Adult Dosing

Assisted Reproductive Technology

• Start post oocyte retrieval: 100 mg bid-tid x 10 wk
• Note: Efficacy in women 35 yrs of age have not been clearly established

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• To support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an assisted reproductive technology (ART) treatment program for infertile women

• Hypersensitivity to any of the ingredients of the product
• Missed abortion or ectopic pregnancy
• Hepatic dysfunction
• Breast cancer
• Thrombophlebitis and its history
• Thromboembolism and its history

• N/A

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Maintain alertness to the earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, pulmonary embolism ,thrombophlebitis, or retinal thrombosis; discontinue therapy on suspicion of these events
• Closely observe patients having history of depression; consider discontinuation of therapy on worsening of these symptoms
• Concomitant use with other intravaginal drug is not recommended, it may alter the absorption and release of drug

Cautions: Use cautiously in

• Renal impairment
• Cardiac disease
• Diabetes mellitus
• History of psychic disorder
• Epilepsy
• Depression
• Undiagnosed vaginal bleeding
• Asthma
• Migraine

Supplemental Patient Information

• Inform patients of the importance of reporting irregular vaginal bleeding to their clinician as soon as possible
• Inform patients of the possible side effects of progesterone therapy
• Inform patients that concomitant use with other vaginal products is not recommended

Pregnancy Category:C

Breastfeeding: Probably Safe, very less amount of progesterone is excreted, which would not cause any adverse effects in breastfed infants; no special precautions are needed. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 3 January 2011). According to manufacturer's data, detectable amount of drug is found in mother's milk. The effect of drug on nursing infant has not been determined.

• REPRODUCTIVE: Breast Pain, moniliasis genital, vaginal discharge, dyspareunia, perineal pain, uterine spasms, ovarian hyperstimulation syndrome, breast cancer, breast enlargement, decreased libido, vaginal bleeding
• GU: UTI, nocturia
• CV: Thromboembolism
• CNS: Headache, dizziness, depression, nervousness, somnolence, fatigue, sleep disorder, emotional lability, anxiety
• GI: Nausea, vomiting, diarrhea, constipation, abdominal pain, bloating, increased appetite
• DERM: Pruritus
• MUSC: Arthralgia, cramps, myalgia, pain
• RESP: Upper respiratory tract symptoms

• Progestin; binds to the progesterone and estrogen receptors, inhibits secretion of pituitary gonadotropins, prevents follicular maturation and ovulation and transforms proliferative endometrium into secretory endometrium
• Metabolism primarily by liver; CYP450: CYP2C19, 3A4 substrate
• Excretion: Renally (50-60%), bile/feces: 10%
• Absorption Half-life: 25-50 hours

US Trade Name(s)

• Endometrin

US Availability

Endometrin

• INSERT: 100 mg

Canadian Trade Name(s)

• Endometrin

Canadian Availability

Endometrin

• TABS: 100 mg

UK Trade Name(s)

• Cyclogest

UK Availability

Cyclogest

• PESSARY: 200, 400 mg

Australian Trade Name(s)

• Only generic available

Australian Availability

progesterone (generic)

• PESSARY: 100 mg

[Outline]

Endocrine/Metabolic

Sex Hormones

Progestins

Obstetrics/Gynecology

Sex Hormones

Progestins

Pricing data from www.DrugStore.com in U.S.A.

• Endometrin 100 MG INST [Box] (FERRING)
  21 mg = $167
  63 mg = $480.95

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.