Farnogest

(Tablet)

Farnogest

Natural, Micronized Progesterone

Farnogest® – 100
Each soft gelatin capsule contains: Progesterone 100 mg (Natural, Micronized)

Farnogest® – 200
Each soft gelatin capsule contains: Progesterone 200 mg (Natural, Micronized)

Oral

  • Endometrial Hyperplasia:
    Prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogen tablets as Hormone Replacement Therapy (HRT).
  • Secondary Amenorrhea

Vaginal

  1. Assisted Reproductive Technology (ART) To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an ART treatment
  2. Premenstrual syndrome
    Progesterone (rectal or vaginal) have been used in Premenstrual syndrome (PMS).
Oral Administration
  • Endometrial hyperplasia: 200 mg/day as a single dose at bedtime for 12 days sequentially per 28-day cycle for postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets.
  • Secondary Amenorrhea 400 mg/day as a single dose at bedtime for 10 days.
Vaginal Administration Each capsule should be inserted deeply into the vagina. Rectal administration should be considered whenever vaginal administration is not possible.
  • Assisted Reproductive Techniques (ART) such as IVF: 400-600 mg/daily in 2 or 3 divided doses, from the day of gonadotropin administration until week 12 of pregnancy.
  • Premenstrual syndrome: Progesterone may be given vaginally or rectally in dose of 200 mg daily to 400 mg twice daily for the management of the premenstrual syndrome. Treatment usually starts on day 12 to 14 of the menstrual cycle and continues until the onset of menstruation.
  • When given orally: Drowsiness or giddiness arising 1-3 hours after ingestion of the medicine. At times there is breast tenderness and abdominal bloating. In case of drowsiness after 1 to 3 hours of oral administration, the dosage may be reduced or the patient may be put on once daily evening dose. Alternatively, the vaginal route for administration of the drug could be resorted to.
  • When given vaginally / rectally: irritation, soreness or dryness may occur when administered by these routes. Some leakage of the capsule base might occur at times.
  • Menses: menstrual cycle may be shortened or there might be intermenstrual bleeding. Menstruation may occur earlier than expected or at times might be delayed.
  • In case of shortening of menstrual cycle or intermittent bleeding, Shift the initiation of the treatment to the late date, e.g., 19th day of the cycle instead of 17th day. Effects on ability to drive and use machine: Progesterone soft gelatin capsules may cause drowsiness and / or dizziness in a minority of patients; therefore, caution is advised in drivers and users of machines. Taking the capsules at bedtime should reduce these effects during the day.

Progesterone capsules should not be used in women with any of the following conditions:

  1. In patients with known hypersensitivity to its ingredients.
  2. Undiagnosed abnormal genital bleeding.
  3. Known, suspected, or history of cancer of the breast.
  4. Active deep vein thrombosis, pulmonary embolism or history of these conditions.
  5. Active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions.
  6. Known liver dysfunction or disease.
  7. Known or suspected pregnancy.

Farnogest® contains progesterone which is a natural, female sex hormone, produced in the body. This medicine works by adjusting the hormonal balance within the body. Progesterone Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization.

Please tell your doctor or pharmacist if you are taking any other medicine.

Progesterone and the progestogens should be used with caution in patient with hypertension, cardiac or renal impairment, asthma, epilepsy, and migraine or other conditions which may be aggravated by fluid retention. Progesterone can be decrease glucose tolerance and diabetic patient should be carefully monitored. They should also be used with care on persons with a history of depression. High doses should be used with caution in patient susceptible to thromboembolism. Progesterone and the progestogens should not be given to patients with undiagnosed vaginal bleeding, nor to those with a history or current high risk of arterial disease and should generally be avoided in hepatic impairment, especially if severe. Unless progestogens are being used as part of the management of breast or genital -tract carcinoma they should not be given to patient with these conditions.
  • Renal impairment: No formal studies have evaluated the effect of renal disease on the disposition of progesterone. Since progesterone metabolites are eliminated mainly by the kidneys, micronized progesterone capsules should be used with caution and only with careful monitoring in patients with renal dysfunction.
  • Hepatic impairment: No formal studies have evaluated the effect of hepatic disease on the disposition of progesterone. However, since progesterone is metabolized by the liver, use in patients with severe liver dysfunction or disease is contraindicated. If treatment with progesterone is indicated in patients with mild to moderate hepatic dysfunction, these patients should be monitored carefully.
<strong>Warnings:</strong> An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. Overdose: Overdose with progesterone capsules can cause sleepiness, dizziness, ‘high’ feeling or you may have bleeding problems such as a painful period. In the case of over dosage, micronized progesterone capsules should be discontinued and the patient should be treated symptomatically.
  • Pregnancy: Consumption during pregnancy is allowed only with a doctor’s prescription, otherwise contraindicated in pregnancy.
  • Nursing Women: Detectable amounts of progestin have been identified in the milk of nursing women receiving progestins.Caution should be exercised when progesterone capsules are administered to a nursing woman.
  • Pediatric Use: Progesterone capsules are not indicated in pediatric patients.
  • Geriatric Use: Clinical studies have not been conducted in the women over 65 years old.

Store below 30°C at dry place. Protect from light and moisture.

Progesterone soft gelatin capsules are available in blister pack.

Steril -Gene Life Sciences (P).

Farnoush Darou Teb Co.

farnogest