Premicon 0.625 mg (Tablet)

Indications

• Moderate-to-severe vasomotor symptoms associated with estrogen deficiency
• Prevention and management of osteoporosis associated with estrogen deficiency
• Decrease of the risk of coronary heart disease and its associated mortality in postmenopausal women
• Atrophic vaginitis and atrophic arthritis
• Female hypoestrogenism

Description

• Relief of vasomotor symptoms like hot flushes
• Prevention of osteoporosis and bone loss in postmenopausal women
• Cardiovascular benefit in postmenopausal women
• Treatment of atrophic vaginitis and atrophic arthritis
• Management of female hypoestrogenism

Pharmacology

• Mixture of estrogens from natural sources
• Promotes development and maintenance of female urogenital system and secondary sex characteristics
• Promotes growth of vagina, uterus, and fallopian tubes
• Contributes to shaping of the skeleton and maintenance of tone and elasticity of urogenital structures

Dosage & Administration

• 0.625 mg daily for osteoporosis
• 0.625 mg-1.25 mg daily for cardiovascular benefit
• 0.3 mg-1.25 mg daily for female hypoestrogenism
• Continuous or cyclic administration
• Individualized dose for optimum patient response

Interaction

• Rifampin decreases estrogenic activity during concomitant use

Contraindications

• Known or suspected cancer of the breast
• Known or suspected estrogen-dependent neoplasia
• Known or suspected pregnancy
• Undiagnosed abnormal genital bleeding
• Active thrombophlebitis or thromboembolic disorders
• Hypersensitivity to any of the components

Side Effects

• Genitourinary system: Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea
• Breasts: Tenderness, enlargement, secretion
• Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating, cholestatic jaundice
• Skin: Chloasma or melasma, alopecia, rash
• Eyes: Steepening of the corneal curvature, intolerance to contact lenses

Pregnancy & Lactation

• Administration to nursing mothers should be done only when clearly necessary

Precautions & Warnings

• Complete medical and family history should be obtained prior to therapy
• Physical examinations should include special reference to blood pressure, breasts, abdomen, and pelvic organs
• Patients with a uterus should be monitored for signs of endometrial hyperplasia or endometrial cancer
• Monitoring should include endometrial sampling when concurrent progestogen therapy is used in women with a uterus
• Patients may develop undesirable manifestations of excessive estrogenic stimulation
• Abnormal vaginal bleeding requires diagnostic measures
• Careful observation for conditions influenced by fluid retention
• Use with caution in patients with metabolic bone diseases associated with hypercalcemia
• Patients should be advised that the resumption of menses is not indicative of fertility

Overdose Effects

• Symptoms may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue

Therapeutic Class

• Female Sex hormones

Storage Conditions

• Store in a cool, dry place protected from light and moisture
• Temperature below 25°C

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• Estracon 0.625 mg (Tablet) - renata-limited