progesterone [Intrauterine]

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

Indications ⬆ ⬇

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

Contraindications ⬆ ⬇

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

Black Box Warnings ⬆ ⬇

Dosing Adjustment ⬆ ⬇

Renal Dose Adjustment

Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

Hepatic impairment: Contraindicated

Warnings/Precautions ⬆ ⬇

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/Breast Feeding ⬆ ⬇

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.

Adverse Reactions ⬆ ⬇

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

Clinical Pharmacology ⬆ ⬇

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

Brands and Availability ⬆ ⬇

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]

Classification ⬆ ⬇

Endocrine/Metabolic

Sex Hormones
Progestins

Obstetrics/Gynecology