Origeron Uses

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Is this medication very expensive?

Consists of estradiol benzoate, Progesterone

What is Estradiol benzoate (Origeron)?

Estradiol benzoate (Origeron) transdermal gel, patch, and spray are used to treat moderate to severe hot flashes and other symptoms of menopause or low amounts of estrogen. It is also used to treat changes in and around the vagina (such as vaginal dryness, itching, and burning) caused by low estrogen levels or menopause. Estradiol benzoate (Origeron) is also used to treat certain conditions in women before menopause if their ovaries do not make enough estrogens naturally, and prevent osteoporosis after menopause.

Estradiol benzoate (Origeron) is an estrogen hormone. The hormone from the patch, gel, and spray is absorbed through your skin into your body. It works by preventing symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating (hot flashes) in women during menopause.

Estradiol benzoate (Origeron) is available only with your doctor's prescription.

Estradiol benzoate (Origeron) 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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Estradiol benzoate (Origeron) is a Hormone Replacement Therapy (HRT). It contains the female hormone Estradiol benzoate (Origeron).

Estradiol benzoate (Origeron) is used in postmenopausal women, particularly in women who have had their womb removed (have had a hysterectomy) and therefore do not require combined oestrogen/progestagen therapy.

Estradiol benzoate (Origeron) is

Used for: Relief of symptoms occurring after menopause: During the menopause, the amount of oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest (‘hot flushes’). Estradiol benzoate (Origeron) alleviates these symptoms after menopause. Estradiol benzoate (Origeron) should only be prescribed if the symptoms seriously hinder the patient’s daily life.

Prevention of osteoporosis (thinning of the bones), if the patient is at high risk of future fracture and if unable to take other medications for this purpose.

There is only limited experience of treating women older than 65 years.

How should I use Estradiol benzoate (Origeron)?

Use Estradiol benzoate (Origeron) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Estradiol benzoate (Origeron). Talk to your pharmacist if you have questions about this information.
  • Estradiol benzoate (Origeron) is applied to the inside of the forearm, between the elbow and the wrist. Do not apply Estradiol benzoate (Origeron) to any other area of the body besides the forearm. If you get Estradiol benzoate (Origeron) on another area of your skin, wash that area of your skin with soap and water right away.
  • Apply Estradiol benzoate (Origeron) to clean, intact skin only. Be sure the area is completely dry before applying Estradiol benzoate (Origeron).
  • Do not apply Estradiol benzoate (Origeron) to skin that is irritated or broken. Do not apply it to your face, in or around the vagina, or to your breasts.
  • You will need to prime the pump before using it for the first time. To prime the pump, leave the cover on, hold the bottle in an upright position, and press the pump completely down 3 times. The pump is now ready for use.
  • Hold the applicator upright and rest the plastic cone flat against the skin of your forearm. Be sure there are no gaps between the cone and your skin. Press the pump firmly and fully 1 time. Do NOT massage or rub the medicine in.
  • If you are applying more than 1 spray, move the cone to an area of the skin next to but not touching the previous area. Then press the pump firmly and fully again.
  • Replace the protective cover over the pump after use.
  • Wash your hands with soap and water after using Estradiol benzoate (Origeron).
  • Allow the medicine to dry for at least 2 minutes before dressing.
  • Do not wash the application area for at least 1 hour after you apply Estradiol benzoate (Origeron).
  • Do not allow others to apply Estradiol benzoate (Origeron) for you. Do not allow other people or pets to come into contact with the site where you applied Estradiol benzoate (Origeron). If someone else comes into contact with Estradiol benzoate (Origeron), have them wash the area with soap and water right away.
  • This pump contains enough medicine for 75 sprays (not counting the 3 sprays used to prime the pump). Throw away the pump after 75 sprays have been used, even if there is still medicine left in the pump. It may no longer give the correct amount of medicine with each dose.
  • Use Estradiol benzoate (Origeron) at the same time each day.
  • If you miss a dose of Estradiol benzoate (Origeron), use it as soon as possible. If your next dose is less than 12 hours away, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Estradiol benzoate (Origeron).

Uses of Estradiol benzoate (Origeron) 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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This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure) and by men to treat prostate cancer.

How to use Estradiol benzoate (Origeron) intramuscular

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is injected into a muscle as directed by your doctor, usually every 4 weeks. For the treatment of prostate cancer, this medication is usually given every 1 to 2 weeks. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. If stored at low temperatures, crystal may form in the liquid. To dissolve these crystals, simply warm the product to room temperature prior to use. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder of when to receive your doses.

Tell your doctor if your condition does not improve or if it worsens.

Estradiol benzoate (Origeron) description

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Generally refers to the 17-beta-isomer of Estradiol benzoate (Origeron), an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol benzoate (Origeron)-17-beta is the most potent form of mammalian estrogenic steroids. In humans, it is produced primarily by the cyclic ovaries and the placenta. It is also produced by the adipose tissue of men and postmenopausal women. The 17-alpha-isomer of Estradiol benzoate (Origeron) binds weakly to estrogen receptors (receptors, estrogen) and exhibits little estrogenic activity in estrogen-responsive tissues. Various isomers can be synthesized. [PubChem]

Estradiol benzoate (Origeron) dosage

For topical use only. Estradiol benzoate (Origeron) is not for ophthalmic, oral, or intravaginal use. Estradiol benzoate (Origeron) should not be applied to the face or breasts.

Generally, when estrogen therapy is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a 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 women. Postmenopausal women should be re-evaluated periodically as clinically appropriate.

Treatment Of Moderate To Severe Vasomotor Symptoms Due To Menopause

The single approved dose of Estradiol benzoate (Origeron) is 3.48 grams daily. Apply one pouch (1.74 grams) to the left thigh and calf and one pouch (1.74 grams) to the right thigh and calf each morning. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.

The lowest effective dose of Estradiol benzoate (Origeron) for this indication has not been determined.

How supplied

Dosage Forms And Strengths

Topical emulsion

Each gram of Estradiol benzoate (Origeron) contains 2.5 mg of Estradiol benzoate (Origeron) hemihydrate. Each pouch contains 1.74 grams of Estradiol benzoate (Origeron).

Estradiol benzoate (Origeron) (Estradiol benzoate (Origeron) topical emulsion), nominal 0.05 mg/day: Estradiol benzoate (Origeron) is packaged in foil-laminated pouches. A daily dose of Estradiol benzoate (Origeron) is two foil-laminated pouches.

Each pouch contains 1.74-grams. Each 1.74-gram, foil-laminated pouch contains 4.35 mg of Estradiol benzoate (Origeron) hemihydrate USP, EP. Each box of Estradiol benzoate (Origeron) contains fourteen 1.74-gram, foil-laminated pouches.

1-month supply carton of 56 pouches, NDC 99207-190-56

Storage And Handling

Store at 20-25°C (68-77°F); excursions permitted to 15-40°C (59-104°F).

Manufactured for: Medicis Pharmaceuticals, A Division of Valeant Pharmaceuticals North America Bridgewater, NJ 08807. Manufactured by: Ei Inc. Kannapolis, NC 28083 Estradiol benzoate (Origeron) is a registered trademark of Medicis Pharmaceutical Corporation. Revised: March 2015

Estradiol benzoate (Origeron) interactions

See also:
What other drugs will affect Estradiol benzoate (Origeron)?

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CYP3A4 Interaction

Estradiol benzoate (Origeron) is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of lovastatin

Pharmacokinetics Itraconazol Ketoconazol Erythromyci Clarithromyci Telithromyci HIV protease inhibitor Nefazodon Cyclosporin Large quantities of grapefruit juice (>1 quart daily

Interactions with lipid-lowering drugs that can cause myopathy when given alone

The risk of myopathy is also increased by the following lipid-lowering drugs that are not potent CYP3A4 inhibitors, but which can cause myopathy when given alone

See WARNINGS, Myopathy/Rhabdomyolysis Gemfibrozi Other fibrate Niacin (nicotinic acid) (=1 g/day

Other drug interaction

Danazol: The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol particularly with higher doses of lovastatin

Amiodarone or Verapamil: The risk of myopathy/rhabdomyolysis is increased when either amiodarone or verapamil is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class

Coumarin Anticoagulants: In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two-second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, prothrombin time be determined before starting lovastatin and frequently enough during early therapy to insure that no significant alteration of prothrombin time occurs Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of lovastatin is changed, the same procedure should be repeated. Estradiol benzoate (Origeron) therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants

Propranolol: In normal volunteers, there was no clinically significant pharmacokinetic o pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol

Digoxin: In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations

Oral Hypoglycemic Agents: In pharmacokinetic studies of MEVACOR in hypercholesterolemic noninsulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide

Estradiol benzoate (Origeron) side effects

See also:
What are the possible side effects of Estradiol benzoate (Origeron)?

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Cardiovascular Disorders
  • Malignant Neoplasms

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Estradiol benzoate (Origeron) 10 mcg vaginal tablets. Adverse reactions with an incidence of ≥5 percent in the Estradiol benzoate (Origeron) 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Estradiol benzoate (Origeron) 10 mcg
Body System Treatment
Adverse Reaction Number (%) of Women
Placebo

N = 103

n (%)

Estradiol benzoate (Origeron)

N = 205

n (%)

N = Total number of women in study.
n = Number of women who experienced adverse reactions.
Body As A Whole
Back Pain 2 (2) 14 (7)
Digestive System
Diarrhea 0 11 (5)
Urogenital System
Vulvovaginal Mycotic Infection 3 (3) 17 (8)
Vulvovaginal Pruritus 2 (2) 16 (8)

In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Estradiol benzoate (Origeron) 25 mcg tablets. Adverse reactions with an incidence of ≥5 percent in the Estradiol benzoate (Origeron) 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

Table 2: Treatment-Emergent Adverse Reactions Reported at a Frequency of ≥ 5 Percent in Women Receiving Estradiol benzoate (Origeron) 25 mcg

Body System

Adverse Reaction

Treatment

Number (%) of Women

Placebo

N = 47

n (%)

Estradiol benzoate (Origeron)

N = 91

n (%)

Body As A Whole

Headache

3 (6)

8 (9)

Abdominal Pain

2 (4)

6 (7)

Back Pain

3 (6)

6 (7)

Respiratory System

Upper Respiratory Tract Infection

2 (4)

5 (5)

Urogenital System

Moniliasis Genital

1 (2)

5 (5)

N = Total number of women in study.

n = Number of women who experienced adverse reactions.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Estradiol benzoate (Origeron) 25 mcg. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

Breast

Breast cancer

Cardiovascular

Deep vein thrombosis

Gastrointestinal

Diarrhea

Skin

Urticaria, erythematous or pruritic rash, genital pruritus

Central Nervous System

Aggravated migraine, depression, insomnia

Miscellaneous

Fluid retention, weight increase, drug ineffectiveness, hypersensitivity, blood estrogen increase

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

Estradiol benzoate (Origeron) contraindications

See also:
What is the most important information I should know about Estradiol benzoate (Origeron)?

Ongoing thromboembolic diseases (inflammation of a vein with formation of a blood clot, obliteration of a pulmonary vessel, myocardial infarction, cerebrovascular accident related to a blood clot). Certain diseases of the liver and malignant tumours of the breast or uterus. Undiagnosed vaginal bleeding. Hypersensitivity to any of the components of Estradiol benzoate (Origeron).

Estradiol benzoate (Origeron) should not generally be used, except if the doctor permits, in the following cases: Recent inflammation of a vein with formation of a blood clot or recent obliteration of a pulmonary vessel. Certain cardiac diseases.

Use in pregnancy: Estradiol benzoate (Origeron) has no indication during pregnancy.

Clinically speaking, the results of numerous epidemiological studies to date have not shown any risk of malformation at the start of pregnancy with estrogens administered alone or in association.

Consequently, the late diagnoses of pregnancy during exposure to estrogens (or estroprogestogens) does not necessitate its interruption. In case of accidental ingestion during pregnancy, stop treatment.

Use in lactation: Not applicable.

What is Progesterone (Origeron)?

Progestins are hormones. They are used by both men and women for different purposes.

Progestins are prescribed for several reasons:

  • To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle..
  • To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough Progesterone (Origeron). Also, Progesterone (Origeron) is given to help maintain a pregnancy when not enough of it is made by the body.
  • To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT).
  • To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs.
  • To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle.
  • To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor.
  • To test the body's production of certain hormones such as estrogen.
  • To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain.

Progestins may also be used for other conditions as determined by your doctor.

Depending on how much and which Progesterone (Origeron) you use or take, a Progesterone (Origeron) can have different effects. For instance, high doses of Progesterone (Origeron) are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy.

Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus.

Progestins are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, progestins are used in certain patients with the following medical conditions:

  • Carcinoma of the prostate
  • Corpus luteum insufficiency
  • Hot flashes
  • Polycystic ovary syndrome
  • Precocious puberty

Progesterone (Origeron) 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.

Disorders related to a Progesterone (Origeron) deficit.

By oral route (vaginal route is recommended as an alternative if oral route is not suitable): Menstrual irregularities due to ovulation disorders or anovulation, premenstrual disorders, breast pain or benign breast disorders (mastopathies), bleeding (due to fibroma), therapy of the menopause (adjunctive use with estrogen in postmenopausal women for prevention of endometrial hyperplasia), menace of preterm delivery and can be used up to 36 week of pregnancy, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to the 12th week of pregnancy, treatment of subfertility or primary or secondary infertility related to Progesterone (Origeron) insufficiency in particular in In Vitro fertilization (IVF) cycles and/or oocyte donation.

For all other Progesterone (Origeron) indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Progesterone (Origeron) (somnolence, dizzinesss).

How should I use Progesterone (Origeron)?

Use Progesterone (Origeron) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Progesterone (Origeron). Talk to your pharmacist if you have questions about this information.
  • Progesterone (Origeron) is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Progesterone (Origeron) at home, a health care provider will teach you how to use it. Be sure you understand how to use Progesterone (Origeron). Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use Progesterone (Origeron) if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of Progesterone (Origeron), contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Progesterone (Origeron).

Uses of Progesterone (Origeron) 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.

Use: Labeled Indications

Oral: Prevention of endometrial hyperplasia in nonhysterectomized, postmenopausal women who are receiving conjugated estrogens; treatment of secondary amenorrhea

IM: Treatment of amenorrhea or abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer

Intravaginal gel: Part of assisted reproductive technology (ART) for infertile women with Progesterone (Origeron) deficiency; treatment of secondary amenorrhea

Vaginal insert: To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of ART for infertile women

Off Label Uses

Reduce the risk of recurrent spontaneous preterm birth

Based on the American College of Obstetricians and Gynecologists (ACOG) practice bulletin for the prediction and prevention of preterm birth, vaginal Progesterone (Origeron) is an effective and recommended treatment option to reduce the risk of recurrent spontaneous preterm birth in appropriately selected women (ie, singleton pregnancy and prior spontaneous preterm singleton birth). Therapy may begin at 16 to 24 weeks (regardless of cervical length) or sooner (ie, <24 weeks) in women who have a cervix <20 mm. Use is not recommended as an intervention for women with multiple gestations.

Progesterone (Origeron) description

The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Progesterone (Origeron) acts on the uterus, the mammary glands and the brain. It is required in embryo implantation; pregnancy maintenance, and the development of mammary tissue for milk production. Progesterone (Origeron), converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.

Progesterone (Origeron) dosage

Assisted Reproductive Technology

Progesterone (Origeron)® 8% is administered vaginally at a dose of 90 mg once daily in women who require Progesterone (Origeron) supplementation. Progesterone (Origeron)® 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require Progesterone (Origeron) replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.

Secondary Amenorrhea

Progesterone (Origeron)® 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Progesterone (Origeron)® 8% every other day up to a total of six doses may be instituted.

It is important to note that a dosage increase from the 4% gel can only be accomplished by using the 8% gel. Increasing the volume of gel administered does not increase the amount of Progesterone (Origeron) absorbed.

Note: The PATIENT INFORMATION SHEET contains special instructions for using the applicator at altitudes above 2500 feet in order to avoid a partial release of Progesterone (Origeron)® before vaginal insertion.

How supplied

Progesterone (Origeron)® is available in the following strengths:

4% gel (45 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-0406-1 - 6 Single-use prefilled applicators.

8% gel (90 mg) in a single use, one piece, disposable, white polyethylene vaginal applicator with a twist-off top. Each applicator contains 1.45 g of gel and delivers 1.125 g of gel.

NDC-55056-1601-6 - 6 Single-use prefilled applicators

NDC-55056-1601-5 - 15 Single-use prefilled applicators

NDC-55056-1601-8 - 18 Single-use prefilled applicators

Each applicator is wrapped and sealed in a foil overwrap.

Store at 25°C (77°F); excurs ions permitted to 15-30°C (59-86°F).

Manufactured for: Columbia Laboratories, Inc. Livingston, NJ 07039. Manufactured by: Fleet Laboratories Ltd., Watford, United Kingdom. Revised: May 2009

Progesterone (Origeron) interactions

See also:
What other drugs will affect Progesterone (Origeron)?

Drugs known to induce the hepatic cytochrome-P450-3A4 system [e.g. rifampicin, carbamazepine or St. John's wort (Hypericum perforatum)-containing herbal products] may increase the elimination rate and thereby decrease the bioavailability of Progesterone (Origeron). In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of Progesterone (Origeron).

The effect of concomitant vaginal products on the exposure of Progesterone (Origeron) from Progesterone (Origeron) has not been assessed. However, Progesterone (Origeron) is not recommended for use with other vaginal products (such as antifungal products) as this may alter Progesterone (Origeron) release and absorption from the vaginal tablet.

Progesterone (Origeron) side effects

See also:
What are the possible side effects of Progesterone (Origeron)?

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data reflect exposure to Progesterone (Origeron) in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Progesterone (Origeron) was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Progesterone (Origeron) group are summarized in Table 1.

Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Progesterone (Origeron) in an Assisted Reproductive Technology Study

Body System Preferred Term Progesterone (Origeron) 100 mg twice daily (N=404) Progesterone (Origeron) 100 mg three times daily (N=404)
Gastrointestinal Disorders
Abdominal pain 50 (12%) 50 (12%)
Nausea 32 (8%) 29 (7%)
Abdominal distension 18(4%) 17(4%)
Constipation 9(2%) 14 (3%)
Vomiting 13(3%) 9(2%)
General Disorders and Administration Site Conditions
Fatigue 7(2%) 12 (3%)
Infections and Infestations
Urinary tract infection 9(2%) 4 (1%)
Injury, Poisoning and Procedural Complications
Post-ooctye retrieval pain 115(28%) 102 (25%)
Nervous System Disorders
Headache 15(4%) 13(3%)
Reproductive System and Breast Disorders
Ovarian hyperstimulation syndrome 30 (7%) 27 (7%)
Uterine spasm 15(4%) 11 (3%)
Vaginal bleeding 13(3%) 14 (3%)

Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.

Expected Adverse Reaction Profile Seen with Progesterone (Origeron)

Progesterone (Origeron) is also expected to have adverse reactions similar to other drugs containing Progesterone (Origeron) that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.

Progesterone (Origeron) contraindications

See also:
What is the most important information I should know about Progesterone (Origeron)?

Do not use Progesterone (Origeron) vaginal without your doctor's consent if you are pregnant, unless you are using the medication as part of your fertility treatment. Tell your doctor if you become pregnant during treatment. If you are not being treated for infertility, use an effective form of birth control while you are using this medication.

Some forms of this medication may contain plant-based oils. Do not use Progesterone (Origeron) vaginal without telling your doctor if you have any type of food allergy.

Using Progesterone (Origeron) vaginal can increase your risk of blood clots, stroke, heart attack, or breast cancer.

You should not use this medication if you have: a history of stroke or blood clot, circulation problems, severe liver disease, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, or if you have recently had a tubal pregnancy or an incomplete abortion.

Progesterone (Origeron) vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, Progesterone (Origeron) vaginal may be given for up to 12 weeks into a pregnancy. Following your dosing schedule is very important for this medication to be effective. Try not to miss any doses.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Progesterone (Origeron) vaginal can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.



Active ingredient matches for Origeron:

Estradiol benzoate/Progesterone in Taiwan.


Unit description / dosage (Manufacturer)Price, USD
Origeron 1 mL x 100's

List of Origeron substitutes (brand and generic names):

References

  1. DailyMed. "PROGESTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DailyMed. "ESTRADIOL HEMIHYDRATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  3. PubChem. "progesterone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

Reviews

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