Empeea Uses

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What is Empeea?

Empeea injection is used to prevent pregnancy. It is a birth control method that works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective than birth control pills. Discuss your options for birth control with your doctor.

Empeea does not prevent AIDS or other sexually transmitted diseases. It will not help as emergency contraception, such as after unprotected sexual contact.

Empeea injection is also used with other medicines to help relieve symptoms of inoperable, recurrent, and metastatic (cancer that has already spread) endometrial or kidney cancer.

Empeea is to be administered only by or under the immediate supervision of your doctor.

Empeea indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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depo-subQ Empeea (Empeea acetate) 104 is indicated for the prevention of pregnancy in women of child bearing potential.

depo-subQ Empeea (Empeea acetate) 104 also is indicated for management of endometriosis-associated pain.

In considering use for either indication, the loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use depo-subQ Empeea 104 long-term.

Contraception Studies

In three clinical studies, no pregnancies were detected among 2,042 women using deposubQ Empeea 104 for up to 1 year. The Pearl Index pregnancy rate in women who were less than 36 years old at baseline, based on cycles in which they used no other contraceptive methods, was 0 pregnancies per 100 women-years of use (upper 95% confidence interval = 0.25).

Pregnancy rates for various contraceptive methods are typically reported for only the first year of use and are shown in Table 2.

Table 2 : Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year: United States

Favorable Response = reduction in severity of symptom or sign of ≥ 1 point on a scale of 0 to 3, as compared to baseline

Additionally, scores from each of the five categories were combined, with the total (composite score) considered a global measurement of overall disease improvement. For subjects with baseline scores for each of the 5 categories, a mean decrease of 4 points relative to baseline was considered a clinically meaningful improvement. Across both studies, for both treatment groups, the mean changes in the composite score met the protocol-defined criterion for improvement.

In the clinical trials, treatment with depo-subQ Empeea (Empeea acetate) 104 was limited to six months. Data on the persistence of benefit with longer treatment are not available.

Subjects recorded daily the occurrence and severity of hot flushes. Of the depo-subQ Empeea (Empeea acetate) 104 users, 28.6% reported experiencing moderate or severe hot flushes at baseline, 36.2% at month 3, and 26.7% at month 6. Of the leuprolide users, 32.8% reported experiencing moderate or severe hot flushes at baseline, 74.2% at month 3, and 68.5% at month 6.

How should I use Empeea?

Use Empeea injectable suspension (subcutaneous) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Empeea injectable suspension (subcutaneous).

Uses of Empeea in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Abnormal uterine bleeding (tablet): Treatment of abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.

Amenorrhea, secondary (tablet): Treatment of secondary amenorrhea due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer.

Contraception (104 mg per 0.65 mL and 150 mg/mL injection): Prevention of pregnancy in females of reproductive potential.

Endometrial hyperplasia prevention (tablet): Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal persons receiving daily oral conjugated estrogens 0.625 mg. Note: Due to safety considerations, when a progesterone is needed, use of micronized progesterone is preferred over Empeea acetate (AACE [Goodman 2011]; AACE/ACE [Cobin 2017])

Endometrial carcinoma (400 mg/mL injection) (100 mg tablet [Canadian product]): Adjunctive therapy and/or palliative treatment of inoperable, recurrent, and/or metastatic endometrial carcinoma.

Endometriosis (104 mg/0.65 mL injection): Management of endometriosis-associated pain.

Off Label Uses

Abnormal uterine bleeding, acute

Data from a randomized, open-label clinical study support the use of oral Empeea in the treatment of acute uterine bleeding in nonpregnant, hemodynamically stable premenopausal women requiring emergent medical intervention. Additional data may be necessary to further define the role of Empeea in the management of this condition.

Empeea description

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Empeea contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Empeea acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether and insoluble in water.

Empeea acetate is pregn-4-ene-3,20-dione,17-(acetyloxy)-6-methyl-,(6α).

Empeea dosage

Empeea Dosage

Generic name: Empeea ACETATE 2.5mg

Dosage form: tablet

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Secondary Amenorrhea

Empeea tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of Empeea daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing Empeea therapy.

Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology

Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of Empeea may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of Empeea daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with Empeea. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with Empeea.

Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens

When estrogen is prescribed for a postmenopausal woman with a uterus, a 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 re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary. 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.

Empeea tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle.

Patients should be started at the lowest dose.

The lowest effective dose of Empeea has not been determined.

More about Empeea (Empeea)

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Other formulations

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Empeea interactions

See also:
What other drugs will affect Empeea?

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Aminoglutethimide administered concomitantly with DEPO-Empeea Sterile Aqueous Suspension may significantly depress the serum concentrations of Empeea acetate. DEPO-Empeea users should be warned of the possibility of decreased efficacy with the use of this or any related drugs.

In vitro

Empeea acetate is metabolized primarily by hydroxylation via the CYP3A4. Though no formal drug interaction trials have been conducted, concomitant administration of strong CYP3A inhibitors is expected to increase concentrations of Empeea acetate, whereas the concomitant administration of strong CYP3A inducers is expected to decrease Empeea acetate concentrations. Therefore, coadministration with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St. John's Wort) should be avoided.

Laboratory Test Interactions

The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including DEPOPROVERA Sterile Aqueous Suspension:

  1. Plasma and urinary steroid levels are decreased (e.g. progesterone, estradiol, pregnanediol, testosterone, cortisol).
  2. Gonadotropin levels are decreased.
  3. Sex-hormone binding globulin concentrations are decreased.
  4. Protein bound iodine and butanol extractable protein bound iodine may increase. T3 uptake values may decrease.
  5. Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase.
  6. Sulfobromophthalein and other liver function test values may be increased.
  7. The effects of Empeea acetate on lipid metabolism are inconsistent. Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

Empeea side effects

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What are the possible side effects of Empeea?

Applies to Empeea: oral tablet

Other dosage forms:

As well as its needed effects, Empeea (the active ingredient contained in Empeea) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Empeea, check with your doctor immediately:

Incidence not known:

Minor Side Effects

Some Empeea side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known:

Empeea contraindications

See also:
What is the most important information I should know about Empeea?

Known hypersensitivity to Empeea acetate or to any other ingredients of Empeea.

Undiagnosed vaginal bleeding; known, suspected or history of breast carcinoma; previous idiopathic or current venous thromboembolism (deep vein thrombosis, pulmonary embolism); active or recent (within the past year) arterial thromboembolic disease (eg, angian, myocardial infarction); known liver dysfunction or disease; missed abortion; known or suspected pregnancy.

Thrombophlebitis, thromboembolic disorders and where there is a high risk of developing such manifestations (presence or history of arterial fibrillation, valvular disorders, endocarditis, heart failure, thromboembolic ishcaemic attack, cerebral infarction; atherosclerosis; immediate post-surgery period); hypercalcaemia in patients with osseous metastases, metrorrhagia.

Progestogens are known to be porphyrogenic. Patients with history of attacks or aged <30 are at greatest risk of an acute attack while on progesterone treatment. A careful assessment of potential benefit should be made where this risk is present.

Use in pregnancy: Empeea acetate is contraindicated in women who are pregnant. If Empeea acetate is used during pregnancy, or if the patient becomes pregnant while using Empeea, the patient should be apprised of the potential hazard to the fetus.

Some reports suggest an association between intrauterine exposure to progestational drugs in the 1st trimester of pregnancy and genital abnormalities in male and female fetuses.

Infants from unintentional pregnancies that occur 1-2 months after injection of Empeea acetate injectable suspension may be at an increased risk of low birth weight, which, in turn, is associated with an increased risk of neonatal death. The attributable risk is low because pregnancies while on Empeea acetate are uncommon.

Use in lactation: Empeea acetate and/or its metabolites are secreted in breast milk. Therefore, the use of Empeea whilst breastfeeding is not recommended.



Active ingredient matches for Empeea:

Medroxyprogesterone in India.


Unit description / dosage (Manufacturer)Price, USD
2.5 mg x 10's$ 0.19
5 mg x 10's$ 0.35
10 mg x 10's$ 0.68
Empeea 2.5mg TAB / 10$ 0.19
Empeea 5mg TAB / 10$ 0.35
Empeea 10mg TAB / 10$ 0.68
EMPEEA 10MG TABLET 1 strip / 10 tablets each (Pfizer Ltd)$ 0.68
EMPEEA tab 2.5 mg x 10's (Wyeth)$ 0.19
EMPEEA tab 5 mg x 10's (Wyeth)$ 0.35
EMPEEA tab 10 mg x 10's (Wyeth)$ 0.68
Empeea 2.5mg TAB / 10$ 0.19
Empeea 5mg TAB / 10$ 0.35
Empeea 10mg TAB / 10$ 0.68
Empeea 10mg Tablet (Pfizer Ltd)$ 0.07

List of Empeea substitutes (brand and generic names):

EMBRYOGEN tab 10 mg x 10's (East West)$ 0.79
Enaf-150 150 mg/3 mL x 3 mL x 10's (Umeda)
Enaf-150 inj 150 mg/3 mL 3 mL x 10 x 1's (Umeda)
Injectable; Injection; Medroxyprogesterone Acetate 200 mg / ml (Pharmacia & Upjohn)
Suspension; Oral; Medroxyprogesterone Acetate 500 mg / 5 ml (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 10 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 100 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 2.5 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 200 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 250 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 5 mg (Pharmacia & Upjohn)
Tablet; Oral; Medroxyprogesterone Acetate 500 mg (Pharmacia & Upjohn)
Farlutal 2.5mg TAB / 10 (Pharmacia & Upjohn)$ 0.24
Farlutal 5mg TAB / 10 (Pharmacia & Upjohn)$ 0.44
Farlutal 10mg TAB / 10 (Pharmacia & Upjohn)$ 0.80
Farlutal 500 mg x 1 Bottle 30 Tablet (Pharmacia & Upjohn)
2.5 mg x 10's (Pharmacia & Upjohn)$ 0.24
5 mg x 10's (Pharmacia & Upjohn)$ 0.44
10 mg x 10's (Pharmacia & Upjohn)$ 0.80
Farlutal 500 mg x 30's (Pharmacia & Upjohn)
Farlutal 200 mg/1 mL x 1's (Pharmacia & Upjohn)
Farlutal 5 mg Tablet (Pharmacia & Upjohn)$ 0.04
Farlutal 100 mg Tablet (Pharmacia & Upjohn)$ 0.48
Farlutal 10 mg Tablet (Pharmacia & Upjohn)$ 0.08
Farlutal 2.5 mg Tablet (Pharmacia & Upjohn)$ 0.02
FARLUTAL tab 2.5 mg x 10's (Pharmacia & Upjohn)$ 0.24
FARLUTAL tab 5 mg x 10's (Pharmacia & Upjohn)$ 0.44
FARLUTAL tab 10 mg x 10's (Pharmacia & Upjohn)$ 0.80
Injectable; Injection; Medroxyprogesterone Acetate 200 mg / ml
Farlutal Depot 500 mg x 2, 5 mL x 1 Bottle
Tablet; Oral; Medroxyprogesterone Acetate 10 mg
Tablet; Oral; Medroxyprogesterone Acetate 2.5 mg
Tablet; Oral; Medroxyprogesterone Acetate 5 mg
Fuan 5 mg x 1000's
Fuan 5 mg x 100 x 10's

Reviews

The results of a survey conducted on ndrugs.com for Empeea are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Empeea. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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