Names and pronunciation
(proe-jess′ter-one) Crinone, Endometrin, Prometrium
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Individual generic drug information
Extracted information for progesterone only.
(proe-jess′ter-one) Crinone, Endometrin, Prometrium
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Func. class.: Hormone, Progestogen
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Chem. class.: Progesterone derivative
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ACTION: Inhibits secretion of pituitary gonadotropins, which prevents follicular maturation, ovulation; stimulates growth of mammary tissue; antineoplastic action against endometrial cancer
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USES: Contraception, amenorrhea, premenstrual syndrome, abnormal uterine bleeding, endometrial hyperplasia prevention, assisted reproductive technology (ART) gel
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Unlabeled uses: PMS, preterm delivery prophylaxis
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Extracted information for progesterone only.
CONTRAINDICATIONS: Preg nancy, ectopic pregnancy; hypersensitivity to this product, peanuts, or peanut oil; thromboembolic disorders, reproductive cancer, genital bleeding (abnormal, undiagnosed), cerebral hemorrhage, PID, STDs, thrombophlebitis
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Black Box Warning: Breast cancer Precautions: Breastfeeding, hyperten- sion, asthma, blood dyscrasias, HF, dia- betes mellitus, bone disease, depression, migraine headache, seizure disorders, gallbladder/renal/hepatic disease, family history of breast/reproductive tract cancer Black Box Warning: Cardiac disease, dementia
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SIDE EFFECTS CNS: Dizziness, headache, depression, fatigue, mood swings CV: Hypotension, thrombophlebitis, edema, thromboembolism, stroke, pulmo- nary embolism, MI EENT: Diplopia, retinal thrombosis GI: Nausea, vomiting, anorexia, cramps, increased weight, cholestatic jaundice, constipation, abdominal pain GU: Amenorrhea, cervical erosion, breakthrough bleeding, dysmenorrhea, nocturia, breast changes, gynecomastia, endometriosis, spontaneous abortion, breast pain, ectopic pregnancy INTEG: Rash, urticaria, acne, hirsutism, alopecia, photosensitivity META: Hyperglycemia SYST: Angioedema, anaphylaxis
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INTERACTIONS Increase: progesterone effect—CYP3A4 inhibitors (ketoconazole, clarithromycin, erythroycin, verapamil) Decrease: progesterone effect—phenyt- oin, barbiturates Drug/Lab Test Increase: alk phos, nitrogen (urine), pregnanediol, amino acids, factors VII, VIII, IX, X Decrease: GTT, HDL
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Extracted information for progesterone only.
DOSAGE AND ROUTES Infertility • Adult: VAG 90 mg/day (micronized gel); 100 mg 2-3 times/day starting day after oocyte retrieval and for ≤10 wk total Amenorrhea/functional uterine bleeding • Adult: IM 5-10 mg/day × 6-8 doses Endometrial hyperplasia prevention • Adult: PO 200 mg/day × 14 days Assisted reproductive therapy • Adult: GEL 90 mg (8%) vaginally daily for supplementation; 90 mg (8%) vagi- nally bid for replacement; if pregnancy occurs, continue × 10-12 wk Corpus luteum insufficiency (assisted reproductive technology [ART]) • Adult: VAG INSERT 90-100 mg bid-tid starting at oocyte retrieval and continuing up to 10-12 wk gestation
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Available forms: Inj 50 mg/mL; vag gel 4%, 8%; caps 100, 200 mg; vag insert 100 mg; vag supp 25, 100, 200, 500 mg; compounding kit 25, 50, 100, 200, 400 mg; oil for IM injection 50 mg/mL
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Administer: PO route • Do not break, crush, or chew caps • Titrated dose; use lowest effective dose • In 1 dose in am • With food or milk to decrease GI symptoms • Start progesterone 14 days after estro- gen dose if given concomitantly Vaginal route • Wait at least 6 hr after any vaginal treatment before using vaginal gel, use applicator provided IM route • Shake vial, inject deeply into large muscle, aspirate • Check for particulate matter and dis- coloration before injecting
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Extracted information for progesterone only.
Assess: • Abnormal uterine bleeding: vaginal bleeding; obtain pad count, patient men- strual history, breast exam, cervical cytology • Weight daily; notify prescriber of weekly weight gain of >5 lb • B/P at beginning of treatment and peri- odically • I&O ratio; be alert for decreasing uri- nary output, increasing edema • Hepatic studies: ALT, AST, bilirubin pe- riodically during long-term therapy • Edema, hypertension, cardiac symp- toms, jaundice, thromboembolism • Mental status: affect, mood, behavioral changes, depression P • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding
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Evaluate: • Therapeutic response: decreased ab- normal uterine bleeding, absence of amenorrhea
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To report breast lumps, vaginal bleed- ing, edema, jaundice, dark urine, clay- colored stools, dyspnea, headache, blurred vision, abdominal pain, numbness or stiffness in legs, chest pain • To avoid gel with other vaginal prod- ucts; if to be used together, to separate by ≥6 hr; for vaginal route, on proper inser- tion technique • To report suspected pregnancy • To monitor blood glucose if diabetic • To avoid activities requiring mental alertness until effects are realized; can cause dizziness HIGH ALERT
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Extracted information for progesterone only.
PHARMACOKINETICS Excreted in urine, feces; metabolized in liver IM/RECT/VAG: Duration 24 hr
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Filter the extracted dose blocks for this individual drug.
Infertility
• Adult: VAG 90 mg/day (micronized gel); 100 mg 2-3 times/day starting day after oocyte retrieval and for ≤10 wk total Amenorrhea/functional uterine bleeding
Candidate age grouping · source page 1092
Infertility
• Adult: IM 5-10 mg/day × 6-8 doses Endometrial hyperplasia prevention
Candidate age grouping · source page 1092
Infertility
• Adult: PO 200 mg/day × 14 days Assisted reproductive therapy
Candidate age grouping · source page 1092
Infertility
• Adult: GEL 90 mg (8%) vaginally daily for supplementation; 90 mg (8%) vagi- nally bid for replacement; if pregnancy occurs, continue × 10-12 wk Corpus luteum insufficiency (assisted reproductive technology [ART])
Candidate age grouping · source page 1092
Infertility
• Adult: VAG INSERT 90-100 mg bid-tid starting at oocyte retrieval and continuing up to 10-12 wk gestation
Candidate age grouping · source page 1092