 0.1 mg/24 hrs

Sandrena gel

• GEL: 0.1% (1g/ sachet)

[Outline]

Endocrine/Metabolic

Sex Hormones

Estrogens

Obstetrics/Gynecology

Sex Hormones

Estrogens

Pricing data from www.DrugStore.com in U.S.A.

• Vivelle-Dot 0.075 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $71.99
  24 24hr = $195.98
• Estraderm 0.1 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $77.99
  24 24hr = $204.96
• Vivelle-Dot 0.05 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $71.99
  24 24hr = $195.98
• Estrogel 0.75 MG/1.25 GM (0.06%) GEL [Bottle] (ASCEND THERAPEUTICS)
  50 (0.06%) = $89.99
  150 (0.06%) = $252.96
• Estrasorb 4.35 MG/1.74GM EMUL [Packet] (GRACEWAY PHARMACEUTICALS)
  111.36 1.74gm = $69.98
  335.82 1.74gm = $189.98
• Climara 0.05 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $95.99
  12 24hr = $272.92
• Climara 0.1 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $97.99
  12 24hr = $272.98
• Divigel 0.25 MG/0.25GM GEL [Box] (UPSHER-SMITH)
  30 0.25gm = $85.99
  90 0.25gm = $239.96
• Climara 0.075 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $94.99
  12 24hr = $264.96
• Divigel 1 MG/GM GEL [Box] (UPSHER-SMITH)
  30 gm = $84.99
  90 gm = $235.96
• Alora 0.1 MG/24HR PTTW [Box] (WATSON LABS)
  8 24hr = $70.99
  24 24hr = $197.97
• Divigel 0.5 MG/0.5GM GEL [Packet] (UPSHER-SMITH)
  30 0.5gm = $86.99
  90 0.5gm = $234.97
• Vivelle-Dot 0.1 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $72.99
  24 24hr = $195.98
• Climara 0.025 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $94.99
  12 24hr = $264.96
• Climara 0.06 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $97.99
  12 24hr = $272.92
• Vivelle-Dot 0.025 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $75.99
  24 24hr = $204.96
• Alora 0.05 MG/24HR PTTW [Box] (WATSON LABS)
  8 24hr = $67.83
  24 24hr = $186.53
• Alora 0.08 MG/24HR PTTW [Box] (WATSON LABS)
  8 24hr = $69.96
  24 24hr = $202.46
• Climara 0.0375 MG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $97.99
  12 24hr = $272.92
• Menostar 14 MCG/24HR PTWK [Box] (BAYER HEALTHCARE PHARMA)
  4 24hr = $97.99
  12 24hr = $275.98
• Vivelle-Dot 0.0375 MG/24HR PTTW [Box] (NOVARTIS)
  8 24hr = $72.99
  24 24hr = $198.97
• Evamist 1.53 MG/SPRAY SOLN [Bottle] (THER RX)
  8.1 spray = $89.99
  16.2 spray = $177.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.