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 Hystrogest. Also, Hystrogest 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 Hystrogest you use or take, a Hystrogest can have different effects. For instance, high doses of Hystrogest 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
Polycystic ovary syndrome
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 Hystrogest 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 Hystrogest insufficiency in particular in In Vitro fertilization (IVF) cycles and/or oocyte donation.
For all other Hystrogest indications, the vaginal route represents an alternative to the oral route, in case of adverse events due to Hystrogest (somnolence, dizzinesss).
How should I use Hystrogest?
Use Hystrogest oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Hystrogest oil. Talk to your pharmacist if you have questions about this information.
Hystrogest oil is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Hystrogest oil at home, a health care provider will teach you how to use it. Be sure you understand how to use Hystrogest oil. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use Hystrogest oil 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 Hystrogest oil, contact your doctor as soon as possible.
Ask your health care provider any questions you may have about how to use Hystrogest oil.
Uses of Hystrogest 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 Hystrogest 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 Hystrogest 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.
The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Hystrogest 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. Hystrogest, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.
Assisted Reproductive Technology
Hystrogest® 8% is administered vaginally at a dose of 90 mg once daily in women who require Hystrogest supplementation. Hystrogest® 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require Hystrogest replacement. If pregnancy occurs, treatment may be continued until placental autonomy is achieved, up to 10-12 weeks.
Hystrogest® 4% is administered vaginally every other day up to a total of six doses. For women who fail to respond, a trial of Hystrogest® 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 Hystrogest 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 Hystrogest® before vaginal insertion.
Hystrogest® 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.
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 Hystrogest. In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of Hystrogest.
The effect of concomitant vaginal products on the exposure of Hystrogest from Hystrogest has not been assessed. However, Hystrogest is not recommended for use with other vaginal products (such as antifungal products) as this may alter Hystrogest release and absorption from the vaginal tablet.
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 Hystrogest 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. Hystrogest 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 Hystrogest group are summarized in Table 1.
Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Hystrogest in an Assisted Reproductive Technology Study
Body System Preferred Term
Hystrogest 100 mg twice daily (N=404)
Hystrogest 100 mg three times daily (N=404)
General Disorders and Administration Site Conditions
Infections and Infestations
Urinary tract infection
Injury, Poisoning and Procedural Complications
Post-ooctye retrieval pain
Nervous System Disorders
Reproductive System and Breast Disorders
Ovarian hyperstimulation syndrome
Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.
Expected Adverse Reaction Profile Seen with Hystrogest
Hystrogest is also expected to have adverse reactions similar to other drugs containing Hystrogest that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.
Do not use Hystrogest 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 Hystrogest vaginal without telling your doctor if you have any type of food allergy.
Using Hystrogest 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.
Hystrogest vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, Hystrogest 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.
Hystrogest 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.
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).
The results of a survey conducted on ndrugs.com for Hystrogest 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 Hystrogest. 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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