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Premarin Indications, Dosage, Storage, Stability - Estrogens Conjugated

Premarin Indications, Dosage, Storage, Stability - Estrogens Conjugated

INDICATIONS

Tablets

Conjugated estrogens tablets are indicated in the treatment of:

1. Moderate to severe vasomotor symptoms associated with the menopause. There is no adequate evidence that estrogens are effective for nervous symptoms or depression which might occur during menopause and they should not be used to treat these conditions.

2. Atrophic vaginitis.

3. Osteoporosis (loss of bone mass). The mainstays of prevention and management of osteoporosis are estrogen and calcium; exercise and nutrition may be important adjuncts. Estrogen replacement therapy is the most effective single modality for the prevention of osteoporosis in women. Estrogen reduces bone resorption and retards or halts postmenopausal bone loss. Case-controlled studies have shown an approximately 60-percent reduction in hip and wrist fractures in women whose estrogen replacement was begun within a few years of menopause. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen prevents further loss of bone mass but does not restore it to premenopausal levels. The lowest effective dose for prevention and treatment of osteoporosis should be utilized. (See

DOSAGE AND ADMINISTRATION

.) Women are at higher risk than men because they have less bone mass, and for several years following natural or induced menopause, the rate of bone mass decline is accelerated. Early menopause is one of the strongest predictors for the development of osteoporosis. White women are at higher risk than black women, and white men are at higher risk than black men. Women who are underweight also have osteoporosis more often than overweight women. Cigarette smoking may be an additional factor in increasing risk. Calcium deficiency has been implicated in the pathogenesis of this disease. Therefore, when not contraindicated, it is recommended that postmenopausal women receive an elemental calcium intake of 1000 to 1500 mg/day. Immobilization and prolonged bed rest produce rapid bone loss, while weight-bearing exercise has been shown both to reduce bone loss and to increase bone mass. The optimal type and amount of physical activity that would prevent osteoporosis have not been established.

4. Hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

5. Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.

6. Advanced androgen-dependent carcinoma of the prostate (for palliation only).

Injection

Intravenous conjugated estrogens are indicated in the treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology.

Vaginal Cream

Conjugated estrogens vaginal cream is indicated in the treatment of atrophic vaginitis and kraurosis vulvae.

Conjugated estrogens vaginal cream HAS NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS. (See BOXED WARNING.)

DOSAGE AND ADMINISTRATION

Tablets

For treatment of moderate to severe vasomotor symptoms and atrophic vaginitis associated with the menopause. The lowest dose 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-month to 6-month intervals.

Usual Dosage Ranges

Vasomotor Symptoms: 1.25 mg daily. If the patient has not menstruated within the last two months or more, cyclic administration is started arbitrarily. If the patient is menstruating, cyclic (e.g., three weeks on and one week off) administration is started on day 5 of bleeding.

Atrophic Vaginitis: 0.3 mg to 1.25 mg or more daily, depending upon the tissue response of the individual patient. Administer cyclically.

Hypoestrogenism Due To

Female Hypogonadism: 2.5 mg to 7.5 mg daily, in divided doses for 20 days, followed by a rest period of 10 days' duration. If bleeding does not occur by the end of this period, the same dosage schedule is repeated. The number of courses of estrogen therapy necessary to produce bleeding may vary depending on the responsiveness of the endometrium.

If bleeding occurs before the end of the 10-day period, begin a 20-day estrogen-progestin cyclic regimen with conjugated estrogens, 2.5 mg to 7.5 mg daily in divided doses, for 20 days. During the last five days of estrogen therapy, give an oral progestin. If bleeding occurs before this regimen is concluded, therapy is discontinued and may be resumed on the fifth day of bleeding.

Female Castration or Primary Ovarian Failure: 1.25 mg daily, cyclically. Adjust dosage, upward or downward, according to severity of symptoms and response of the patient. For maintenance, adjust dosage to lowest level that will provide effective control.

Osteoporosis (Loss Of Bone Mass): 0.625 mg daily. Administration should be cyclic (e.g., three weeks on and one week off).

Advanced Androgen-Dependent Carcinoma of the Prostate, for Palliation Only

1.25 mg to 2.5 mg three times daily. The effectiveness of therapy can be judged by phosphatase determinations as well as by symptomatic improvement of the patient.

Breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Suggested dosage is 10 mg three times daily for a period of at least three months.

Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Injection

Abnormal Uterine Bleeding Due to Hormonal Imbalance: One 25 mg injection, intravenously or intramuscularly. Intravenous use is preferred since more rapid response can be expected from this mode of administration.

Repeat in 6 to 12 hours if necessary. The use of conjugated estrogens intravenous for injection does not preclude the advisability of other appropriate measures.

The usual precautionary measures governing intravenous administration should be adhered to. Injection should be made SLOWLY to obviate the occurrence of flushes.

Infusion of conjugated estrogens intravenous for injection with other agents is not generally recommended. In emergencies, however, when an infusion has already been started it may be expedient to make the injection into the tubing just distal to the infusion needle. If so used, compatibility of solutions must be considered.

Compatibility of Solutions: Conjugated estrogens intravenous is compatible with normal saline, dextrose, and invert sugar solutions. IT IS NOT COMPATIBLE WITH PROTEIN HYDROLYSATE, ASCORBIC ACID, OR ANY SOLUTION WITH AN ACID pH.

Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Directions for Storage and Reconstitution

Storage Before Reconstitution: Store package in refrigerator, 2°-8° C (36°-46° F).

To Reconstitute: First withdraw air from Secule vial so as to facilitate introduction of sterile diluent. Then, wflow the sterile diluent slowly against side of Secule vial and agitate gently. DO NOT SHAKE VIOLENTLY.

Storage After Reconstitution: It is common practice to utilize the reconstituted solution within a few hours. If it is necessary to keep the reconstituted solution for more than a few hours, store the reconstituted solution under refrigeration (2°-8° C). Under these conditions, the solution is stable for 60 days, and is suitable for use unless darkening or precipitation occurs.

Vaginal Cream

Given Cyclically for Short-Term Use Only: For treatment of atrophic vaginitis, or kraurosis vulvae.

The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible.

Administration should be cyclic (e.g., three weeks on and one week off).

Attempts to discontinue or taper medication should be made at three- to six-month intervals.

Usual Dosage Range: 1/2 to 2 g daily, intravaginally, depending on the severity of the condition. Treated patients with an intact uterus should be monitored closely for signs of endometrial cancer, and appropriate diagnostic measures should be taken to rule out malignancy in the event of persistent or recurring abnormal vaginal bleeding.

Instructions for Use of Gentle Measure Applicator:

1. Remove cap from tube.

2. Screw nozzle end of applicator onto tube.

3. Gently squeeze tube from the bottom to force sufficient cream into the barrel to provide the prescribed dose. Use the marked stopping points on the applicator as a guideline to measure the correct dose.

4. Unscrew applicator from tube.

5. Lie on back with knees drawn up. To deliver medication, gently insert applicator deeply into vagina and press plunger downward to its original position.

To Cleanse: Pull plunger to remove it from barrel. Wash with mild soap and warm water.

Do not boil or use hot water.

HOW SUPPLIED

Tablets

Premarin: Each oval purple tablet contains 2.5 mg, each oval yellow tablet contains 1.25 mg, each oval white tablet contains 0.625 mg, each oval maroon tablet contains 0.625 mg, each oval green tablet contains 0.3 mg, each oval white (dye-free) tablet contains 0.625 mg. The appearance on these tablets is a trademark of Wyeth-Ayerst Laboratories.

Storage: Store at room temperature (approximately 25° C). Dispense in a well-closed container.

Injection

Each package provides: (1) One Secule vial containing 25 mg of conjugated estrogens, for injection (also lactose 200 mg, sodium citrate 12.2 mg, and simethicone 0.2 mg). The pH is adjusted with sodium hydroxide or hydrochloric acid. (2) One 5 ml ampul sterile diluent with 2% benzyl alcohol in sterile water.

Premarin Intravenous (conjugated estrogens) for injection is prepared by cryodesiccation.

Secule-registered trademark to designate a vial containing an injectable preparation in dry form.

To Reconstitute: First withdraw air from secule vial so as to facilitate introduction of sterile diluent. Then, flow the sterile diluent slowly against side of secule vial and agitate gently. DO NOT SHAKE VIOLENTLY.

Storage After Reconstitution: It is common practice to utilize the reconstituted solution within a few hours. If it is necessary to keep the reconstituted solution for more than a few hours, store the reconstituted solution under refrigeration (2-8° C). Under these conditions, the solution is stable for 60 days, and is suitable for use unless darkening or precipitation occurs.

Vaginal Cream

Premarin Vaginal Cream: Each gram contains 0.625 mg conjugated estrogens.

Combination Package: Each contains Net Wt. 1 ½ oz (42.5 g) tube with one plastic applicator calibrated in ½ g increments to a maximum of 2 g.

Refill Package: Each contains Net Wt. 1 ½ oz (42.5 g) tube.

Storage: Store at room temperature (approximately 25° C).

REFERENCES

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