Fertigest®

Therapeutic Area:

,

Generic Name:

Progesterone

Dosage Form:

Ampoule

Drug Dose

Therapeutic Indications:

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

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

Mechanism of Action:

Natural steroid hormone that induces secretory changes in the endometrium, promotes mammary gland development, relaxes uterine smooth muscle, blocks follicular maturation and ovulation, and maintains pregnancy. When used as part of an ART program in the luteal phase, progesterone supports embryo implantation.

Method of Administration:

Amenorrhea, secondary: IM:

5 to 10 mg/day for 6 to 8 consecutive days.

Uterine bleeding, abnormal: IM:

 5 to 10 mg/day for 6 doses. Start 2 weeks after estrogen therapy (if also being used). Bleeding should cease within 6 days. Discontinue use if menstrual flow begins during therapy.

Notes

Allergy to progesterone, known or suspected tumor that is hormone sensitive, porphyria disorders, blood clot in the legs, lungs, eyes or elsewhere in the body, severe liver problems.

Interactions:

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

 Antifungal Agents (Vaginal): May diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Pregnancy and Lactation:

Adverse events following oral maternal use in pregnancy (eg, hypospadias, congenital heart disease, cleft lip/palate) have been noted in postmarketing data; however, a causal relationship has not been clearly established.

The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother

Warning and Precaution:

  • Breast cancer: The risk of breast cancer in postmenopausal patients on hormone therapy may depend upon type of estrogen and/or progestin, dose, timing of therapy initiation, duration of therapy, route of administration, and individual patient.
  • CNS depression: Oral progesterone may cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
  • Dementia: Progestin plus estrogens should not be used for the prevention of dementia. Hormone therapy is not recommended at any age to prevent or treat cognitive decline or dementia
  • Endometrial cancer: Progesterone is used to reduce the risk of endometrial hyperplasia in nonhysterectomized postmenopausal patients receiving conjugated estrogens. The use of unopposed estrogen in patients with an intact uterus is associated with an increased risk of endometrial cancer. The addition of a progestin to estrogen therapy may decrease the risk of endometrial hyperplasia, a precursor to endometrial cancer.
  • Endometriosis: Estrogens may exacerbate endometriosis. Malignant transformation of residual endometrial implants has been reported posthysterectomy with unopposed estrogen therapy. Consider adding a progestin in women with residual endometriosis posthysterectomy.
  • Eosinophilic pneumonia: Cases of acute eosinophilic pneumonia have been reported with use of progesterone injection in sesame oil; symptoms have included fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary infiltrates and generally develop 2 to 4 weeks after treatment

Adverse Reactions:

Cardiovascular: Edema Dermatologic: Acne vulgaris, allergic skin rash, alopecia, hirsutism, pruritus, skin rash, urticaria

Endocrine & metabolic: Amenorrhea, change in menstrual flow, galactorrhea not associated with childbirth, weight gain, weight loss

Gastrointestinal: Nausea

Genitourinary: Breakthrough bleeding, breast tenderness, cervical erosion, change in cervical secretions, spotting

Hepatic: Cholestatic jaundice Hypersensitivity: Anaphylactoid shock

Local: Erythema at injection site, irritation at injection site, pain at injection site

Nervous system: Depression, drowsiness, insomnia

Storage:

Store below 30ºC and protect from freezing.