Estromarin®

Estrogen may be taken without regard to meals.

For treatment of moderate to-severe vasomotor symptoms and/or moderate-to-severe symptoms of vulvar and vaginal atrophy associated with the menopause:

When prescribing solely for the treatment of moderate-to-severe symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Patients should be treated with the lowest effective dose. Generally, women should be started at 0.3 mg estrogen daily at the same time. Subsequent dosage adjustment may be made based upon the individual patient response. This dose should be periodically reassessed by the healthcare provider. (for example, every 3 to 6 months) Estrogen therapy may be given continuously, with no interruption in therapy, or in cyclical regimens (regimens such as 25 days on drug followed by five days off drug).

If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your normal schedule. Do not take 2 doses at the same time.

Contraindications:

-Angioedema or anaphylactic reaction to estrogen conjugated A synthetic or any component of the formulation.

-Undiagnosed abnormal genital bleeding; DVT or PE (current or history of).

-Active or history of arterial thromboembolic disease (eg, stroke, MI)

-Breast cancer (known, suspected or history of).

-Estrogen-dependent tumor (known or suspected)

-Hepatic impairment or disease.

-Antithrombin deficiency or other known thrombophilic disorders;

-Pregnancy

Interactions:

Inducers of CYP3A4, such as St. John’sWort (Hypericumperforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens.

Inhibitors of CYP3A4, such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice, may increase plasma concentrations of estrogens and may result in side effects.

Pregnancy and Lactation:

Estrogen is contraindicated for use during pregnancy.

Administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when estrogen is administered to a nursing woman.

Warning and Precaution:

• Use is contraindicated in patients with known or suspected breast cancer. Estrogen use may also lead to severe hypercalcemia in patients with breast cancer and bone metastases; discontinue estrogen if hypercalcemia occurs.
• The risk of endometrial cancer appears to be dose and duration dependent; risk appears to be greatest with use ≥5 years and may persist following discontinuation of therapy.
• Endometriosis: Estrogens may exacerbate endometriosis.
• Lipid effects: Estrogen compounds are generally associated with lipid effects such as increased HDL-cholesterol and decreased LDL-cholesterol. Triglycerides may also be increased in women with preexisting hypertriglyceridemia; discontinue if pancreatitis occurs.
• Ovarian cancer: Postmenopausal estrogens with or without progestins may increase the risk of ovarian cancer; however, the absolute risk to an individual woman is small.
• Use with caution in patients with Hepatic dysfunction, Renal impairment, Migraine, Epilepsy, Asthma, Cardiovascular disease, Gallbladder disease, Hereditary angioedema.
• Estrogens should be discontinued at least 4 to 6 weeks prior to elective surgery associated with an increased risk of thromboembolism or during periods of prolonged immobilization.

Adverse Reactions:

Incidence>10%:

Headache, paresthesia dizziness, pain, abdominal pain, nausea, mastalgia, endometrial hyperplasia, uterine hemorrhage, Infection, back pain,upper respiratory tract infection.

Incidence < 10%:

Anxiety, hypertonia, weight gain, dyspepsia, vomiting, constipation, diarrhea, vaginitis, leg cramps, Tenderness and enlargement of breasts.

Storage:

Store below 30 and protect from light and moisture.