MINIVELLE Rx

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MINIVELLE

Bone disorders
Menopause and HRT
Only 4 drugs may be compared at once

Generic Name and Formulations:

Estradiol 0.025mg/day, 0.0375mg/day, 0.05mg/day, 0.075mg/day, 0.1mg/day; transdermal patch.

Select therapeutic use:

Indications for MINIVELLE:

Prevention of postmenopausal osteoporosis.

Limitations Of use:

Limitations of use: only consider for women at significant risk of osteoporosis and should carefully consider non-estrogen medications.

Adult:

Apply to clean, dry area on the lower abdomen or buttocks (not to breasts or waist); rotate application sites. Use lowest effective dose and for the shortest duration. Initially one 0.025mg/day patch twice weekly (every 3–4 days); adjust dose as necessary. Reevaluate periodically.

Children:

Not studied.

Contraindications:

Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy (Cat.X).

Warnings/Precautions:

Increased risk of cardiovascular disorders. Endometrial or breast cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. History of hypertriglyceridemia. Hepatic impairment. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Caution in asthma, diabetes, epilepsy, migraines, porphyria, SLE, hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice, cardiac events, severe hypercalcemia, pancreatitis, sudden partial or complete vision loss, sudden onset of proptosis, diplopia, or migraine occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.

Interactions:

May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice). May interefere with lab tests (eg, aPTT/PTT, thyroid, other binding proteins, cholesterol, glucose tolerance).

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, intermenstrual bleeding.

How Supplied:

Patches—8

MINIVELLE 8 patches of 0.1mg packages (Qty:1)

appx. price $162.00

Indications for MINIVELLE:

Moderate-to-severe vasomotor symptoms due to menopause.

Adult:

Apply to clean, dry area on the lower abdomen or buttocks (not to breasts or waist); rotate application sites. Use lowest effective dose and for the shortest duration. Initially one 0.0375mg/day patch twice weekly (every 3–4 days). Reevaluate periodically. Attempt to taper or discontinue at 3–6 month intervals.

Children:

Not studied.

Contraindications:

Undiagnosed abnormal genital bleeding. Known, suspected or history of breast cancer. Known or suspected estrogen-dependent neoplasia. Active DVT, PE or history of. Active arterial thromboembolic disease or history of. Hepatic impairment. Known protein C, protein S, or antithrombin deficiency or other known thrombophilic disorders. Pregnancy (Cat.X).

Warnings/Precautions:

Increased risk of cardiovascular disorders. Endometrial or breast cancer. Risk of probable dementia in women >65yrs of age. Gallbladder disease. Bone disease associated with hypercalcemia. Visual abnormalities. Consider the addition of a progestin in patients with an intact uterus to avoid endometrial hyperplasia. History of hypertriglyceridemia. Hepatic impairment. Monitor thyroid function. Conditions aggravated by fluid retention. Hypoparathyroidism. Endometriosis. Hereditary angioedema. Caution in asthma, diabetes, epilepsy, migraines, porphyria, SLE, hepatic hemangiomas. Do initial complete physical and repeat yearly (include Pap smear, mammogram, BP). Discontinue if jaundice, cardiac events, severe hypercalcemia, pancreatitis, sudden partial or complete vision loss, sudden onset of proptosis, diplopia, or migraine occurs. Discontinue at least 4–6 weeks before surgery type associated with increased risk of thromboembolism or during prolonged immobilization. Nursing mothers.

Interactions:

May be antagonized by CYP3A4 inducers (eg, phenobarbital, carbamazepine, rifampin, St. John’s wort). May be potentiated by CYP3A4 inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir, and grapefruit juice). May interefere with lab tests (eg, aPTT/PTT, thyroid, other binding proteins, cholesterol, glucose tolerance).

Pharmacological Class:

Estrogen.

Adverse Reactions:

See full labeling. Headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, intermenstrual bleeding.

How Supplied:

Patches—8

MINIVELLE 8 patches of 0.1mg packages (Qty:1)

appx. price $162.00