• Gestageno indications
• Uses of Gestageno in details
• Gestageno description
• Gestageno dosage
• Gestageno interactions
• Gestageno side effects
• Gestageno contraindications

What is Gestageno?

Gestageno is a female hormone important for ovulation and menstruation. Gestageno causes changes in the lining of your uterus, making it easier for a fertilized egg to attach to the uterus at the beginning of pregnancy. Gestageno then helps your body maintain the pregnancy.

Gestageno vaginal is used in fertility treatment as part of Assisted Reproductive Technology (ART) for women unable to get pregnant due to a lack of natural Gestageno in the body.

Gestageno vaginal is also used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of Gestageno in the body.

This medication also prevents overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Gestageno vaginal may also be used for other purposes not listed in this medication guide.

Gestageno indications

Disorders related to a Gestageno 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 Gestageno insufficiency in particular in In Vitro fertilization (IVF) cycles and/or oocyte donation.

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

How should I use Gestageno?

Use Gestageno oil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Gestageno oil. Talk to your pharmacist if you have questions about this information.
• Gestageno oil is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Gestageno oil at home, a health care provider will teach you how to use it. Be sure you understand how to use Gestageno 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 Gestageno 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 Gestageno oil, contact your doctor as soon as possible.

Ask your health care provider any questions you may have about how to use Gestageno oil.

Uses of Gestageno in details

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 Gestageno 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 Gestageno 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.

Gestageno description

The major progestational steroid that is secreted primarily by the corpus luteum and the placenta. Gestageno 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. Gestageno, converted from pregnenolone, also serves as an intermediate in the biosynthesis of gonadal steroid hormones and adrenal corticosteroids.

Gestageno dosage

Gestageno Dosage

Generic name: Gestageno 100mg

Dosage form: vaginal insert

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

General Dosing Information

The dose of Gestageno is 100 mg administered vaginally two or three times daily starting the day after oocyte retrieval and continuing for up to 10 weeks total duration. Efficacy in women 35 years of age and older has not been clearly established. The appropriate dose of Gestageno in this age group has not been determined.

More about Gestageno (Gestageno)

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Consumer resources

• Gestageno
• Gestageno insert

• Other brands: Prometrium, Gestageno, Menopause Formula Gestageno, First Gestageno MC10, More (1) »

Professional resources

• Gestageno (FDA)
• Gestageno (AHFS Monograph)

Related treatment guides

• Amenorrhea
• Endometrial Hyperplasia, Prophylaxis
• Perimenopausal Symptoms
• Premature Labor
• Gestageno Insufficiency
• More (1) »

Gestageno interactions

See also:
What other drugs will affect Gestageno?

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 Gestageno. In contrast ketoconazole and other inhibitors of cytochrome P450-3A4 may decrease elimination rate and thereby increase the bioavailability of Gestageno.

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

Gestageno side effects

See also:
What are the possible side effects of Gestageno?

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 Gestageno 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. Gestageno 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 Gestageno group are summarized in Table 1.

Table 1: Number and Frequency of Reported Adverse Reactions in Women Treated with Gestageno in an Assisted Reproductive Technology Study

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

Expected Adverse Reaction Profile Seen with Gestageno

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

Gestageno contraindications

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

Do not use Gestageno 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 Gestageno vaginal without telling your doctor if you have any type of food allergy.

Using Gestageno 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.

Gestageno vaginal is sometimes given for only 6 to 12 days at a time. When used as part of fertility treatment, Gestageno 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.

Gestageno 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 Gestageno:

Progesterone in Mexico.

Hydroxyprogesterone Caproate

Hydroxyprogesterone acetate in Argentina, Mexico.

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. "HYDROXYPROGESTERONE CAPROATE: 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. "hydroxyprogesterone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology