Depo-Estradiol (Estradiol Cypionate) - Indications and Dosage

INDICATIONS AND USAGE

DEPO-Estradiol Injection is indicated in the treatment of:

1. Moderate to severe vasomotor symptoms associated with the menopause.
2. Hypoestrogenism due to hypogonadism.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Warming and shaking the vial should redissolve any crystals that may have formed during storage at temperatures lower than recommended.

DEPO-Estradiol INJECTION IS FOR INTRAMUSCULAR USE ONLY.

When estrogen is prescribed for a woman with a uterus, progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (e.g., 3-month to 6-month intervals) to determine if treatment is still necessary. (See BOXED WARNINGS and WARNINGS.) For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

1. Short-term cyclic use for treatment of moderate to severe vasomotor symptoms, vulval and vaginal atrophy associated with the menopause, the lowest dose and regimen that will control symptoms should be chosen and medication should be discontinued as promptly as possible.
    
   Attempts to discontinue or taper medication should be made at 3- to 6-month intervals. The usual dosage range is 1 to 5 mg injected every 3 to 4 weeks.
2. For treatment of female hypoestrogenism due to hypogonadism 1.5 to 2 mg injected at monthly intervals.

HOW SUPPLIED

DEPO-Estradiol Injection is available in the following concentration containing per mL:

5 mg estradiol cypionate; also 5.4 mg chlorobutanol anhydrous (chloral deriv.) added as preservative; in 913 mg cottonseed oil— in 5 mL vials, NDC 0009-0271-01.

WARNING: Chlorobutanol may be habit forming.

Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].