Estradiol + Progesterone

Estradiol + Progesterone is a combination capsule indicated for use during continuous combined Hormone Replacement Therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses.

Each soft gelatin capsule contains Estradiol Hemihydrate BP equivalent to Estradiol 1 mg and Micronized Progesterone BP 100 mg.

• Estrogen deficiency symptoms: Used for hot flushes, night sweats and mood changes in postmenopausal women.
• Osteoporosis prevention: Used for prevention of bone loss in postmenopausal women.

Drugs for menopausal symptoms: Hormone replacement therapy, Female Sex hormones

Estrogen + Progestin

Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues. The addition of progesterone opposes the development of endometrial hyperplasia.

Estradiol is an estrogen that helps relieve menopause symptoms. Progesterone helps prevent endometrial hyperplasia.

Adult Dose:

• Take a single capsule orally each evening with food.

Take a single capsule orally each evening with food.

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose.

Common Side Effects:

• Alopecia (hair loss)
• Nausea
• Abdominal pain
• Headache
• Fatigue
• Flatulence
• Dizziness
• Vaginal hemorrhage
• Vaginal discharge
• Uterine spasm
• Pelvic pain
• Breast pain

Precautions:

• Blood pressure should be monitored with HRT use.
• Estrogens with or without progestins may cause fluid retention; caution in cardiac or renal dysfunction or asthma.
• Patients who develop visual disturbances, classical migraine, transient aphasia, paralysis or loss of consciousness should discontinue medication.

Contraindications:

• Hypersensitivity
• Liver dysfunction or disease (until LFTs normal)
• History of estrogen-dependent or progestogen-dependent malignant neoplasia
• Endometrial hyperplasia
• Undiagnosed abnormal genital bleeding
• Pregnancy
• Breastfeeding
• History of arterial thromboembolic disease
• Classical migraine

Drug Interactions:

• CYP 3A4 inhibitors (grapefruit juice): May increase plasma concentrations of estrogens and may result in side effects.

Food Interactions: Food intake may affect drug exposure. Caution with grapefruit juice.

Use in Pregnancy: Not recommended during pregnancy, labor or delivery.

Use in Lactation: Not recommended for mothers who are breastfeeding.

Pediatric Use: Not studied; not recommended.

Geriatric Use: Not studied; not recommended.

Renal Impairment: Use with caution in women with renal dysfunction.

Hepatic Impairment: Contraindicated in liver dysfunction or disease (until LFTs normal).

Overdose: Overdose may be expressed by feeling sick, breast discomfort, fluid retention, bloating and vaginal bleeding. Other signs: sadness, tiredness, acne and excess hair growth.

Storage: Do not store above 25 degree C. Protect from light. Keep out of reach of children.

Estradiol + Progesterone