Fertlite 100 Injection

Progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. They are also indicated for use in secondary amenorrhea.

• Prevention of Endometrial Hyperplasia Progesterone capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets
• Treatment of Secondary Amenorrhea Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days
• Some women may experience difficulty swallowing progesterone capsules
• For these women, progesterone capsules should be taken with a glass of water while in the standing position

• Pediatric Use Progesterone capsules are not indicated in children
• Clinical studies have not been conducted in the pediatric population

H. Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing progesterone capsules to determine whether those over 65 years of age differ from younger subjects in their response to progesterone capsules. …

• Patient Information General: This product contains peanut oil and should not be used if you are allergic to peanuts
• Physicians are advised to discuss the contents of the Patient Information leaflet with patients for whom they prescribe PROGESTERONE Capsules
• PATIENT INFORMATION Progesterone Capsules, 100 mg Progesterone Capsules, 200 mg Read this PATIENT INFORMATION before you start taking progesterone capsules and read what you get each time you refill your progesterone capsules prescription
• There may be new information
• This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. …

• Progesterone capsules should not be used in women with any of the following conditions: Progesterone capsules should not be used in patients with known hypersensitivity to its ingredients
• Progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts
• Undiagnosed abnormal genital bleeding
• Known, suspected, or history of breast cancer
• Active deep vein thrombosis, pulmonary embolism or history of these conditions. …

See BOXED WARNING . 1. Cardiovascular disorders An increased risk of pulmonary embolism, deep vein thrombosis (DVT), stroke, and myocardial infarction has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (for example, personal history or family history of venous thromboembolism [VTE], obesity, and systemic lupus erythematosus) should be managed appropriately. a. …

See BOXED WARNING , WARNINGS and PRECAUTIONS. 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 multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of progesterone capsules on the endometrium was studied in a total of 875 postmenopausal women. …

E. Pregnancy Progesterone capsules should not be used during pregnancy. (See CONTRAINDICATIONS .) Pregnancy Category B: Reproductive studies have been performed in mice at doses up to 9 times the human oral dose, in rats at doses up to 44 times the human oral dose, in rabbits at a dose of 10 mcg/day delivered locally within the uterus by an implanted device, in guinea pigs at doses of approximately one-half the human oral dose and in rhesus monke …

No studies on overdosage have been conducted in humans. In the case of overdosage, progesterone capsules should be discontinued and the patient should be treated symptomatically.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.